Diacomit
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ANNEX I 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 

Diacomit 250 mg hard capsules 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 250 mg of stiripentol. 

Excipient with known effect  

0.16 mg sodium per capsule. 
For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM

Hard capsule 

Size 2, pink capsule, imprinted with “Diacomit 250 mg”. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of 
refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy 
(SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and 
valproate. 

4.2 Posology and method of administration 

Diacomit should only be administered under the supervision of a paediatrician / paediatric neurologist 
experienced in the diagnosis and management of epilepsy in infants and children.  

Posology 

Paediatric population
The dose of stiripentol is calculated on a mg/kg body weight basis. 

The daily dosage may be administered in 2 or 3 divided doses. 

The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards 
dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with 
clobazam and valproate.  

Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 
30mg/kg/day for 1 week. Further dosage escalation is age dependent: 
- children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus 
achieving the recommended dose of 50 mg/kg/day in three weeks; 
- children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus 
achieving the recommended dose of 50 mg/kg/day in four weeks; 
- children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week 
until the optimum dose is reached based on clinical judgment. 



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The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the 
only dose of Diacomit evaluated in the pivotal studies (see section 5.1). 

Stiripentol must always be taken with food as it degrades rapidly in an acidic environment (e.g. 
exposure to gastric acid in an empty stomach). 
Stiripentol should not be taken with milk or dairy products (yoghurt, soft cream cheese, etc.), 
carbonated drinks, fruit juice or food and drinks that contain caffeine or theophylline. 

Children aged less than 3 years 
The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 
The clinical decision for use of stiripentol in children with SMEI less than 3 years of age needs to be 
made on an individual patient basis taking into consideration the potential clinical benefits and risks. 
In this younger group of patients, adjunctive therapy with stiripentol should only be started when the 
diagnosis of SMEI has been clinically confirmed (see section 5.1). Data are limited about the use of 
stiripentolunder 12 months of age. For these children the use of stiripentol will be done under the 
close supervision of the doctor. 

Patients aged ≥ 18 years of age 
Long-term data has not been collected in a sufficient number of adults to confirm maintenance of 
effect in this population. Treatment should be continued for as long as efficacy is observed. 

Dose adjustments of other antiepileptics used in combination with stiripentol 
Despite the absence of comprehensive pharmacology data on potential drug interactions, the 
following advice regarding modification of the dose and dosage schedules of other anti-epileptic 
medicinal products administered in conjunction with stiripentol is provided based on clinical 
experience. 

- Clobazam 
In the pivotal studies, when the use of stiripentol was initiated, the daily dose of clobazam was 
0.5 mg/kg/day usually administered in divided doses, twice daily. In the event of clinical signs of 
adverse reactions or overdose of clobazam (i.e., drowsiness, hypotonia, and irritability in young 
children), this daily dose was reduced by 25% every week. Approximately two to three-fold increases 
in clobazam and five-fold increases in norclobazam plasma levels respectively have been reported 
with co-administration of stiripentol in children with Dravet’s syndrome. 

- Valproate 
The potential for metabolic interaction between stiripentol and valproate is considered modest and 
thus, no modification of valproate dosage should be needed when stiripentol is added, except for 
clinical safety reasons. In the pivotal studies in the event of gastrointestinal adverse reactions such as 
loss of appetite, loss of weight, the daily dose of valproate was reduced by around 30% every week. 

Abnormal laboratory findings 
In the event of an abnormal blood count or liver function test finding, the clinical decision for 
continuing use or adjusting the dose of stiripentol in conjunction with adjusting the doses of clobazam 
and valproate needs to be made on an individual patient basis taking into consideration the potential 
clinical benefits and risks (see section 4.4). 

Effect of formulation 
The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not 
bioequivalent. It is recommended that if a switch of formulations is required this is done under 
clinical supervision, in case of problems with tolerability (see section 5.2). 

Renal and hepatic impairment 
Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see 
section 4.4). 



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Method of administration 

Oral use 
The capsule should be swallowed whole with a glass of water.  
The capsules should not be chewed. 
For the interaction of stiripentol with food, please see section 4.5. 

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
A past history of psychoses in the form of episodes of delirium. 

4.4 Special warnings and precautions for use

Carbamazepine, phenytoin and phenobarbital 

These substances should not be used in conjunction with stiripentol in the management of Dravet’s 
syndrome. The daily dosage of clobazam and/or valproate should be reduced according to the onset of 
side effects whilst on stiripentol therapy (see section 4.2). 

Growth rate of children 

Given the frequency of gastrointestinal adverse reactions to treatment with stiripentol and valproate 
(anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of 
treatment should be carefully monitored. 

Blood count

Neutropenia may be associated with the administration of stiripentol, clobazam and valproate. Blood 
counts should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically 
indicated, blood counts should be checked every 6 months. 

Liver function 

It should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically indicated, 
liver function should be checked every 6 months. 

Hepatic or renal impairment 

In the absence of specific clinical data in patients with impaired hepatic or renal function, stiripentol 
is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.2). 

Substances interfering with CYP enzymes

Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly 
increase the plasma concentrations of substances metabolised by these enzymes and increase the risk 
of adverse reactions (see section 4.5). In vitro studies suggested that stiripentol phase 1 metabolism is 
catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes. Caution is advised when 
combining stiripentol with other substances that inhibit or induce one or more of these enzymes. 

Paediatric population 

The pivotal clinical studies did not include children below 3 years old. As a consequence, it is 
recommended that children between 6 months and 3 years of age are carefully monitored whilst on 
stiripentol therapy. 



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4.5 Interaction with other medicinal products and other forms of interaction

Potential medicinal product interactions affecting stiripentol 

The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well 
established. 
The impact of macrolides and azole antifungal medicinal agents on stiripentol metabolism, that are 
known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known. Likewise, the 
effect of stiripentol on their metabolism is not known. 

In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and 
CYP3A4 and possibly other enzymes. Caution is advised when combining stiripentol with other 
substances that inhibit or induce one or more of these enzymes. 

Effect of stiripentol on cytochrome P450 enzymes 

Many of these interactions have been partially confirmed by in vitro studies and in clinical trials. The 
increase in steady state levels with the combined use of stiripentol, valproate, and clobazam is similar 
in adults and children, though inter-individual variability is marked. 

At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for 
example, CYP2C19, CYP2D6 and CYP3A4. As a result, pharmacokinetic interactions of metabolic 
origin with other medicines may be expected. These interactions may result in increased systemic 
levels of these active substances that may lead to enhanced pharmacological effects and to an increase 
in adverse reactions. 

Caution must be exercised if clinical circumstances require combining stiripentol with substances 
metabolised by CYP2C19 (e.g. citalopram, omeprazole) or CYP3A4 (e.g. HIV protease inhibitors, 
antihistamines such as astemizole and chlorpheniramine, calcium channel blockers, statins, oral 
contraceptives, codeine) due to the increased risk of adverse reactions (see further in this section for 
antiepileptic medicines). Monitoring of plasma concentrations or adverse reactions is recommended. 
A dose adjustment may be necessary. 

Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to 
the markedly increased risk of severe adverse reactions.  

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with 
theophylline and caffeine cannot be excluded because of the increased plasma levels of theophylline 
and caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to 
toxicity. Use in combination with stiripentol is not recommended. This warning is not only restricted 
to medicinal products but also to a considerable number of foods and nutritional products aimed at 
children: Patient should not drink cola drinks, which contain significant quantities of caffeine or 
chocolate, which contains trace amounts of theophylline (see section 4.2). 

As stiripentol inhibited CYP2D6 in vitro at concentrations that are achieved clinically in plasma, 
substances that are metabolized by this isoenzyme like: beta-blockers (propranolol, carvedilol, 
timolol), antidepressants (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), 
antipsychotics (haloperidol), analgesics (codeine, dextromethorphan, tramadol) may be subject to 
metabolic interactions with stiripentol. A dose-adjustment may be necessary for substances 
metabolised by CYP2D6 and that are individually dose titrated. 

Potential for stiripentol to interact with other medicinal products 

In the absence of available clinical data, caution should be taken with the following clinically relevant 
interactions with stiripentol: 



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Undesirable combinations (to be avoided unless strictly necessary) 
- Rye ergot alkaloids (ergotamine, dihydroergotamine) 
Ergotism with possibility of necrosis of the extremities (inhibition of hepatic elimination of rye ergot). 

- Cisapride, halofantrine, pimozide, quinidine, bepridil 
Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular. 

- Immunosuppressants (tacrolimus, cyclosporine, sirolimus) 
Raised blood levels of immunosuppressants (decreased hepatic metabolism). 

- Statins (atorvastatin, simvastatin, etc.) 
Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic 
metabolism of cholesterol-lowering medicinal product). 

Combinations requiring precautions 

- Midazolam, triazolam, alprazolam 
Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to 
excessive sedation. 

- Chlorpromazine 
Stiripentol enhances the central depressant effect of chlorpromazine. 

- Effects on other antiepileptic drugs (AEDs) 
Inhibition of CYP450 isoenzyme CYP2C19 and CYP3A4 may provoke pharmacokinetic interactions 
(inhibition of their hepatic metabolism) with phenobarbital, primidone, phenytoin, carbamazepine, 
clobazam (see section 4.2), valproate (see section 4.2), diazepam (enhanced myorelaxation), 
ethosuximide, and tiagabine. The consequences are increased plasma levels of these anticonvulsants 
with potential risk of overdose. Clinical monitoring of plasma levels of other anticonvulsants when 
combined with stiripentol with possible dose adjustments is recommended. 

- Topiramate 
In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam 
and valproate in 41% of 230 cases. Based on the clinical observations in this group of patients, there 
is no evidence to suggest that a change in topiramate dose and dosage schedules is needed if co-
administered with stiripentol. 
With regard to topiramate, it is considered that potential competition of inhibition on CYP2C19 
should not occur because it probably requires plasma concentrations 5-15 times higher than plasma 
concentrations obtained with the standard recommended topiramate dose and dosage schedules. 

- Levetiracetam 
Levetiracetam does not undergo hepatic metabolism to a major extent. As a result, no 
pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated. 

4.6 Fertility, pregnancy and lactation

Pregnancy 

Risk related to epilepsy and antiepileptic medicinal products in general 
It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is 
two to three times greater than the rate of approximately 3% in the general population. Although other 
factors, e.g. the epilepsy, can contribute, available evidence suggests that this increase, to a large 
extent, is caused by the treatment. In the treated population, an increase in malformations has been 
noted with polytherapy. 
However, effective anti-epileptic therapy should not be interrupted during pregnancy, since the 
aggravation of the illness may be detrimental to both the mother and the foetus. 



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Risk related to stiripentol 
No data on exposed pregnancies are available. Animal studies do not indicate direct or indirect 
harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at 
non-maternotoxic doses (see section 5.3). In view of the indication, administration of stiripentol 
during pregnancy and in women of childbearing potential would not be expected. The clinical 
decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into 
consideration the potential clinical benefits and risks. Caution should be exercised when prescribing 
to pregnant women and use of efficient methods of contraception is advisable. 

Breastfeeding 

In the absence of human studies on excretion in breast milk, and given that stiripentol passes freely 
from plasma into milk in the goat, breast-feeding is not recommended during treatment. In case 
stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully 
observed for potential adverse effects. 

Fertility 

No impact on fertility was detected in animal studies (see section 5.3). No clinical data are available, 
potential risk for human is unknown. 

4.7 Effects on ability to drive and use machines 

No studies on the effects on the ability to drive and use machines have been performed. However, 
some patients may experience dizziness and ataxiathat may affect ability to drive and use machines 
and patients should not drive or use machinery whilst on stiripentol therapy. 

4.8 Undesirable effects 

Summary of the safety profile 

The most common side effects with stiripentol are anorexia, weight loss, insomnia, drowsiness, 
ataxia, hypotonia and dystonia.  

Tabulated list of adverse reactions 
Adverse reactions encountered most often are as follows: very common (≥ 1/10), common (≥ 1/100 to 
< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not 
known (cannot be estimated from the available data). Within each frequency grouping, undesirable 
effects are presented in order of decreasing severity. 

System Organ 
Class 
(MedDRA 
terminology)

Very common Common Uncommon Rare 

Blood and 
lymphatic 
system 
disorders

Neutropenia  Thrombocytopenia 
* 

Metabolism and 
nutrition 
disorders 

Anorexia, loss of 
appetite, weight 
loss 



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Psychiatric 
disorders 

Insomnia Aggressiveness, 
irritability, behaviour 
disorders, opposing 
behaviour, 
hyperexcitability, 
sleep disorders 

Nervous system 
disorders 

Drowsiness, 
ataxia, 
hypotonia, 
dystonia

Hyperkinesias 

Eye disorders Diplopia 
Gastrointestinal 
disorders 

Nausea, vomiting 

Skin and 
subcutaneous 
tissue disorders 

Photosensitivity, 
rash, cutaneous 
allergy, urticaria

General 
disorders and 
administration 
site conditions 

Fatigue 

Investigations Raised γ-GT  Liver function test 
abnormal

* Thrombocytopenia data are derived from both clinical trials and post-marketing experience. 

Description of selected adverse reactions 

Many of the above adverse reactions are often due to an increase in plasma levels of other 
anticonvulsant medicinal products (see sections 4.4 and 4.5) and may regress when the dose of these 
medicinal products is reduced. 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

4.9 Overdose

Data on clinical overdose are not available. Treatment is supportive (symptomatic measures in 
intensive care units). 

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17 

Mechanism of action 
In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and 
bicuculline. In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid 
(GABA) - the major inhibitory neurotransmitter in mammalian brain. This could occur by inhibition 
of synaptosomal uptake of GABA and/or inhibition of GABA transaminase. Stiripentol has also been 
shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a 
barbiturate-like mechanism. Stiripentol potentiates the efficacy of other anticonvulsants, such as 
carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result 
of pharmacokinetic interactions. The second effect of stiripentol is mainly based on metabolic 
inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic 
metabolism of other anti-epileptic medicines. 

Clinical efficacy and safety 

The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 

A French compassionate use program included children from 6 months of age because the diagnosis 
of Dravet’s syndrome may be made with confidence at that age in some patients. The clinical decision 
for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual 
patient basis taking into consideration the potential clinical benefits and risks (see section 4.2). 

41 children with SMEI were included in a randomised, placebo-controlled, add-on trial. After a 
baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam 
during a double-blind period of 2 months. Patients then received stiripentol in an open fashion. 
Responders were defined as having more than 50% reduction in the frequency of clonic (or tonic-
clonic) seizures during the second month of the double-blind period compared with baseline. 
15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic 
seizures), whereas there was only one (5%) on placebo (none was seizure free; stiripentol 95% CI 
52.1-90.7 vs. placebo 0-14.6). The 95% CI of the difference was 42.2-85.7. Percentage of change 
from baseline was higher on stiripentol (-69%) than on placebo (+7%), p< 0.0001. 21 patients on 
stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, 
but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases 
(Chiron et al, Lancet, 2000).  

There are no clinical study data to support the clinical safety of stiripentol administered at daily doses 
greater than 50 mg/kg/day. There are no clinical study data to support the use of stiripentol as 
monotherapy in Dravet’s syndrome. 

5.2 Pharmacokinetic properties

The following pharmacokinetic properties of stiripentol have been reported from studies in adult 
healthy volunteers and adult patients. 

Absorption 

Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours. The 
absolute bioavailability of stiripentol is not known since an intravenous formulation is not available 
for testing. It is well absorbed by the oral route since the majority of an oral dose is excreted in urine. 

Relative bioavailability between the capsules and powder for oral suspension in sachet formulations 
has been studied in healthy male volunteers after a 1,000 mg single oral administration. The two 
formulations were bioequivalent in terms of AUC but not in terms of Cmax. Cmax of the sachet was 
slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence. Tmax
was similar with both formulations. Clinical supervision is recommended if switching between the 
stiripentol capsule and powder for oral suspension in sachet formulations. 

Distribution 

Stiripentol binds extensively to circulating plasma proteins (about 99%). 



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Elimination 

Systemic exposure to stiripentol increases markedly compared to dose proportionality. Plasma 
clearance decreases markedly at high doses; it falls from approximately 40 l/kg/day at the dose of 
600 mg/day to about 8 l/kg/day at the dose of 2,400 mg. Clearance is decreased after repeated 
administration of stiripentol, probably due to inhibition of the cytochrome P450 isoenzymes 
responsible for its metabolism. The half-life of elimination was in the range of 4.5 hours to 13 hours, 
increasing with dose. 

Biotransformation 

Stiripentol is extensively metabolized, 13 different metabolites having been found in urine. The main 
metabolic processes are demethylenation and glucuronidation, although precise identification of the 
enzymes involved has not yet been achieved. 
On the basis of in vitro studies, the principal liver cytochrome P450 isoenzymes involved in phase 1 
metabolism are considered to be CYP1A2, CYP2C19 and CYP3A4. 

Excretion 

Most stiripentol is excreted via the kidney. 
Urinary metabolites of stiripentol accounted collectively for the majority (73%) of an oral acute dose 
whereas a further 13-24% was recovered in faeces as unchanged substance. 

Paediatric population pharmacokinetic study 

A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with 
stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and 
clobazam. The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of 
stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses. 

The data were best fitted with a one compartment model with first order absorption and elimination 
processes. The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard 
deviation of random effect = 122%). Clearance and volume of distribution were related to body 
weight by an allometric model with exponents of 0.433 and 1, respectively: as body weight increased 
from 10 to 60 kg, apparent oral clearance increased from 2.60 to 5.65 L/hr and apparent volume of 
distribution increased from 32.0 to 191.8 L. As a result, elimination half-life increased from 8.5hr (for 
10 kg) to 23.5 hr (for 60 kg). 

5.3 Preclinical safety data 

Toxicity studies in animals (rat, monkey, mouse) have not revealed any consistent pattern of toxicity 
apart from liver enlargement associated with hepatocellular hypertrophy, which occurred when high 
doses of stiripentol were administered to both rodents and non-rodents. This finding is considered to 
be an adaptive response to a high metabolic burden on the liver.  
Stiripentol was not teratogenic when tested in the rat and rabbit; in one study in the mouse, but not in 
several other similar studies, a low incidence of cleft palate formation was observed at a maternotoxic 
dose (800 mg/kg/day). These studies in mice and rabbits were undertaken prior to the introduction of 
Good Laboratory Practice requirements. Studies in the rat on fertility and general reproductive 
performance and on pre- and postnatal development were uneventful except for a minor reduction in 
the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 
800 mg/kg/day (see section 4.6).  
Genotoxicity studies have not detected any mutagenic or clastogenic activity.  
Carcinogenicity studies gave negative results in the rat. In the mouse there was only a small increase 
in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600 mg/kg/day 
for 78 weeks but not in those given 60 mg/kg/day. In view of the lack of genotoxicity of stiripentol 
and the well known, special susceptibility of the mouse liver to tumour formation in the presence of 



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hepatic enzyme induction, this finding is not considered to indicate a risk of tumorigenicity in 
patients. 

6. PHARMACEUTICAL PARTICULARS 

6.1 List of excipients

Capsule core 

Povidone (K29/32) 
Sodium starch glycolate (type A) 
Magnesium stearate 

Capsule shell 

Gelatin 
Titanium dioxide (E171) 
Erythrosine (E127) 
Indigotine (E132) 

Printing ink 

Shellac (E904) 
Black iron oxide (E172) 

6.2 Incompatibilities

Not applicable. 

6.3 Shelf life

3 years 

6.4 Special precautions for storage

Store in the original package in order to protect from light.  

6.5 Nature and contents of container 

Polyethylene bottle with tamper-evident seal and child-resistant polypropylene screw cap. 
Bottles of 30, 60 and 90 capsules in cardboard cartons.  
Not all pack sizes may be marketed. 

6.6 Special precautions for disposal

No special requirements. 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 

7. MARKETING AUTHORISATION HOLDER

Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France. 



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8. MARKETING AUTHORISATION NUMBER(S)  

EU/1/06/367/001-3 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 04 January 2007 
Date of latest renewal: 24 September 2018 

10. DATE OF REVISION OF THE TEXT 

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu

http://www.ema.europa.eu/


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1. NAME OF THE MEDICINAL PRODUCT

Diacomit 500 mg hard capsules 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 500 mg of stiripentol. 

Excipient with known effect  

0.32 mg sodium per capsule.  
For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM

Hard capsules 

Size 0, white capsule, imprinted with “Diacomit 500 mg”. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of 
refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy 
(SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and 
valproate. 

4.2 Posology and method of administration 

Diacomit should only be administered under the supervision of a paediatrician / paediatric neurologist 
experienced in the diagnosis and management of epilepsy in infants and children.  

Posology 

The dose of stiripentol is calculated on a mg/kg body weight basis. 

The daily dosage may be administered in 2 or 3 divided doses. 

The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards 
dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with 
clobazam and valproate.  

Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 
30mg/kg/day for 1 week. Further dosage escalation is age dependent: 
- children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus 
achieving the recommended dose of 50 mg/kg/day in three weeks; 
- children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus 
achieving the recommended dose of 50 mg/kg/day in four weeks; 
- children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week 
until the optimum dose is reached based on clinical judgment. 

The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the 
only dose of Diacomit evaluated in the pivotal studies (see section 5.1). 



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Stiripentol must always be taken with food as it degrades rapidly in an acidic environment (e.g. 
exposure to gastric acid in an empty stomach). 
Stiripentol should not be taken with milk or dairy products (yoghurt, soft cream cheese, etc.), 
carbonated drinks, fruit juice or food and drinks that contain caffeine or theophylline. 

Children aged less than 3 years 
The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 
The clinical decision for use of stiripentol in children with SMEI less than 3 years of age needs to be 
made on an individual patient basis taking into consideration the potential clinical benefits and risks. 
In this younger group of patients, adjunctive therapy with stiripentol should only be started when the 
diagnosis of SMEI has been clinically confirmed (see section 5.1). Data are limited about the use of 
stiripentol under 12 months of age. For these children the use of stiripentol will be done under the 
close supervision of the doctor. 

Patients aged ≥ 18 years of age 
Long-term data has not been collected in a sufficient number of adults to confirm maintenance of 
effect in this population. Treatment should be continued for as long as efficacy is observed. 

Dose adjustments of other antiepileptics used in combination with stiripentol 

Despite the absence of comprehensive pharmacology data on potential drug interactions, the 
following advice regarding modification of the dose and dosage schedules of other anti-epileptic 
medicinal products administered in conjunction with stiripentol is provided based on clinical 
experience. 

- Clobazam 
In the pivotal studies, when the use of stiripentol was initiated, the daily dose of clobazam was 
0.5 mg/kg/day usually administered in divided doses, twice daily. In the event of clinical signs of 
adverse reactions or overdose of clobazam (i.e., drowsiness, hypotonia, and irritability in young 
children), this daily dose was reduced by 25% every week. Approximately two to three-fold increases 
in clobazam and five-fold increases in norclobazam plasma levels respectively have been reported 
with co-administration of stiripentol in children with Dravet’s syndrome. 

- Valproate 
The potential for metabolic interaction between stiripentol and valproate is considered modest and 
thus, no modification of valproate dosage should be needed when stiripentol is added, except for 
clinical safety reasons. In the pivotal studies in the event of gastrointestinal adverse reactions such as 
loss of appetite, loss of weight, the daily dose of valproate was reduced by around 30% every week. 

Abnormal laboratory findings 
In the event of an abnormal blood count or liver function test finding, the clinical decision for 
continuing use or adjusting the dose of stiripentol in conjunction with adjusting the doses of clobazam 
and valproate needs to be made on an individual patient basis taking into consideration the potential 
clinical benefits and risks (see section 4.4). 

Effect of formulation 
The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not 
bioequivalent. It is recommended that if a switch of formulations is required this is done under 
clinical supervision, in case of problems with tolerability (see section 5.2). 

Renal and hepatic impairment 
Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see 
section 4.4). 

Method of administration 



15

Oral use 
The capsule should be swallowed whole with a glass of water. 
The capsules should not be chewed. 
For the interaction of stiripentol with food, please see section 4.5. 

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
A past history of psychoses in the form of episodes of delirium. 

4.4 Special warnings and precautions for use

Carbamazepine, phenytoin and phenobarbital 

These substances should not be used in conjunction with stiripentol in the management of Dravet’s 
syndrome. The daily dosage of clobazam and/or valproate should be reduced according to the onset of 
side effects whilst on stiripentol therapy (see section 4.2). 

Growth rate of children 

Given the frequency of gastrointestinal adverse reactions to treatment with stiripentol and valproate 
(anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of 
treatment should be carefully monitored. 

Blood count

Neutropenia may be associated with the administration of stiripentol, clobazam and valproate. Blood 
counts should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically 
indicated, blood counts should be checked every 6 months. 

Liver function 

It should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically indicated, 
liver function should be checked every 6 months. 

Hepatic or renal impairment 

In the absence of specific clinical data in patients with impaired hepatic or renal function, Stiripentol 
is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.2). 

Substances interfering with CYP enzymes

Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly 
increase the plasma concentrations of substances metabolised by these enzymes and increase the risk 
of adverse reactions (see section 4.5). In vitro studies suggested that stiripentol phase 1 metabolism is 
catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes. Caution is advised when 
combining stiripentol with other substances that inhibit or induce one or more of these enzymes. 

Paediatric population 

The pivotal clinical studies did not include children below 3 years old. As a consequence, it is 
recommended that children between 6 months and 3 years of age are carefully monitored whilst on 
stiripentol therapy. 



16

4.5 Interaction with other medicinal products and other forms of interaction

Potential medicinal product interactions affecting stiripentol 

The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well 
established. 
The impact of macrolides and azole antifungal medicinal products on stiripentol metabolism, that are 
known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known. Likewise, the 
effect of stiripentol on their metabolism is not known. 

In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and 
CYP3A4 and possibly other enzymes. Caution is advised when combining stiripentol with other 
substances that inhibit or induce one or more of these enzymes. 

Effect of stiripentol on cytochrome P450 enzymes 

Many of these interactions have been partially confirmed by in vitro studies and in clinical trials. The 
increase in steady state levels with the combined use of stiripentol, valproate, and clobazam is similar 
in adults and children, though inter-individual variability is marked. 

At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for 
example, CYP2C19, CYP2D6 and CYP3A4. As a result, pharmacokinetic interactions of metabolic 
origin with other medicines may be expected. These interactions may result in increased systemic 
levels of these active substances that may lead to enhanced pharmacological effects and to an increase 
in adverse reactions. 
Caution must be exercised if clinical circumstances require combining stiripentol with substances 
metabolised by CYP2C19 (e.g. citalopram, omeprazole) or CYP3A4 (e.g. HIV protease inhibitors, 
antihistamines such as astemizole and chlorpheniramine, calcium channel blockers, statins, oral 
contraceptives, codeine) due to the increased risk of adverse reactions (see further in this section for 
antiepileptic medicines). Monitoring of plasma concentrations or adverse reactions is recommended. 
A dose adjustment may be necessary. 

Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to 
the markedly increased risk of severe adverse reactions.  

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with 
theophylline and caffeine cannot be excluded because of increased plasma levels of theophylline and 
caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity. 
Use in combination with stiripentol is not recommended. This warning is not only restricted to 
medicinal products but also to a considerable number of foods and nutritional products aimed at 
children: Patient should not drink cola drinks, which contain significant quantities of caffeine or 
chocolate, which contains trace amounts of theophylline (see section 4.2). 

As stiripentol inhibited CYP2D6 in vitro at concentrations that are achieved clinically in plasma, 
substances that are metabolized by this isoenzyme like: beta-blockers (propranolol, carvedilol, 
timolol), antidepressants (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), 
antipsychotics (haloperidol), analgesics (codeine, dextromethorphan, tramadol) may be subject to 
metabolic interactions with stiripentol. A dose-adjustment may be necessary for substances 
metabolised by CYP2D6 and that are individually dose titrated. 

Potential for stiripentol to interact with other medicinal products 

In the absence of available clinical data, caution should be taken with the following clinically relevant 
interactions with stiripentol: 



17

Undesirable combinations (to be avoided unless strictly necessary) 
- Rye ergot alkaloids (ergotamine, dihydroergotamine) 
Ergotism with possibility of necrosis of the extremities (inhibition of hepatic elimination of rye ergot). 

- Cisapride, halofantrine, pimozide, quinidine, bepridil 
Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular. 

- Immunosuppressants (tacrolimus, cyclosporine, sirolimus) 
Raised blood levels of immunosuppressants (decreased hepatic metabolism). 

- Statins (atorvastatin, simvastatin, etc.) 
Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic 
metabolism of cholesterol-lowering medicinal product). 

Combinations requiring precautions 

- Midazolam, triazolam, alprazolam 
Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to 
excessive sedation. 

- Chlorpromazine 
Stiripentol enhances the central depressant effect of chlorpromazine. 

- Effects on other antiepileptic drugs (AEDs) 
Inhibition of CYP450 isoenzyme CYP2C19 and CYP3A4 may provoke pharmacokinetic interactions 
(inhibition of their hepatic metabolism) with phenobarbital, primidone, phenytoin, carbamazepine, 
clobazam (see section 4.2), valproate (see section 4.2), diazepam (enhanced myorelaxation), 
ethosuximide, and tiagabine. The consequences are increased plasma levels of these anticonvulsants 
with potential risk of overdose. Clinical monitoring of plasma levels of other anticonvulsants when 
combined with stiripentol with possible dose adjustments is recommended. 

- Topiramate 
In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam 
and valproate in 41% of 230 cases. Based on the clinical observations in this group of patients, there 
is no evidence to suggest that a change in topiramate dose and dosage schedules is needed if co-
administered with stiripentol. 
With regard to topiramate, it is considered that potential competition of inhibition on CYP2C19 
should not occur because it probably requires plasma concentrations 5-15 times higher than plasma 
concentrations obtained with the standard recommended topiramate dose and dosage schedules. 

- Levetiracetam 
Levetiracetam does not undergo hepatic metabolism to a major extent. As a result, no 
pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated. 

4.6 Fertility, pregnancy and lactation

Pregnancy 

Risk related to epilepsy and antiepileptic medicinal products in general  
It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is 
two to three times greater than the rate of approximately 3% in the general population. Although other 
factors, e.g. the epilepsy, can contribute, available evidence suggests that this increase, to a large 
extent, is caused by the treatment. In the treated population, an increase in malformations has been 
noted with polytherapy. 
However, effective anti-epileptic therapy should not be interrupted during pregnancy, since the 
aggravation of the illness may be detrimental to both the mother and the foetus. 



18

Risk related to stiripentol 
No data on exposed pregnancies are available. Animal studies do not indicate direct or indirect 
harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at 
non-maternotoxic doses (see section 5.3). In view of the indication, administration of stiripentol 
during pregnancy and in women of childbearing potential would not be expected. The clinical 
decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into 
consideration the potential clinical benefits and risks. Caution should be exercised when prescribing 
to pregnant women and use of efficient methods of contraception is advisable. 

Breastfeeding 

In the absence of human studies on excretion in breast milk and given that stiripentol passes freely 
from plasma into milk in the goat, breast-feeding is not recommended during treatment. In case 
stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully 
observed for potential adverse effects. 

Fertility 

No impact on fertility was detected in animal studies (see section 5.3). No clinical data are available, 
potential risk for human is unknown. 

4.7 Effects on ability to drive and use machines 

No studies on the effects on the ability to drive and use machines have been performed. However, 
some patients may experience dizziness and ataxia that may affect ability to drive and use machines 
and patients should not drive or use machinery whilst on stiripentol therapy. 

4.8 Undesirable effects 

Summary of the safety profile 

The most common side effects with stiripentol are anorexia, weight loss, insomnia, drowsiness, 
ataxia, hypotonia and dystonia. 

Tabulated list of adverse reaction 

Adverse reactions encountered most often are as follows: very common (≥ 1/10), common (≥ 1/100 to 
< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not 
known (cannot be estimated from the available data). Within each frequency grouping, undesirable 
effects are presented in order of decreasing severity. 

System Organ 
Class 
(MedDRA 
terminology)

Very common Common Uncommon Rare 

Blood and 
lymphatic 
system 
disorders

Neutropenia  Thrombocytopenia *

Metabolism 
and nutrition 
disorders 

Anorexia, loss 
of appetite, 
weight loss 



19

Psychiatric 
disorders 

Insomnia Aggressiveness, 
irritability, behaviour 
disorders, opposing 
behaviour, 
hyperexcitability, 
sleep disorders 

Nervous system 
disorders 

Drowsiness, 
ataxia, 
hypotonia, 
dystonia

Hyperkinesias 

Eye disorders Diplopia 
Gastrointestinal 
disorders 

Nausea, vomiting 

Skin and 
subcutaneous 
tissue disorders

Photosensitivity, 
rash, cutaneous 
allergy, urticaria

General 
disorders and 
administration 
site conditions 

Fatigue 

Investigations Raised γGT  Liver function test 
abnormal

* Thrombocytopenia data are derived from both clinical trials and post-marketing experience. 

Description of selected adverse reactions 

Many of the above adverse reactions are often due to an increase in plasma levels of other 
anticonvulsant medicinal products (see sections 4.4 and 4.5) and may regress when the dose of these 
medicinal products is reduced. 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

4.9 Overdose

Data on clinical overdose are not available. Treatment is supportive (symptomatic measures in 
intensive care units). 

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17 

Mechanism of action 

In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and 
bicuculline. In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid 
(GABA) - the major inhibitory neurotransmitter in mammalian brain. This could occur by inhibition 
of synaptosomal uptake of GABA and/or inhibition of GABA transaminase. Stiripentol has also been 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


20

shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and 
increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a 
barbiturate-like mechanism. Stiripentol potentiates the efficacy of other anticonvulsants, such as 
carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result 
of pharmacokinetic interactions. The second effect of stiripentol is mainly based on metabolic 
inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic 
metabolism of other anti-epileptic medicines. 

Clinical efficacy and safety 

The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 

A French compassionate use program included children from 6 months of age because the diagnosis 
of Dravet’s syndrome may be made with confidence at that age in some patients. The clinical decision 
for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual 
patient basis taking into consideration the potential clinical benefits and risks (see section 4.2). 

41 children with SMEI were included in a randomised, placebo-controlled, add-on trial. After a 
baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam 
during a double-blind period of 2 months. Patients then received stiripentol in an open fashion. 
Responders were defined as having more than 50% reduction in the frequency of clonic (or tonic-
clonic) seizures during the second month of the double-blind period compared with baseline. 
15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic 
seizures), whereas there was only one (5%) on placebo (none was seizure free; stiripentol 95% CI 
52.1-90.7 vs. placebo 0-14.6). The 95% CI of the difference was 42.2-85.7. Percentage of change 
from baseline was higher on stiripentol (-69%) than on placebo (+7%), p<0.0001. 21 patients on 
stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, 
but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases 
(Chiron et al, Lancet, 2000).  

There are no clinical study data to support the clinical safety of stiripentol administered at daily doses 
greater than 50 mg/kg/day.  
There are no clinical study data to support the use of stiripentol as monotherapy in Dravet’s 
syndrome. 

5.2 Pharmacokinetic properties

The following pharmacokinetic properties of stiripentol have been reported from studies in adult 
healthy volunteers and adult patients. 

Absorption 

Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours. The 
absolute bioavailability of stiripentol is not known since an intravenous formulation is not available 
for testing. It is well absorbed by the oral route since the majority of an oral dose is excreted in urine. 

Relative bioavailability between the capsules and powder for oral suspension in sachet formulations 
has been studied in healthy male volunteers after a 1,000 mg single oral administration. The two 
formulations were bioequivalent in terms of AUC but not in terms of Cmax. Cmax of the sachet was 
slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence. Tmax
was similar with both formulations. Clinical supervision is recommended if switching between the 
stiripentol capsule and powder for oral suspension in sachet formulations. 

Distribution 

Stiripentol binds extensively to circulating plasma proteins (about 99%). 



21

Elimination 

Systemic exposure to stiripentol increases markedly compared to dose proportionality. Plasma 
clearance decreases markedly at high doses; it falls from approximately 40 l/kg/day at the dose of 
600 mg/day to about 8 l/kg/day at the dose of 2,400 mg. Clearance is decreased after repeated 
administration of stiripentol, probably due to inhibition of the cytochrome P450 isoenzymes 
responsible for its metabolism. The half-life of elimination was in the range of 4.5 hours to 13 hours, 
increasing with dose. 

Biotransformation 

Stiripentol is extensively metabolized, 13 different metabolites having been found in urine. The main 
metabolic processes are demethylenation and glucuronidation, although precise identification of the 
enzymes involved has not yet been achieved. 
On the basis of in vitro studies, the principal liver cytochrome P450 isoenzymes involved in phase 1 
metabolism are considered to be CYP1A2, CYP2C19 and CYP3A4. 

Excretion 

Most stiripentol is excreted via the kidney. 
Urinary metabolites of stiripentol accounted collectively for the majority (73%) of an oral acute dose 
whereas a further 13-24% was recovered in faeces as unchanged substance. 

Paediatric population pharmacokinetic study 

A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with 
stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and 
clobazam. The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of 
stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses. 

The data were best fitted with a one compartment model with first order absorption and elimination 
processes. The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard 
deviation of random effect = 122%). Clearance and volume of distribution were related to body 
weight by an allometric model with exponents of 0.433 and 1, respectively: as body weight increased 
from 10 to 60 kg, apparent oral clearance increased from 2.60 to 5.65 L/hr and apparent volume of 
distribution increased from 32.0 to 191.8 L. As a result, elimination half-life increased from 8.5hr (for 
10 kg) to 23.5 hr (for 60 kg). 

5.3 Preclinical safety data 

Toxicity studies in animals (rat, monkey, mouse) have not revealed any consistent pattern of toxicity 
apart from liver enlargement associated with hepatocellular hypertrophy, which occurred when high 
doses of stiripentol were administered to both rodents and nonrodents. This finding is considered to 
be an adaptive response to a high metabolic burden on the liver.  
Stiripentol was not teratogenic when tested in the rat and rabbit; in one study in the mouse, but not in 
several other similar studies, a low incidence of cleft palate formation was observed at a maternotoxic 
dose (800 mg/kg/day). These studies in mice and rabbits were undertaken prior to the introduction of 
Good Laboratory Practice requirements. Studies in the rat on fertility and general reproductive 
performance and on pre- and postnatal development were uneventful except for a minor reduction in 
the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 
800 mg/kg/day (see section 4.6).  
Genotoxicity studies have not detected any mutagenic or clastogenic activity.  
Carcinogenicity studies gave negative results in the rat. In the mouse there was only a small increase 
in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600 mg/kg/day 
for 78 weeks but not in those given 60 mg/kg/day. In view of the lack of genotoxicity of stiripentol 
and the well known, special susceptibility of the mouse liver to tumour formation in the presence of 



22

hepatic enzyme induction, this finding is not considered to indicate a risk of tumorigenicity in 
patients. 

6. PHARMACEUTICAL PARTICULARS 

6.1 List of excipients

Capsule core 

Povidone (K29/32) 
Sodium starch glycolate (type A) 
Magnesium stearate 

Capsule shell 

Gelatin 
Titanium dioxide (E171) 

Printing ink 

Shellac (E904) 
Black iron oxide (E172) 

6.2 Incompatibilities

Not applicable. 

6.3 Shelf life

3 years 

6.4 Special precautions for storage

Store in the original package in order to protect from light. 

6.5 Nature and contents of container 

Polyethylene bottle with tamper-evident seal and child-resistant polypropylene screw cap. 
Bottles of 30, 60 and 90 capsules in cardboard cartons.  
Not all pack sizes may be marketed. 

6.6 Special precautions for disposal 

No special requirements. 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 

7. MARKETING AUTHORISATION HOLDER

Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France. 

8. MARKETING AUTHORISATION NUMBER(S)  

EU/1/06/367/004-6 



23

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 04 January 2007 
Date of latest renewal: 24 September 2018 

10. DATE OF REVISION OF THE TEXT 

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu

http://www.ema.europa.eu/


24

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 250 mg powder for oral suspension in sachet 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 250 mg of stiripentol. 

Excipient with known effect  

0.11 mg sodium per sachet. 
Each sachet contains 2.5 mg of aspartame, 500 mg of glucose liquid spray and 2.4 mg of sorbitol. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM

Powder for oral suspension 
Pale pink crystalline powder

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of 
refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy 
(SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and 
valproate. 

4.2 Posology and method of administration 

Diacomit should only be administered under the supervision of a paediatrician / paediatric neurologist 
experienced in the diagnosis and management of epilepsy in infants and children.  

Posology 

The dose of stiripentol is calculated on a mg/kg body weight basis. 

The daily dosage may be administered in 2 or 3 divided doses. 

The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards 
dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with 
clobazam and valproate.  

Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 
30mg/kg/day for 1 week. Further dosage escalation is age dependent: 
- children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus 
achieving the recommended dose of 50 mg/kg/day in three weeks; 
- children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus 
achieving the recommended dose of 50 mg/kg/day in four weeks; 
- children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week 
until the optimum dose is reached based on clinical judgment. 



25

The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the 
only dose of Diacomit evaluated in the pivotal studies (see section 5.1). 

Stiripentol must always be taken with food as it degrades rapidly in an acidic environment (e.g. 
exposure to gastric acid in an empty stomach). 
Stiripentol should not be taken with milk or dairy products (yoghurt, soft cream cheese, etc.), 
carbonated drinks, fruit juice or food and drinks that contain caffeine or theophylline 

Children aged less than 3 years 
The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 
The clinical decision for use of stiripentol in children with SMEI less than 3 years of age needs to be 
made on an individual patient basis taking into consideration the potential clinical benefits and risks. 
In this younger group of patients, adjunctive therapy with Diacomit should only be started when the 
diagnosis of SMEI has been clinically confirmed (see section 5.1). Data are limited about the use of 
stiripentol under 12 months of age. For these children the use of stiripentol will be done under the 
close supervision of the doctor. 

Patients aged ≥ 18 years of age 
Long-term data has not been collected in a sufficient number of adults to confirm maintenance of 
effect in this population. Treatment should be continued for as long as efficacy is observed. 

Dose adjustments of other antiepileptics used in combination with stiripentol 

Despite the absence of comprehensive pharmacology data on potential drug interactions, the 
following advice regarding modification of the dose and dosage schedules of other anti-epileptic 
medicinal products administered in conjunction with stiripentol is provided based on clinical 
experience. 

- Clobazam 
In the pivotal studies, when the use of stiripentol was initiated, the daily dose of clobazam was 
0.5 mg/kg/day usually administered in divided doses, twice daily. In the event of clinical signs of 
adverse reactions or overdose of clobazam (i.e., drowsiness, hypotonia, and irritability in young 
children), this daily dose was reduced by 25% every week. Approximately two to three-fold increases 
in clobazam and five-fold increases in norclobazam plasma levels respectively have been reported 
with co-administration of stiripentol in children with Dravet’s syndrome. 

- Valproate 
The potential for metabolic interaction between stiripentol and valproate is considered modest and 
thus, no modification of valproate dosage should be needed when stiripentol is added, except for 
clinical safety reasons. In the pivotal studies in the event of gastrointestinal adverse reactions such as 
loss of appetite, loss of weight, the daily dose of valproate was reduced by around 30% every week. 

Abnormal laboratory findings 
In the event of an abnormal blood count or liver function test finding, the clinical decision for 
continuing use or adjusting the dose of stiripentol in conjunction with adjusting the doses of clobazam 
and valproate needs to be made on an individual patient basis taking into consideration the potential 
clinical benefits and risks (see section 4.4).

Effect of formulation 
The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not 
bioequivalent. It is recommended that if a switch of formulations is required this is done under 
clinical supervision, in case of problems with tolerability (see section 5.2). 

Renal and hepatic impairment 
Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see 
section 4.4). 



26

Method of administration 

Oral use 
The powder should be mixed in a glass of water and should be taken immediately after mixing. 
For the interaction of stiripentol with food, please see section 4.5. 

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
A past history of psychoses in the form of episodes of delirium. 

4.4 Special warnings and precautions for use

Carbamazepine, phenytoin and phenobarbital 

These substances should not be used in conjunction with stiripentol in the management of Dravet’s 
syndrome. The daily dosage of clobazam and/or valproate should be reduced according to the onset of 
side effects whilst on stiripentol therapy (see section 4.2). 

Growth rate of children 

Given the frequency of gastrointestinal adverse reactions to treatment with stiripentol and valproate 
(anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of 
treatment should be carefully monitored. 

Blood count 

Neutropenia may be associated with the administration of stiripentol, clobazam and valproate. Blood 
counts should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically 
indicated, blood counts should be checked every 6 months. 

Liver function 

It should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically indicated, 
liver function should be checked every 6 months. 

Hepatic or renal impairment 

In the absence of specific clinical data in patients with impaired hepatic or renal function, stiripentol 
is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.2). 

Substances interfering with CYP enzymes 

Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly 
increase the plasma concentrations of substances metabolised by these enzymes and increase the risk 
of adverse reactions (see section 4.5). In vitro studies suggested that stiripentol phase 1 metabolism is 
catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes. Caution is advised when 
combining stiripentol with other substances that inhibit or induce one or more of these enzymes. 

Paediatric population 

The pivotal clinical studies did not include children below 3 years old. As a consequence, it is 
recommended that children between 6 months and 3 years of age are carefully monitored whilst on 
stiripentol therapy. 

Stiripentol powder for oral suspension in sachet contains aspartame, a source of phenylalanine.  



27

Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks 
of age. Therefore it may be harmful for people with phenylketonuria. Patients with rare glucose-
galactose malabsorption should not take this medicine, as the formulation contains glucose. As the 
flavouring component contains small amount of sorbitol, patients with hereditary problems of fructose 
intolerance should not take this medicine. 

4.5 Interaction with other medicinal products and other forms of interaction

Potential medicinal product interactions affecting stiripentol 

The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well 
established. 
The impact of macrolides and azole antifungal medicinal product on stiripentol metabolism, that are 
known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known. Likewise, the 
effect of stiripentol on their metabolism is not known. 

In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and 
CYP3A4 and possibly other enzymes. Caution is advised when combining stiripentol with other 
substances that inhibit or induce one or more of these enzymes. 

Effect of stiripentol on cytochrome P450 enzymes 

Many of these interactions have been partially confirmed by in vitro studies and in clinical trials. The 
increase in steady state levels with the combined use of stiripentol, valproate, and clobazam is similar 
in adults and children, though inter-individual variability is marked. 

At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for 
example, CYP2C19, CYP2D6 and CYP3A4. As a result, pharmacokinetic interactions of metabolic 
origin with other medicines may be expected. These interactions may result in increased systemic 
levels of these active substances that may lead to enhanced pharmacological effects and to an increase 
in adverse reactions. 
Caution must be exercised if clinical circumstances require combining stiripentol with substances 
metabolised by CYP2C19 (e.g. citalopram, omeprazole) or CYP3A4 (e.g. several HIV protease 
inhibitors, antihistamines such as astemizole and chlorpheniramine, calcium channel blockers, statins, 
oral contraceptives, codeine) due to the increased risk of adverse reactions (see further in this section 
for antiepileptic medicines). Monitoring of plasma concentrations or adverse reactions is 
recommended. A dose adjustment may be necessary. 

Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to 
the markedly increased risk of severe adverse reactions.  

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with 
theophylline and caffeine cannot be excluded because of increased plasma levels of theophylline and 
caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity. 
Use in combination with stiripentol is not recommended. This warning is not only restricted to 
medicinal products but also to a considerable number of foods and nutritional products aimed at 
children: Patient should not drink cola drinks, which contain significant quantities of caffeine or 
chocolate, which contains trace amounts of theophylline (see section 4.2). 

As stiripentol inhibited CYP2D6 in vitro at concentrations that are achieved clinically in plasma, 
substances that are metabolized by this isoenzyme like: beta-blockers (propranolol, carvedilol, 
timolol), antidepressants (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), 
antipsychotics (haloperidol), analgesics (codeine, dextromethorphan, tramadol) may be subject to 
metabolic interactions with stiripentol. A dose-adjustment may be necessary for substances 
metabolised by CYP2D6 and that are individually dose titrated. 



28

Potential for stiripentol to interact with other medicinal products 

In the absence of available clinical data, caution should be taken with the following clinically relevant 
interactions with stiripentol: 

Undesirable combinations (to be avoided unless strictly necessary) 
- Rye ergot alkaloids (ergotamine, dihydroergotamine) 
Ergotism with possibility of necrosis of the extremities (inhibition of hepatic elimination of rye ergot). 

- Cisapride, halofantrine, pimozide, quinidine, bepridil 
Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular. 

- Immunosuppressants (tacrolimus, cyclosporine, sirolimus) 
Raised blood levels of immunosuppressants (decreased hepatic metabolism). 

- Statins (atorvastatin, simvastatin, etc.) 
Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic 
metabolism of cholesterol-lowering medicinal product). 

Combinations requiring precautions 

- Midazolam, triazolam, alprazolam 
Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to 
excessive sedation. 

- Chlorpromazine 
Stiripentol enhances the central depressant effect of chlorpromazine. 

- Effects on other antiepileptic drugs (AEDs) 
Inhibition of CYP450 isoenzyme CYP2C19 and CYP3A4 may provoke pharmacokinetic interactions 
(inhibition of their hepatic metabolism) with phenobarbital, primidone, phenytoin, carbamazepine, 
clobazam (see section 4.2), valproate (see section 4.2), diazepam (enhanced myorelaxation), 
ethosuximide, and tiagabine. The consequences are increased plasma levels of these anticonvulsants 
with potential risk of overdose. Clinical monitoring of plasma levels of other anticonvulsants when 
combined with stiripentol with possible dose adjustments is recommended. 

- Topiramate 
In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam 
and valproate in 41% of 230 cases. Based on the clinical observations in this group of patients, there 
is no evidence to suggest that a change in topiramate dose and dosage schedules is needed if co-
administered with stiripentol. 
With regard to topiramate, it is considered that potential competition of inhibition on CYP2C19 
should not occur because it probably requires plasma concentrations 5-15 times higher than plasma 
concentrations obtained with the standard recommended topiramate dose and dosage schedules. 

- Levetiracetam 
Levetiracetam does not undergo hepatic metabolism to a major extent. As a result, no 
pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated. 

4.6 Fertility, pregnancy and lactation 

Pregnancy 

Risk related to epilepsy and antiepileptic medicinal products in general  
It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is 
two to three times greater than the rate of approximately 3% in the general population. Although other 
factors, e.g. the epilepsy, can contribute, available evidence suggests that this increase, to a large 



29

extent, is caused by the treatment. In the treated population, an increase in malformations has been 
noted with polytherapy. 
However, effective anti-epileptic therapy should not be interrupted during pregnancy, since the 
aggravation of the illness may be detrimental to both the mother and the foetus. 

Risk related to stiripentol 
No data on exposed pregnancies are available. Animal studies do not indicate direct or indirect 
harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at 
non-maternotoxic doses (see section 5.3). In view of the indication, administration of stiripentol 
during pregnancy and in women of childbearing potential would not be expected. The clinical 
decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into 
consideration the potential clinical benefits and risks. Caution should be exercised when prescribing 
to pregnant women and use of efficient methods of contraception is advisable. 

Breastfeeding 

In the absence of human studies on excretion in breast milk, and given that stiripentol passes freely 
from plasma into milk in the goat, breast-feeding is not recommended during treatment. In case 
stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully 
observed for potential adverse effects. 

Fertility 

No impact on fertility was detected in animal studies (see section 5.3). No clinical data are available, 
potential risk for human is unknown. 

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, 
some patients may experience dizziness and ataxia that may affect ability to drive and use machines 
and patients should not drive or use machinery whilst on stiripentol therapy. 

4.8 Undesirable effects 

Summary of the safety profile 

The most common side effects with stiripentol are anorexia, weight loss, insomnia, drowsiness, 
ataxia, hypotonia and dystonia. 

Tabulated list of adverse reactions 

Adverse reactions encountered most often are as follows: very common (≥ 1/10), common (≥ 1/100 to 
< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not 
known (cannot be estimated from the available data). Within each frequency grouping, undesirable 
effects are presented in order of decreasing severity. 

System Organ 
Class 
(MedDRA 
terminology)

Very common Common Uncommon Rare 

Blood and 
lymphatic 
system 
disorders

Neutropenia  Thrombocytopenia *

Metabolism 
and nutrition 
disorders 

Anorexia, loss 
of appetite, 
weight loss 



30

Psychiatric 
disorders 

Insomnia Aggressiveness, 
irritability, 
behaviour disorders, 
opposing behaviour, 
hyperexcitability, 
sleep disorders 

Nervous system 
disorders 

Drowsiness, 
ataxia, 
hypotonia, 
dystonia

Hyperkinesias 

Eye disorders Diplopia 
Gastrointestinal 
disorders 

Nausea, vomiting 

Skin and 
subcutaneous 
tissue disorders

Photosensitivity, 
rash, cutaneous 
allergy, urticaria

General 
disorders and 
administration 
site conditions 

Fatigue 

Investigations Raised γGT  Liver function test 
abnormal

* Thrombocytopenia data are derived from both clinical trials and post-marketing experience. 

Description of selected adverse reactions 

Many of the above adverse reactions are often due to an increase in plasma levels of other 
anticonvulsant medicinal products (see sections 4.4 and 4.5) and may regress when the dose of these 
medicinal products is reduced. 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

4.9 Overdose

Data on clinical overdose are not available. Treatment is supportive (symptomatic measures in 
intensive care units). 

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17 

Mechanism of action 

In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and 
bicuculline. In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid 
(GABA) - the major inhibitory neurotransmitter in mammalian brain. This could occur by inhibition 
of synaptosomal uptake of GABA and/or inhibition of GABA transaminase. Stiripentol has also been 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


31

shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and 
increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a 
barbiturate-like mechanism. Stiripentol potentiates the efficacy of other anticonvulsants, such as 
carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result 
of pharmacokinetic interactions. The second effect of stiripentol is mainly based on metabolic 
inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic 
metabolism of other anti-epileptic medicines. 

Clinical efficacy and safety 

The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 

A French compassionate use program included children from 6 months of age because the diagnosis 
of Dravet’s syndrome may be made with confidence at that age in some patients. The clinical decision 
for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual 
patient basis taking into consideration the potential clinical benefits and risks (see section 4.2). 

41 children with SMEI were included in a randomised, placebo-controlled, add-on trial. After a 
baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam 
during a double-blind period of 2 months. Patients then received stiripentol in an open fashion. 
Responders were defined as having more than 50% reduction in the frequency of clonic (or tonic-
clonic) seizures during the second month of the double-blind period compared with baseline. 
15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic 
seizures), whereas there was only one (5%) on placebo (none was seizure free; stiripentol 95% CI 
52.1-90.7 vs. placebo 0-14.6). The 95% CI of the difference was 42.2-85.7. Percentage of change 
from baseline was higher on stiripentol (-69%) than on placebo (+7%), p<0.0001. 21 patients on 
stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, 
but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases 
(Chiron et al, Lancet, 2000).  

There are no clinical study data to support the clinical safety of stiripentol administered at daily doses 
greater than 50 mg/kg/day.  
There are no clinical study data to support the use of stiripentol as monotherapy in Dravet’s 
syndrome. 

5.2 Pharmacokinetic properties

The following pharmacokinetic properties of stiripentol have been reported from studies in adult 
healthy volunteers and adult patients. 

Absorption 

Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours. The 
absolute bioavailability of stiripentol is not known since an intravenous formulation is not available 
for testing. It is well absorbed by the oral route since the majority of an oral dose is excreted in urine. 

Relative bioavailability between the capsules and powder for oral suspension in sachet formulations 
has been studied in healthy male volunteers after a 1,000 mg single oral administration. The two 
formulations were bioequivalent in terms of AUC but not in terms of Cmax. Cmax of the sachet was 
slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence. Tmax
was similar with both formulations. Clinical supervision is recommended if switching between the 
stiripentol capsule and powder for oral suspension in sachet formulations. 

Distribution 

Stiripentol binds extensively to circulating plasma proteins (about 99%). 



32

Elimination 

Systemic exposure to stiripentol increases markedly compared to dose proportionality. Plasma 
clearance decreases markedly at high doses; it falls from approximately 40 l/kg/day at the dose of 
600 mg/day to about 8 l/kg/day at the dose of 2,400 mg. Clearance is decreased after repeated 
administration of stiripentol, probably due to inhibition of the cytochrome P450 isoenzymes 
responsible for its metabolism. The half-life of elimination was in the range of 4.5 hours to 13 hours, 
increasing with dose. 

Biotransformation 

Stiripentol is extensively metabolized, 13 different metabolites having been found in urine. The main 
metabolic processes are demethylenation and glucuronidation, although precise identification of the 
enzymes involved has not yet been achieved. 
On the basis of in vitro studies, the principal liver cytochrome P450 isoenzymes involved in phase 1 
metabolism are considered to be CYP1A2, CYP2C19 and CYP3A4. 

Excretion 

Most stiripentol is excreted via the kidney. 
Urinary metabolites of stiripentol accounted collectively for the majority (73%) of an oral acute dose 
whereas a further 13-24% was recovered in faeces as unchanged substance. 

Paediatric population pharmacokinetic study 

A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with 
stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and 
clobazam. The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of 
stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses. 

The data were best fitted with a one compartment model with first order absorption and elimination 
processes. The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard 
deviation of random effect = 122%). Clearance and volume of distribution were related to body 
weight by an allometric model with exponents of 0.433 and 1, respectively: as body weight increased 
from 10 to 60 kg, apparent oral clearance increased from 2.60 to 5.65 L/hr and apparent volume of 
distribution increased from 32.0 to 191.8 L. As a result, elimination half-life increased from 8.5hr (for 
10 kg) to 23.5 hr (for 60 kg). 

5.3 Preclinical safety data

Toxicity studies in animals (rat, monkey, mouse) have not revealed any consistent pattern of toxicity 
apart from liver enlargement associated with hepatocellular hypertrophy, which occurred when high 
doses of stiripentol were administered to both rodents and nonrodents. This finding is considered to 
be an adaptive response to a high metabolic burden on the liver.  
Stiripentol was not teratogenic when tested in the rat and rabbit; in one study in the mouse, but not in 
several other similar studies, a low incidence of cleft palate formation was observed at a maternotoxic 
dose (800 mg/kg/day). These studies in mice and rabbits were undertaken prior to the introduction of 
Good Laboratory Practice requirements. Studies in the rat on fertility and general reproductive 
performance and on pre- and postnatal development were uneventful except for a minor reduction in 
the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 
800 mg/kg/day (see section 4.6).  
Genotoxicity studies have not detected any mutagenic or clastogenic activity.  
Carcinogenicity studies gave negative results in the rat. In the mouse there was only a small increase 
in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600 mg/kg/day 
for 78 weeks but not in those given 60 mg/kg/day. In view of the lack of genotoxicity of stiripentol 
and the well known, special susceptibility of the mouse liver to tumour formation in the presence of 



33

hepatic enzyme induction, this finding is not considered to indicate a risk of tumorigenicity in 
patients. 

6. PHARMACEUTICAL PARTICULARS 

6.1 List of excipients

Povidone (K29/32) 
Sodium starch glycolate type A 
Glucose liquid, spray dried 
Erythrosine (E127) 
Titanium dioxide (E171) 
Aspartame (E951) 
Tutti frutti flavour (contains sorbitol) 
Carmellose sodium 
Hydroxyethylcellulose 

6.2 Incompatibilities

Not applicable. 

6.3 Shelf life

3 years 

6.4 Special precautions for storage 

Store in the original package in order to protect from light. 

6.5 Nature and contents of container 

Sachets are made with a composite paper/aluminium/polyethylene film.  
Boxes of 30, 60 and 90 sachets. 
Not all pack sizes may be marketed.

6.6 Special precautions for disposal 

No special requirements. 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 

7. MARKETING AUTHORISATION HOLDER

Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France. 

8. MARKETING AUTHORISATION NUMBER(S)  

EU/1/06/367/007-9 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 04 January 2007 
Date of latest renewal: 24 September 2018 



34

10. DATE OF REVISION OF THE TEXT 

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 

http://www.ema.europa.eu/


35

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 500 mg powder for oral suspension in sachet 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 500 mg of stiripentol. 

Excipient with known effect  

0.22 mg sodium per sachet. 
Each sachet contains 5 mg of aspartame, 1,000 mg of glucose liquid spray and 4.8 mg of sorbitol. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM

Powder for oral suspension 
Pale pink crystalline powder

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of 
refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy 
(SMEI, Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and 
valproate. 

4.2 Posology and method of administration 

Diacomit should only be administered under the supervision of a paediatrician / paediatric neurologist 
experienced in the diagnosis and management of epilepsy in infants and children.  

Posology 

The dose of stiripentol is calculated on a mg/kg body weight basis. 

The daily dosage may be administered in 2 or 3 divided doses. 

The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards 
dose escalation to reach the recommended dose of 50 mg/kg/day administered in conjunction with 
clobazam and valproate.  

Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 
30mg/kg/day for 1 week.  Further dosage escalation is age dependent: 
- children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus 
achieving the recommended dose of 50 mg/kg/day in three weeks; 
- children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus 
achieving the recommended dose of 50 mg/kg/day in four weeks; 
- children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week 
until the optimum dose is reached based on clinical judgment. 



36

The recommended dose of 50 mg/kg/day is based on the available clinical study findings and was the 
only dose of Diacomit evaluated in the pivotal studies (see section 5.1). 

Stiripentol must always be taken with food as it degrades rapidly in an acidic environment (e.g. 
exposure to gastric acid in an empty stomach). 
Stiripentol should not be taken with milk or dairy products (yoghurt, soft cream cheese, etc.), 
carbonated drinks, fruit juice or food and drinks that contain caffeine or theophylline. 

Children aged less than 3 years 
The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 
The clinical decision for use of stiripentol in children with SMEI less than 3 years of age needs to be 
made on an individual patient basis taking into consideration the potential clinical benefits and risks. 
In this younger group of patients, adjunctive therapy with Diacomit should only be started when the 
diagnosis of SMEI has been clinically confirmed (see section 5.1). Data are limited about the use of 
stiripentol under 12 months of age. In these children, the use of stiripentol will be done under the 
close supervision of the doctor. 

Patients aged ≥ 18 years of age 
Long-term data has not been collected in a sufficient number of adults to confirm maintenance of 
effect in this population. Treatment should be continued for as long as efficacy is observed. 

Dose adjustments of other antiepileptics used in combination with stiripentol 

Despite the absence of comprehensive pharmacology data on potential drug interactions, the 
following advice regarding modification of the dose and dosage schedules of other anti-epileptic 
medicinal products administered in conjunction with stiripentol is provided based on clinical 
experience. 

- Clobazam 
In the pivotal studies, when the use of stiripentol was initiated, the daily dose of clobazam was 
0.5 mg/kg/day usually administered in divided doses, twice daily. In the event of clinical signs of 
adverse reactions or overdose of clobazam (i.e., drowsiness, hypotonia, and irritability in young 
children), this daily dose was reduced by 25% every week. Approximately two to three-fold increases 
in clobazam and five-fold increases in norclobazam plasma levels respectively have been reported 
with co-administration of stiripentol in children with Dravet’s syndrome. 

- Valproate 
The potential for metabolic interaction between stiripentol and valproate is considered modest and 
thus, no modification of valproate dosage should be needed when stiripentol is added, except for 
clinical safety reasons. In the pivotal studies in the event of gastrointestinal adverse reactions such as 
loss of appetite, loss of weight, the daily dose of valproate was reduced by around 30% every week. 

Abnormal laboratory findings 
In the event of an abnormal blood count or liver function test finding, the clinical decision for 
continuing use or adjusting the dose of stiripentol in conjunction with adjusting the doses of clobazam 
and valproate needs to be made on an individual patient basis taking into consideration the potential 
clinical benefits and risks (see section 4.4). 

Effect of formulation 
The sachet formulation has a slightly higher Cmax than the capsules and thus the formulations are not 
bioequivalent. It is recommended that if a switch of formulations is required this is done under 
clinical supervision, in case of problems with tolerability (see section 5.2). 

Renal and hepatic impairment 
Stiripentol is not recommended for use in patients with impaired hepatic and/or renal function (see 
section 4.4). 



37

Method of administration 

Oral use 
The powder should be mixed in a glass of water and should be taken immediately after mixing. For 
the interaction of stiripentol with food, see section 4.5. 

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
A past history of psychoses in the form of episodes of delirium. 

4.4 Special warnings and precautions for use

Carbamazepine, phenytoin and phenobarbital 

These substances should not be used in conjunction with stiripentol in the management of Dravet’s 
syndrome. The daily dosage of clobazam and/or valproate should be reduced according to the onset of 
side effects whilst on stiripentol therapy (see section 4.2). 

Growth rate of children 

Given the frequency of gastrointestinal adverse reactions to treatment with stiripentol and valproate 
(anorexia, loss of appetite, nausea, vomiting), the growth rate of children under this combination of 
treatment should be carefully monitored. 

Blood count 

Neutropenia may be associated with the administration of stiripentol, clobazam and valproate. Blood 
counts should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically 
indicated, blood counts should be checked every 6 months. 

Liver function 

It should be assessed prior to starting treatment with stiripentol. Unless otherwise clinically indicated, 
liver function should be checked every 6 months. 

Hepatic or renal impairment 

In the absence of specific clinical data in patients with impaired hepatic or renal function, stiripentol 
is not recommended for use in patients with impaired hepatic and/or renal function (see section 4.2). 

Substances interfering with CYP enzymes 

Stiripentol is an inhibitor of the enzymes CYP2C19, CYP3A4 and CYP2D6 and may markedly 
increase the plasma concentrations of substances metabolised by these enzymes and increase the risk 
of adverse reactions (see section 4.5). In vitro studies suggested that stiripentol phase 1 metabolism is 
catalyzed by CYP1A2, CYP2C19 and CYP3A4 and possibly other enzymes. Caution is advised when 
combining stiripentol with other substances that inhibit or induce one or more of these enzymes. 

Paediatric population 

The pivotal clinical studies did not include children below 3 years old. As a consequence, it is 
recommended that children between 6 months and 3 years of age are carefully monitored whilst on 
Diacomit therapy. 



38

Diacomit powder for oral suspension in sachet contains aspartame, a source of phenylalanine. Neither 
non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. 
Therefore it may be harmful for people with phenylketonuria. Patients with rare glucose-galactose 
malabsorption should not take this medicine, as the formulation contains glucose. As the flavouring 
component contains small amount of sorbitol, patients with hereditary problems of fructose 
intolerance should not take this medicine. 

4.5 Interaction with other medicinal products and other forms of interaction

Potential medicinal product interactions affecting stiripentol 

The influence of other antiepileptic medicinal products on stiripentol pharmacokinetics is not well 
established. 
The impact of macrolides and azole antifungal medicinal product on stiripentol metabolism, that are 
known to be inhibitors of CYP3A4 and substrates of the same enzyme, is not known. Likewise, the 
effect of stiripentol on their metabolism is not known. 

In vitro studies suggested that stiripentol phase 1 metabolism is catalyzed by CYP1A2, CYP2C19 and 
CYP3A4 and possibly other enzymes. Caution is advised when combining stiripentol with other 
substances that inhibit or induce one or more of these enzymes. 

Effect of stiripentol on cytochrome P450 enzymes 

Many of these interactions have been partially confirmed by in vitro studies and in clinical trials. The 
increase in steady state levels with the combined use of stiripentol, valproate, and clobazam is similar 
in adults and children, though inter-individual variability is marked. 

At therapeutic concentrations, stiripentol significantly inhibits several CYP450 isoenzymes: for 
example, CYP2C19, CYP2D6 and CYP3A4. As a result, pharmacokinetic interactions of metabolic 
origin with other medicines may be expected. These interactions may result in increased systemic 
levels of these active substances that may lead to enhanced pharmacological effects and to an increase 
in adverse reactions. 

Caution must be exercised if clinical circumstances require combining stiripentol with substances 
metabolised by CYP2C19 (e.g. citalopram, omeprazole) or CYP3A4 (e.g. several HIV protease 
inhibitors, antihistamines such as astemizole and chlorpheniramine, calcium channel blockers, statins, 
oral contraceptives, codeine) due to the increased risk of adverse reactions (see further in this section 
for antiepileptic medicines). Monitoring of plasma concentrations or adverse reactions is 
recommended. A dose adjustment may be necessary. 

Co-administration with CYP3A4 substrates with a narrow therapeutic index should be avoided due to 
the markedly increased risk of severe adverse reactions.  

Data on the potential for inhibition of CYP1A2 are limited, and therefore, interactions with 
theophylline and caffeine cannot be excluded because of increased plasma levels of theophylline and 
caffeine which may occur via inhibition of their hepatic metabolism, potentially leading to toxicity. 
Use in combination with stiripentol is not recommended. This warning is not only restricted to 
medicinal products but also to a considerable number of foods and nutritional products aimed at 
children: Patient should not drink cola drinks, which contain significant quantities of caffeine or 
chocolate, which contains trace amounts of theophylline (see section 4.2). 

As stiripentol inhibited CYP2D6 in vitro at concentrations that are achieved clinically in plasma, 
substances that are metabolized by this isoenzyme like: beta-blockers (propranolol, carvedilol, 
timolol), antidepressants (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), 
antipsychotics (haloperidol), analgesics (codeine, dextromethorphan, tramadol) may be subject to 
metabolic interactions with stiripentol. A dose-adjustment may be necessary for substances 
metabolised by CYP2D6 and that are individually dose titrated. 



39

Potential for stiripentol to interact with other medicinal products 

In the absence of available clinical data, caution should be taken with the following clinically relevant 
interactions with stiripentol: 

Undesirable combinations (to be avoided unless strictly necessary) 
- Rye ergot alkaloids (ergotamine, dihydroergotamine) 
Ergotism with possibility of necrosis of the extremities (inhibition of hepatic elimination of rye ergot). 

- Cisapride, halofantrine, pimozide, quinidine, bepridil 
Increased risk of cardiac arrhythmias and torsades de pointes/wave burst arrhythmia in particular. 

- Immunosuppressants (tacrolimus, cyclosporine, sirolimus) 
Raised blood levels of immunosuppressants (decreased hepatic metabolism). 

- Statins (atorvastatin, simvastatin, etc.) 
Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic 
metabolism of cholesterol-lowering medicinal product).  

Combinations requiring precautions 

- Midazolam, triazolam, alprazolam 
Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to 
excessive sedation. 

- Chlorpromazine 
Stiripentol enhances the central depressant effect of chlorpromazine. 

- Effects on other antiepileptic drugs (AEDs) 
Inhibition of CYP450 isoenzyme CYP2C19 and CYP3A4 may provoke pharmacokinetic interactions 
(inhibition of their hepatic metabolism) with phenobarbital, primidone, phenytoin, carbamazepine, 
clobazam (see section 4.2), valproate (see section 4.2), diazepam (enhanced myorelaxation), 
ethosuximide, and tiagabine. The consequences are increased plasma levels of these anticonvulsants 
with potential risk of overdose. Clinical monitoring of plasma levels of other anticonvulsants when 
combined with stiripentol with possible dose adjustments is recommended. 

- Topiramate 
In a French compassionate use program for stiripentol, topiramate was added to stiripentol, clobazam 
and valproate in 41% of 230 cases. Based on the clinical observations in this group of patients, there 
is no evidence to suggest that a change in topiramate dose and dosage schedules is needed if co-
administered with stiripentol. 
With regard to topiramate, it is considered that potential competition of inhibition on CYP2C19 
should not occur because it probably requires plasma concentrations 5-15 times higher than plasma 
concentrations obtained with the standard recommended topiramate dose and dosage schedules. 

- Levetiracetam 
Levetiracetam does not undergo hepatic metabolism to a major extent. As a result, no 
pharmacokinetic metabolic drug interaction between stiripentol and levetiracetam is anticipated. 

4.6 Fertility, pregnancy and lactation

Pregnancy 

Risk related to epilepsy and antiepileptic medicinal products in general 
It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is 
two to three times greater than the rate of approximately 3% in the general population. Although other 



40

factors, e.g. the epilepsy, can contribute, available evidence suggests that this increase, to a large 
extent, is caused by the treatment. In the treated population, an increase in malformations has been 
noted with polytherapy. 
However, effective anti-epileptic therapy should not be interrupted during pregnancy, since the 
aggravation of the illness may be detrimental to both the mother and the foetus. 

Risk related to stiripentol 
No data on exposed pregnancies are available. Animal studies do not indicate direct or indirect 
harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at 
non-maternotoxic doses (see section 5.3). In view of the indication, administration of stiripentol 
during pregnancy and in women of childbearing potential would not be expected. The clinical 
decision for use of stiripentol in pregnancy needs to be made on an individual patient basis taking into 
consideration the potential clinical benefits and risks. Caution should be exercised when prescribing 
to pregnant women and use of efficient methods of contraception is advisable. 

Breastfeeding 

In the absence of human studies on excretion in breast milk, and given that stiripentol passes freely 
from plasma into milk in the goat, breast-feeding is not recommended during treatment. In case 
stiripentol therapy is continued during breast-feeding, the breast-fed infant should be carefully 
observed for potential adverse effects. 

Fertility 

No impact on fertility was detected in animal studies (see section 5.3). No clinical data are available, 
potential risk for human is unknown. 

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, 
some patients may experience dizziness and ataxia that may affect ability to drive and use machines 
and patients should not drive or use machinery whilst on stiripentol therapy. 

4.8 Undesirable effects 

Summary of the safety profile 

The most common side effects with stiripentol are anorexia, weight loss, insomnia, drowsiness, 
ataxia, hypotonia and dystonia. 

Tabulated list of adverse reactions 

Adverse reactions encountered most often are as follows: very common (≥ 1/10), common (≥ 1/100 to 
< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not 
known (cannot be estimated from the available data). Within each frequency grouping, undesirable 
effects are presented in order of decreasing severity. 

System Organ 
Class 
(MedDRA 
terminology)

Very common Common Uncommon Rare 

Blood and 
lymphatic 
system 
disorders

Neutropenia  Thrombocytopenia 
* 



41

Metabolism 
and nutrition 
disorders 

Anorexia, loss 
of appetite, 
weight loss 

Psychiatric 
disorders 

Insomnia Aggressiveness, 
irritability, behaviour 
disorders, opposing 
behaviour, 
hyperexcitability, 
sleep disorders 

Nervous system 
disorders 

Drowsiness, 
ataxia, 
hypotonia, 
dystonia

Hyperkinesias 

Eye disorders Diplopia 
Gastrointestinal 
disorders 

Nausea, vomiting 

Skin and 
subcutaneous 
tissue disorders

Photosensitivity, 
rash, cutaneous 
allergy, urticaria

General 
disorders and 
administration 
site conditions 

Fatigue 

Investigations Raised γGT  Liver function test 
abnormal

* Thrombocytopenia data are derived from both clinical trials and post-marketing experience. 

Description of selected adverse reactions 

Many of the above adverse reactions are often due to an increase in plasma levels of other 
anticonvulsant medicinal products (see sections 4.4 and 4.5) and may regress when the dose of these 
medicinal products is reduced.

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

4.9 Overdose

Data on clinical overdose are not available. Treatment is supportive (symptomatic measures in 
intensive care units). 

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX17 

Mechanism of action 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


42

In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and 
bicuculline. In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid 
(GABA) - the major inhibitory neurotransmitter in mammalian brain. This could occur by inhibition 
of synaptosomal uptake of GABA and/or inhibition of GABA transaminase. Stiripentol has also been 
shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and 
increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a 
barbiturate-like mechanism. Stiripentol potentiates the efficacy of other anticonvulsants, such as 
carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result 
of pharmacokinetic interactions. The second effect of stiripentol is mainly based on metabolic 
inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic 
metabolism of other anti-epileptic medicines. 

Clinical efficacy and safety 

The pivotal clinical evaluation of stiripentol was in children of 3 years of age and over with SMEI. 

A French compassionate use program included children from 6 months of age because the diagnosis 
of Dravet’s syndrome may be made with confidence at that age in some patients. The clinical decision 
for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual 
patient basis taking into consideration the potential clinical benefits and risks (see section 4.2). 

41 children with SMEI were included in a randomised, placebo-controlled, add-on trial. After a 
baseline period of 1 month, placebo (n=20) or stiripentol (n=21) was added to valproate and clobazam 
during a double-blind period of 2 months. Patients then received stiripentol in an open fashion. 
Responders were defined as having more than 50% reduction in the frequency of clonic (or tonic-
clonic) seizures during the second month of the double-blind period compared with baseline. 
15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic 
seizures), whereas there was only one (5%) on placebo (none was seizure free; stiripentol 95% CI 
52.1-90.7 vs. placebo 0-14.6). The 95% CI of the difference was 42.2-85.7. Percentage of change 
from baseline was higher on stiripentol (-69%) than on placebo (+7%), p<0.0001. 21 patients on 
stiripentol had moderate side-effects (drowsiness, loss of appetite) compared with eight on placebo, 
but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases 
(Chiron et al, Lancet, 2000).  

There are no clinical study data to support the clinical safety of stiripentol administered at daily doses 
greater than 50 mg/kg/day.  
There are no clinical study data to support the use of stiripentol as monotherapy in Dravet’s 
syndrome. 

5.2 Pharmacokinetic properties

The following pharmacokinetic properties of stiripentol have been reported from studies in adult 
healthy volunteers and adult patients. 

Absorption  

Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours. The 
absolute bioavailability of stiripentol is not known since an intravenous formulation is not available 
for testing. It is well absorbed by the oral route since the majority of an oral dose is excreted in urine. 

Relative bioavailability between the capsules and powder for oral suspension in sachet formulations 
has been studied in healthy male volunteers after a 1,000 mg single oral administration. The two 
formulations were bioequivalent in terms of AUC but not in terms of Cmax. Cmax of the sachet was 
slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence. Tmax
was similar with both formulations. Clinical supervision is recommended if switching between the 
stiripentol capsule and powder for oral suspension in sachet formulations. 



43

Distribution 

Stiripentol binds extensively to circulating plasma proteins (about 99%). 

Elimination 

Systemic exposure to stiripentol increases markedly compared to dose proportionality. Plasma 
clearance decreases markedly at high doses; it falls from approximately 40 l/kg/day at the dose of 
600 mg/day to about 8 l/kg/day at the dose of 2,400 mg. Clearance is decreased after repeated 
administration of stiripentol, probably due to inhibition of the cytochrome P450 isoenzymes 
responsible for its metabolism. The half-life of elimination was in the range of 4.5 hours to 13 hours, 
increasing with dose. 

Biotransformation 

Stiripentol is extensively metabolized, 13 different metabolites having been found in urine. The main 
metabolic processes are demethylenation and glucuronidation, although precise identification of the 
enzymes involved has not yet been achieved. 
On the basis of in vitro studies, the principal liver cytochrome P450 isoenzymes involved in phase 1 
metabolism are considered to be CYP1A2, CYP2C19 and CYP3A4. 

Excretion 

Most stiripentol is excreted via the kidney. 
Urinary metabolites of stiripentol accounted collectively for the majority (73%) of an oral acute dose 
whereas a further 13-24% was recovered in faeces as unchanged substance. 

Paediatric population pharmacokinetic study 

A population pharmacokinetic study was conducted in 35 children with Dravet Syndrome treated with 
stiripentol and two substances not known to affect stiripentol pharmacokinetics, valproate and 
clobazam. The median age was 7.3 years (range: 1 to 17.6 years) and the median daily dose of 
stiripentol was 45.4 mg/kg/day (range: 27.1 to 89.3 mg/kg/day) received in two or three divided doses. 

The data were best fitted with a one compartment model with first order absorption and elimination 
processes. The population estimate for the absorption rate constant Ka was 2.08 hr-1 (standard 
deviation of random effect = 122%). Clearance and volume of distribution were related to body 
weight by an allometric model with exponents of 0.433 and 1, respectively: as body weight increased 
from 10 to 60 kg, apparent oral clearance increased from 2.60 to 5.65 L/hr and apparent volume of 
distribution increased from 32.0 to 191.8 L. As a result, elimination half-life increased from 8.5hr (for 
10 kg) to 23.5 hr (for 60 kg). 

5.3 Preclinical safety data

Toxicity studies in animals (rat, monkey, mouse) have not revealed any consistent pattern of toxicity 
apart from liver enlargement associated with hepatocellular hypertrophy, which occurred when high 
doses of stiripentol were administered to both rodents and nonrodents. This finding is considered to 
be an adaptive response to a high metabolic burden on the liver.  
Stiripentol was not teratogenic when tested in the rat and rabbit; in one study in the mouse, but not in 
several other similar studies, a low incidence of cleft palate formation was observed at a maternotoxic 
dose (800 mg/kg/day). These studies in mice and rabbits were undertaken prior to the introduction of 
Good Laboratory Practice requirements. Studies in the rat on fertility and general reproductive 
performance and on pre- and postnatal development were uneventful except for a minor reduction in 
the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 
800 mg/kg/day (see section 4.6).  
Genotoxicity studies have not detected any mutagenic or clastogenic activity.  



44

Carcinogenicity studies gave negative results in the rat. In the mouse there was only a small increase 
in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600 mg/kg/day 
for 78 weeks but not in those given 60 mg/kg/day. In view of the lack of genotoxicity of stiripentol 
and the well known, special susceptibility of the mouse liver to tumour formation in the presence of 
hepatic enzyme induction, this finding is not considered to indicate a risk of tumorigenicity in 
patients. 
6. PHARMACEUTICAL PARTICULARS 

6.1 List of excipients

Povidone (K29/32) 
Sodium starch glycolate type A 
Glucose liquid, spray dried 
Erythrosine (E127) 
Titanium dioxide (E171) 
Aspartame (E951) 
Tutti frutti flavour (contains sorbitol) 
Carmellose sodium 
Hydroxyethylcellulose 

6.2 Incompatibilities

Not applicable. 

6.3 Shelf life

3 years 

6.4 Special precautions for storage

Store in the original package in order to protect from light.  

6.5 Nature and contents of container 

Sachets are made with a composite paper/aluminium/polyethylene film.  
Boxes of 30, 60 and 90 sachets. 
Not all pack sizes may be marketed.

6.6 Special precautions for disposal 

No special requirements. 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 

7. MARKETING AUTHORISATION HOLDER

Biocodex, 7 Avenue Gallieni, 94250 Gentilly, France. 

8. MARKETING AUTHORISATION NUMBER(S)  

EU/1/06/367/010-12 



45

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 04 January 2007 
Date of latest renewal: 24 September 2018 

10. DATE OF REVISION OF THE TEXT 

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu

http://www.ema.europa.eu/


46

ANNEX II

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION  

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



47

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer responsible for batch release 

Laboratoires BIOCODEX 
1 avenue Blaise Pascal,  
60000 Beauvais 
FRANCE 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

Periodic safety update reports (PSURs) 

The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT  

Risk management plan (RMP) 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing 
authorisation and any agreed subsequent updates of the RMP. 

An updated RMP should be submitted: 
 At the request of the European medicine Agency;  
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached.  



48

ANNEX III 

LABELLING AND PACKAGE LEAFLET 



49

A. LABELLING 



50

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 250 mg hard capsules 
stiripentol 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

1 capsule contains 250 mg stiripentol. 

3. LIST OF EXCIPIENTS

Contains sodium. 

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules 
60 hard capsules 
90 hard capsules 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
For oral use. 
These capsules should be swallowed whole with water. The capsules should not be chewed. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light. 



51

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

BIOCODEX 
7 avenue Gallieni 
94250 Gentilly 
France 
Tel: + 33 1 41 24 30 00 
e-mail: medinfo@biocodex.com 

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/06/367/001 30 hard capsules 
EU/1/06/367/002 60 hard capsules 
EU/1/06/367/003 90 hard capsules 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Diacomit 250 mg hard capsules 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code] 
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal 
product]



52

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING  

BOTTLE LABEL TEXT  

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 250 mg hard capsules 
stiripentol 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

1 capsule contains 250 mg stiripentol. 

3. LIST OF EXCIPIENTS

Contains sodium 

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules 
60 hard capsules 
90 hard capsules 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
For oral use. 
These capsules should be swallowed whole with water. The capsules should not be chewed. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light. 



53

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

BIOCODEX 
7 avenue Gallieni 
94250 Gentilly 
France 
Tel: + 33 1 41 24 30 00 
e-mail: medinfo@biocodex.com 

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/06/367/001 30 hard capsules 
EU/1/06/367/002 60 hard capsules 
EU/1/06/367/003 90 hard capsules 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE



54

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 500 mg hard capsules 
stiripentol 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

1 capsule contains 500 mg stiripentol. 

3. LIST OF EXCIPIENTS

Contains sodium.  

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules 
60 hard capsules 
90 hard capsules 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
For oral use. 
These capsules should be swallowed whole with water. The capsules should not be chewed. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light. 



55

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

BIOCODEX 
7 avenue Gallieni 
94250 Gentilly 
France 
Tel: + 33 1 41 24 30 00 
e-mail: medinfo@biocodex.com 

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/06/367/004 30 hard capsules 
EU/1/06/367/005 60 hard capsules 
EU/1/06/367/006 90 hard capsules 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Diacomit 500 mg hard capsules 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code] 
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal 
product]



56

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 

BOTTLE LABEL TEXT  

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 500 mg hard capsules 
stiripentol 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

1 capsule contains 500 mg stiripentol. 

3. LIST OF EXCIPIENTS

Contains sodium.  

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

30 hard capsules 
60 hard capsules 
90 hard capsules 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
For oral use. 
These capsules should be swallowed whole with water. The capsules should not be chewed. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light. 



57

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

BIOCODEX 
7 avenue Gallieni 
94250 Gentilly 
France 
Tel: + 33 1 41 24 30 00 
e-mail: medinfo@biocodex.com 

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/06/367/004 30 hard capsules 
EU/1/06/367/005 60 hard capsules 
EU/1/06/367/006 90 hard capsules 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE



58

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 250 mg powder for oral suspension in sachet 
stiripentol 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

1 sachet contains 250 mg stiripentol. 

3. LIST OF EXCIPIENTS

Aspartame (E951) 
Sorbitol 
Glucose liquid spray dried 
Sodium 

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension in sachet 
30 sachets  
60 sachets  
90 sachets  

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
For oral use. 
The powder should be mixed in a glass of water and should be taken immediately after mixing during 
a meal. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 



59

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light. 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

BIOCODEX 
7 avenue Gallieni 
94250 Gentilly 
France 
Tel: + 33 1 41 24 30 00 
e-mail: medinfo@biocodex.com 

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/06/367/007 30 sachets 
EU/1/06/367/008 60 sachets 
EU/1/06/367/009 90 sachets 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Diacomit 250 mg powder for oral suspension 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code] 
SN: {number} [serial number]



60

NN: {number} [national reimbursement number or other national number identifying the medicinal 
product]



61

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

SACHET LABEL TEXT  

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

Diacomit 250 mg powder for oral suspension in sachet 
stiripentol
Oral use. 

2. METHOD OF ADMINISTRATION 

Read the package leaflet before use. 

3. EXPIRY DATE 

EXP 

4. BATCH NUMBER 

Lot 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

250 mg 

6. OTHER 

Store in the original package in order to protect from light. 



62

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Diacomit 500 mg powder for oral suspension in sachet 
stiripentol 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

1 sachet contains 500 mg stiripentol. 

3. LIST OF EXCIPIENTS

Aspartame (E951) 
Sorbitol 
Glucose liquid spray dried 
Sodium  

See leaflet for further information. 

4. PHARMACEUTICAL FORM AND CONTENTS

Powder for oral suspension in sachet 
30 sachets  
60 sachets 90 sachets  

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
For oral use. 
The powder should be mixed in a glass of water and should be taken immediately after mixing during 
a meal. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 



63

9. SPECIAL STORAGE CONDITIONS

Store in the original package in order to protect from light. 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

BIOCODEX 
7 avenue Gallieni 
94250 Gentilly 
France 
Tel: + 33 1 41 24 30 00 
e-mail: medinfo@biocodex.com 

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/06/367/010 30 sachets 
EU/1/06/367/011 60 sachets 
EU/1/06/367/012 90 sachets 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Diacomit 500 mg powder for oral suspension 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: {number} [product code] 
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal 
product]



64

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

SACHET LABEL TEXT  

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

Diacomit 500 mg powder for oral suspension in sachet 
stiripentol
Oral use. 

2. METHOD OF ADMINISTRATION 

Read the package leaflet before use. 

3. EXPIRY DATE 

EXP 

4. BATCH NUMBER 

Lot 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

500 mg 

6. OTHER 

Store in the original package in order to protect from light. 



65

B. PACKAGE LEAFLET 



66

Package leaflet: Information for the user

Diacomit 250 mg hard capsule 
Diacomit 500 mg hard capsule 

stiripentol 

Read all of this leaflet carefully before your child starts taking this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your child’s doctor or pharmacist. 
- This medicine has been prescribed for your child only. Do not pass it on to others. It may harm 

them, even if their symptoms are the same as your child’s.
- If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any 

possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet 

1. What Diacomit is and what it is used for 
2. What you need to know before your child takes Diacomit 
3. How to take Diacomit 
4. Possible side effects 
5 How to store Diacomit 
6. Contents of the pack and other information 

1. What Diacomit is and what it is used for

Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.  

It is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain 
form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’s syndrome), which affects 
children. Your child’s doctor has prescribed this medicine to help treat your child’s epilepsy. It should 
always be taken in combination with clobazam and valproate under the direction of a doctor.  

2. What you need to know before your child takes Diacomit

Your child must NOT take Diacomit 
 if your child is allergic to stiripentol or to any of the other ingredients of this medicine (listed in 

section 6). 
 if your child has ever experienced attacks of delirium (a mental state with confusion, 

excitement, restlessness and hallucinations). 

Warnings and precautions 
Talk to your child’s doctor or pharmacist before taking Diacomit 
 if your child has kidney or liver problems. 
 Your child’s liver function should be assessed prior to starting Diacomit and checked every 6 

months. 
 Your child’s blood count should be assessed prior to starting Diacomit and checked every 6 

months. 
 Because the frequency of gastrointestinal side effect with Diacomit, clobazam and valproate, 

such as anorexia, loss of appetite, vomiting, your child’s growth rate should be carefully 
monitored. 



67

Other medicines and Diacomit 

Tell your child’s doctor or pharmacist if your child is using, has recently used or might use any other 
medicines. 

Tell your doctor if your child is taking any of the following medicines: 
 medicines containing:  
- cisapride (used to treat symptoms of night time heartburn);  
- pimozide (used to treat the symptoms of Tourette's syndrome e.g. vocal outbursts and 

uncontrolled, repeated movements of the body);  
- ergotamine (used to treat migraine);  
- dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to 

the aging process);  
- halofantrine (an antimalarial treatment);  
- quinidine (used to treat abnormal heart rhythms);  
- bepridil (used to control chest pain);  
- cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and 

heart transplants); 
- statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
- antiepileptic medicines containing: 

phenobarbital, primidone, phenytoin, carbamazepine, diazepam. 
- medicines containing:  

midazolam or triazolam (medicines used to reduce anxiety and sleeplessness – in combination 
with Diacomit they may make your child very sleepy);  
chlorpromazine (used for mental illness such as psychosis). 

- If your child takes medicines containing:  
caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in 
case of asthma). The combination with Diacomit should be avoided as it may increase their 
blood levels, leading to digestive disorders, racing heart and insomnia. 

 If your child takes medicines metabolized by certain liver enzymes: 
- citalopram (used in the treatment of depressive episodes);  
- omeprazole (used in case of gastric ulcer); 
- HIV protease inhibitors (used in the treatment of HIV); 
- astemizole, chlorpheniramine (antihistamines); 
- calcium channel blockers (used in the treatment of angor or troubles of heart rhythm);  
- oral contraceptives;  
- propranolol, carvedilol, timolol (used in the treatment of high blood pressure);  
- fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants) ;  
- haloperidol (antipsychotics);  
- codeine, dextromethorphan, tramadol (used in the treatment of pain).  

Diacomit with food and drink
Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, 
fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, 
coffee, tea and energy drinks).  

Pregnancy and breast-feeding 
If your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, 
ask your doctor for advice before taking this medicine. 
During pregnancy, effective antiepileptic treatment must NOT be stopped. 

Breast-feeding is not recommended during treatment with this medicine. 

Driving and using machines
This medicine may make your child feel sleepy. 

http://en.wikipedia.org/wiki/Anxiety
http://en.wikipedia.org/wiki/Sleep#Sleepiness


68

Your child should not use any tools, machines, ride or drive if affected in this way. Check with your 
child’s doctor.  

Diacomit contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 
‘sodium-free’. 

3. How to take Diacomit

Your child should always take these capsules exactly as your child’s doctor has told you. You should 
check with your child’s doctor or pharmacist if you are not sure.  

Dosage 
The dose is adjusted by the doctor according to your child’s age, weight and condition, generally 
50 mg per kg bodyweight and per day.  

When to take Diacomit 
Your child should take this medicine two or three times a day at regular intervals as directed by your 
child’s doctor, for example morning - noon - bed-time to cover the night-and-day period.  

Dose adjustment 
Dose increases should be gradual, taking place over a few weeks while the dose(s) of the other 
antiepileptic medicine(s) is (are) reduced at the same time. Your child’s doctor will tell you the new 
dose of the other antiepileptic medicine(s). 

If you have the impression that the effect of this medicine is too strong or too weak, talk to your 
child’s doctor or pharmacist. The dose will be adjusted by the doctor according to your child’s 
condition.  

Please consult your child’s doctor in the event of any side effects as the doctor may have to adjust the 
dose of this medicine and the other antiepileptic medicine(s). 

There are slight differences between the Diacomit capsules and powder for oral suspension. If your 
child experiences any problems when switching from taking the capsules to the powder for oral 
suspension or vice versa please inform your doctor. In case of switch between capsule and powder 
formulations it should be done under the close supervision of your child’s doctor. 

In case of vomiting within the first few minutes of intake it is assumed that no medicine has been 
absorbed and a new dose should be given. 
However, the situation is different if the vomiting occurs more than one hour after medicine intake 
because stiripentol is quickly absorbed.  
In such a case, it is assumed that a significant fraction of the administered dose has been absorbed 
systemically from the digestive tract. Thus, there would be no need for a new intake or for an 
adjustment of the next dose. 

How to take the Diacomit capsules 
These capsules should be swallowed whole with water. The capsules should not be chewed. Your 
child should take Diacomit with food, it should NOT be taken on an empty stomach. For food and 
drinks to be avoided, see the section “Diacomit with food and drink” above.  

If your child takes more Diacomit than he or she should
Contact your child’s doctor if you know or think your child has taken more medicine than he or she 
should have.  



69

If your child forgets to take Diacomit
It is important that your child takes this medicine regularly at the same time each day. If your child 
forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next 
dose. In that case carry on with the next dose as normal. Your child should not take a double dose to 
make up for a forgotten individual dose. 

If your child stops taking Diacomit
Your child must not stop taking this medicine unless the doctor tells you to. Stopping treatment 
suddenly can lead to an outbreak of seizures. 

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist. 

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

Very common side effects (may affect more than one in 10 people): 
 loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium 

valproate); 
 insomnia (sleeplessness), drowsiness; 
 ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia 

(involuntary muscle contractions). 

Common side effects (may affect up to 1 in 10 people): 
 raised levels of liver enzymes, especially when given with either of the antiepileptic medicines 

carbamazepine and sodium valproate; 
 aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable); 
 sleep disorders (abnormal sleeping); 
 hyperkinesis (exaggerated movements); 
 nausea, vomiting; 
 a low number of a type of white blood cells. 

Uncommon side effects (may affect up to 1 in 100 people): 
 double vision when used in combination with the antiepileptic medicine carbamazepine;
 sensitivity to light;
 rash, skin allergy, urticaria (pinkish, itchy swellings on the skin); 
 fatigue (tiredness).

Rare side effects (may affect up to 1 in 1,000 people)
 decrease of platelet level in the blood; 
 abnormal liver function test. 

To eliminate these side effects, your child’s doctor may have to change the dose of Diacomit or one of 
the other medicines prescribed for your child. 

Reporting of side effects 
If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any 
possible side effects not listed in this leaflet. You can also report side effects directly via the national 
reporting system listed in Appendix V. 
By reporting side effects you can help provide more information on the safety of this medicine. 

5. How to store Diacomit 

 Keep this medicine out of the sight and reach of children. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


70

 Your child should not take Diacomit after the expiry date, which is stated on the label after 
“EXP”. The expiry date refers to the last day of that month. 

 Store in the original package in order to protect from light. 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 

6. Contents of the pack and other information 

What Diacomit 250 mg contains 
 The active substance is stiripentol. Each hard capsule contains 250 mg of stiripentol. 
 The other ingredients of the capsule are povidone K29/32, sodium starch glycolate type A and 

magnesium stearate. 
 The capsule shell is made of gelatin, titanium dioxide (E171), erythrosine (E127), indigotin 

(E132). 
 The printing ink contains shellac (E904), black iron oxide (E172). 

What Diacomit 500 mg contains 
 The active substance is stiripentol. Each hard capsule contains 500 mg of stiripentol. 
 The other ingredients of the capsule are povidone K29/32, sodium starch glycolate type A and 

magnesium stearate. 
 The capsule shell is made of gelatin, titanium dioxide (E171).
 The printing ink contains shellac (E904), black iron oxide (E172).

What Diacomit 250 mg looks like and contents of the pack 
Diacomit 250 mg hard capsule is pink and imprinted with “Diacomit 250 mg”.  
The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard 
cartons. Not all pack sizes may be marketed.  

What Diacomit 500 mg looks like and contents of the pack 
Diacomit 500 mg hard capsule is white and imprinted with “Diacomit 500 mg”.  
The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard 
cartons. Not all pack sizes may be marketed.  

Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.  

Marketing Authorisation Holder  

Biocodex, 7 avenue Gallieni - F-94250 Gentilly - France 
Tel: + 33 1 41 24 30 00 - e-mail: medinfo@biocodex.com

Manufacturer  

Biocodex, 1 avenue Blaise Pascal - F-60000 Beauvais - France 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 

AT/BE/BG/CY/EL/ES/FR/HR/HU/IE/IS/IT/LU/MT/NL/PL/PT/SI/UK 
Biocodex 
7 avenue Gallieni - F-94250 Gentilly 
Франция/ Γαλλία/ France/ Francia/ Franciaország/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja 
Tél/Tel/Teл/Τηλ/Sími: + 33 (0)1 41 24 30 00  
e-mail: medinfo@biocodex.com

mailto:webar@biocodex.fr
mailto:webar@biocodex.fr


71

CZ
Desitin Pharma spol. s r.o  
Opletalova 25  
11121 Prague 1  
Czech Republic 
Tel: 00420-2-222 45 375  
e-mail: desitin@desitin.cz

DE 
Desitin Arzneimittel GmbH 
Weg beim Jäger 214 
D-22335 Hamburg  
Germany 
Tel: +49 (0)40 59101 525  
e-mail: epi.info@desitin.de 

DK 
Biocodex Oy  
Metsänneidonkuja 8 
02130 Espoo 
Finland  
Tel: +358 9 329 59100 
e-mail: info@biocodex.fi

EE 
Biocodex OÜ 
Väike-Paala 1 
11415 Tallinn 
Estonia 
Tel: +372 605 6014 
e-mail: info@biocodex.ee

FI 
Biocodex Oy  
Metsänneidonkuja 8 
02130 Espoo 
Finland  
Tel: +358 9 329 59100 
e-mail: info@biocodex.fi

LT 
Biocodex UAB 
Savanorių av. 349
LT-51480 Kaunas  
Lithuania
Tel: +370 37 408681 
e-mail: info@biocodex.lt

LV 
Biocodex SIA 
Kalniņi A, Mārupes nov., 
Mārupe, LV-2167 
Latvia 
Tel: +371 67 619365 
e-mail: info@biocodex.lv

mailto:desitin@desitin.cz
mailto:epi.info@desitin.de
mailto:info@biocodex.fi
mailto:info@biocodex.ee
mailto:info@biocodex.fi
mailto:info@biocodex.lt
mailto:info@biocodex.lv


72

NO 
Biocodex AS 
C/O regus Lysaker 
Lysaker Torg 5, 3 etg 
NO-1366 Lysaker 
Norway 
Tel: +47 66 90 55 66 
e-mail: info@biocodex.no

RO
Desitin Pharma s.r.l  
Sevastopol street, no 13-17  
Diplomat Business Centre, office 102  
Sector 1, 010991 Bucharest  
Romania  
Tel: 004021-252-3481  
e-mail: office@desitin.ro

SE 
Biocodex AB 
Knarrnäsgatan 7 
164 40 Kista 
Sweden 
Tel: +46 8 615 2760 
e-mail: info@biocodex.se

SK
Desitin Pharma s.r.o.  
Trojicné námestie 13  
82106 Bratislava  
Slovakia 
Tel: 00421-2-5556 38 10  
e-mail: desitin@desitin.sk

This leaflet was last revised in  

Other sources of information 

Detailed information on this medicine is available on the European Medicine Agency website: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

mailto:info@biocodex.no
mailto:office@desitin.ro
mailto:info@biocodex.se
mailto:desitin@desitin.sk


73

Package leaflet: information for the user

Diacomit 250 mg powder for oral suspension in sachet 
Diacomit 500 mg powder for oral suspension in sachet 

stiripentol 

Read all of this leaflet carefully before your child starts taking this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your child’s doctor or pharmacist. 
- This medicine has been prescribed for your child only. Do not pass it on to others. It may harm 

them, even if their symptoms are the same as your child’s.
- If your child gets any  side effects, talk to your child’s doctor or pharmacist. This includes any 

possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet:
1. What Diacomit is and what it is used for 
2. What you need to know before your child takes Diacomit 
3. How to take Diacomit 
4. Possible side effects 
5 How to store Diacomit 
6. Contents of the pack and other information 

1. What Diacomit is and what it is used for

Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.  

It is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain 
form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’s syndrome), which affects 
children. Your child’s doctor has prescribed this medicine to help treat your child’s epilepsy. It should 
always be taken in combination with clobazam and valproate under the direction of a doctor.  

2. What you need to know before your child takes Diacomit

Your child must NOT take Diacomit 
 if your child is allergic to stiripentol or to any of the other ingredients of this medicine (listed in 

section 6). 
 if your child has ever experienced attacks of delirium (a mental state with confusion, 

excitement, restlessness and hallucinations). 

Warnings and precautions  
Talk to your child’s doctor or pharmacist before taking Diacomit 
 if your child has kidney or liver problems. 
 Your child’s liver function should be assessed prior to starting Diacomit and checked every 6 

months. 
 Your child’s blood count should be assessed prior to starting Diacomit and checked every 6 

months. 
 Because of the frequency of gastrointestinal side effects with Diacomit, clobazam and 

valproate, such as anorexia, loss of appetite, vomiting, your child’s growth rate should be 
carefully monitored. 

If your child has problems with certain ingredients of Diacomit (e.g. aspartame, glucose, sorbitol). In 
this case, please see below: “Important information about some of the ingredients of Diacomit”. 



74

Other medicines and Diacomit 

Tell your child’s doctor or pharmacist if your child is using, has recently used or might use any other 
medicines. 
Tell your doctor if your child is taking any of the following medicines: 
 medicines containing:  
- cisapride (used to treat symptoms of night time heartburn);  
- pimozide (used to treat the symptoms of Tourette's syndrome e.g. vocal outbursts and 

uncontrolled, repeated movements of the body);  
- ergotamine (used to treat migraine);  
- dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to 

the aging process);  
- halofantrine (an antimalarial treatment);  
- quinidine (used to treat abnormal heart rhythms);  
- bepridil (used to control chest pain);  
- cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and 

heart transplants); 
- statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood).
- antiepileptic medicines containing: 

phenobarbital, primidone, phenytoin, carbamazepine, diazepam. 
- medicines containing:  

midazolam or triazolam (medicines used to reduce anxiety and sleeplessness – in combination 
with Diacomit they may make your child very sleepy);  
chlorpromazine (used for mental illness such as psychosis). 

- If your child takes medicines containing:  
Caffeine (this substance helps restore mental alertness) or theophylline (this substance is used 
in case of asthma). The combination with Diacomit should be avoided as it may increase their 
blood levels, leading to digestive disorders, racing heart and insomnia. 

 If your child takes medicines metabolized by certain liver enzymes: 
- citalopram (used in the treatment of depressive episodes); 
- omeprazole (used in case of gastric ulcer); 
- HIV protease inhibitors (used in the treatment of HIV); 
- astemizole, chlorpheniramine (antihistamines); 
- calcium channel blockers (used in the treatment of angor or troubles of heart rhythm);  
- oral contraceptives;  
- propranolol, carvedilol, timolol (used in the treatment of high blood pressure);  
- fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants) ;  
- haloperidol (antipsychotics);  
- codeine, dextromethorphan, tramadol (used in the treatment of pain).  

Diacomit with food and drink
Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, 
fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, 
coffee, tea and energy drinks).  

Pregnancy and breast-feeding 
If your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, 
ask your doctor for advice before taking this medicine.
During pregnancy, effective antiepileptic treatment must NOT be stopped. 

Breast-feeding is not recommended during treatment with this medicine. 

Driving and using machines
This medicine may make your child feel sleepy. 

http://en.wikipedia.org/wiki/Anxiety
http://en.wikipedia.org/wiki/Sleep#Sleepiness


75

Your child should not use any tools, machines, ride or drive if affected in this way. Check with your 
child’s doctor.  

Diacomit contains aspartame, glucose, sorbitol and sodium 
This medicine contains 2.5 mg aspartame in each 250mg-sachet and 5 mg each 500mg-sachet. 
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare 
genetic disorder in which phenylalanine builds up because the body cannot remove it properly. 
This medicine contains sorbitol: 2.4 mg in each 250mg-sachet and 4.8 mg in each 500mg-sachet. 
Glucose may be harmful to the teeth. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 
‘sodium-free’. 

3. How to take Diacomit

Your child should always take the contents of each sachet exactly as your child’s doctor has told you. 
You should check with your child’s doctor or pharmacist if you are not sure. 

Dosage 
The dose is adjusted by the doctor according to your child’s age, weight and condition, generally 
50 mg per kg bodyweight and per day.  

When to take Diacomit 
Your child should take this medicine two or three times a day at regular intervals as directed by your 
child’s doctor: for example morning - noon - bed-time to cover the night-and-day period. 

Dose adjustment 
Dose increases should be gradual, taking place over a few weeks while the dose(s) of the other 
antiepileptic medicine(s) is (are) reduced at the same time. Your child’s doctor will tell you the new 
dose of the other antiepileptic medicine(s). 

If you have the impression that the effect of this medicine is too strong or too weak, talk to your 
child’s doctor or pharmacist. The dose will be adjusted by the doctor according to your child’s 
condition.  

Please consult your child’s doctor in the event of any side effects as the doctor may have to adjust the 
dose of this medicine and the other antiepileptic medicine(s). 

There are slight differences between the Diacomit capsules and powder for oral suspension. If your 
child experiences any problems when switching from taking the capsules to the powder for oral 
suspension or vice versa please inform your doctor. In case of switch between capsule and powder 
formulation it should be done under the close supervision of your child’s doctor. 

In case of vomiting within the first few minutes of intake it is assumed that no medicine has been 
absorbed and a new dose should be given. 
However, the situation is different if the vomiting occurs more than one hour after medicine intake 
because stiripentol is quickly absorbed. In such a case, it is assumed that a significant fraction of the 
administered dose has been absorbed systemically from the digestive tract. Thus, there would be no 
need for a new intake or for an adjustment of the next dose. 

How to take the Diacomit powder for oral suspension 
The powder should be mixed in a glass of water and should be taken immediately after mixing during 
the meal. Your child should take Diacomit with food, it should NOT be taken on an empty stomach. 
For food and drinks to be avoided, see the section “Diacomit with food and drink” above. 



76

If your child takes more Diacomit than he or she should
Contact your child’s doctor if you know or think your child has taken more medicine than he or she 
should have.  

If your child forgets to take Diacomit
It is important that your child takes this medicine regularly at the same time each day. If your child 
forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next 
dose. In that case carry on with the next dose as normal. Your child should not take a double dose to 
make up for a forgotten individual dose. 

If your child stops taking Diacomit
Your child must not stop taking this medicine unless the doctor tells you to. Stopping treatment 
suddenly can lead to an outbreak of seizures. 

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist. 

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.  

Very common side effects (may affect more than one in 10 people): 
 loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium 

valproate); 
 insomnia (sleeplessness), drowsiness; 
 ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia 

(involuntary muscle contractions). 

Common side effects (may affect up to1 in 10 people): 
 raised levels of liver enzymes, especially when given with either of the antiepileptic medicines 

carbamazepine and sodium valproate; 
 aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable); 
 sleep disorders (abnormal sleeping); 
 hyperkinesis (exaggerated movements); 
 nausea, vomiting; 
 a low number of a type of white blood cells. 

Uncommon side effects (may affect up to 1 in 100 people): 
 double vision when used in combination with the antiepileptic medicine carbamazepine;
 sensitivity to light;
 rash, skin allergy, urticaria (pinkish, itchy swellings on the skin); 
 fatigue (tiredness).

Rare side effects (may affect up to 1 in 1,000 people)
 decrease of platelet level in the blood; 
 abnormal liver function test 

To eliminate these side effects, your child’s doctor may have to change the dose of Diacomit or one of 
the other medicines prescribed for your child. 

Reporting of side effects 
If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any 
possible side effects not listed in this leaflet. You can also report side effects directly via the national 
reporting system listed in Appendix V. 
By reporting side effects you can help provide more information on the safety of this medicine. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


77

5. How to store Diacomit 

 Keep this medicine out of the sight and reach of children. 
 Your child should not take Diacomit after the expiry date, which is stated on the label after 

“EXP”. The expiry date refers to the last day of that month. 
 Store in the original package in order to protect from light. 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 

6. Contents of the pack and other information 

What Diacomit 250 mg contains 
 The active substance is stiripentol. Each sachet contains 250 mg of stiripentol. 
 The other ingredients of the sachet are povidone K29/32, sodium starch glycolate type A, 

glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), 
tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.

What Diacomit 500 mg contains 
 The active substance is stiripentol. Each sachet contains 500 mg of stiripentol. 
 The other ingredients of the sachet are povidone K29/32, sodium starch glycolate type A, 

glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), 
tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.

What Diacomit 250 mg looks like and contents of the pack 
This medicine is a pale pink powder supplied in sachets.  
Cartons contain either 30, 60 or 90 sachets. Not all pack sizes may be marketed.  

What Diacomit 500 mg looks like and contents of the pack 
This medicine is a pale pink powder supplied in sachets.  
Cartons contain either 30, 60 or 90 sachets. Not all pack sizes may be marketed.  
Diacomit is also available as 250 mg and 500 mg capsules for oral use  

Marketing Authorisation Holder  

Biocodex,7 avenue Gallieni – F-94250 Gentilly - France 
Tel: + 33 1 41 24 30 00 - e-mail: medinfo@biocodex.com

Manufacturer  

Biocodex, 1 avenue Blaise Pascal - F-60000 Beauvais - France 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 

AT/BE/BG/CY/EL/ES/FR/HR/HU/IE/IS/IT/LU/MT/NL/PL/PT/SI/UK 
Biocodex 
7 avenue Gallieni - F-94250 Gentilly 
Франция/ Γαλλία/ France/ Francia/ Franciaország/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja 
Tél/Tel/Teл/Τηλ/Sími: + 33 (0)1 41 24 30 00  
e-mail: medinfo@biocodex.com

mailto:medinfo


78

CZ
Desitin Pharma spol. s r.o  
Opletalova 25  
11121 Prague 1  
Czech Republic 
Tel: 00420-2-222 45 375  
e-mail: desitin@desitin.cz

DE 
Desitin Arzneimittel GmbH 
Weg beim Jäger 214 
D-22335 Hamburg 
Germany  
Tel: +49 (0)40 59101 525  
e-mail: epi.info@desitin.de

DK 
Biocodex Oy  
Metsänneidonkuja 8 
02130 Espoo 
Finland  
Tel: +358 9 329 59100 
e-mail: info@biocodex.fi

EE 
Biocodex OÜ 
Väike-Paala 1 
11415 Tallinn 
Estonia 
Tel: +372 605 6014 
e-mail: info@biocodex.ee

FI 
Biocodex Oy  
Metsänneidonkuja 8 
02130 Espoo 
Finland  
Tel: +358 9 329 59100 
e-mail: info@biocodex.fi

LT 
Biocodex UAB 
Savanorių av. 349
LT-51480 Kaunas  
Lithuania
Tel: +370 37 408681 
e-mail: info@biocodex.lt

LV 
Biocodex SIA 
Kalniņi A, Mārupes nov., 
Mārupe, LV-2167 
Latvia 
Tel: +371 67 619365 
e-mail: info@biocodex.lv

mailto:desitin@desitin.cz
mailto:epi.info@desitin.de
mailto:info@biocodex.fi
mailto:info@biocodex.ee
mailto:info@biocodex.fi
mailto:info@biocodex.lt
mailto:info@biocodex.lv


79

NO 
Biocodex AS 
C/O regus Lysaker 
Lysaker Torg 5, 3 etg 
NO-1366 Lysaker 
Norway 
Tel: +47 66 90 55 66 
e-mail: info@biocodex.no

RO
Desitin Pharma s.r.l  
Sevastopol street, no 13-17  
Diplomat Business Centre, office 102  
Sector 1, 010991 Bucharest  
Romania  
Tel: 004021-252-3481  
e-mail: office@desitin.ro

SE 
Biocodex AB 
Knarrnäsgatan 7 
164 40 Kista 
Sweden 
Tel: +46 8 615 2760 
e-mail: info@biocodex.se

SK
Desitin Pharma s.r.o.  
Trojicné námestie 13  
82106 Bratislava  
Slovakia 
Tel: 00421-2-5556 38 10  
e-mail: desitin@desitin.sk

This leaflet was last revised in  

Other sources of information 

Detailed information on this medicine is available on the European Medicine Agency website: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

mailto:info@biocodex.no
mailto:office@desitin.ro
mailto:info@biocodex.se
mailto:desitin@desitin.sk

	SUMMARY OF PRODUCT CHARACTERISTICS
	A.	MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B.	CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what diacomit is and what it is used for', 'Section_Content': "stiripentol, the active ingredient of diacomit, belongs to a group of medicines called antiepileptics. it is used in conjunction with clobazam and valproate (other antiepileptic medicines) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (dravet's syndrome), which affects children. your child's doctor has prescribed this medicine to help treat your child's epilepsy. it should always be taken in combination with clobazam and valproate under the direction of a doctor.", 'Entity_Recognition': [{'Text': 'diacomit', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 0, 'EndOffset': 11, 'Score': 0.8923765420913696, 'Text': 'stiripentol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 79}, {'Id': 10, 'BeginOffset': 87, 'EndOffset': 101, 'Score': 0.48210442066192627, 'Text': 'antiepileptics', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 134, 'EndOffset': 142, 'Score': 0.8865297436714172, 'Text': 'clobazam', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 2, 'BeginOffset': 147, 'EndOffset': 156, 'Score': 0.9341320991516113, 'Text': 'valproate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'other antiepileptic medicines', 'Type': 'TREATMENT', 'BeginOffset': 158, 'EndOffset': 187}, {'Id': 5, 'BeginOffset': 216, 'EndOffset': 224, 'Score': 0.9696876406669617, 'Text': 'epilepsy', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9736263751983643}]}, {'Text': 'severe myoclonic epilepsy', 'Type': 'PROBLEM', 'BeginOffset': 232, 'EndOffset': 257}, {'Text': "infancy (dravet's syndrome", 'Type': 'PROBLEM', 'BeginOffset': 261, 'EndOffset': 287}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 349, 'EndOffset': 362}, {'Text': "your child's epilepsy", 'Type': 'PROBLEM', 'BeginOffset': 377, 'EndOffset': 398}, {'Id': 3, 'BeginOffset': 446, 'EndOffset': 454, 'Score': 0.8725510239601135, 'Text': 'clobazam', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 4, 'BeginOffset': 459, 'EndOffset': 468, 'Score': 0.9104461669921875, 'Text': 'valproate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}]}
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recently used or might use any other medicines. tell your doctor if your child is taking any of the following medicines: medicines containing: - cisapride (used to treat symptoms of night time heartburn); - pimozide (used to treat the symptoms of tourette's syndrome e.g. vocal outbursts and uncontrolled, repeated movements of the body); - ergotamine (used to treat migraine); - dihydroergotamine (used to relieve the signs and symptoms of decreased mental capacity due to the aging process); - halofantrine (an antimalarial treatment); - quinidine (used to treat abnormal heart rhythms); - bepridil (used to control chest pain); - cyclosporine, tacrolimus, sirolimus (all three used to prevent rejections of liver, kidney and heart transplants); - statins (simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood). - antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam. - medicines containing: midazolam or triazolam (medicines used to reduce anxiety and sleeplessness in combination with diacomit they may make your child very sleepy); chlorpromazine (used for mental illness such as psychosis). - if your child takes medicines containing: caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in case of asthma). the combination with diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia. if your child takes medicines metabolized by certain liver enzymes: - citalopram (used in the treatment of depressive episodes); - omeprazole (used in case of gastric ulcer); - hiv protease inhibitors (used in the treatment of hiv); - astemizole, chlorpheniramine (antihistamines); - calcium channel blockers (used in the treatment of angor or troubles of heart rhythm); - oral contraceptives; - propranolol, carvedilol, timolol (used in the treatment of high blood pressure); - fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants) ; - haloperidol (antipsychotics); - codeine, dextromethorphan, tramadol (used in the treatment of pain). diacomit with food and drink do not take diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks). pregnancy and breast-feeding if your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine. during pregnancy, effective antiepileptic treatment must not be stopped. breast-feeding is not recommended during treatment with this medicine. driving and using machines this medicine may make your child feel sleepy. your child should not use any tools, machines, ride or drive if affected in this way. check with your child's doctor. diacomit contains sodium this medicine contains less than 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{'Title': '3. how to take diacomit', 'Section_Content': 'your child should always take these capsules exactly as your child\'s doctor has told you. you should check with your child\'s doctor or pharmacist if you are not sure. dosage the dose is adjusted by the doctor according to your child\'s age, weight and condition, generally 50 mg per kg bodyweight and per day. when to take diacomit your child should take this medicine two or three times a day at regular intervals as directed by your child\'s doctor, for example morning - noon - bed-time to cover the night-and-day period. dose adjustment dose increases should be gradual, taking place over a few weeks while the dose(s) of the other antiepileptic medicine(s) is (are) reduced at the same time. your child\'s doctor will tell you the new dose of the other antiepileptic medicine(s). if you have the impression that the effect of this medicine is too strong or too weak, talk to your child\'s doctor or pharmacist. the dose will be adjusted by the doctor according to your child\'s condition. please consult your child\'s doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s). there are slight differences between the diacomit capsules and powder for oral suspension. if your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor. in case of switch between capsule and powder formulations it should be done under the close supervision of your child\'s doctor. in case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given. however, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed. in such a case, it is assumed that a significant fraction of the administered dose has been absorbed systemically from the digestive tract. thus, there would be no need for a new intake or for an adjustment of the next dose. how to take the diacomit capsules these capsules should be swallowed whole with water. the capsules should not be chewed. your child should take diacomit with food, it should not be taken on an empty stomach. for food and drinks to be avoided, see the section "diacomit with food and drink" above. if your child takes more diacomit than he or she should contact your child\'s doctor if you know or think your child has taken more medicine than he or she should have. if your child forgets to take diacomit it is important that your child takes this medicine regularly at the same time each day. if your child forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next dose. in that case carry on with the next dose as normal. your child should not take a double dose to make up for a forgotten individual dose. if your child stops taking diacomit your 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{'Title': '4. possible side effects', 'Section_Content': "like all medicines, this medicine can cause side effects, although not everybody gets them. very common side effects (may affect more than one in 10 people): loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate); insomnia (sleeplessness), drowsiness; ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia (involuntary muscle contractions). common side effects (may affect up to 1 in 10 people): raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate; aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable); sleep disorders (abnormal sleeping); hyperkinesis (exaggerated movements); nausea, vomiting; a low number of a type of white blood cells. uncommon side effects (may affect up to 1 in 100 people): double vision when used in combination with the antiepileptic medicine carbamazepine; sensitivity to light; rash, skin allergy, urticaria (pinkish, itchy swellings on the skin); fatigue (tiredness). rare side effects (may affect up to 1 in 1,000 people) decrease of platelet level in the blood; abnormal liver function test. to eliminate these side effects, your child's doctor may have to change the dose of diacomit or one of the other medicines prescribed for your child. reporting of side effects if your child gets any side effects, talk to your child's doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.", 'Entity_Recognition': [{'Text': 'diacomit', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 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{'Title': '5 how to store diacomit', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what diacomit 250 mg contains the active substance is stiripentol. each hard capsule contains 250 mg of stiripentol. the other ingredients of the capsule are povidone k29/32, sodium starch glycolate type a and magnesium stearate. the capsule shell is made of gelatin, titanium dioxide (e171), erythrosine (e127), indigotin (e132). the printing ink contains shellac (e904), black iron oxide (e172). what diacomit 500 mg contains the active substance is stiripentol. each hard capsule contains 500 mg of stiripentol. the other ingredients of the capsule are povidone k29/32, sodium starch glycolate type a and magnesium stearate. the capsule shell is made of gelatin, titanium dioxide (e171). the printing ink contains shellac (e904), black iron oxide (e172). what diacomit 250 mg looks like and contents of the pack diacomit 250 mg hard capsule is pink and imprinted with "diacomit 250 mg". the hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons. not all pack sizes may be marketed. what diacomit 500 mg looks like and contents of the pack diacomit 500 mg hard capsule is white and imprinted with "diacomit 500 mg". the hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons. not all pack sizes may be marketed. diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.', 'Entity_Recognition': [{'Text': 'diacomit', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'diacomit', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 13}, {'Text': '250', 'Type': 'NUMBER', 'BeginOffset': 14, 'EndOffset': 17}, {'Id': 1, 'BeginOffset': 54, 'EndOffset': 65, 'Score': 0.9605056643486023, 'Text': 'stiripentol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.6170142292976379, 'RelationshipScore': 0.9993864297866821, 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