Namuscla
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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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1. NAME OF THE MEDICINAL PRODUCT 

 

Namuscla 167 mg hard capsules 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each capsule contains mexiletine hydrochloride corresponding to 166.62 mg mexiletine . 

  

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Hard capsule (capsule). 

 

Namuscla capsules are Swedish orange hard shell gelatin capsules (20 mm) filled with white powder. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications   

 

Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-

dystrophic myotonic disorders. 

 

4.2 Posology and method of administration 

 

Posology 

 

The recommended starting dose of mexiletine is 167 mg daily (1 capsule per day). After at least 

1 week of treatment, based on the clinical response, the daily dose can be increased to 333 mg daily 

(2 capsules per day). After at least 1 further week of treatment, based on clinical response, dose can be 

further increased to 500 mg daily (3 capsules per day).  

Maintenance treatment is between 167 mg – 500 mg daily (1 to 3 capsules per day), according to the 

intensity of symptoms and the clinical response, taken regularly throughout the day. 

 

The dose should not exceed 500 mg/day. Regular reassessment should be implemented, not to 

continue long-term treatment in a patient not responding or not experiencing benefit of the treatment.  

Before starting mexiletine treatment, detailed and careful cardiac evaluation should be carried out; 

throughout treatment with mexiletine, cardiac monitoring needs to be continued and adapted as a 

function of the heart condition of the patient (see contraindications in section 4.3 and warning in 

section 4.4). 

 

Patients with cardiac disorders 

In case of modification of the mexiletine dose, or if medicinal products susceptible to affect cardiac 

conduction are co-administered with mexiletine, patients should be closely monitored by ECG 

(especially patients with conduction anomalies) (see sections 4.3 and 4.4).  

 

Elderly 

Experience with mexiletine in patients with myotonic disorders aged > 65 years is limited. Based on 

the pharmacokinetic properties of mexiletine, no dosage adjustment is required in patients aged 65 

years and over.  

 



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Hepatic impairment 

Mexiletine should be used with caution in patients with mild or moderate hepatic impairment. In these 

patients, it is recommended that the dose should only be increased after at least 2 weeks of treatment. 

Mexiletine should not be used in patients with severe hepatic impairment (see section 4.4). 

 

Renal impairment 

No dosage adjustment is considered necessary in patients with mild or moderate renal impairment. 

The experience with mexiletine in patients with severe renal impairment is limited. Therefore, the use 

of mexiletine is not recommended in this patient population (see section 4.4). 

 

Paediatric population 

The safety and efficacy of mexiletine in children and adolescents aged 0 to 18 years have not been 

established. No data are available. 

 

Poor and extensive CYP2D6 metabolisers 

Patients who are CYP2D6 poor metabolisers may exhibit higher mexiletine blood levels (see section 

5.2). A period of at least 7 days before dose increase must be respected to ensure that steady-state 

levels are reached, irrespective of the patient’s CYP450 polymorphism.   

 

Method of administration  

 

Oral use. 

 

The capsules should be swallowed with water, avoiding the supine position. In case of digestive 

intolerance, capsules should be taken during a meal. 

 

4.3 Contraindications 

 

• Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1 
• Hypersensitivity to any local anaesthetic  
• Ventricular tachyarrhythmia 
• Complete heart block (i.e. third-degree atrioventricular block) or any heart block susceptible to 

evolve to complete heart block (first-degree atrioventricular block with markedly prolonged PR 

interval (≥ 240 ms) and/or wide QRS complex (≥ 120 ms), second-degree atrioventricular block, 

bundle branch block, bifascicular and trifascicular block),  

• Myocardial infarction (acute or past), or abnormal Q-waves 
• Symptomatic coronary artery disease  
• Heart failure with mid-range (40-49%) and reduced (<40%) ejection fraction  
• Atrial tachyarrhythmia, fibrillation or flutter 
• Sinus node dysfunction (including sinus rate < 50 bpm) 
• Co-administration with medicinal products inducing torsades de pointes (see section 4.5) 
• Co-administration with medicinal products with narrow therapeutic index (see section 4.5). 
 

4.4 Special warnings and precautions for use 

 

Cardiac arrhythmogenic effects 

 

Mexiletine may induce an arrhythmia or accentuate a pre-existing arrhythmia, either diagnosed or 

undiagnosed. See also sections 4.3 and 4.5 regarding association with other products with 

arrhythmogenic effects.  

 

Before starting mexiletine treatment, detailed and careful cardiac evaluation (ECG, 24-48-hour Holter-

monitoring and echocardiography) should be carried out in all patients in order to determine the 

cardiac tolerability of mexiletine. A cardiac evaluation is recommended shortly after treatment start 

(e.g. within 48 hours). 

 



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Throughout treatment with mexiletine, and in relation with dose changes, cardiac monitoring of 

patients needs to be adapted as a function of the heart condition of the patient: 

 

• In patients without cardiac abnormalities, periodic ECG monitoring is recommended (every 
2 years or more frequently if considered necessary). 

• In patients with cardiac abnormalities, and in patients prone to such abnormalities, detailed 
cardiac evaluation, including ECG, should be carried out before and after any dose increase. 

During maintenance treatment, detailed cardiac evaluation, including ECG, 24-48 hour Holter-

monitoring and echocardiography, is recommended at least annually, or more frequently if 

considered necessary as part of routine cardiac assessment.  

 

Patients should be informed about the presenting symptoms of arrhythmias (fainting, palpitation, chest 

pain, shortness of breath, light-headedness, lipothymia, and syncope) and should be advised to 

immediately contact an emergency centre if there are any symptoms of arrhythmias.  

 

For cardiac disorders not listed in section 4.3, the benefit of the antimyotonic effects of mexiletine 

needs to be balanced against the risk of cardiac complications on a case by case basis. 

Mexiletine should be stopped immediately in case any cardiac conduction abnormalities or any of the 

contraindications listed in the section 4.3 are detected. 

 

Electrolytic imbalance such as hypokalaemia, hyperkalaemia or hypomagnesaemia may increase the 

proarrhythmic effects of mexiletine. Therefore, electrolytic evaluation should be done prior to 

initiating therapy with mexiletine in every patient. Electrolyte imbalance needs to be corrected before 

administering mexiletine and to be monitored throughout treatment (with a periodicity to be adapted 

patient by patient). 

 

Drug reaction with eosinophilia and systemic symptoms (DRESS) 

 

DRESS refers to a syndrome which includes in its complete form severe cutaneous eruptions, fever, 

lymphadenopathy, hepatitis, haematological abnormalities with eosinophilia and atypical 

lymphocytes, and can involve other organs. Symptoms typically occur 1-8 weeks after exposure to the 

medicinal product. Severe systemic manifestations are responsible for a 10% mortality rate. Incidence 

of DRESS has been reported between 1:100 and 1:10.000 patients treated.  

Several medicinal products including anticonvulsants, antibiotics and also mexiletine have been 

identified as possible causes. Patients with known hypersensitivity to mexiletine or any other 

ingredients of this product or to any local anaesthetic are at high risk of developing DRESS and should 

not receive mexiletine. 

 

Hepatic impairment  

 

The experience with mexiletine in patients with severe hepatic impairment is limited. Therefore, 

mexiletine should not be used in this patient population (see section 4.2). 

 

Renal impairment  

 

The experience with mexiletine in patients with severe renal impairment is limited. Therefore, the use 

of mexiletine is not recommended in this patient population (see section 4.2).  

 

Epilepsy 

 

Epileptic patients need to be monitored because mexiletine can increase the frequency of seizure 

episodes.  

 

CYP2D6 polymorphism 

 

CYP2D6 polymorphism may affect mexiletine pharmacokinetics (see section 5.2). Higher systemic 

exposure is expected in patients who are CYP2D6 poor metabolisers or who take medicinal products 



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that inhibit CYP2D6 (see section 4.5). A period of at least 7 days before dose increase must be 

respected to ensure that steady-state levels are reached and that mexiletine is well tolerated in all 

patients, irrespective of CYP450 polymorphism.    

 

Smoking 

 

Smoking affects mexiletine pharmacokinetics (see section 4.5). Mexiletine dose may need to be 

increased if a patient starts to smoke and decreased if a patient stops to smoke. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Pharmacodynamic interactions 

 

Antiarrhythmics inducing torsades de pointes (class Ia, Ic, III antiarrhythmics): 

Co-administration of mexiletine and antiarrhythmics inducing torsades de pointes (class Ia: quinidine, 

procainamide, disopyramide, ajmaline; class Ic: encainide, flecainide, propafenone, moricizine; class 

III: amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant) increases the risk of 

potentially lethal torsades de pointes. The concomitant use of mexiletine and antiarrhythmic medicines 

inducing torsades de pointes is contraindicated (see section 4.3). 

 

Other antiarrhythmics (class Ib, II, IV antiarrhythmics): 

Co-administration of mexiletine and other classes of antiarrhythmics (class Ib: lidocaine, phenytoin, 

tocainide; class II: propranolol, esmolol, timolol, metoprolol, atenolol, carvedilol, bisoprolol, 

nebivolol; class IV: verapamil, diltiazem) is not recommended, unless exceptionally, because of the 

increased risk of adverse cardiac reactions (see section 4.4). 

 

Pharmacokinetic interactions 

 

Effect of other medicinal products on mexiletine 

 

Mexiletine is a substrate for the metabolic pathways involving hepatic enzymes; inhibition or 

induction of these enzymes is expected to alter mexiletine plasma concentrations.  

 

CYP1A2 & CYP2D6 inhibitors 

Co-administration of mexiletine with a hepatic enzyme inhibitor (CYP1A2 inhibitor: ciprofloxacin, 

fluvoxamine, propafenone; CYP2D6 inhibitor: propafenone, quinidine) significantly increases 

mexiletine exposure and thus the associated risk of adverse reactions to mexiletine.  

In a single-dose interaction study, the clearance of mexiletine was decreased by 38% following the co-

administration of fluvoxamine, an inhibitor of CYP1A2.  

Therefore, clinical and ECG monitoring, as well as adaptation of mexiletine dosage may be indicated 

throughout and after treatment with a CYP1A2 or CYP2D6 inhibitor. 

 

CYP1A2 & CYP2D6 inducers 

Co-administration of mexiletine with a hepatic enzyme inducer (CYP1A2 inducer: omeprazole; 

CYP2D6 inducer: phenytoin, rifampicin) may increase the clearance and elimination rate of 

mexiletine due to an increased hepatic metabolism, resulting in decreased plasmatic concentrations 

and half-life of mexiletine. 

In a clinical study, co-administration of mexiletine with phenytoin resulted in a significant decrease in 

exposure to mexiletine (p < 0.003) due to enhanced clearance as reflected in significantly decreased 

elimination half-life (17.2 to 8.4 hours, p < 0.02). 

Therefore, based on the clinical response, the mexiletine dosage should be adapted during and after 

treatment with the enzyme inducer.  

 

After the oral administration of single (167 mg) and multiple (83 mg twice a day during 8 days) doses 

of mexiletine, total clearance of mexiletine is significantly increased in smokers (1.3 to 1.7-fold) due 

to induction of CYP1A2, resulting in a correspondingly decreased elimination half-life and drug 



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exposure. Mexiletine dose may need to be increased if a patient starts to smoke during mexiletine 

treatment and decreased if a patient stops smoking.  

 

Effect of mexiletine on other medicinal products  

 

The potential of mexiletine as a drug-drug-interaction perpetrator is unknown. Patients should be 

carefully monitored if co-treated with other medicinal products with especially emphasis to medicinal 

products with narrow therapeutic windows. 

 

CYP1A2 substrates 

Mexiletine is a potent inhibitor of CYP1A2; therefore, co-administration of mexiletine with medicinal 

products metabolised by CYP1A2 (such as theophylline, caffeine, lidocaine or tizanidine) may be 

associated with elevations in plasma concentrations of the concomitant medicine that could increase or 

prolong the therapeutic efficacy and/or the adverse reactions, especially if mexiletine is co-

administered with CYP1A2 substrates with narrow therapeutic window, e.g. theophylline and 

tizanidine. 

The CYP1A2 substrate blood levels should be monitored, particularly when the mexiletine dose is 

changed. An appropriate adjustment in the dose of the CYP1A2 substrate should be considered.  

 

 

Caffeine 

In a clinical study in 12 subjects (5 healthy subjects and 7 patients with cardiac arrhythmias), the 

clearance of caffeine was decreased by 50% following the administration of mexiletine. Increased 

concentrations of caffeine occurring with the co-administration of mexiletine may be of concern in 

patients with cardiac arrhythmia. It is, therefore, recommended to reduce caffeine intake during 

treatment with mexiletine. 

 

OCT2 substrates 

The organic cation transporter 2 (OCT2) provides an important pathway for the uptake of cationic 

compounds in the kidney. Mexiletine may interact with drugs transported by OCT2 (such as 

metformin and dofetilide). 

If mexiletine and other OCT2 substrates are to be used concurrently, the OCT2 substrate blood levels 

should be monitored, particularly when the mexiletine dose is changed. An appropriate adjustment in 

the dose of the OCT2 substrate should be considered.  

 

Substrates of other enzymes and transporters 

The potential interactions between mexiletine and substrates of other common enzymes and 

transporters have not yet been assessed; it is currently contra-indicated to use mexiletine with any 

substrate having a narrow therapeutic window such as digoxin, lithium, phenytoin, theophylline or 

warfarin (see section 4.3).  

 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no or limited amount of data from the use of mexiletine in pregnant women. Limited clinical 

data of the use of mexiletine in pregnant women shows that mexiletine crosses the placenta and 

reaches the foetus. Animal studies do not indicate direct or indirect harmful effects with respect to 

reproductive toxicity (see section 5.3). 

As a precautionary measure, it is preferable to avoid the use of mexiletine during pregnancy. 

 

Breast-feeding 

 

Mexiletine is excreted in human milk. There is insufficient information on the effects of mexiletine in 

newborns/infants. A decision must be made whether to discontinue breast-feeding or to 



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discontinue/abstain from mexiletine therapy taking into account the benefit of breast feeding for the 

child and the benefit of therapy for the woman.  

 

Fertility 

 

The effects of mexiletine on fertility in humans have not been studied. Animal studies with mexiletine 

do not indicate harmful effects with respect to fertility (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

Mexiletine may have minor influence on the ability to drive and use machines. Fatigue, confusion, 

blurred vision may occur following administration of mexiletine (see section 4.8). 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most commonly reported adverse reactions in patients treated with mexiletine are abdominal pain 

(12%), vertigo (8%) and insomnia (12%).  

The most serious reported adverse reactions in patients treated with mexiletine are drug reaction with 

eosinophilia and systemic symptoms and arrhythmia (atrioventricular block, arrhythmia, ventricular 

fibrillation).  

 

Tabulated list of adverse reactions 

 

Frequency categories are derived according to the following conventions: 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). Very common and 

common adverse reactions are derived from data from the MYOMEX study; less common adverse 

effects are derived from post-marketing data. 

 

Blood and lymphatic system disorders 

Not known: leukopenia, thrombocytopenia 

Immune system disorders 

Very rare: drug reaction with eosinophilia and systemic symptoms 

Not known: lupus-like syndrome, dermatitis exfoliative, Stevens-Johnson syndrome  

Psychiatric disorders 

Very common: insomnia 

Common: somnolence 

Not known: hallucinations, confusional state 

Nervous system disorders 

Common: headache, paraesthesia, vision blurred 

Uncommon: seizure, speech disorders 

Not known: diplopia, dysgeusia 

Ear and labyrinth disorders 

Common: vertigo 

Cardiac disorders 

Common: tachycardia 

Uncommon: bradycardia 

Not known: atrioventricular block  

Vascular disorders 

Common: flushing, hypotension 

Not known: circulatory collapse, hot flush 

Respiratory, thoracic and mediastinal disorders 

Not known: pulmonary fibrosis 



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Gastrointestinal disorders 

Very common: abdominal pain 

Common: nausea 

Not known: diarrhoea, vomiting, oesophageal ulcers and perforation 

Hepatobiliary disorders 

Rare: hepatic function abnormal 

Very rare: drug-induced liver injury, liver disorder, hepatitis 

Skin and subcutaneous tissue disorders 

Common: acne 

Musculoskeletal and connective tissue disorders 

Common: pain in the extremities 

General disorders and administration site conditions 

Common: fatigue, asthenia, chest discomfort, malaise 

 

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 

 

Symptoms 

 

Fatal outcomes have been reported for acute overdoses at 4.4 g of mexiletine hydrochloride ingestion 

but survival has also been reported following acute overdose of approximately 4 g of oral mexiletine 

hydrochloride. 

 

The symptoms of mexiletine overdose include neurological disorders (paresthesia, confusion, 

hallucination, seizure) and cardiac disorders (sinusal bradycardia, hypotension, collapse, and in 

extreme cases, cardiac arrest). 

 

Overdose management 

 

The treatment is mainly symptomatic. The seriousness of the symptoms may require hospital 

supervision. In case of bradycardia with hypotension, intravenous atropine should be used.  In case of 

seizure, benzodiazepines should be used. 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Cardiac therapy, antiarrhythmics, class Ib, ATC code: C01BB02. 

 

Mechanism of action 

 

Mexiletine blocks sodium channels with a stronger potency in situations of excessive burst of action 

potentials (use-dependent block) and/or prolonged depolarization (voltage-dependent block), as 

occurring in diseased tissues, rather than on physiological excitability (resting or tonic block). 

Mexiletine is, therefore, mostly active on muscle fibres subject to repeated discharges (such as skeletal 

muscles). It improves myotonic symptoms by decreasing muscle stiffness through reduction of the 

delay of muscle relaxation.  

 

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


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Clinical efficacy and safety 

 

The efficacy and safety of mexiletine in non-dystrophic myotonia was evaluated in MYOMEX, a 

multi-centre, double-blind, placebo-controlled, cross-over (2 treatment periods of 18 days) study with 

a 4-day wash-out period in 13 patients with myotonia congenita (MC) and 12 patients with 

paramyotonia congenita (PC). Age of the overall study population ranged from 20 to 66 years old and 

about 2/3 of the patients were male. Patients who experienced myotonic symptoms that involved at 

least 2 segments and that had an impact on at least 3 daily activities were included into the study. The 

patients were randomized according to a cross-over design to a sequence including the 2 following 

treatments: a) mexiletine, started at 167 mg/day and titrated by increments of 167 mg every 3 days to 

reach a maximum dose of 500 mg/day in 1 week or b) placebo.1  

The primary efficacy measure for both MC and PC was the score of stiffness severity as self-reported 

by the patients on a Visual Analogue Scale (VAS). The VAS is constructed as an absolute measure, 

with a 100 mm straight horizontal line having the endpoints “no stiffness at all” (0) and “worst 

possible stiffness” (100). The main secondary endpoints were changes in health–related quality of life 

as measured by individualised neuromuscular quality of life (INQoL) scale and the time needed to 

stand up from a chair, walk around the chair and sit down again (chair test). 

Results for the primary and key secondary endpoints are summarised in the table below. 

 

 Mexiletine Placebo 

Primary Analysis 

Stiffness score (VAS) (mm) 

  

Number of subjects 25 25 

Median VAS value at Baseline 71.0 81.0 

Median VAS value at Day 18 16.0 78.0 

Median VAS absolute change from baseline -42.0 2.0 

Percentage of Patients with an Absolute VAS  

Change from Baseline ≥ 50 mm at Day 18 

12/21 (57.1%) 3/22 (13.6%) 

Effect of treatment (Mixed Effect Linear Model) p < 0.001 

Secondary Analysis 

Chair test (s) 

  

Number of subjects 25 25 

Mean (SD) value at Baseline 7.3 (3.5) 

Mean (SD) value at Day 18 5.2 (1.6) 7.5 (4.1) 

Mean (SD) absolute change from baseline -2.1 (2.9) 0.2 (1.6) 

Effect of treatment (Wilcoxon signed-rank test) p = 0.0007 

Secondary Analysis 

Individualised neuromuscular quality of life – Overall quality of 

life 

  

Number of subjects 25 25 

Median value at Baseline 51.1 

Median value at Day 18 23.3 48.3 

Median absolute change from baseline -25.0 1.1 

Effect of treatment (linear mixed model) p < 0.001 

Secondary Analysis 

Clinical Global Impression (CGI) Efficacy index 

  

Number of subjects 25 25 

CGI as judged efficient by the investigators 22 (91.7%) 5 (20.0%) 

CGI as judged efficient by the patients 23 (92.0%) 6 (24.0%) 

Effect of treatment (Mc Nemar test) p < 0.001 

Secondary Analysis   

 
1 Clinical Study Report refers to 200 mg dose which is the amount of mexiletine hydrochloride (corresponding to 

166.62mg mexiletine base) 



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Preference between the 2 treatment periods 

Number of subjects 25 25 

Period preferred 20 (80.0%) 5 (20.0%) 

Effect of treatment (binomial test) p = 0.0041 

Secondary Analysis 

Clinical Myotonia Scale – Severity Global Score 

  

Number of subjects 25 25 

Mean (SD) value at Baseline 53.8 (10.0) 

Mean (SD) value at Day 18 24.0 (17.1) 47.6 (23.3) 

Mean (SD) absolute change from baseline -29.8 (16.0) -6.2 (19.0) 

Effect of treatment (linear mixed model) p < 0.001 

Secondary Analysis 

Clinical Myotonia Scale – Disability Global Score 

  

Number of subjects 25 25 

Mean (SD) value at Baseline 7.8 (2.8) 

Mean (SD) value at Day 18 2.7 (2.6) 7.0 (3.8) 

Mean (SD) absolute change from baseline -5.1 (3.1) -0.8 (3.4) 

Effect of treatment (linear mixed model) p < 0.001 

 

  

 

Paediatric population 

 

The European Medicines Agency has deferred the obligation to submit the results of studies with 

Namuscla in all subsets of the paediatric population in the symptomatic treatment of myotonic 

disorders (see section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Mexiletine is rapidly and almost completely absorbed following oral administration with a 

bioavailability of about 90% in healthy subjects. Peak plasma concentrations following oral 

administration occur within 2 to 3 hours. No notable accumulation of mexiletine was observed after 

repeated administration.  

Food does not affect the rate or extent of absorption of mexiletine. Therefore, mexiletine can be taken 

with or without food. 

 

Distribution 

 

Mexiletine is rapidly distributed in the body; its volume of distribution is large and varies from 5 to 9 

L/kg in healthy individuals.  

Mexiletine is weakly bound to plasma proteins (55%).  

Mexiletine crosses the placental barrier and diffuses into breast milk. 

 

Biotransformation 

 

Mexiletine is mainly (90%) metabolized in the liver, the primary pathway being CYP2D6 metabolism, 

although it is also a substrate for CYP1A2. The metabolic degradation proceeds via various pathways, 

including aromatic and aliphatic hydroxylation, dealkylation, deamination and N-oxidation. Several of 

the resulting metabolites are submitted to further conjugation with glucuronic acid (phase II 

metabolism); among these are the major metabolites p-hydroxymexiletine, hydroxy-methylmexiletine 

and N-hydroxymexiletine. 

The influence of CYP2D6 phenotype on mexiletine metabolism has been extensively investigated. 

Mexiletine pharmacokinetics are characterised by significantly lower total and renal clearance 



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resulting in prolonged elimination half-life, higher exposure, and lower volume of distribution in poor 

metabolisers compared to extensive metabolisers. 

 

Approximately 10% is excreted unchanged by the kidney. 

 

Elimination 

 

Mexiletine is eliminated slowly in humans (with a mean elimination half-life of 10 hours, ranging 

from 5 to 15 hours). 

Excretion of mexiletine essentially occurs through the kidney (90% of the dose, including 10% as 

unchanged mexiletine).  

 

Mexiletine excretion may increase when the urinary pH is acidic, compared to normal or alkaline pH. 

In a clinical study, 51% of the mexiletine dose was excreted via the kidney at a urinary pH of 5, 

compared to 10% at normal pH. Changes in urinary pH are not expected to affect efficacy or safety. 

 

Linearity/non-linearity 

 

A linear relationship between mexiletine dose and plasma concentration has been observed in the dose 

range of 83 to 500 mg. 

 

Special populations 

 

CYP2D6 polymorphism 

CYP2D6 polymorphism affects mexiletine pharmacokinetics. Individuals who are CYP2D6 poor 

metabolisers (PM) exhibit higher mexiletine concentrations than CYP2D6 intermediate (IM), 

extensive (i.e. normal) or ultra-rapid (UM) metabolisers. The proportions of different ethnic 

populations across these various classes are tabulated below. 

 

Ethnicity Poor metabolisers  

(PM) 

Intermediate 

metabolisers (IM) 

Ultra-rapid 

metabolisers(UM) 

Caucasians Up to 10% 1-2% Up to 10% 

Africans Up to 10% - Up to 5% 

Asians Up to 5% More than 50% Up to 2% 

 

Weight 

In population pharmacokinetic analyses, weight was found to influence mexiletine pharmacokinetics. 

 

Age 

There is no clinically relevant effect of age on the exposure of mexiletine in adults.  

 

5.3 Preclinical safety data 

 

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, 

repeated dose toxicity, toxicity to reproduction and development. The main observed effects in rats 

and/or dogs were vomiting, diarrhoea, tremor, ataxia, convulsions and tachycardia. However, these 

studies were not performed in accordance with contemporary standards and are, hence, of unclear 

clinical relevance.  

The studies in rats on carcinogenic potential were negative, but not performed in accordance with 

current standards and therefore of unclear clinical relevance. The negative genotoxicity potential does 

not indicate an increased carcinogenic risk of treatment with mexiletine. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 



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Capsule content 

 

Maize starch 

Colloidal anhydrous silica 

Magnesium stearate 

 

Capsule shell  

 

Iron (III) oxide (E 172)  

Titanium dioxide (E 171) 

Gelatin 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

3 years. 

 

6.4 Special precautions for storage 

 

Do not store above 30°C. 

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

 

6.5 Nature and contents of container  

 

Capsules are packed in Aluminium/PVC/PVDC blisters containing 30, 50, 100 or 200 capsules.  

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

7. MARKETING AUTHORISATION HOLDER 

 

Lupin Europe GmbH 

Hanauer Landstraße 139-143,  

60314 Frankfurt am Main 

Germany 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/18/1325/001 - 004 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 18.12.2018 

 

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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ANNEX II 

 

A. MANUFACTURER(S) 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 

 

 



Internal Doc Ref: v6.6 

14 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer(s) responsible for batch release 

 

Hormosan Pharma GmbH 

Hanauer Landstraße 139-143,  

60314 Frankfurt am Main 

Germany 

 

Lupin Healthcare (UK) Ltd  

The Urban Building, second floor, 3-9 Albert Street  

SL1 2BE Slough, Berkshire,  

United Kingdom 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to medical prescription. 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  

• Periodic safety update reports  

 

The requirements for submission of periodic safety update reports 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. 

The marketing authorisation holder shall submit the first periodic safety update report for this 

product within 6 months following authorisation.  

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

• Risk Management Plan (RMP) 

 

The 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 Medicines 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.  

 



Internal Doc Ref: v6.6 

15 

• Additional risk minimisation measures 

 

Prior to launch of Namuscla in each Member State (MS) the Marketing Authorisation Holder (MAH) 

must agree about the content and format of the educational programme, including communication 

media, distribution modalities, and any other aspects of the programme, with the National Competent 

Authority (NCA).  

In order to prevent and / or minimise the important identified risks of Cardiac Arrhythmia in patients 

with Dystrophic Myotonia (off-label use) and Decreased Namuscla clearance, thus the risk of adverse 

reactions in patients with hepatic impairment, the MAH shall ensure that in each MS where 

Namuscla is marketed, all healthcare professionals (HCPs) and patients are provided, respectively, 

with: 

• Educational guide for HCPs; 

• Patient alert card  

The Educational guide for HCPs, which should always be read in conjunction with the Summary of 

Product Characteristics (SmPC) before prescribing Namuscla, should contain the following key 

elements: 

• Information about the risk of cardiac arrhythmias in patients using Namuscla; 
 

• Guidance to identify (and exclude) patients at a greater risk of developing arrhythmias due to 
Namuscla treatment; 

 

• Contraindications with Namuscla which may increase the susceptibility to arrhythmias; 
 

• Before starting treatment, HCPs should perform a detailed and careful cardiac evaluation in all 
patients, in order to determine the cardiac tolerability of Namuscla. A cardiac evaluation is also 

recommended shortly after starting Namuscla (e.g. within 48 hours). 

 

• Throughout treatment with Namuscla: 
 

o In patients without cardiac abnormalities, an electrocardiogram (ECG) monitoring should be 
performed periodically (every 2 years or more frequently, if considered necessary); 

 

o In patients with cardiac abnormalities, and in patients prone to such abnormalities, a detailed 
cardiac evaluation (including ECG) should be carried out before and after any dose increase. 

During Namuscla maintenance treatment, a detailed cardiac evaluation should be carried out 

every 24-48 hour. Holter-monitoring and echocardiography are recommended at least 

annually, or more frequently, if considered necessary, as part of routine cardiac assessment.  

 

• Namuscla should be stopped immediately if the patient develops cardiac abnormalities, is not 
responding or experiencing benefit within Namuscla long-term treatment; 

 

• Highlight the risk of decreased Namuscla clearance in patients with hepatic impairment and 
provide guidance on how to treat those patients in order to prevent it, ensuring Namuscla 

cautious titration in patients with mild or moderate hepatic impairment (increasing the dose after 

at least 2 weeks of treatment). Namuscla should not be used in patients with severe hepatic 

impairment; 

 

• HCPs should counsel patients on: 
 

o The risk of cardiac arrhythmias (informing about symptoms of arrhythmias, advising patients 
to contact immediately their HCP, or emergency centres, if they experience any of these 

symptoms); 



Internal Doc Ref: v6.6 

16 

 

o The risk of decreased Namuscla clearance in patients with hepatic impairment (advising 
patients to inform their HCP if they have any underlying hepatic disorder); 

 

• Reporting of adverse reactions in patients using Namuscla. 
 

 

The patient alert card (wallet size), to be handed by prescribing specialist and to be read in 

conjunction with the patient leaflet, should contain the following key messages: 

 

• Patients should carry the card at all times, and show it at all medical visits to HCPs other than the 
prescriber (e.g. emergency HCPs); 

 

• Prompts to enter the contact details of the patient, the treating physician, and Namuscla treatment 
starting date; 

 

• Inform patients that, before starting and throughout treatment with Namuscla, HCPs should 
perform a detailed and careful cardiac evaluation; 

 

• Patients should inform the HCP about any ongoing medications or before starting any new 
medication, while on treatment with Namuscla; 

 

• Information about symptoms of cardiac arrhythmias, which can be life-threatening, and when 
patients should seek HCP attention;  

 

• Patients should not take more than 3 capsules of Namuscla per day or a double dose to make up 
for a forgotten dose; 

 



Internal Doc Ref: v6.6 

17 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



Internal Doc Ref: v6.6 

18 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



Internal Doc Ref: v6.6 

19 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Namuscla 167 mg hard capsules 

mexiletine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each hard capsule contains mexiletine hydrochloride corresponding to 166.62 mg of mexiletine  

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

30 hard capsules 

50 hard capsules 

100 hard capsules 

200 hard capsules 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use 

Oral use 

 

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 

 

Do not store above 30°C. 

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

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 



Internal Doc Ref: v6.6 

20 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Lupin Europe GmbH 

Hanauer Landstraße 139-143,  

60314 Frankfurt am Main 

Germany 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/0/00/000/000  

 

 

13. BATCH NUMBER 

 

Lot 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Namuscla 167 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

NN:  

 



Internal Doc Ref: v6.6 

21 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Namuscla 167 mg capsules 

mexiletine 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Lupin Europe GmbH 

 

 

3. EXPIRY DATE 

 

EXP 

 

4. BATCH NUMBER 

 

Lot 

 

5. OTHER 



Internal Doc Ref: v6.6 

22 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



Internal Doc Ref: v6.6 

23 

Package leaflet: Information for the patient 

 

Namuscla 167 mg hard capsules 

mexiletine 

 

 

Read all of this leaflet carefully before you start 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 doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

 

There is an Alert Card distributed with Namuscla, to remind you and medical staff of the risk of 

cardiac arrythmias. Read the Alert Card in conjunction with this leaflet and keep the card it with 

you at all times. 

 

What is in this leaflet 

 

1. What Namuscla is and what it is used for  

2. What you need to know before you take Namuscla  

3. How to take Namuscla  

4. Possible side effects  

5. How to store Namuscla  

6. Contents of the pack and other information 

 

1. What Namuscla is and what it is used for 

 

Namuscla is a medicine that contains the active substance mexiletine. 

 

Namuscla is used to treat the symptoms of myotonia (when muscles relax slowly and with difficulty 

after they are used) in adults with non-dystrophic myotonic disorders, which are caused by genetic 

defects that affect muscle function.  

 

2. What you need to know before you take Namuscla  

 

Do not take Namuscla 

- if you are allergic to mexiletine or to any of the other ingredients of this medicine (listed in 

section 6) 

- if you are allergic to any local anaesthetic 

-  if you have had heart attack  

- if your heart does not work well enough 

- if you have certain disorders of the heart rhythm 

- if your heart beats too fast 

- if the blood vessels of your heart are damaged 

- if you also take certain medicines to treat disorders of the heart rhythm (see Other medicines 

and Namuscla) 

- if you also take certain medicines which have a narrow therapeutic window (see Other 

medicines and Namuscla). 

 

If you have any doubt, ask your doctor or pharmacist. 

 

Warnings and precautions  

Talk to your doctor or pharmacist or nurse before taking Namuscla if you have: 

- heart problems  



Internal Doc Ref: v6.6 

24 

- liver problems 

- kidney problems 

- low or high potassium blood levels 

-  low magnesium blood levels 

-  epilepsy  

 

Heart function 

Before starting treatment with Namuscla, you will have tests to check how well your heart is working, 

including ECG (Electrocardiogram). These tests will also be performed regularly during treatment 

with Namuscla, and before and after your dose of Namuscla is modified. How often these tests will be 

performed depends on your heart function.  

If you or your doctor detects any heart rhythm disturbances or any of the conditions stated in section 

“Do not take Namuscla”, your doctor will stop your treatment with Namuscla. 

 

If you notice that the rhythm of your heart changes (the heart beats faster or slower), if you feel 

fluttering or pain in your chest, if you have difficulty breathing, if you feel dizzy, if you sweat or if 

you faint, you have to contact an emergency centre immediately. 

 

Some patients may have higher blood levels of Namuscla because of slower break down in the liver 

and the dose may need to be adjusted accordingly. 

  

Children and adolescents 

Namuscla should not be used in children and adolescents younger than 18 years old. 

 

Other medicines and Namuscla 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines.  

 

Do not take Namuscla with certain medicines for treating heart rhythm disorders (quinidine, 

procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine, amiodarone, 

sotalol, ibutilide, dofetilide, dronedarone, vernakalant). See section “Do not take Namuscla”. Taking 

Namuscla together with any of these medicines increases the risk of a serious heart rhythm disturbance 

called torsades de pointes. 

 

Do not take Namuscla with certain medicines which have a so called narrow therapeutic window 

(these are medicines where small differences in dose or blood concentration may impact the effect of 

the medicine or side effects). Examples of such medicines are digoxin (for heart problems), lithium 

(mood stabiliser), phenytoin (for treating epilepsy), theophylline (against asthma) and warfarin 

(against blood clots).  

 

Tell your doctor or pharmacist if you are taking any of the following since these medicines may affect 

or be affected by Namuscla:  

• medicines for heart problems (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, 
carvedilol, bisoprolol, nebivolol, verapamil, diltiazem),  

• certain other medicines:  
o timolol for treating high pressure in the eye (glaucoma),  

 

o certain antibiotics (ciprofloxacin, rifampicin),  
o certain antidepressants (fluvoxamine),  
o tizanidine (used to relax the muscles),  
o metformin (used against diabetes) 
o omeprazole (to treat stomach ulcer and gastric acid reflux).  

 

Smoking and Namuscla 

Tell your doctor or pharmacist if you start to smoke or quit smoking while taking Namuscla because 

smoking impacts the Namuscla blood levels and your dose may need to be adjusted accordingly. 

 



Internal Doc Ref: v6.6 

25 

Namuscla with drink 

It is recommended to reduce your caffeine intake by half while on treatment with mexiletine because 

the medicine can increase caffeine levels in your blood. 

 

Pregnancy and breast-feeding  

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor for advice before taking this medicine. If you become pregnant while taking Namuscla, 

see your doctor immediately as it is preferable not to take Namuscla while you are pregnant. If you 

become pregnant while taking Namuscla, see your doctor immediately. 

 

Mexiletine passes into human milk. You should talk to your doctor about this, together you will make 

a decision whether to abstain breast-feeding or to discontinue/abstain from mexiletine therapy. 

 

Driving and using machines 

 

Namuscla may in rare cases cause tiredness, confusion, blurred vision: If you have these effects do not 

drive, cycle and use machines.  

 

3. How to take Namuscla 

 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure.  

 

The recommended starting dose is 1 capsule per day. The doctor will increase the dose gradually 

depending on how well the medicine is working. The maintenance dose is 1 to 3 capsules daily taken 

at regular intervals throughout the day. 

 

Do not take more than 3 capsules a day. 

 

Check of heart function 

Before starting treatment with Namuscla and regularly during treatment, you will have tests to check 

how well your heart is working,. Depending on your heart function you may also need testing before 

and after any dose adjustment. See section “Warnings and precautions”. Your doctor will also 

regularly reassess your treatment to make sure Namuscla is still the best medicine for you. 

 

Method of administration 

Namuscla is for oral use. 

 

Swallow the capsule with a glass of water, while standing or sitting up. You may take Namuscla 

during a meal to avoid belly pain (see section “Possible side effects”). 

 

If you take more Namuscla than you should 

Contact your doctor if you take more than the recommended dose of Namuscla. This could be very 

harmful to your health. You or your companion should contact the doctor immediately if you have 

tingling in the arms and legs, if you feel unable to think clearly or concentrate, if you have 

hallucinations, convulsions, if you feel that your heart beats slower, if you feel dizzy and faint, if you 

collapse or if your heart stops beating. 

 

If you forget to take Namuscla 

If you have forgotten a dose, do not take a double dose and take the next dose at your regular schedule. 

 

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

 

4. Possible side effects 

 

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



Internal Doc Ref: v6.6 

26 

 

The most serious side effects are:  

Contact your doctor or go to your nearest emergency center immediately if you experience any of the 

following side effects: 

- severe allergy to mexiletine (with symptoms such as severe rash with fever); this is a very rare side 

effect, may affect up to 1 in 10,000 people. 

- disorders of heart rhythm, see section “Warnings and precautions” for symptoms and more 

information; this is a common side effect, may affect up to 1 in 10 people. 

 

Other side effects that may occur: 

Very common side effects (may affect more than 1 in 10 people): 

- Abdominal (belly) pain 

- Insomnia (difficulty sleeping) 

 

Common side effects (may affect up to 1 in 10 people): 

- Somnolence (sleepiness) 

- Headache 

- Tingling in the arms and legs 

- Blurred vision 

- Vertigo (sensation of feeling off balance) 

- Rapid heart rate 

- Flushing 

- Low blood pressure (which can cause dizziness and feeling faint) 

- Nausea (feeling sick) 

- Acne 

- Pain in the arms and legs 

- Tiredness 

- Weakness 

- Chest discomfort 

- Malaise (a feeling of general discomfort and illness) 

 

Uncommon side effects (may affect up to 1 in 100 people): 

- Convulsions (fits) 

- Speech disorders 

- Slow heart rate 

 

Rare side effects (may affect up to 1 in 1,000 people): 

- Abnormal functioning of the liver (observed after blood analysis). 

 

Very rare side effects (may affect up to 1 in 10,000 people): 

- Liver injury including inflammation (hepatitis) 

- Severe reaction to the medicine (with rash and fever) 

 

Not known (frequency cannot be estimated from the available data): 

- Decrease in white blood cells or in platelets  

- Lupus syndrome (disease of the immune system) 

- Redness and peeling of the skin  

- Stevens-Johnson syndrome: a severe allergic reaction with skin rashes, often in the form of blisters 

and sores in the mouth and eyes, and other mucous membranes 

- Blisters of the skin, malaise and fever in the context of a condition called DRESS 

- Hallucinations (seeing or hearing something that is not present). 

- Transient confusion (a temporary inability to think clearly or concentrate) 

- Double vision 

- Altered sense of taste 

- Disorders of heart rhythm 

- Collapse 

- Hot flushes 



Internal Doc Ref: v6.6 

27 

- Pulmonary fibrosis (disease of the lung) 

- Diarrhoea 

- Vomiting 

- Injury of the oesophagus (food pipe) 

 

Reporting of side effects 

If you get any side effects, talk to your 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 Namuscla 

 

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

 

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date 

refers to the last day of that month. 

 

Store below 30°C. Store in the original package in order to protect from moisture. 

 

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 Namuscla contains  

Each hard capsule contains: 

- mexiletine hydrochloride corresponding to 166.62 mg of mexiletine (active substance) 
- Other ingredients (maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, iron 

oxide [E 172], titanium dioxide [E 171]).  

 

What Namuscla looks like and contents of the pack 

Namuscla hard capsules are reddish hard gelatin capsules filled with white powder. 

Namuscla is available in blister packs containing 30, 50, 100 or 200 capsules. 

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder 

Lupin Europe GmbH 

Hanauer Landstraße 139-143,  

60314 Frankfurt am Main 

Germany 

 

Manufacturer 

Hormosan Pharma GmbH 

Hanauer Landstraße 139-143,  

60314 Frankfurt am Main 

Germany 

 

Lupin Healthcare (UK) Ltd 

The Urban Building, second floor, 3-9 Albert Street 

SL1 2BE Slough, Berkshire,  

United Kingdom 

 

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

Authorisation Holder: 

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


Internal Doc Ref: v6.6 

28 

 

AT, BE, BG, CZ, CY, DK, EE, EL, ES, FR, 

FI, HR, IE, IS, IT, LV, LT, LU, HU, MT, NL, 

NO, PL, PT, RO, SI, SK, SE 

DE 

 

Lupin Europe GmbH 

Tel: +49 69 96759087 

Email: customerserviceLEG@lupin.com  

 

Lupin Europe GmbH 

Tel: +49 (0) 800 182 4160 

Email: customerserviceLEG@lupin.com 

 

UK 

 

Lupin Europe GmbH 

Tel: +44 (0) 800-088-5969 

Email: customerserviceLEG@lupin.com 

 

 

This leaflet was last revised in 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

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

 

 

 

mailto:customerserviceLEG@lupin.com
mailto:customerserviceLEG@lupin.com
tel:+49-800-182-41605969
mailto:customerserviceLEG@lupin.com

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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
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{'Title': '2. what you need to know before you take namuscla', 'Section_Content': 'do not take namuscla - if you are allergic to mexiletine or to any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any local anaesthetic - if you have had heart attack - if your heart does not work well enough - if you have certain disorders of the heart rhythm - if your heart beats too fast - if the blood vessels of your heart are damaged - if you also take certain medicines to treat disorders of the heart rhythm (see other medicines and namuscla) - if you also take certain medicines which have a narrow therapeutic window (see other medicines and namuscla). if you have any doubt, ask your doctor or pharmacist. warnings and precautions talk to your doctor or pharmacist or nurse before taking namuscla if you have: - heart problems internal doc ref: v6.6 24 - liver problems - kidney problems - low or high potassium blood levels - low magnesium blood levels - epilepsy heart function before starting treatment with namuscla, you will have tests to check how well your heart is working, including ecg (electrocardiogram). these tests will also be performed regularly during treatment with namuscla, and before and after your dose of namuscla is modified. how often these tests will be performed depends on your heart function. if you or your doctor detects any heart rhythm disturbances or any of the conditions stated in section "do not take namuscla", your doctor will stop your treatment with namuscla. if you notice that the rhythm of your heart changes (the heart beats faster or slower), if you feel fluttering or pain in your chest, if you have difficulty breathing, if you feel dizzy, if you sweat or if you faint, you have to contact an emergency centre immediately. some patients may have higher blood levels of namuscla because of slower break down in the liver and the dose may need to be adjusted accordingly. children and adolescents namuscla should not be used in children and adolescents younger than 18 years old. other medicines and namuscla tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. do not take namuscla with certain medicines for treating heart rhythm disorders (quinidine, procainamide, disopyramide, ajmaline, encainide, flecainide, propafenone, moricizine, amiodarone, sotalol, ibutilide, dofetilide, dronedarone, vernakalant). see section "do not take namuscla". taking namuscla together with any of these medicines increases the risk of a serious heart rhythm disturbance called torsades de pointes. do not take namuscla with certain medicines which have a so called narrow therapeutic window (these are medicines where small differences in dose or blood concentration may impact the effect of the medicine or side effects). examples of such medicines are digoxin (for heart problems), lithium (mood stabiliser), phenytoin (for treating epilepsy), theophylline (against asthma) and warfarin (against blood clots). tell your doctor or pharmacist if you are taking any of the following since these medicines may affect or be affected by namuscla: medicines for heart problems (lidocaine, tocainide, propranolol, esmolol, metoprolol, atenolol, carvedilol, bisoprolol, nebivolol, verapamil, diltiazem), certain other medicines: o timolol for treating high pressure in the eye (glaucoma), o certain antibiotics (ciprofloxacin, rifampicin), o certain antidepressants (fluvoxamine), o tizanidine (used to relax the muscles), o metformin (used against diabetes) o omeprazole (to treat stomach ulcer and gastric acid reflux). smoking and namuscla tell your doctor or pharmacist if you start to smoke or quit smoking while taking namuscla because smoking impacts the namuscla blood levels and your dose may need to be adjusted accordingly. internal doc ref: v6.6 25 namuscla with drink it is recommended to reduce your caffeine intake by half while on treatment with mexiletine 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{'Title': '3. how to take namuscla', 'Section_Content': 'always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. the recommended starting dose is 1 capsule per day. the doctor will increase the dose gradually depending on how well the medicine is working. the maintenance dose is 1 to 3 capsules daily taken at regular intervals throughout the day. do not take more than 3 capsules a day. check of heart function before starting treatment with namuscla and regularly during treatment, you will have tests to check how well your heart is working,. depending on your heart function you may also need testing before and after any dose adjustment. see section "warnings and precautions". your doctor will also regularly reassess your treatment to make sure namuscla is still the best medicine for you. method of administration namuscla is for oral use. swallow the capsule with a glass of water, while standing or sitting up. you may take namuscla during a meal to avoid belly pain (see section "possible side effects"). if you take more namuscla than you should contact your doctor if you take more than the recommended dose of namuscla. this could be very harmful to your health. you or your companion should contact the doctor immediately if you have tingling in the arms and legs, if you feel unable to think clearly or concentrate, if you have hallucinations, convulsions, if you feel that your heart beats slower, if you feel dizzy and faint, if you collapse or if your heart stops beating. if you forget to take namuscla if you have forgotten a dose, do not take a double dose and take the next dose at your regular schedule. if you have further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'namuscla', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': '1', 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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. internal doc ref: v6.6 26 the most serious side effects are: contact your doctor or go to your nearest emergency center immediately if you experience any of the following side effects: - severe allergy to mexiletine (with symptoms such as severe rash with fever); this is a very rare side effect, may affect up to 1 in 10,000 people. - disorders of heart rhythm, see section "warnings and precautions" for symptoms and more information; this is a common side effect, may affect up to 1 in 10 people. other side effects that may occur: very common side effects (may affect more than 1 in 10 people): - abdominal (belly) pain - insomnia (difficulty sleeping) common side effects (may affect up to 1 in 10 people): - somnolence (sleepiness) - headache - tingling in the arms and legs - blurred vision - vertigo (sensation of feeling off balance) - rapid heart rate - flushing - low blood pressure (which can cause dizziness and feeling faint) - nausea (feeling sick) - acne - pain in the arms and legs - tiredness - weakness - chest discomfort - malaise (a feeling of general discomfort and illness) uncommon side effects (may affect up to 1 in 100 people): - convulsions (fits) - speech disorders - slow heart rate rare side effects (may affect up to 1 in 1,000 people): - abnormal functioning of the liver (observed after blood analysis). very rare side effects (may affect up to 1 in 10,000 people): - liver injury including inflammation (hepatitis) - severe reaction to the medicine (with rash and fever) not known (frequency cannot be estimated from the available data): - decrease in white blood cells or in platelets - lupus syndrome (disease of the immune system) - redness and peeling of the skin - stevens-johnson syndrome: a severe allergic reaction with skin rashes, often in the form of blisters and sores in the mouth and eyes, and other mucous membranes - blisters of the skin, malaise and fever in the context of a condition called dress - hallucinations (seeing or hearing something that is not present). - transient confusion (a temporary inability to think clearly or concentrate) - double vision - altered sense of taste - disorders of heart rhythm - collapse - hot flushes internal doc ref: v6.6 27 - pulmonary fibrosis (disease of the lung) - diarrhoea - vomiting - injury of the oesophagus (food pipe) reporting of side effects if you get any side effects, talk to your 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': 'namuscla', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 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{'Id': 95, 'BeginOffset': 2146, 'EndOffset': 2187, 'Score': 0.9128450751304626, 'Text': 'inability to think clearly or concentrate', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.88384610414505}]}, {'Id': 96, 'BeginOffset': 2191, 'EndOffset': 2204, 'Score': 0.9281786680221558, 'Text': 'double vision', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9081447720527649}]}, {'Id': 97, 'BeginOffset': 2207, 'EndOffset': 2241, 'Score': 0.8106512427330017, 'Text': 'altered sense of taste - disorders', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Id': 98, 'BeginOffset': 2245, 'EndOffset': 2257, 'Score': 0.8879389762878418, 'Text': 'heart rhythm', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.510511040687561}]}, {'Id': 99, 'BeginOffset': 2260, 'EndOffset': 2303, 'Score': 0.277630090713501, 'Text': 'collapse - hot flushes internal doc ref: v6', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Id': 110, 'BeginOffset': 2304, 'EndOffset': 2305, 'Score': 0.6101587414741516, 'Text': '6', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_DX_NAME', 'Traits': [], 'Attributes': [{'Type': 'DX_NAME', 'Score': 0.9326149225234985, 'RelationshipScore': 0.6259104013442993, 'RelationshipType': 'OVERLAP', 'Id': 100, 'BeginOffset': 2311, 'EndOffset': 2329, 'Text': 'pulmonary fibrosis', 'Category': 'MEDICAL_CONDITION', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.8308331966400146}]}]}, {'Text': '27', 'Type': 'NUMBER', 'BeginOffset': 2306, 'EndOffset': 2308}, {'Text': 'pulmonary fibrosis (disease of the lung', 'Type': 'PROBLEM', 'BeginOffset': 2311, 'EndOffset': 2350}, {'Id': 102, 'BeginOffset': 2354, 'EndOffset': 2363, 'Score': 0.9503099322319031, 'Text': 'diarrhoea', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.4295148551464081}]}, {'Id': 103, 'BeginOffset': 2366, 'EndOffset': 2374, 'Score': 0.9795829653739929, 'Text': 'vomiting', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6165911555290222}]}, {'Text': 'injury of the oesophagus', 'Type': 'PROBLEM', 'BeginOffset': 2377, 'EndOffset': 2401}, {'Id': 105, 'BeginOffset': 2427, 'EndOffset': 2439, 'Score': 0.8878180384635925, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7337923049926758}]}, {'Id': 106, 'BeginOffset': 2455, 'EndOffset': 2467, 'Score': 0.9114460945129395, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7352327704429626}]}, {'Id': 107, 'BeginOffset': 2531, 'EndOffset': 2543, 'Score': 0.9567546844482422, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6877769827842712}]}, {'Id': 108, 'BeginOffset': 2592, 'EndOffset': 2604, 'Score': 0.8632871508598328, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7126182913780212}], 'Attributes': [{'Type': 'SYSTEM_ORGAN_SITE', 'Score': 0.5866972804069519, 'RelationshipScore': 0.5376417636871338, 'RelationshipType': 'SYSTEM_ORGAN_SITE', 'Id': 85, 'BeginOffset': 2658, 'EndOffset': 2666, 'Text': 'appendix', 'Category': 'ANATOMY', 'Traits': []}]}, {'Id': 85, 'BeginOffset': 2658, 'EndOffset': 2666, 'Score': 0.5866972804069519, 'Text': 'appendix', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 109, 'BeginOffset': 2683, 'EndOffset': 2695, 'Score': 0.770922839641571, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7213595509529114}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 2751, 'EndOffset': 2764}]}
{'Title': '5. how to store namuscla', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton and blister. the expiry date refers to the last day of that month. store below 30. store in the original package in order to protect from moisture. 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.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what namuscla contains each hard capsule contains: - mexiletine hydrochloride corresponding to 166.62 mg of mexiletine (active substance) - other ingredients (maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, iron oxide [e 172], titanium dioxide [e 171]). what namuscla looks like and contents of the pack namuscla hard capsules are reddish hard gelatin capsules filled with white powder. namuscla is available in blister packs containing 30, 50, 100 or 200 capsules. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'namuscla', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 53, 'EndOffset': 77, 'Score': 0.9931491017341614, 'Text': 'mexiletine hydrochloride', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9369446635246277, 'RelationshipScore': 0.9982929825782776, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 95, 'EndOffset': 104, 'Text': '166.62 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '166.62', 'Type': 'NUMBER', 'BeginOffset': 95, 'EndOffset': 101}, {'Text': 'mexiletine (active substance', 'Type': 'TREATMENT', 'BeginOffset': 108, 'EndOffset': 136}, {'Text': 'other ingredients (maize starch', 'Type': 'TREATMENT', 'BeginOffset': 140, 'EndOffset': 171}, {'Text': 'colloidal anhydrous silica, magnesium stearate', 'Type': 'TREATMENT', 'BeginOffset': 173, 'EndOffset': 219}, {'Text': 'gelatin, iron oxide', 'Type': 'TREATMENT', 'BeginOffset': 221, 'EndOffset': 240}, {'Id': 7, 'BeginOffset': 250, 'EndOffset': 266, 'Score': 0.9648154377937317, 'Text': 'titanium dioxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the pack namuscla hard capsules', 'Type': 'TREATMENT', 'BeginOffset': 318, 'EndOffset': 349}, {'Text': 'reddish hard gelatin capsules', 'Type': 'TREATMENT', 'BeginOffset': 354, 'EndOffset': 383}, {'Text': 'white powder', 'Type': 'TREATMENT', 'BeginOffset': 396, 'EndOffset': 408}, {'Text': 'namuscla', 'Type': 'TREATMENT', 'BeginOffset': 410, 'EndOffset': 418}, {'Text': 'blister packs', 'Type': 'TREATMENT', 'BeginOffset': 435, 'EndOffset': 448}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 460, 'EndOffset': 462}, {'Text': '50', 'Type': 'NUMBER', 'BeginOffset': 464, 'EndOffset': 466}, {'Text': '100', 'Type': 'NUMBER', 'BeginOffset': 468, 'EndOffset': 471}, {'Text': '200', 'Type': 'NUMBER', 'BeginOffset': 475, 'EndOffset': 478}]}