Clopidogrel Sandoz
ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Clopidogrel Sandoz 75 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 75 mg of clopidogrel (as besilate). 
Excipients: each tablet contains 3.80 mg hydrogenated castor oil. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet. 
 
White to off-white, marbled, round and biconvex film-coated tablets.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 
 

 Patients suffering from myocardial infarction (from a few days until less than 35 days), 
ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial 
disease. 

 
For further information please refer to section 5.1. 
 
4.2 Posology and method of administration 
 
 Adults and elderly 
 Clopidogrel should be given as a single daily dose of 75 mg with or without food. 
 
 Pharmacogenetics 
 CYP2C19 poor metaboliser status is associated with diminished response to clopidogrel. The 

optimal dose regimen for poor metabolisers has yet to be determined (see section 5.2). 
 
 Paediatric patients 
 The safety and efficacy of clopidogrel in children and adolescents have not yet been 

established. 
 
 Renal impairment 
 Therapeutic experience is limited in patients with renal impairment (see section 4.4). 
 
 Hepatic impairment 
 Therapeutic experience is limited in patients with moderate hepatic disease who may have 
 bleeding diatheses (see section 4.4). 
 
4.3 Contraindications 
 
 Hypersensitivity to the active substance or to any of the excipients. 
 Severe liver impairment. 
 Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. 

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4.4 Special warnings and precautions for use 
 
Bleeding and haematological disorders 
Due to the risk of bleeding and haematological adverse reactions, blood cell count determination 
and/or other appropriate testing should be promptly considered whenever clinical symptoms 
suggestive of bleeding arise during the course of treatment (see section 4.8). As with other antiplatelet 
agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding 
from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, 
heparin, glycoprotein IIb/IIIa inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) including 
Cox-2 inhibitors. Patients should be followed carefully for any signs of bleeding including occult 
bleeding,especially during the first weeks of treatment and/or after invasive cardiac procedures or 
surgery. The concomitant administration of clopidogrel with oral anticoagulants is not recommended 
since it may increase the intensity of bleedings (see section 4.5). 
 
If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, 
clopidogrel should be discontinued 7 days prior to surgery. Patients should inform physicians and 
dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal 
product is taken. Clopidogrel prolongs bleeding time and should be used with caution in patients who 
have lesions with a propensity to bleed (particularly gastrointestinal and intraocular). 
 
Patients should be told that it might take longer than usual to stop bleeding when they take 
clopidogrel, and that they should report any unusual bleeding (site or duration) to their physician.  
 
Thrombotic Thrombocytopenic Purpura (TTP) 
Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of 
clopidogrel, sometimes after a short exposure. It is characterised by thrombocytopenia and 
microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction 
or fever. TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.  
 
Recent ischaemic stroke 
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute 
ischaemic stroke. 
 
Cytochrome P450 2C19 (CYP2C19) 
Pharmacogenetics: Based on literature data, patients with genetically reduced CYP2C19 function have 
lower systemic exposure to the active metabolite of clopidogrel and diminished antiplatelet responses, 
and generally exhibit higher cardiovascular event rates following myocardial infarction than do 
patients with normal CYP2C19 function (see section 5.2). 
 
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products 
that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active 
metabolite of clopidogrel. The clinical relevance of this interaction is uncertain. As a precaution 
concomitant use of medicinal products that inhibit CYP2C19 should be discouraged (see section 4.5 
for a list of CYP2C19 inhibitors, see also section 5.2).  
 
Renal impairment 
Therapeutic experience with clopidogrel is limited in patients with renal impairment. Therefore 
clopidogrel should be used with caution in these patients (see section 4.2). 
 
Hepatic impairment 
Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. 
Clopidogrel should therefore be used with caution in this population (see section 4.2). 
 
Excipients  
Clopidogrel Sandoz  contains hydrogenated castor oil which may cause stomach upset and diarrhoea.  
 

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4.5 Interaction with other medicinal products and other forms of interaction 
 
Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not 
recommended since it may increase the intensity of bleedings (see section 4.4). 
 
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive 
concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4). 
 
Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced 
platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet 
aggregation. However, concomitant administration of 500 mg of ASA twice a day for one day did not 
significantly increase the prolongation of bleeding time induced by clopidogrel intake. A 
pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to 
increased risk of bleeding. Therefore, concomitant use should be undertaken with caution (see section 
4.4).  
 
Heparin: in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification 
of the heparin dose or alter the effect of heparin on coagulation. Co-administration of heparin had no 
effect on the inhibition of platelet aggregation induced by clopidogrel. A pharmacodynamic 
interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding. 
Therefore, concomitant use should be undertaken with caution (see section 4.4). 
 
Thrombolytics: the safety of the concomitant administration of clopidogrel, fibrin or non-fibrin 
specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction. 
The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents 
and heparin are co-administered with ASA (see section 4.8) 
 
NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of 
clopidogrel and naproxen increased occult gastrointestinal blood loss. However, due to the lack of 
interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of 
gastrointestinal bleeding with all NSAIDs. Consequently, NSAIDs including Cox-2 inhibitors and 
clopidogrel should be co-administered with caution (see section 4.4). 
 
Other concomitant therapy:  
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal 
products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of 
the active metabolite of clopidogrel. The clinical relevance of this interaction is uncertain. As a 
precaution concomitant use of medicinal products that inhibit CYP2C19 should be discouraged (see 
sections 4.4 and 5.2). 
 
Medicinal products that inhibit CYP2C19 include omeprazole and esomeprazole, fluvoxamine, 
fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, 
carbamazepine, oxcarbazepine and chloramphenicol. 
 
Proton Pump Inhibitors (PPI):  
In a crossover clinical study, clopidogrel (300-mg loading dose followed by 75 mg/day) alone and with 
omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days. The exposure to the 
active metabolite of clopidogrel was decreased by 45% (Day 1) and 40% (Day 5) when clopidogrel 
and omeprazole were administered together. Mean inhibition of platelet aggregation (IPA) with 
5 μM ADP was diminished by 39% (24 hours) and 21% (Day 5) when clopidogrel and omeprazole 
were administered together. In another study it was shown that administering clopidogrel and 
omeprazole 12 hours apart did not prevent their interaction that is likely to be driven by the inhibitory 
effect of omeprazole on CYP2C19. Esomeprazole is expected to give a similar interaction with 
clopidogrel. 
 
Inconsistent data on the clinical implications of this pharmacokinetic (PK)/pharmacodynamic (PD)  
interaction in terms of major cardiovascular events have been reported from both observational and 

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clinical studies. As a precaution, concomitant use of omeprazole or esomeprozole should be 
discouraged (see section 4.4). No conclusive data on the pharmacodynamic interaction of clopidogrel 
and other PPIs are available. 
 
There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers 
(except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of 
clopidogrel. 
 
Other medicinal products: 
A number of other clinical studies have been conducted with clopidogrel and other concomitant 
medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic 
interactions. No clinically significant pharmacodynamic interactions were observed when clopidogrel 
was co-administered with atenolol, nifedipine, or both atenolol and nifedipine. Furthermore, the 
pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of 
phenobarbital, or oestrogen. 
 
The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of 
clopidogrel. Antacids did not modify the extent of clopidogrel absorption. 
 
Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of 
clopidogrel could inhibit the activity of Cytochrome P450 2C9. This could potentially lead to 
increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, 
which are metabolised by Cytochrome P450 2C9. Data from the CAPRIE study indicate that 
phenytoin and tolbutamide can be safely co-administered with clopidogrel. 
 
Apart from the specific medicinal products interaction information described above, interaction studies 
with clopidogrel and some medicinal products commonly administered in patients with 
atherothrombotic disease have not been performed. However, patients entered into clinical trials with 
clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, 
ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents 
(including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically 
significant adverse interactions. 
 
4.6 Fertility, pregnancy and lactation 
 
As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to 
use clopidogrel during pregnancy as a precautionary measure. 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, 
embryonal/foetal development, parturition or postnatal development (see section 5.3).  
 
It is unknown whether clopidogrel is excreted in human breast milk. Animal studies have shown 
excretion of clopidogrel in breast milk. As a precautionary measure, breast-feeding should not be 
continued during treatment with clopidogrel. 
 
4.7 Effects on ability to drive and use machines 
 
Clopidogrel has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Clopidogrel has been evaluated for safety for 1 year or more. The clinically relevant adverse reactions 
observed in the CAPRIE study are discussed below. Overall, clopidogrel 75 mg/day was comparable 
to ASA 325 mg/day in CAPRIE regardless of age, gender and race. In addition to clinical studies 
experience, adverse reactions have been spontaneously reported. 
 
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing 
experience where it was mostly reported during the first month of treatment. 

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In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding 
was 9.3%. The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA. 
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are 
presented in the table below. Their frequency is defined using the following conventions: 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). Within each system organ class, adverse drug reactions are presented in order of 
decreasing seriousness. 
 

System Organ 
Class  

Common  Uncommon  Rare  Very rare  

Blood and the 
lymphatic 
system disorders  

 Thrombocytopenia, 
leucopenia, 
eosinophilia  

Neutropenia, 
including severe 
neutropenia  

Thrombotic 
thrombocytopenic 
purpura (TTP) (see 
section 4.4), aplastic 
anaemia, 
pancytopenia, 
agranulocytosis, 
severe 
thrombocytopenia, 
granulocytopenia, 
anaemia  

Immune system 
disorders  

   Serum sickness, 
anaphylactoid 
reactions  

Psychiatric 
disorders  

   Hallucinations, 
confusion  

Nervous system 
disorders  

 Intracranial 
bleeding (some 
cases were reported 
with fatal 
outcome), 
headache, 
paraesthesia, 
dizziness  

 Taste disturbances  

Eye disorders   Eye bleeding 
(conjunctival, 
ocular, retinal)  

  

Ear and 
labyrinth 
disorders  

  Vertigo   

Vascular 
disorders  

Haematoma    Serious 
haemorrhage, 
haemorrhage of 
operative wound, 
vasculitis, 
hypotension  

Respiratory, 
thoracic and 
mediastinal 
disorders  

Epistaxis    Respiratory tract 
bleeding 
(haemoptysis, 
pulmonary 
haemorrhage), 
bronchospasm, 
interstitial 
pneumonitis  

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Gastrointestinal 
disorders  

Gastrointestinal 
haemorrhage, 
diarrhoea, 
abdominal pain, 
dyspepsia  

Gastric ulcer and 
duodenal ulcer, 
gastritis, vomiting, 
nausea, constipation, 
flatulence  

Retroperitoneal 
haemorrhage  

Gastrointestinal and 
retroperitoneal 
haemorrhage with 
fatal outcome, 
pancreatitis, colitis 
(including ulcerative 
or lymphocytic 
colitis), stomatitis  

Hepato-biliary 
disorders  

   Acute liver failure, 
hepatitis, abnormal 
liver function test  

Skin and 
subcutaneous 
tissue disorders  

Bruising  Rash, pruritus, skin 
bleeding (purpura)  

 Bullous dermatitis 
(toxic epidermal 
necrolysis, Stevens 
Johnson Syndrome, 
erythema 
multiforme), 
angioedema, rash 
erythematous, 
urticaria, eczema, 
lichen planus  

Musculoskeletal
, connective 
tissue and bone 
disorders  

   Musculo-skeletal 
bleeding 
(haemarthrosis), 
arthritis, arthralgia, 
myalgia  

Renal and 
urinary 
disorders  

 Haematuria   Glomerulonephritis, 
blood creatinine 
increased  

General 
disorders and 
administration 
site conditions  

Bleeding at 
puncture site  

  Fever  

Investigations   Bleeding time 
prolonged, 
neutrophil count 
decreased, platelet 
count decreased  

  

 
4.9 Overdose 
 
Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent 
bleeding complications. Appropriate therapy should be considered if bleedings are observed. No 
antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of 
prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin,  
ATC Code: B01AC-04.  
 
Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. Clopidogrel 
must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet 

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aggregation. The active metabolite of clopidogrel selectively inhibits the binding of adenosine 
diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the 
glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Due to the irreversible 
binding, platelets exposed are affected for the remainder of their lifespan (approximately 7 - 10 days) 
and recovery of normal platelet function occurs at a rate consistent with platelet turnover. Platelet 
aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of 
platelet activation by released ADP. 
 
Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or 
subject to inhibition by other drugs, not all patients will have adequate platelet inhibition. 
 
Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation 
from the first day; this increased progressively and reached steady state between Day 3 and Day 7. At 
steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 
60%. Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 
days after treatment was discontinued.  
 
Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease 
 
The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent 
myocardial infarction (< 35 days), recent ischaemic stroke (between 7 days and 6 months) or 
established peripheral arterial disease (PAD). Patients were randomised to clopidogrel 75 mg/day or 
ASA 325 mg/day, and were followed for 1 to 3 years. In the myocardial infarction subgroup, most of 
the patients received ASA for the first few days following the acute myocardial infarction.  
 
Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of 
myocardial infarction, ischaemic stroke and vascular death) when compared to ASA. In the intention 
to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA 
(relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 
1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from 
experiencing a new ischaemic event. Analysis of total mortality as a secondary endpoint did not show 
any significant difference between clopidogrel (5.8%) and ASA (6.0%).  
 
In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the 
benefit appeared to be strongest (achieving statistical significance at p = 0.003) in patients enrolled 
due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 
to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 
18.7 [p = 0.258]). In patients who were enrolled in the trial on the sole basis of a recent myocardial 
infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = 
-4.0%; CI: -22.5 to 11.7 [p = 0.639]). In addition, a subgroup analysis by age suggested that the benefit 
of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.  
 
Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear 
whether the differences in relative risk reduction across qualifying conditions are real, or a result of 
chance. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed. Mean peak 
plasma levels of unchanged clopidogrel (approximately 2.2 - 2.5 ng/ml after a single 75 mg oral dose) 
occurred approximately 45 minutes after dosing. Absorption is at least 50%, based on urinary 
excretion of clopidogrel metabolites. 
 

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Distribution 
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma 
proteins (98% and 94% respectively). The binding is non-saturable in vitro over a wide concentration 
range. 
 
Metabolism 
Clopidogrel is extensively metabolised by the liver. In vitro and in vivo, clopidogrel is metabolised 
according to two main metabolic pathways: one mediated by esterases and leading to hydrolysis into 
its inactive carboxylic acid derivative (85% of circulating metabolites), and one mediated by multiple 
cytochromes P450. Clopidogrel is first metabolised to a 2-oxo-clopidogrel intermediate metabolite. 
Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the 
active metabolite, a thiol derivative of clopidogrel. In vitro, this metabolic pathway is mediated by 
CYP3A4, CYP2C19, CYP1A2 and CYP2B6. The active thiol metabolite which has been isolated in 
vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.  
 
Elimination 
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the 
urine and approximately 46% in the faeces in the 120-hour interval after dosing. After a single oral 
dose of 75 mg, clopidogrel has a half-life of approximately 6 hours. The elimination half-life of the 
main circulating (inactive) metabolite was 8 hours after single and repeated administration. 
 
Pharmacogenetics 
Several polymorphic CYP450 enzymes activate clopidogrel. CYP2C19 is involved in the formation of 
both the active metabolite and the 2-oxo-clopidogrel intermediate metabolite. Clopidogrel active 
metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation 
assays, differ according to CYP2C19 genotype. The CYP2C19*1 allele corresponds to fully functional 
metabolism while the CYP2C19*2 and CYP2C19*3 alleles correspond to reduced metabolism. The 
CYP2C19*2 and CYP2C19*3 alleles account for 85% of reduced function alleles in whites and 99% 
in Asians. Other alleles associated with reduced metabolism include CYP2C19*4, *5, *6, *7, and *8, 
but these are less frequent in the general population. Published frequencies for the common CYP2C19 
phenotypes and genotypes are listed in the table below. 
 

CYP2C19 Phenotype and Genotype Frequency 
 

Frequency (%)  
White 

(n=1356) 
Black 

(n=966) 
Chinese 
(n=573) 

Extensive metabolism: CYP2C19*1/*1 74 66 38 
Intermediate metabolism: CYP2C19*1/*2  
or *1/*3 

26 29 50 

Poor metabolism: CYP2C19*2/*2, *2/*3  
or *3/*3 

2 4 14 

 
To date, the impact of CYP2C19 genotype on the pharmacokinetics of the active metabolite of 
clopidogrel has been evaluated in 227 subjects from 7 reported studies. Reduced CYP2C19 
metabolism in intermediate and poor metabolisers decreased the Cmax and AUC of the active 
metabolite by 30-50% following 300- or 600 - mg loading doses and 75 - mg maintenance doses. 
Lower active metabolite exposure results in less platelet inhibition or higher residual platelet 
reactivity. To date, diminished antiplatelet responses to clopidogrel have been described for 
intermediate and poor metabolisers in 21 reported studies involving 4,520 subjects. The relative 
difference in antiplatelet response between genotype groups varies across studies depending on the 
method used to evaluate response, but is typically greater than 30%. 
 
The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 
post hoc clinical trial analyses (substudies of CLARITY [n = 465] and TRITON-TIMI 38 [n = 1,477]) 
and 5 cohort studies (total n = 6,489). In CLARITY and one of the cohort studies (n = 765; Trenk), 

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cardiovascular event rates did not differ significantly by genotype. In TRITON-TIMI 38 and 3 of the 
cohort studies (n = 3,516; Collet, Sibbing, Giusti), patients with an impaired metaboliser status 
(intermediate and poor combined) had a higher rate of cardiovascular events (death, myocardial 
infarction, and stroke) or stent thrombosis compared to extensive metabolisers. In the fifth cohort 
study (n = 2,208; Simon), the increased event rate was observed only in poor metabolisers. 
 
Pharmacogenetic testing can identify genotypes associated with variability in CYP2C19 activity. 
 
There may be genetic variants of other CYP450 enzymes with effects on the ability to form the active 
metabolite of clopidogrel. 
 
Special populations 
 
The pharmacokinetics of the active metabolite of clopidogrel is not known in these special 
populations. 
 
Renal impairment 
After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine 
clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than 
that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen 
in healthy subjects receiving 75 mg of clopidogrel per day. In addition, clinical tolerance was good in 
all patients. 
 
Hepatic impairment 
After repeated doses of 75 mg clopidogrel per day for 10 days in patients with severe hepatic 
impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy 
subjects. The mean bleeding time prolongation was also similar in the two groups. 
 
Race 
The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs 
according to race/ethnicity (see Pharmacogenetics). From literature, limited data in Asian populations 
are available to assess the clinical implication of genotyping of this CYP on clinical outcome events. 
 
5.3 Preclinical safety data 
 
During non clinical studies in rat and baboon, the most frequently observed effects were liver changes. 
These occurred at doses representing at least 25 times the exposure seen in humans receiving the 
clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes. No 
effect on hepatic metabolising enzymes was observed in humans receiving clopidogrel at the 
therapeutic dose. 
 
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of 
clopidogrel was also reported in rat and baboon. 
 
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to 
mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times 
the exposure seen in humans receiving the clinical dose of 75 mg/day). 
 
Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no 
genotoxic activity. 
 
Clopidogrel was found to have no effect on the fertility of male and female rats and was not 
teratogenic in either rats or rabbits. When given to lactating rats, clopidogrel caused a slight delay in 
the development of the offspring. Specific pharmacokinetic studies performed with radiolabelled 
clopidogrel have shown that the parent compound or its metabolites are excreted in the milk. 
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be 
excluded. 

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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core: 
Macrogol 6000 
Cellulose, microcrystalline (E460) 
Crospovidone type A 
Castor oil, hydrogenated 
 
Film-coating: 
Macrogol 6000 
Ethylcellulose (E462) 
Titanium dioxide (E 171) 
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Store in the original blister in order to protect from moisture. 
 
6.5 Nature and contents of container 
 
Alu/Alu blisters containing 14, 28, 30, 50, 84, 90 and 100 film-coated tablets packed in cardboard 
cartons. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Acino Pharma GmbH 
Am Windfeld 35 
83714 Miesbach  
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/547/001-007 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
21/09/2009 
 
 

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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/

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ANNEX II 
 

A. MANUFACTURING AUTHORISATION HOLDER 
RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 

 

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A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
Name and address of the manufacturer responsible for batch release 
 
Acino AG 
Am Windfeld 35 
83714 Miesbach 
Germany 
 
Salutas Pharma GmbH 
Otto-von-Guericke-Allee 1 
39179 Barleben 
Germany 
 
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 OF THE MARKETING AUTHORISATION 
 
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription. 
 
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
 OTHER CONDITIONS 
 
Pharmacovigilance system 
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in 
Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and 
whilst the product is on the market. 
 
Risk Management Plan 
Not applicable. 
The application is based on a reference medicinal product for which no safety concerns requiring 
additional risk minimisation activities have been identified. 
 
PSURs 
The PSUR submission schedule should follow the PSUR schedule for the reference product. 
 
 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Clopidogrel Sandoz 75 mg film-coated tablets  
Clopidogrel 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 75 mg of clopidogrel (as besilate). 
 
3. LIST OF EXCIPIENTS 
 
It also contains hydrogenated castor oil. See leaflet for further information. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
50 film-coated tablets 
84 film-coated tablets 
90 film-coated tablets 
100 film-coated tablets 
 
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 REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children.  
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in the original blister in order to protect from moisture. 

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18 

 
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 
 
Acino Pharma GmbH 
Am Windfeld 35 
83714 Miesbach 
Germany 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/547/001-007 
 
 
13. BATCH NUMBER 
 
Batch 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
  
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Clopidogrel Sandoz 75 mg 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Clopidogrel Sandoz 75 mg film-coated tablets 
 
Clopidogrel 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Acino Pharma GmbH 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Batch 
 
5. OTHER 
 

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B. PACKAGE LEAFLET 
 

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PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Clopidogrel Sandoz 75 mg film-coated tablets 

Clopidogrel  
 
Read all of this leaflet carefully before you start taking this medicine. 
- 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. Do not pass it on to others. It may harm them, 

even if their symptoms are the same as yours. 
- If  any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist, 
 
In this leaflet:  
1. What Clopidogrel Sandoz is and what it is used for 
2. Before you take Clopidogrel Sandoz 
3. How to take Clopidogrel Sandoz 
4. Possible side effects 
5.   How to store Clopidogrel Sandoz 
6. Further information 
 
 
1. WHAT CLOPIDOGREL SANDOZ IS AND WHAT IT IS USED FOR 
 
Clopidogrel Sandoz contains the active ingredient Clopidogrel which belongs to a group of medicines 
called antiplatelet medicinal products. Platelets (so-called thrombocytes) are very small structures, 
which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal 
products reduce the chances of blood clots forming (a process called thrombosis). 
  
Clopidogrel Sandoz is taken to prevent blood clots (thrombi) forming in hardened blood vessels 
(arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as 
stroke, heart attack, or death). 
 
You have been prescribed Clopidogrel Sandoz to help prevent blood clots and reduce the risk of these 
severe events because: 
- You have a condition of hardening of arteries (also known as atherosclerosis), and  
- You have previously experienced a heart attack, stroke or have a condition known as 

peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular 
occlusions) 

 
 
2. BEFORE YOU TAKE CLOPIDOGREL SANDOZ 
 
Do not take Clopidogrel Sandoz: 
 If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of 

Clopidogrel Sandoz; 
 If you have a medical condition that is currently causing bleeding such as a stomach ulcer or 

bleeding within the brain; 
 If you suffer from severe liver disease; 
 
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before 
taking Clopidogrel Sandoz. 
 

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Take special care with Clopidogrel Sandoz: 
If any of the situations mentioned below apply to you, you should tell your doctor before taking 
Clopidogrel Sandoz: 
 if you have a risk of bleeding such as 

-  a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) 
-  a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, 

organs or joints of your body) 
-  a recent serious injury 
-  a recent surgery (including dental) 
-  a planned surgery (including dental) in the next seven days 

 
 if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the 

last seven days 
 if you have kidney or liver disease 
 
While you are taking Clopidogrel Sandoz: 
 You should tell your doctor if a surgery (including dental) is planned. 
 You should also tell your doctor immediately if you develop a medical condition (also known 

as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the 
skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, 
confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE 
EFFECTS’). 

 If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked 
to the way your medicine works as it prevents the ability of blood clots to form. For minor 
cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you 
are concerned by your bleeding, you should contact your doctor straightaway (see section 4 
Your doctor may order blood tests. 

 
Children and adolescents 
Clopidogrel Sandoz is not intended for use in children or adolescents. 
 
Taking other medicines 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription.  
Some other medicines may influence the use of Clopidogrel Sandoz or vice versa.  
 
You should specifically tell your doctor if you take 
- oral anticoagulants, medicines used to reduce blood clotting, 
- a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory 

conditions of muscle or joints 
- heparin or any other medicine used to reduce blood clotting 
- a proton pump inhibitor (e.g, omeprazole) for upset stomach 
- fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and 

fungal infections 
- cimetidine, medicine to treat upset stomach 
- fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression 
- carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy 
- ticlopidine, other antiplatelet agent. 
 
Acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever: An 
occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally 
not cause a problem, but prolonged use in other circumstances should be discussed with your doctor. 
 
Taking Clopidogrel Sandoz with food and drink 
Clopidogrel Sandoz may be taken with or without food. 
 

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Pregnancy and breast-feeding 
It is preferable not to use this product during pregnancy and breast-feeding. 
 
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist 
before taking Clopidogrel Sandoz. If you become pregnant while taking Clopidogrel Sandoz, consult 
your doctor immediately as it is recommended not to take clopidogrel while you are pregnant. 
 
While taking Clopidogrel Sandoz, consult your doctor about the breast-feeding of a baby.   
 
Ask your doctor or pharmacist for advice before taking any medicine. 
 
Driving and using machines 
Clopidogrel Sandoz is unlikely to affect your ability to drive or to use machines. 
 
Important information about some of the ingredients of Clopidogrel Sandoz: 
Clopidogrel Sandoz contains hydrogenated castor oil which  
may cause stomach upset or diarrhoea. 
 
 
3. HOW TO TAKE CLOPIDOGREL SANDOZ 
 
Always take Clopidogrel Sandoz exactly as your doctor has told you. You should check with your 
doctor or pharmacist if you are not sure.  
  
The usual dose is one 75 mg tablet of Clopidogrel Sandoz per day to be taken orally with or without 
food, and at the same time each day. 
 
You should take Clopidogrel Sandoz for as long as your doctor continues to prescribe it. 
 
If you take more Clopidogrel Sandoz than you should 
Contact your doctor or the nearest hospital emergency department because of the increased risk of 
bleeding. 
 
If you forget to take Clopidogrel Sandoz 
If you forget to take a dose of Clopidogrel Sandoz, but remember within 12 hours of your usual time, 
take your tablet straight away and then take your next tablet at the usual time. If you forget for more 
than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up 
for the forgotten individual doses.  
 
If you stop taking Clopidogrel Sandoz 
Do not stop the treatment. Contact your doctor or pharmacist before stopping.  
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Clopidogrel Sandoz can cause side effects, although not everybody gets them.  
 
Contact your doctor immediately if you experience: 

- fever, signs of infection or extreme tiredness. These may be due to rare decrease of some 
blood cells.  

- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether 
or not associated with bleeding which appears under the skin as red pinpoint dots and/or 
confusion (see section 2 ‘Take special care with Clopidogrel Sandoz’).  

- swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. 
These may be the signs of an allergic reaction. 

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The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding. 
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or 
bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the 
eye, inside the head, the lung or the joints has also been reported. 
 
If you experience prolonged bleeding when taking Clopidogrel Sandoz.  
If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the 
way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries 
e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your 
bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with 
Clopidogrel Sandoz’). 
 
Side effects may occur with certain frequencies, which are defined as follows:  
 very common: affects more than 1 user in 10  
 common: affects 1 to 10 users in 100  
 uncommon: affects 1 to 10 users in 1,000  
 rare: affects 1 to 10 users in 10,000  
 very rare: affects less than 1 user in 10,000  
 not known: frequency cannot be estimated from the available data. 
 
Other side effects reported with clopidogrel are:  
-Common side effects:  
Diarrhoea, abdominal pain, indigestion or heartburn.   
 
-Uncommon side effects:  
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, 
rashes, itching, dizziness, sensation of tingling and numbness. 
 
-Rare side effect:  
Vertigo.   
 
-Very rare side effects:  
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes 
associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin 
allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; 
joint pain; muscular pain; changes in the way things taste. 
 
In addition, your doctor may identify changes in your blood or urine test results. 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist.  
 
 
5. HOW TO STORE CLOPIDOGREL SANDOZ 
 
Store in the original blister in order to protect from moisture. 
 
Keep out of the reach and sight of children.  
 
Do not use Clopidogrel Sandoz after the expiry date which is stated on the carton and on the blister 
after EXP. The expiry date refers to the last day of that month. 
 
Do not use Clopidogrel Sandoz if you notice any visible sign of damage of blister or film-coated 
tablets. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 

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dispose of medicines no longer required. These measures will help to protect the environment.  
 
 
6. FURTHER INFORMATION 
 
What Clopidogrel Sandoz contains 
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besilate). 
 
The other ingredients are: 
 
Tablet core: 
Macrogol 6000 
Cellulose, microcrystalline (E460) 
Crospovidone type A 
Castor oil, hydrogenated 
 
Film-coating: 
Macrogol 6000 
Ethylcellulose (E462) 
Titanium dioxide (E 171) 
 
What Clopidogrel Sandoz looks like and contents of the pack  
 
Clopidogrel Sandoz 75 mg film-coated tablets are white to off-white, marbled, round and biconvex. 
They are supplied in cardboard cartons containing 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium 
blisters. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
 
Acino Pharma GmbH 
Am Windfeld 35 
83714 Miesbach 
Germany 
 
Manufacturer 
 
Acino AG 
Am Windfeld 35 
83714 Miesbach 
Germany 
 
Salutas Pharma GmbH 
Otto-von-Guericke-Allee 1 
39179 Barleben 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Sandoz N.V.  
Telecom Gardens 
Medialaan 40 
B-1800 Vilvoorde 
Tél/Tel: +32 (0)2 722  97 97  

Luxembourg/Luxemburg 
Sandoz Pharmaceuticals GmbH 
Raiffeisenstraße 11 
D-83607 Holzkirchen 
Deutschland 
Tél/Tel: +49 8024 902 4000 
info@sandoz.de  
 

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България 
Representative office Sandoz d.d. 
Business Park Sofia, buil. 8B, fl. 6  
BG-1766 Sofia  
Teл.: + 359 2 970 47 47  

Magyarország 
Sandoz Hungária Kft. 
Tímár u. 20. 
H-1034 Budapest 
Tel: +36 1 430 2890 
info.hungary@sandoz.com  
 

Česká republika 
Sandoz s.r.o. 
Jeseniova 30 
CZ-13000 Praha 3 
Tel: +420 221 421 611  
office.cz@sandoz.com,  
 

Malta 
V.J.Salomone Pharma Limited 
79, Simpson Street 
MT-Marsa HMR 14 
Tel: + 356 21220174 
info@vjsalomone.com 
 

Danmark 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
info.sandoz-dk@sandoz.com 
 

Nederland 
Sandoz B.V. 
Veluwezoom 22  
NL-1327 AH Almere 
Tel: +31 36 5241600 
info.sandoz-nl@sandoz.com  
 

Deutschland 
Sandoz Pharmaceuticals GmbH 
Raiffeisenstraße 11 
D-83607 Holzkirchen 
Tel: +49 8024 902 4000 
info@sandoz.de 
  

Norge 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
Danmark 
info.sandoz-dk@sandoz.com  
 

Eesti 
Sandoz d.d. Eesti filiaal,  
Pärnu mnt 105,  
EE-11312 Tallinn,  
Tel: +372 6652400  

Österreich 
Sandoz GmbH 
Biochemiestrasse 10 
A-6250 Kundl 
Tel: +43 (0)53382000  
 

Ελλάδα 
Sambrook Med SA 
Καρτσιβάνη 6 
Π.Φάληρο 
GR-175 64 Πειραιας 
Τηλ: + 30 210 8194 322  
ldimomeleti@gerolymatos.gr 
 

Polska 
Lek Polska Sp.z o.o. 
ul. Domaniewska 50 C 
PL - 02-672 Warszawa 
Tel: +48 22 549 15 00 

España 
Sandoz Farmacéutica, SA 
Avda. Osa Mayor, 4 
E-28023 Aravaca (Madrid) 
Tel. +34 917401280 
sandoz.responde@sandoz.com 
 

Portugal 
Sandoz Farmacêutica Lda. 
Alameda da Beloura 
Edifício 1, 2º andar - Escritório 15 
P-2710-693 Sintra 
Tel: +351 21 0008781  
 

France 
Sandoz SAS 
49, avenue Georges Pompidou 
F-92593 Levallois-Perret Cedex 
Tél: +33 1 4964 4800  

România 
Sandoz Pharma Services S.R.L. 
Victoria Business Park 
Soseaua Bucuresti-Ploiesti 73-81 
Corp 2, etaj 2, Sector 1-RO 
Tel: +40 21 4075183  
 

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Ireland 
Sandoz Pharmaceuticals GmbH 
Raiffeisenstraße 11 
D-83607 Holzkirchen 
Germany 
Tel: +49 8024 902 4000 
info@sandoz.de 
 

Slovenija 
Lek Pharmaceuticals d.d. 
Verovśkova 57 
SI-1526 Ljubljana 
Tel: +386 1 5802111 
info.lek@sandoz.com 
 

Ísland 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
Danmörk 
info.sandoz-dk@sandoz.com 
 

Slovenská republika 
Sandoz d.d. - organizačná zložka 
Galvaniho 15/C 
SK-821 04 Bratislava 
Tel: +421 2 48 200 600 
 

Italia 
Sandoz S.p.A. 
Largo Umberto Boccioni, 1 
I-21040 Origgio / VA 
Tel: +39 02 96541  

Suomi/Finland 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
Tanska/Danmark 
info.sandoz-dk@sandoz.com  
 

Κύπρος 
Panicos Hadjigeorgiou  
για P. T. Hadjigeorgiou Co Ltd 
Ταχυδρομική Διεύθυνση: Τ.K. 53158 CY-3301 
Λεμεσός 
Διεύθυνση γραφείου: Γιλτίζ 31 CY-3042 
Λεμεσός 
Τηλ: 00357 25372425 
hapanicos@cytanet.com.cy 
 

Sverige 
Sandoz A/S 
Edvard Thomsens Vej 14 
DK-2300 København S 
Danmark 
info.sandoz-dk@sandoz.com  
 

Latvija 
Sandoz d.d. Representative Office in Latvia 
Meza Str. 4 
LV-1048, Riga 
Tel: +371 67892006  

United Kingdom 
Sandoz Ltd 
37 Woolmer Way 
Bordon GU35 9QE – UK 
Tel: +44 1420 478301 
uk.drugsafety@sandoz.com  
 

Lietuva 
Sandoz Pharmaceuticals d.d., 
Branch Office Lithuania 
Seimyniskiu Str. 3A 
LT-09312 Vilnius 
Tel: +370 5 2636037  
 

 

 
This leaflet was last approved in. 
 
Detailed information is available on the European Medicines Agency website: 
http://www.ema.europa.eu/ 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. before you take clopidogrel sandoz', 'Section_Content': "do not take clopidogrel sandoz: if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of clopidogrel sandoz; if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain; if you suffer from severe liver disease; if you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking clopidogrel sandoz. take special care with clopidogrel sandoz: if any of the situations mentioned below apply to you, you should tell your doctor before taking clopidogrel sandoz: if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) - a recent serious injury - a recent surgery (including dental) - a planned surgery (including dental) in the next seven days if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days if you have kidney or liver disease while you are taking clopidogrel sandoz: you should tell your doctor if a surgery (including dental) is planned. you should also tell your doctor immediately if you develop a medical condition (also known as thrombotic thrombocytopenic purpura or ttp) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 'possible side effects'). if you cut or injure yourself, it may take longer than usual for bleeding to stop. this is linked to the way your medicine works as it prevents the ability of blood clots to form. for minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. however, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 your doctor may order blood tests. children and adolescents clopidogrel sandoz is not intended for use in children or adolescents. taking other medicines please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. some other medicines may influence the use of clopidogrel sandoz or vice versa. you should specifically tell your doctor if you take - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints - heparin or any other medicine used to reduce blood clotting - a proton pump inhibitor (e.g, omeprazole) for upset stomach - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections - cimetidine, medicine to treat upset stomach - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy - ticlopidine, other antiplatelet agent. acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever: an occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor. taking clopidogrel sandoz with food and drink clopidogrel sandoz may be taken with or without food. pregnancy and breast-feeding it is preferable not to use this product during pregnancy and breast-feeding. if you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking clopidogrel sandoz. if you become pregnant while taking clopidogrel sandoz, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant. while taking clopidogrel sandoz, consult your doctor about the breast-feeding of a baby. ask your doctor or pharmacist for advice before taking any medicine. driving and using machines clopidogrel sandoz is unlikely to affect your ability to drive or to use machines. important information about some of the ingredients of clopidogrel sandoz: clopidogrel sandoz contains hydrogenated castor oil which may cause stomach upset or diarrhoea.", 'Entity_Recognition': [{'Text': 'clopidogrel sandoz', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 30}, {'Id': 25, 'BeginOffset': 43, 'EndOffset': 67, 'Score': 0.3041936159133911, 'Text': 'allergic (hypersensitive', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.4061504304409027}, {'Name': 'DIAGNOSIS', 'Score': 0.7090170383453369}]}, {'Id': 19, 'BeginOffset': 72, 'EndOffset': 83, 'Score': 0.9941222071647644, 'Text': 'clopidogrel', 'Category': 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{'Title': '3. how to take clopidogrel sandoz', 'Section_Content': 'always take clopidogrel sandoz exactly as your doctor has told you. you should check with your doctor or pharmacist if you are not sure. the usual dose is one 75 mg tablet of clopidogrel sandoz per day to be taken orally with or without food, and at the same time each day. you should take clopidogrel sandoz for as long as your doctor continues to prescribe it. if you take more clopidogrel sandoz than you should contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding. if you forget to take clopidogrel sandoz if you forget to take a dose of clopidogrel sandoz, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time. if you forget for more than 12 hours, simply take the next single dose at the usual time. do not take a double dose to make up for the forgotten individual doses. if you stop taking clopidogrel sandoz do not stop the treatment. contact your doctor or pharmacist before stopping. if you have any further questions on the use of this product, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'clopidogrel sandoz', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 30}, {'Text': '75', 'Type': 'NUMBER', 'BeginOffset': 159, 'EndOffset': 161}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 175, 'EndOffset': 193}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 290, 'EndOffset': 308}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 380, 'EndOffset': 398}, {'Id': 14, 'BeginOffset': 459, 'EndOffset': 479, 'Score': 0.9715046882629395, 'Text': 'emergency department', 'Category': 'PROTECTED_HEALTH_INFORMATION', 'Type': 'ADDRESS', 'Traits': []}, {'Id': 13, 'BeginOffset': 513, 'EndOffset': 521, 'Score': 0.9870599508285522, 'Text': 'bleeding', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.48095348477363586}, {'Name': 'DIAGNOSIS', 'Score': 0.41207414865493774}]}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 545, 'EndOffset': 563}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 596, 'EndOffset': 614}, {'Text': '12', 'Type': 'NUMBER', 'BeginOffset': 636, 'EndOffset': 638}, {'Text': '12', 'Type': 'NUMBER', 'BeginOffset': 774, 'EndOffset': 776}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 848, 'EndOffset': 861}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 928, 'EndOffset': 946}, {'Text': 'the treatment', 'Type': 'TREATMENT', 'BeginOffset': 959, 'EndOffset': 972}]}
{'Title': '4. possible side effects', 'Section_Content': "like all medicines, clopidogrel sandoz can cause side effects, although not everybody gets them. contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness. these may be due to rare decrease of some blood cells. - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 'take special care with clopidogrel sandoz'). - swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. these may be the signs of an allergic reaction. the most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding. bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. in a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported. if you experience prolonged bleeding when taking clopidogrel sandoz. if you cut or injure yourself, it may take longer than usual for bleeding to stop. this is linked to the way your medicine works as it prevents the ability of blood clots to form. for minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. however, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 'take special care with clopidogrel sandoz'). side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data. other side effects reported with clopidogrel are: -common side effects: diarrhoea, abdominal pain, indigestion or heartburn. -uncommon side effects: headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness. -rare side effect: vertigo. -very rare side effects: jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste. in addition, your doctor may identify changes in your blood or urine test results. if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.", 'Entity_Recognition': [{'Text': 'clopidogrel sandoz', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 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{'Title': '5. how to store clopidogrel sandoz', 'Section_Content': 'store in the original blister in order to protect from moisture. keep out of the reach and sight of children. do not use clopidogrel sandoz after the expiry date which is stated on the carton and on the blister after exp. the expiry date refers to the last day of that month. do not use clopidogrel sandoz if you notice any visible sign of damage of blister or film-coated tablets. medicines should not be disposed of via wastewater or household waste. ask your pharmacist how to 24 dispose of medicines no longer required. these measures will help to protect the environment.', 'Entity_Recognition': [{'Text': 'clopidogrel sandoz', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 121, 'EndOffset': 139}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 287, 'EndOffset': 305}, {'Id': 2, 'BeginOffset': 340, 'EndOffset': 357, 'Score': 0.41089141368865967, 'Text': 'damage of blister', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.568500280380249}]}, {'Text': 'film-coated tablets', 'Type': 'TREATMENT', 'BeginOffset': 361, 'EndOffset': 380}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 382, 'EndOffset': 391}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 480, 'EndOffset': 482}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 494, 'EndOffset': 503}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 524, 'EndOffset': 538}]}
{'Title': '6. further information', 'Section_Content': 'what clopidogrel sandoz contains the active substance is clopidogrel. each tablet contains 75 mg of clopidogrel (as besilate). the other ingredients are: tablet core: macrogol 6000 cellulose, microcrystalline (e460) crospovidone type a castor oil, hydrogenated film-coating: macrogol 6000 ethylcellulose (e462) titanium dioxide (e 171) what clopidogrel sandoz looks like and contents of the pack clopidogrel sandoz 75 mg film-coated tablets are white to off-white, marbled, round and biconvex. they are supplied in cardboard cartons containing 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'clopidogrel sandoz', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'what clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 23}, {'Id': 1, 'BeginOffset': 57, 'EndOffset': 68, 'Score': 0.9983308911323547, 'Text': 'clopidogrel', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.8564538359642029, 'RelationshipScore': 0.9507244825363159, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 75, 'EndOffset': 81, 'Text': 'tablet', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '75', 'Type': 'NUMBER', 'BeginOffset': 91, 'EndOffset': 93}, {'Id': 4, 'BeginOffset': 100, 'EndOffset': 111, 'Score': 0.9985041618347168, 'Text': 'clopidogrel', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.8564538359642029, 'RelationshipScore': 0.5949229001998901, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 75, 'EndOffset': 81, 'Text': 'tablet', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9838761687278748, 'RelationshipScore': 0.998782217502594, 'RelationshipType': 'DOSAGE', 'Id': 3, 'BeginOffset': 91, 'EndOffset': 96, 'Text': '75 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 5, 'BeginOffset': 167, 'EndOffset': 190, 'Score': 0.4486970603466034, 'Text': 'macrogol 6000 cellulose', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': '6000', 'Type': 'NUMBER', 'BeginOffset': 176, 'EndOffset': 180}, {'Text': 'microcrystalline (e', 'Type': 'TREATMENT', 'BeginOffset': 192, 'EndOffset': 211}, {'Id': 7, 'BeginOffset': 216, 'EndOffset': 228, 'Score': 0.6206777691841125, 'Text': 'crospovidone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a castor oil', 'Type': 'TREATMENT', 'BeginOffset': 234, 'EndOffset': 246}, {'Id': 9, 'BeginOffset': 248, 'EndOffset': 265, 'Score': 0.7591944336891174, 'Text': 'hydrogenated film', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'macrogol 6000 ethylcellulose (e462) titanium dioxide', 'Type': 'TREATMENT', 'BeginOffset': 275, 'EndOffset': 327}, {'Text': '6000', 'Type': 'NUMBER', 'BeginOffset': 284, 'EndOffset': 288}, {'Text': '171', 'Type': 'NUMBER', 'BeginOffset': 331, 'EndOffset': 334}, {'Text': 'clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 341, 'EndOffset': 359}, {'Text': 'the pack clopidogrel sandoz', 'Type': 'TREATMENT', 'BeginOffset': 387, 'EndOffset': 414}, {'Text': '75', 'Type': 'NUMBER', 'BeginOffset': 415, 'EndOffset': 417}, {'Id': 17, 'BeginOffset': 484, 'EndOffset': 492, 'Score': 0.4738830327987671, 'Text': 'biconvex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.39984574913978577, 'RelationshipScore': 0.6075654029846191, 'RelationshipType': 'DOSAGE', 'Id': 18, 'BeginOffset': 571, 'EndOffset': 582, 'Text': '100 tablets', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '14', 'Type': 'NUMBER', 'BeginOffset': 544, 'EndOffset': 546}, {'Text': '28', 'Type': 'NUMBER', 'BeginOffset': 548, 'EndOffset': 550}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 552, 'EndOffset': 554}, {'Text': '50', 'Type': 'NUMBER', 'BeginOffset': 556, 'EndOffset': 558}, {'Text': '84', 'Type': 'NUMBER', 'BeginOffset': 560, 'EndOffset': 562}, {'Text': '90', 'Type': 'NUMBER', 'BeginOffset': 564, 'EndOffset': 566}, {'Text': '100', 'Type': 'NUMBER', 'BeginOffset': 571, 'EndOffset': 574}, {'Id': 19, 'BeginOffset': 586, 'EndOffset': 604, 'Score': 0.32445627450942993, 'Text': 'aluminium blisters', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.39984574913978577, 'RelationshipScore': 0.9998914003372192, 'RelationshipType': 'DOSAGE', 'Id': 18, 'BeginOffset': 571, 'EndOffset': 582, 'Text': '100 tablets', 'Category': 'MEDICATION', 'Traits': []}]}]}