COPLAVIX Film-coated tablet Ref.[50670] Active ingredients: Acetylsalicylic acid Clopidogrel

Adults and elderly

CoPlavix fixed dose combination (FDC) should be given as a single daily 75 mg/100 mg dose. CoPlavix FDC is used in adult patients already taking both clopidogrel and ASA given separately at the appropriate dose, and replaces the individual clopidogrel and ASA product. It may be given with or without food.

In patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), treatment should be initiated with a single 300 mg loading dose of clopidogrel and an appropriate dose of ASA and then continued with CoPlavix 75 mg/100 mg once a day. The optimal duration of treatment has not been formally established. Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section “Pharmacodynamic properties”).

In patients with ST segment elevation acute myocardial infarction: Therapy should be started as early as possible after symptoms start and continued for at least four weeks. The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section “Pharmacodynamic properties”). For patients greater than 75 years of age therapy should be initiated without a loading dose of clopidogrel. However, there is limited clinical experience in patients >75 years of age.

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).

Children and adolescents

There is no experience in children. CoPlavix is not indicated for use in children or adolescents.

Renal impairment

CoPlavix must not be used in patients with severe renal impairment (see section “Contraindications”). Therapeutic experience is limited in patients with mild to moderate renal impairment (see section “Special warnings and precautions for use”). Therefore CoPlavix should be used with caution in these patients.

Liver impairment

CoPlavix must not be used in patients with severe liver impairment (see section “Contraindications”). Therapeutic experience is limited in patients with moderate liver disease who may have bleeding diatheses (see section “Special warnings and precautions for use”). Therefore CoPlavix should be used with caution in these patients.

There is no information concerning overdosage with CoPlavix.

Clopidogrel: 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.

ASA: Overdosage is manifested by the following symptoms:

• Moderate overdose: ringing in the ears, sensation of reduced hearing, headaches, vertigo.
• Severe overdose: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia.

Overdose with salicylates, particularly in young children, can result in severe hypoglycaemia and potentially fatal poisoning.

In case of ASA severe overdose, the following actions should be undertaken: control of acid-base balance, forced alkaline diuresis, possibility of haemodialysis or peritoneal dialysis if necessary.

24 months.

Store below 25°C.

Store in the original package.

14, 28, 30, 50, 84 and, 90, and 100 film-coated tablets packed in aluminium blister packs in cardboard cartons.

Not all pack sizes may be marketed.

No special requirements.