clopidogrel

Film coated tablets 75 mg

PACKAGE INSRT. INFORMATION FOR THE PATIENT

Please, read this package insert carefully before using the pteraration!

Keep this package insert. You may need to read it again.

If you have any additional questions, please, consult your doctor.

This preparation is indicated for you personally and should not be given to other individuals. Doing so may harm their health even if their symptoms are similar to yours.

Composition of the medicinal preparation:

Active substance: 1 tablet contains clopidogrel bisulphate equivalent to clopidogrel 75 mg;

Auxiliary substances: microcrystalline cellulose, lactose, sodium croscarmellose, hydroxypropyl cellulose low-substituted, magnesium stearate, purified talc, colloidal silicon dioxide, hydrogenated castor oil, filmy coating SOL Code IC-S-279 (Brown) (contains titanium dioxide and red ferric oxide).

Medicinal form. Film coated tablets.

Pharmacotherapeutical group. Antithrombotic agent. Antiaggregants.

Pharmacological properties. Antiaggregants. Clopidogrel selectively inhibits binding of adenosine diphosphate (ADP) to its receptors on thrombocyte surface and activation of GP IIb/IIIa complex ADP action, inhibiting this way thrombocyte aggregation. For such action clopidogrel’s biotransformation is needed. Clopidogrel also inhibits thrombocyte aggregation caused by other factors. Clopidogrel acts by means of irreversible transformation of thrombocyte receptors to ADP; thrombocytes that interact with it stay damaged life-long, normal thrombocyte function restores with the rate equal to the rate of new thrombocyte formation. Recurring use in the dose of 75 mg/day leads to significant inhibition of thrombocyte aggregation, caused by ADP. Inhibiting effect enhances progressively, stable state is achieved in 3-7 days of treatment. At course use the mean level of inhibition of thrombocyte aggregation is 40-60 %. Thrombocyte aggregation and duration of the haemorrhage restore to the initial level in about 5 days after end of treatment.

Indications. Prophylaxis of myocardial infarction, ischemic stroke, sudden coronary death in patients with clinical manifestations of atherosclerosis.

Contraindications. Hypersensitivity to the preparation, severe hepatic diseases, acute haemorrhages (in case of peptic ulcer and intracranial hemorrhage), pregnancy and lactation, children under 18 years old.

 Precautions at use. If you are pregnant or nursing mother, tell you doctor about it before using the preparation. Flamogrel 75 should not be indicated to acute myocardial infarction patients for first 5-7 days after myocardial infarction. Due to the lack of clinical data use of Flamogrel 75 is not recommended in case of unstable stenocardia, after intercutaneus coronary angioplasty, coronary artery grafting and acute ischemic stroke (less than 7 days). 

Flamogrel 75 should be used with caution by the patients with increased risk of hemorrhage due to the trauma, surgery or pathological states. In case of surgery, if antiaggregant action is not desirable, treatment with Flamogrel 75 should be stopped 7 days before surgery.

Flamogrel 75 prolongs the time of hemorrhage, so it should be used with caution by patients with risk ofhemorrhage (especially gastro-intestinal and intraocular). Patients should know that hemorrhage stop against the background of Flamogrel 75 use requires more attention. Patients should inform the doctor about each case of unusual hemorrhage. Patients should also inform the doctor about intake of the preparation in case of planned surgery or if the doctor indicates a new preparation for the patient. The preparation should be used with caution by the patients with renal dysfunction, moderate hepatic dysfunction, in case of possible development of haemorrhage. Influence of the preparation on psycho-motor reaction rate has not been established.

If you have history of allergic reactions, tell your doctor about it.

Interaction with other drugs. If you receive any other medicinal preparations tell your doctor about it. Concomitant use of Flamogrel 75 with warfarin is not recommended as such combination may increase haemorrhage intensity.

Acetylsalicylic acid does not change inhibiting effect of Flamogrel 75 on ADP-induced thrombocyte aggregation, but Flamogrel 75 potentiates the action of acetylsalicylic acid on thrombocyte aggregation, induced by collagen. But concomitant use of acetylsalicylic acid in dose of 500 mg, twice a day does not cause significant increase of haemorrhage time, prolonged due to Flamogrel 75 intake. Safety of long-term use of Flamogrel 75 and acetylsalicylic acid has not been established.

Concomitant use of Flamogrel 75 and heparin does not require dose adjustment of the last and does not influence antiaggregant action of Flamogrel 75, but this combination should be indicated with caution.

During treatment with Flamogrel 75 thrombolytic agents (recombinant activator of tissue plasminogen (rt-PA)) should be indicated with caution.

Combination of Flamogrel 75 and non-steroid anti-inflammatory preparations requires caution due to the possibility of the development of gastro-intestinal haemorrhage.

Clinical importance of pharmacodynamic interaction in case of concomitant use of Flamogrel 75 and atenolol or nifedipine has not been established. Pharmacodynamic activity of Flamogrel 75 practically does not change at concomitant use with phenobarbital, cimetidine or oestrogens. Pharmacokinetic properties of digoxin or theophylline do not change at concomitant use with Flamogrel 75. Antacids do not change the absorption of Flamogrel 75.

Flamogrel 75 may inhibit the activity of one of cytochrome P 450 enzymes (CYP2C9). So, plasma level of some preparations, such as fluvastatin, phenytoin, tamoxifen, tolbutamide, torasemide, warfarin, may be increased, because they metabolize with participation of CYP2C9. CAPRIE studies found that use of phenytoin and tolbutamide concomitantly with Flamogrel 75 is safe.

Way of introduction and doses. Internally, adults 75 mg, once a day, irrespectively of meals time. Maximal daily dose is 150 mg a day.

Overdose. There is no specific antidote. In case of fast adjustment need of prolonged haemorrhage time the effect of clopidogrel may be eliminated by thrombocyte mass transfusion.

Side effects. Headache, dizziness, paresthesia, abdominal pain, dyspeptic phenomena, gastritis, constipation, teeth lesions, vomiting, meteorism, haematoma, hematuria, conjunctival haemorrhage, purpura and nose bleedings, sometimes - dysfunction of liver and biliary tracts, very seldom – intracranial haemorrhage, neutropenia, thrombocytopenia, skin rash, aplastic anaemia, bronchiospasm, angioneurotic edema, anaphylactic reactions.

In case of these adverse reactions discontinue the intake of the preparation and consult the doctor.

Shelf life. 2 years. Do not use the preparation after the expiary date indicated on the package.

Storage conditions. Keep out of the reach of children in dry protected from light place at temperature below 30ºC.

Packing. 10 tablets in a blister; 1 or 10 blisters in a carton.

Terms of dispensing. On prescription.

Name and adress of an applicant. Ananta Medicare Ltd.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, London, U.K.