Trombonet-Pharmak of the tab. of p/o of 75 mg No. 30

tablets "Trombonet-Pharmak" are applied at indications which are provided below.

Secondary prevention of manifestations of an aterotromboz at adults:

• patients, had a myocardial infarction (an initiation of treatment - in several days, but not later than in 35 days after emergence), an ischemic stroke (an initiation of treatment - in 7 days, but not later than in 6 months after emergence) or for which the disease of peripheral arteries is diagnosed (damage of arteries and aterotromboz vessels of the lower extremities);
• patients with a sharp coronary syndrome:
  • with a sharp coronary syndrome without raising of a segment of ST (unstable stenocardia or a myocardial infarction without tooth Q), including at patients to whom the stent was established during performing transdermal coronary angioplasty, in a combination with acetylsalicylic acid (ASK);
  • with an acute myocardial infarction with raising of a segment of ST, in a combination with acetylsalicylic acid (at the patients receiving standard medicament treatment and to which thrombolytic therapy is shown).

Prevention of aterotrombotichesky and thromboembolic events at fibrillation of auricles. Klopidogrel in a combination with ASK is shown to adult patients with fibrillation of auricles which have at least one risk factor of emergence of vascular events which have contraindications to treatment by the antagonists of vitamin K (AVK) and which have low risk of developing of bleedings, for prevention of aterotrombotichesky and thromboembolic events, including a stroke.

Structure

Active ingredient: klopidogrelya bisulphate (klopidogrelya hydrosulphate). One tablet contains klopidogrelya bisulphate (klopidogrelya hydrosulphate) 97.875 mg in terms of klopidogrel - 75 mg.

Excipients: a mannitol (E 421), cellulose microcrystalline, hydroxypropyl cellulose the low-substituted, castor oil hydrogenated, polyethyleneglycol, Opadry II 85F 240069 Pink (polyvinyl alcohol, the titan dioxide (E 171), talc, ferrous oxide red (E 172), ferrous oxide yellow (E 172), polyethyleneglycol).

Contraindication

1. Hypersensitivity to active ingredient or to any component of drug.
2. Heavy liver failure.
3. Acute bleeding (for example round ulcer or intracraneal hemorrhage).

Route of administration

Adult, including patients of advanced age

Trombonet-Pharmak to accept on 75 mg of 1 times a day irrespective of meal.

At patients with a sharp coronary syndrome without raising of a segment of ST (unstable stenocardia or a myocardial infarction without Q tooth on the ECG) with a single load dose 300 mg, and then to continue in a dose 75 mg of 1 times a day (with acetylsalicylic acid (ASK) in a dose of 75-325 mg a day). As use of higher doses of ASK increases risk of bleeding, it is recommended not to exceed a dose of acetylsalicylic acid of 100 mg. The optimum duration of treatment is formally not established. Results of clinical trials testify in favor of use of medicament up to 12 months, and the maximum effect was observed in 3 months of treatment.

on 75 mg of 1 times a day, since a single load dose of 300 mg in a combination with ASK, using thrombolytic medicaments or without them. Treatment of patients is more senior than 75 years to begin without load dose klopidogrelya. Combination therapy should be begun as soon as possible after emergence of symptoms and to continue at least 4 weeks. The advantage of use of a combination klopidogrelya with ASK in this disease was not studied more than 4 weeks.

to Patients with fibrillation of auricles klopidogrel to apply 75 mg in a single daily dose. Together with klopidogrely it is necessary to begin and continue use of ASK (in a dose of 75-100 mg a day).

gave a fact-finding part of the instruction, read the full instruction in packing.

Pregnant

due to the lack of clinical data on use klopidogrelya during pregnancy medicament it is undesirable to pregnant women (precautionary measure) to appoint

Feature of use

whether it is excreted klopidogrel in breast milk of the person. In researches on animals it was shown that it is excreted in breast milk therefore during the Trombonet-Pharmak medicament treatment the feeding by a breast should be stopped.

during the researches on laboratory animals did not reveal negative influence klopidogrelya on fertility.

Children

Klopidogrel should not be applied to children as there are no data on efficiency of medicament for this age category of patients.

Drivers

Klopidogrel does not influence or has insignificant impact on speed of response at control of motor transport or work with other mechanisms.

At overdose klopidogrelya lengthening of a bleeding time with the subsequent complications is possible

. In case of developing of bleeding the symptomatic treatment is recommended.

Antidote of pharmacological activity klopidogrelya is unknown to

. In need of immediate correction of the extended bleeding time klopidogrelya it can be terminated by transfusion of platelet concentrate.

Side effects

Bleeding was the most widespread side reaction which was observed both in clinical trials, and in the post-marketing period during which it most often arose in the first month of treatment.

to Store

in original packing at a temperature not above 25 °C, out of children's reach.

Expiration date - 2 years.