PREDUCTAL OD CAPSULES PROLONGED RELEASE 80MG

Indications and usage

- long-term treatment of coronary artery disease: prevention of attacks of stable angina in the composition of mono-or combination therapy.

The drug is taken orally, 1 capsule 1 time / day, in the morning during breakfast. Capsules should be taken whole, not liquid, squeezed water.

Evaluation of the benefits of treatment can be carried out after 3 months of the drug. If during this time the improvement has not come, the use of the drug Preductal® OD should stop.

Have patients with moderate renal failure (CC 30-60 ml / min) (see sections "Pharmacokinetics" and "Special Instructions") a dose reduction is recommended, i.e. 1 pill containing 35 mg of Trimetazidine, per day.

Care should be taken when treating patients with severe hepatic insufficiency (see the section "Special Instructions") due to the fact that the available data are limited and do not completely eliminate the absence of the effect of impaired liver function on the metabolism of trimetazidine.

Have patients older than 75 years increased exposure to trimetazidine may be observed due to age-related decline in renal function (see the Pharmacokinetics section).In patients with moderately severe renal failure (CK 30–60 ml / min), a dose reduction is recommended, i.e. 1 pill containing 35 mg of trimetazidine, per day. Selection of the dose in patients older than 75 years should be done with caution (see section "Special instructions").

Safety and efficacy of trimetazidine in patients under the age of 18 not installed. No data available.

Adverse reactions, defined as adverse events, at least having a possible relationship to the treatment with trimetazidine, are given in the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10 000), unspecified frequency (frequency cannot be calculated from available data).

From the side of the central nervous system: often - dizziness, headache; unspecified frequency - symptoms of parkinsonism (tremor, akinesia, increased tone), "shaky" gait, restless legs syndrome, other motor disturbances associated with them, usually reversible after cessation of therapy. Sleep disturbances (insomnia, drowsiness).

Cardiovascular: rarely - palpitations, extrasystoles, tachycardia, marked reduction in blood pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness or loss of balance, especially with the simultaneous use of antihypertensive drugs, "flushes" of blood to the skin of the face.

Gastrointestinal: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting; unspecified frequency - constipation.

Liver and biliary tract: unspecified frequency - hepatitis.

Hemic and lymphatic: unspecified frequency - agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

From the skin and subcutaneous fat: often - skin rash, itching, urticaria; unspecified frequency - angioedema, acute generalized exantmatous pustus.

Common disorders: often - asthenia.

Contraindications

- severe renal failure (CC less than 30 ml / min);

- Parkinson's disease, parkinsonism symptoms, tremor, restless legs syndrome and other motor disorders associated with them;

- fructose / sucrose intolerance, glucose-galactose malabsorption syndrome, sucrase / isomaltase deficiency and other fermentopathies associated with intolerance to sucrose, which is part of the preparation;

- age up to 18 years (due to the lack of sufficient clinical data);

- Hypersensitivity to any of the components of the drug.

WITH caution the drug should be prescribed to patients with severe liver failure (10 to 15 points on the Child-Pugh scale), moderate renal failure (CC 30-60 ml / min), patients over 75 years of age (see the sections "Dosage regimen" and " Special instructions").

Pregnancy and Breastfeeding

Data on the use of the drug Preductal® OD in pregnant women are absent. Animal studies have not revealed direct or indirect reproductive toxicity. Reproductive toxicity studies did not show the effect of trimetazidine on reproductive function in rats of both sexes. As a precaution, it is not recommended to use the drug Preductal® OD during pregnancy.

There are no data on the release of trimetazidine or its metabolites in breast milk. The risk for a newborn / child cannot be excluded. If necessary, the use of the drug Preductal® OD during lactation breastfeeding should be stopped.

Care should be taken when treating patients with severe hepatic insufficiency due to the fact that the available data are limited and do not completely eliminate the absence of the effect of impaired liver function on the metabolism of trimetazidine.

Have patients with moderate renal failure (CC 30-60 ml / min) dose reduction is recommended, i.e. 1 pill containing 35 mg of trimetazidine, per day.

Use in children

Safety and efficacy of trimetazidine in patients under the age of 18 not installed. No data available.

Have patients older than 75 years increased exposure to trimetazidine may be observed due to age-related decline in renal function. Selection of the dose in patients older than 75 years should be carried out with caution.

Special notes

Preductal® OD is not intended to relieve angina attacks and is not indicated for the initial course of treatment of unstable angina or myocardial infarction in the prehospital or in the first days of hospitalization.

In the event of an attack of angina, treatment should be reviewed and adapted (drug therapy or revascularization). Preductal® OD can cause or worsen parkinsonism symptoms (tremor, akinesia, increased tone), so patients should be regularly monitored, especially in the elderly. In doubtful cases, the patient should be referred to a neurologist for an appropriate examination.

With the appearance of motor disorders such as parkinsonism symptoms, restless legs syndrome, tremor, "shaky" gait, Preductal® ML should be permanently canceled. Such cases are rare and symptoms usually disappear after discontinuation of therapy: in most patients, within 4 months after discontinuation of the drug. If the symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, you should consult a neurologist.

There may be cases of falling associated with instability in the Romberg position and "shaky" gait or a pronounced decrease in blood pressure, especially in patients taking antihypertensive drugs (see the section "Side effect").

Precautionary Preductal should be prescribed.® OD patients who may increase its exposure:

- in case of moderate renal failure (see sections "Pharmacological action" and "Dosage regimen");

- in elderly patients older than 75 years (see section "Dosage regimen").

The preparation contains sucrose, so the drug is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome and sucrase-isomaltase deficiency.

Influence on ability to drive motor transport and control mechanisms

During clinical studies, no effect of trimetazidine on hemodynamic parameters was detected, however, during the period of post-registration use, there were cases of dizziness and drowsiness (see the section “Side effect”). These symptoms can affect the ability to drive and perform work that requires an increased rate of physical and mental reactions.

There is only very limited information on trimetazidine overdose.

Treatment: in case of overdose, symptomatic therapy should be carried out.

Not observed. The patient must inform the doctor about all the drugs taken.

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.