Trimectal CF, 35 mg 120 pcs

Indications

Active ingredient

Composition

One film-coated, modified-release tablet contains:

acting substance: trimetazidine dihydrochloride – 35.0 mg;

excipients: collidone SR (polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%) – 137.5 mg; calcium hydrophosphate dihydrate – 73.8 mg; magnesium stearate – 2.5 mg; colloidal silicon dioxide – 1.2 mg;

film coating: [hypromellose – 4.80 mg, talc – 1.60 mg, titanium dioxide – 0.88 mg, macrogol 4000 (polyethylene glycol 4000) – 0.72 mg] or [dry film coating mixture containing hypromellose (60%), talc (20%), titanium dioxide (11%), macrogol 4000 (polyethylene glycol 4000) (9%)] – 8.0 mg.

How to take, the dosage

The tablets should be taken whole, without chewing, with water.

Overly, 1 tablet 2 times a day, morning and evening, with meals.

The benefits of treatment should be evaluated after 3 months of taking the drug.

Trimetazidine should be discontinued if there is no improvement during this time.

The duration of treatment is according to the doctor’s recommendation.

Special patient groups

Patients with impaired renal function

. In patients with moderate renal impairment
(CKR 30-60 ml/min), the daily dose is 35 mg (1 tablet), in the morning with breakfast.

Elderly patients

In elderly patients there may be increased exposure to trimetazidine due to age-related decreased renal function (see section on Pharmacological properties). In patients with moderate renal impairment (CKD 30-60 ml/min), the recommended daily dose is 35 mg (1 tablet), in the morning with breakfast.

The dose in patients over 75 years of age should be adjusted with caution (see section “Special Precautions”).

Interaction

Special Instructions

The drug is not intended to control angina attacks and is not indicated for initial therapy of unstable angina or myocardial infarction in the pre-hospital phase or during the first days of hospitalization.

In the event of an angina attack, the degree of coronary artery damage should be reassessed and, if necessary, treatment should be adapted (drug therapy or revascularization procedure).

Trimetazidine may cause or worsen symptoms of parkinsonism (tremor, akinesia, increased tone), therefore patients, especially elderly patients, should be monitored regularly. In doubtful cases, patients should be referred to a neurologist for appropriate evaluation.

Trimetazidine should be permanently withdrawn if movement disorders, such as parkinsonian symptoms, restless legs, tremor, unsteady gait, occur.

These cases are rare, and symptoms usually disappear after discontinuation of therapy: most patients have symptoms within 4 months of discontinuation. If the parkinsonian symptoms persist longer than 4 months after discontinuation, a neurologist should be consulted.

There may be cases of falls associated with unsteady gait or arterial hypotension, especially in patients taking hypotensive medications (see section “Side effects”).

Trimetazidine should be used with caution in patients with possible increased exposure in mild renal dysfunction (see sections “Pharmacological properties” and “Administration and dosing”) and in elderly patients older than 75 years (see section “Administration and dosing”).

Influence on driving and operating ability

In clinical studies there was no effect of trimetazidine on hemodynamic parameters, but there were cases of dizziness and somnolence during post-registration use (see section “Side effects”). Side effects), which may affect the ability to drive vehicles and perform work requiring increased speed of physical and mental reactions.

Synopsis

Contraindications

With caution

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO):

very often ≥ 1/10;

often from ≥ 1/100 to < 1/10;

infrequently from ≥ 1/1000 to < 1/100;

rarely from ≥ 1/10000 to < 1/1000;

very rarely < 1/10000, including individual reports;

frequency is unknown – it is not possible to determine the frequency of occurrence from the available data.

Blood and lymphatic system disorders:

frequency unknown – agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

Nervous system disorders:

often – dizziness, headache;

frequency unknown – symptoms of parkinsonism (tremor, akinesia, increased tone), unsteady gait, restless legs syndrome, other related movement disorders, usually reversible after discontinuation of therapy; sleep disorders (insomnia, somnolence).

Hearing and labyrinth disorders:

frequency unknown – vertigo.

Cardiac disorders:

rarely – sensation of palpitations, extrasystole, tachycardia.

Vascular disorders:

rarely – arterial hypotension, orthostatic hypotension, which may be accompanied by general malaise, dizziness or falling, especially with the simultaneous use of hypotensive drugs, “flushes” of blood to the face.

Gastrointestinal disorders:

often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting;

frequency unknown – constipation.

Liver and biliary tract disorders:

frequency unknown – hepatitis.

Dermal and subcutaneous tissue disorders:

often – skin rash, skin itching, urticaria;

frequency unknown – acute generalized exanthematous pustulosis (OGEP), angioedema.

General disorders and reactions at the site of administration:

often – asthenia.

Overdose

Pregnancy use

Pregnancy
There are no data on the use of trimetazidine in pregnant women. Animal studies have shown no direct or indirect adverse effects on reproduction.
The use of trimetazidine during pregnancy is contraindicated.
Breastfeeding
No data on excretion of trimetazidine or its metabolites into breast milk. The risk to the newborn/infant cannot be excluded. Breast-feeding should be discontinued if it is necessary to use the drug during lactation.
Fertility
Reproductive toxicity studies have shown no effect of trimetazidine in rats of either sex.

Similarities