Trimectal CF, 35 mg 60 pcs

Indications

Active ingredient

Composition

One film-coated, modified-release tablet contains:

the active ingredient: trimetazidine dihydrochloride – 35.0 mg;

auxiliary substances: 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

Tablets should be taken whole, without chewing, with water.

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

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

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

Length of treatment is as recommended by the physician.

Particular 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

Elderly patients may have increased exposure to trimetazidine due to age-related decreased renal function (see 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 older than 75 years 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 in the first days of hospitalization.

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Trimetazidine should be permanently withdrawn if movement disorders, such as parkinsonian symptoms, restless legs, tremor, unsteady gait, occur.

This is uncommon and symptoms usually disappear after therapy is stopped: most patients have symptoms within 4 months of stopping the drug. If the parkinsonian symptoms persist longer than 4 months after discontinuation of the drug, a neurologist should be consulted.

There may be falls associated with unsteady gait or arterial hypotension, especially in patients taking hypotensive medications (see

Trimetazidine should be used with caution in patients with possible increased exposure in mild renal impairment (see “Pharmacological properties” and “Dosage and administration”) and in elderly patients >75 years (see “Administration and dosage”).

Influence on driving and operating ability

Trimetazidine has not been found to affect hemodynamics in clinical studies, but there have been cases of dizziness and somnolence during post-registration use (see “Adverse effects”). This may affect the ability to drive a vehicle and perform tasks requiring increased physical and mental responsiveness.

In a clinical study, there have been cases of dizziness and somnolence during post-registration.

Synopsis

Contraindications

With caution

Side effects

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

very frequently ≥ 1/10;

frequently ≥ 1/100 to < 1/10;

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

frequently 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:

frequent – dizziness, headache;

frequent 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:

frequently – feeling of palpitations, extrasystole, tachycardia.

vascular disorders:

frequently, arterial hypotension, orthostatic hypotension, which may be accompanied by general malaise, dizziness or falling, especially when simultaneously taking hypotensive drugs, “flushes” of blood to the face.

Gastrointestinal disorders:

frequently, abdominal pain, diarrhea, dyspepsia, nausea, vomiting;

frequently unknown, constipation.

Liver and biliary tract disorders:

frequency unknown – hepatitis.

Skin and subcutaneous tissue disorders:

frequently – skin rash, skin itching, urticaria;

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

General disorders and reactions at the site of administration:

frequently – asthenia.

Overdose

Pregnancy use

Pregnancy
Data on the use of trimetazidine in pregnant women are not available. Animal studies have shown no direct or indirect adverse effects on reproduction.
The use of trimetazidine during pregnancy is contraindicated.
Breastfeeding
Data on excretion of trimetazidine or its metabolites into breast milk are not available. The risk to the newborn/infant cannot be excluded. Breastfeeding 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