Deprenorm CF, 35 mg 60 pcs

Antianginal drug that improves myocardial metabolism.

It has antihypoxic and antianginal action. It directly improves metabolism and function of cardiomyocytes and brain neurons. Cytoprotective effect is due to increased energy potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (by enhancing aerobic glycolysis and inhibition of fatty acid oxidation). Maintains normal myocardial contractility, prevents intracellular depletion of ATP and creatine phosphate.

Under acidosis it normalizes membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes intracellular potassium ions. Reduces intracellular acidosis and phosphate content caused by myocardial ischemia and reperfusion. Prevents damaging effects of free radicals, maintains the integrity of cell membranes, increases the duration of electrical potential, prevents the activation of neutrophils in the ischemic zone, reduces the output of CPK from cells and the severity of ischemic myocardial damage. With angina reduces the frequency of attacks and reduces the need for nitrates.

In 2 weeks of treatment the tolerance to exercise increases, BP fluctuations decrease. Against the background of using the drug, hearing and the results of vestibular tests improve, dizziness and tinnitus decrease. In case of vascular eye pathology, the functional state of the retina improves.

Indications

Active ingredient

Composition

1 long-acting film-coated tablet contains:

Active substance:

Trimetazidine dihydrochloride 35 mg.

Auxiliary substances:

calcium hydrophosphate dihydrate,

microcrystalline cellulose,

colloidal silicon dioxide (aerosil),
.

hydroxypropylcellulose Clucel LF,

hydroxypropyl methylcellulose,

Plasdon S-630,

Magnesium stearate.

Composition of the film coating:

Selecoat (hydroxypropyl methylcellulose, plasdon S-630, polyethylene glycol, talc, iron oxide red, titanium dioxide).

The blister contains 15 tablets. In a carton pack of 4 blisters.

How to take, the dosage

Orally, with meals.

Deprenorm® MB is taken 1 tablet of 70 mg once daily (in the morning). The course of treatment is according to the doctor’s recommendation.

Interaction

There are no data on interactions with other drugs.

Special Instructions

Deprenorm® MB is not indicated for the management of angina attacks, for initial therapy of unstable angina or myocardial infarction, or in preparation for or during the first days of hospitalization.

In the event of an angina attack, treatment (drug therapy or revascularization) should be reviewed and adapted.

The drug may cause or worsen symptoms of parkinsonism (tremor, akinesia, increased tone), therefore patients, especially elderly patients, should be monitored regularly. If movement disorders such as parkinsonian symptoms, restless legs, tremor, unsteadiness in the Romberg posture and wobbly gait occur, Deprenorm® MB should be permanently discontinued.

These cases are rare and symptoms usually go away after discontinuation of therapy, in most patients within 4 months of discontinuation. If symptoms of parkinsonism persist more than 4 months after discontinuation of the drug, a neurologist should be consulted. There may be cases of falls associated with unsteadiness in the Romberg posture and a “wobbly” gait or arterial hypotension, especially in patients taking hypotensive drugs (see section “Adverse effects”).

Impact on ability to drive vehicles and other mechanisms requiring high concentration

Because of the possible development of dizziness and other side effects when using Deprenorm® MB, care must be taken when driving vehicles and engaging in other potentially dangerous activities requiring high concentration and quick psychomotor reactions.

Contraindications

Side effects

The frequency of side effects noted when taking trimetazidine is given in the following gradation:

Central nervous system: common – dizziness, headache. Unspecified frequency – symptoms of parkinsonism (tremor, akinesia, increased tone), instability in Romberg posture and “wobbly” gait, “restless” legs syndrome, other related motor disorders, usually reversible after discontinuation of therapy. Sleep disorders (insomnia, somnolence).

Cardiovascular system disorders: rare – orthostatic hypotension, “rushes” of blood to the face, palpitations, extrasystole, tachycardia, marked BP reduction.

Blood and lymphatic system disorders: unspecified frequency – agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

In the digestive system: frequently – abdominal pain, diarrhea, dyspepsia, nausea, vomiting. Unspecified frequency – constipation.

Liver and biliary tract: unspecified frequency – hepatitis.

Skin disorders: often – skin rash, itching, urticaria. Unspecified frequency – acute generalized exanthematous pustulosis, Quincke’s edema.

General disorders: often – asthenia.

Overdose

There is only limited information about trimetazidine overdose.

In case of overdose symptomatic therapy should be administered.

Pregnancy use

There are no data on the use of Deprenorm® MB in pregnant women. Animal studies have shown no direct or indirect reproductive toxicity. Reproductive toxicity studies have shown no effect of trimetazidine on reproductive function in rats of either sex. The drug is contraindicated in pregnancy due to a lack of clinical safety data.

There are no data on excretion of trimetazidine or its metabolites into breast milk. The risk to the newborn/infant cannot be excluded. Deprenorm® MB should not be used during breastfeeding.

Similarities