Composition
1 tablet of prolonged action, film-coated, contains:
Active ingredient:
trimetazidine dihydrochloride 35 mg.
Auxiliary substances:
calcium hydrophosphate dihydrate,
microcrystalline cellulose,
colloidal silicon dioxide (aerosil),
hydroxypropylcellulose Klucel LF,
hydroxypropylmethylcellulose,
plasdon S-630,
magnesium stearate.
Composition of the film shell:
Selekout (hydroxypropylmethylcellulose, plasdon S-630, polyethylene glycol, talc, iron oxide red, titanium dioxide).
The blister contains 15 tablets. There are 4 blisters in a cardboard box.
Pharmacological action
Antianginal drug that improves myocardial metabolism. It has antihypoxic and antianginal effects. Directly improves the metabolism and function of cardiomyocytes and brain neurons. The cytoprotective effect is due to an increase in the energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (due to increased aerobic glycolysis and inhibition of fatty acid oxidation). Supports normal myocardial contractility, prevents intracellular depletion of ATP and creatine phosphate. In conditions of acidosis, it normalizes the state of ion channels of membranes, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular content of potassium ions. Reduces intracellular acidosis and phosphate levels due to myocardial ischemia and reperfusion. It prevents the damaging effect of free radicals, preserves the integrity of cell membranes, increases the duration of the electrical potential, prevents neutrophil activation in the ischemic zone, reduces the release of CPK from cells and the severity of ischemic myocardial damage. For angina, it reduces the frequency of seizures and reduces the need for nitrates. After 2 weeks of treatment, tolerance to physical activity increases, blood pressure drops decrease. Against the background of the use of the drug, hearing and vestibular test results improve, dizziness and tinnitus decrease. With vascular pathology of the eye, the functional state of the retina improves.
Indications
for coronary heart disease: prevention of angina attacks (as part of complex therapy); chorioretinal vascular disorders;dizziness of vascular origin;cochlea-vestibular disorders of ischemic nature (tinnitus, hearing disorders).
Use during pregnancy and lactation
There are no data on the use of Deprenorm MV in pregnant women. Animal studies have not revealed the presence of direct or indirect reproductive toxicity. Reproductive toxicity studies have not shown the effect of trimetazidine on reproductive function in rats of both sexes. The drug is contraindicated during pregnancy due to the lack of clinical data on the safety of its use.
There are no data on the excretion of trimetazidine or its metabolites in breast milk. The risk to the newborn/child cannot be excluded. Do not use Deprenorm MB during breastfeeding.
Contraindications
renal failure (CC
Side effects
The frequency of side effects reported when taking trimetazidine is given in the following gradation:
- very common (more than 1/10);
- common (more than 1/100, less than 1/10);
- infrequent (more than 1/1000, less than 1/100);
- rare (more than 1/10000, less than 1/1000);
- very rare (less than 1/10000, including individual messages);
- unspecified frequency (frequency cannot be calculated from available data).
From the central nervous system: often – dizziness, headache. Unspecified frequency – symptoms of Parkinsonism (tremor, akinesia, increased tone), instability in the Romberg position and “shaky” gait, restless legs syndrome, and other associated motor disorders, usually reversible after discontinuation of therapy. Sleep disorders (insomnia, drowsiness).
From the cardiovascular system: rarely-orthostatic hypotension, “flushes” of blood to the skin of the face, palpitation, extrasystole, tachycardia, marked decrease in blood pressure.
From the circulatory and lymphatic system: unspecified frequency-agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
From the digestive system: often-abdominal pain, diarrhea, dyspepsia, nausea, vomiting. Unspecified frequency-constipation.
From the liver and biliary tract: unspecified frequency-hepatitis.
From the skin: often – skin rash, itching, urticaria. Unspecified frequency – acute generalized exanthematous pustulosis, angioedema.
Common disorders: often-asthenia.
Interaction
There are no data on interactions with other drugs.
How to take, course of use and dosage
Inside, while eating.
Deprenorm MB is taken 1 tablet of 70 mg once a day (in the morning). The course of treatment is based on the doctor’s recommendation.
Overdose
There is only limited information about trimetazidine overdose.
In case of overdose, symptomatic therapy should be performed.
Special instructions
Deprenorm ® MB is not intended for the management of angina attacks, for the initial course of treatment for unstable angina or myocardial infarction, or in preparation for hospitalization or in the first days of it.
If an angina attack develops, treatment should be reviewed and adapted (drug therapy or revascularization).
The drug may cause or worsen the symptoms of parkinsonism (tremor, akinesia, increased tone), so patients, especially the elderly, should be regularly monitored. If motor disorders such as Parkinsonism symptoms, restless legs syndrome, tremor, instability in the Romberg position, and unsteadiness of gait occur, Deprenorm MB should be permanently discontinued.
Such cases are rare and symptoms usually resolve after discontinuation of therapy, in most patients within 4 months after discontinuation of the drug. If symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, you should consult a neurologist. There may be cases of falls associated with instability in the Romberg position and “unsteadiness” of gait or arterial hypotension, especially in patients taking antihypertensive drugs (see the section “Side effects”).
Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention
Due to the possible development of dizziness and other side effects when using Deprenorm MB, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Long-acting, film-coated tablets.
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25 °C
Shelf life
3 years
Active ingredient
Trimetazidine
Conditions of release from pharmacies
By prescription
Dosage form
long-acting tablets
Description
For adults as directed by your doctor
Indications
Angina
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