Description
Release form
Film-modified release tablets.
Packing
60 pcs.
Indications
Coronary heart disease: prevention of attacks of stable angina pectoris (as part of complex therapy).
Contraindications
hypersensitivity to any component of the drug Trimectal MV
Parkinson’s disease, symptoms of parkinsonism, tremor, restless legs syndrome and other related motor disorders
severe renal failure (creatinine Cl less than 30 ml / min)
age under 18 years of age (efficacy and safety not established).
Precautions: severe liver failure, moderate renal failure (creatinine Cl 30-60 ml / min) elderly patients (over 75 years old).
Pregnancy and lactation
There are no data on the use of trimetazidine in pregnant women. As a precaution, it is not recommended to use Trimectal MV during pregnancy.
There is no data on the release of trimetazidine or its metabolites into breast milk. The risk to the newborn / child cannot be excluded. Do not use Trimectal MV while breastfeeding.
Special instructions
Trimektal ® MV is not intended for the relief of angina attacks and is not indicated for the initial course of treatment of unstable angina pectoris or myocardial infarction at the prehospital stage or in the early days of hospitalization. In the event of an attack of angina pectoris, treatment (drug therapy or revascularization) should be reviewed and adapted.
Trimetazidine can cause or worsen symptoms of parkinsonism (tremor, akinesia, increased tone), therefore, regular monitoring of patients, especially the elderly, should be carried out. In doubtful cases, patients should be referred to a neurologist for an appropriate examination. With the appearance of motor disorders, such as symptoms of parkinsonism, restless legs syndrome, tremors, instability in the Romberg position and unsteady gait, trimetazidine 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 symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, consult a neurologist.
There may be cases of a fall associated with instability in the Romberg posture and uneven gait or a marked decrease in blood pressure, especially in patients taking antihypertensive drugs.
Caution is advised to administer Trimectal MV to patients in whom exposure may be increased: with moderate renal failure in elderly patients older than 75 years.
Due to the dosage form of the drug TrimectalMB, film-coated modified release tablets, the tablet may not dissolve in the intestines and excrete with feces, which does not affect the therapeutic efficacy of the drug.
Influence on the ability to drive vehicles and work with mechanisms. Given the possibility of developing adverse reactions from the central nervous system when taking trimetazidine, caution should be exercised when driving vehicles and other technical devices that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 tablet with a modified release coating, srdl, active substance:
trimetazidine dihydrochloride – 0.035 g
excipients:
collidone SR [polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%], calcium hydrogen phosphate dihydrate, silicon dioxide colloidal (aerosil), magnesium stearate
film coating:
hypromellose (hydroxypropylmethyl)
talc,
titanium dioxide,
macrogol 4000 (polyethylene oxide 4000 or polyethylene glycol 4000) or film coat Advantia Prime 390009ZA09-white (hypromellose, talc, titanium dioxide, macrogol 4000).
Dosage and administration
Inside, during meals, 1 tablet 2 times a day (morning and evening).
The course of treatment – on the recommendation of a doctor.
Special patient groups
Impaired renal function and elderly patients. When used in patients with moderate impaired renal function (Cl creatinine 30-60 ml / min) and elderly patients, it is necessary to reduce the frequency of administration of the drug to 1 time per day (in the morning, during breakfast).
Side effects
Adverse reactions, defined as adverse events that are at least possible related to treatment with trimetazidine are given in the following gradation: very often (more than 1/10) often (more than 1/100, less than 1/10) infrequently (more than 1/1000, less than 1 / 100) rarely (more than 1/10000, less than 1/1000) very rarely (less than 1/10000) the frequency is unknown (the frequency cannot be calculated from the available data).
From the digestive system: often – abdominal pain, diarrhea, dyspepsia, nausea, vomiting, frequency is unknown – constipation.
General disorders: often – asthenia.
From the side of the central nervous system: often – dizziness, headache, frequency is unknown – symptoms of parkinsonism (tremor, akinesia, increased tone), instability in the Romberg position and unsteady gait, restless legs syndrome, other motor disorders associated with them, usually reversible after discontinuation of therapy, sleep disturbances (insomnia, drowsiness).
From the skin and subcutaneous fat: often – skin rash, itching, urticaria, frequency is unknown – acute generalized exanthematous pustulosis, Quincke’s edema.
From the CCC side: rarely – palpitations, extrasystole, tachycardia, marked decrease in blood pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness, or loss of balance, especially while taking antihypertensive drugs, flushing of the face.
From the circulatory and lymphatic systems: frequency unknown – agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
From the liver and biliary tract: frequency unknown – hepatitis.
Overdose
There is only limited information on an overdose of trimetazidine.
In case of overdose, symptomatic therapy should be given.
Storage Conditions
In a dry, dark place at a temperature not exceeding 25 ° C.
Expiration
3 years.
Terms leave from
pharmacies prescription
The dosage form of
tablet
Possible product names
Pampers Pants diapers-panties Junior 12-18kg N15 Poland
TRIMEKTAL MV 0,035 N60 TABLE WITH MODIFIC EXTRA P / O
Trimektal MV 35mg Tab. with modif. exp. p / pl / rev X60
Trimektal MV 35mg No. 60 tab
TRIMEKTAL MV 35MG. No. 60 TAB. MODIF. HIGH. / VERTE /
Vertex, Russia
