Preduktal of MV

Preduktal of MV – anti-anginal medicine for improvement of metabolism of a myocardium in the conditions of ischemia.

Form of release and structure

Dosage form of Preduktal of MV – a tablet with the modified release: round, biconvex, covered pink color with a film cover, on a break – white color (on 30 pieces in blisters, in a cardboard pack 2 blisters).

Structure of 1 tablet:

• Active ingredient: a trimetazidina dihydrochloride – 0,035 g;
• Auxiliary components: povidone, hydrophosphate calcium dihydrate, gipromelloz, magnesium stearate, macrogoal-6000, silicon dioxide colloid;
• Film cover: premix No. 5361 dry (dye ferrous oxide red, titanium dioxide, глицерол, magnesium stearate, gipromelloz, macrogoal-6000).

Indications to use

Preduktal MV apply to long therapy of the coronary heart disease (CHD) for the purpose of prevention of attacks of stable stenocardia as a part of the combined treatment or as monodrug.

Contraindications

Absolute:

• The expressed renal failure (the clearance of creatinine (CC) <30 ml a minute);
• Parkinson's disease, including symptoms, characteristic of it, – the tremor, a syndrome of "uneasy legs", other motive disturbances connected with parkinsonism;
• Pregnancy and period of breastfeeding;
• Children's and teenage in age up to 18 years (there are no data of clinical trials in required volume);
• Hypersensitivity to a trimetazidin to dihydrochloride and other components of drug.

Relative (drug is used with care, the probability of side effects is increased):

• Renal failure of moderate severity (ml KK=30-60 in a minute);
• Heavy liver failure (clinical data are limited);
• Advanced age (75 years are more senior).

Route of administration and dosage

Preduktal MV take a pill inside entirely, without chewing, wash down with water.

Duration of therapy is determined by the attending physician.

The recommended dosing mode – 1 tablet 2 times a day (in the morning and in the evening), along with meal. The most admissible daily dose – 0,07 g (2 tablets).

For patients with a renal failure of moderate severity (ml KK=30-60 in a minute) a daily dose – 0,035 g (1 tablet), in the morning along with a breakfast.

Due to age depression of function of kidneys the increased exposure of a trimetazidin can be observed at patients 75 years therefore they should select a dose with care are more senior.

Side effects

• Alimentary system: often – diarrhea, dyspepsia, abdominal pains, nausea, vomiting; frequency is unknown – a lock;
• Central Nervous System (CNS): often – a headache, dizziness; frequency is unknown – sleep disorders (drowsiness, sleeplessness), symptoms of a disease of Parkinson (an akineziya, a tremor, increase in a tone), unsteadiness of gait and instability in Romberg's pose, a syndrome of "uneasy legs" and other related motive disturbances, usually reversible after cancellation of a trimetazidin;
• Integuments and hypodermic fatty tissue: often – an itch, urticaria, skin rash; frequency is unknown – an acute Quincke's disease, acute generalized exanthematous пустулез;
• Cardiovascular system: seldom – premature ventricular contraction, a heart consciousness, tachycardia, the expressed lowering of arterial pressure (ABP), the orthostatic hypotension which is followed by the general weakness, loss of balance or dizziness (especially in case of simultaneous use of hypotensive drugs), rushes of blood to the person;
• Hemopoietic system: frequency is unknown – thrombocytopenia, an agranulocytosis, a Werlhof's disease;
• Gepatobiliarny system: frequency is unknown – hepatitis;
• General reactions: often – an adynamy.

Gradation of the undesirable side effects arising at therapy Preduktaly MV: ≥1/10 – very often; <1/10-≥ 1/100 – it is frequent; <1/100-≥ 1/1000 – infrequently; <1/1000-≥ 1/10 000 – it is rare; <1/10 000 – it is very rare; frequency cannot be counted according to available data – frequency is unknown.

Special instructions

Drug is not shown for stopping of attacks of stenocardia and not intended for treatment of a myocardial infarction or unstable stenocardia during an initial stage before hospitalization or in the first days of stay in a hospital.

At development of an attack of stenocardia it is required to reconsider treatment and to adapt it (medicinal therapy or holding a procedure of revascularization of a myocardium).

Owing to reception of a trimetazidin emergence or aggravation of symptoms of a disease of Parkinson (a tremor, an akineziya, increase in a tone) is possible that demands regular monitoring of patients, especially at advanced age. Patients need to undergo the corresponding inspection at the neurologist in disputable situations.

It is final it is necessary to cancel Preduktal of MV in case of such motive disturbances: instability in Romberg's pose, unsteadiness of gait, parkinsonism symptoms, a tremor, a syndrome of "uneasy legs". Such disturbances meet extremely seldom and take place usually at most of patients for 4 months after drug withdrawal. At preservation of symptoms of parkinsonism more than 4 months it is necessary to address for consultation the neurologist.

Cases of falling of patients which are connected with "unsteadiness" of gait, the instability in Romberg's pose expressed by decrease in the ABP, especially, at a therapy combination Preduktaly MV with reception of hypotensive drugs take place.

In results of clinical trials influence of drug on indicators of a hemodynamics was not noted, but during post-registration observations episodes of drowsiness and dizziness were registered. Such states can exert impact on ability to performance of work, the psychomotor reactions and special attention demanding speed, including on control of motor transport.

Medicinal interaction

Interaction of a trimetazidin with other medicinal substances / drugs was not observed.

Terms and storage conditions

Special storage conditions are not required. To protect from children.

Period of validity – 3 years.