Predizin tablets p / o 35mg, No. 60

Ischemic heart disease: prevention of angina attacks (in complex therapy)
Cochleo-vestibular disorders of an ischemic nature (dizziness, tinnitus, hearing impairment).

Inside, 1 tablet 35 mg 2 times a day, morning and evening with meals.
The duration of the course is according to the doctor's recommendation.

1 prolonged-release film-coated tablet contains:

active substance: trimetazidine dihydrochloride 35 mg;
excipients: microcrystalline cellulose 88.22 mg, hypromellose 36.04 mg, pregelatinized starch 88.22 mg, colloidal silicon dioxide 1.26 mg, magnesium stearate 1.26 mg; shell: Opadry II 85G24057 - 7.50 mg (polyvinyl alcohol 3.30000 mg, talc 1.50000 mg, titanium dioxide 1.46025 mg, macrogol 3350 - 0.92625 mg, soy lecithin 0.26250 mg, iron dye red oxide 0.02775 mg, iron dye yellow oxide 0.01950 mg, iron dye black oxide 0.00375 mg).

• hypersensitivity to any component of the drug;

• renal failure (CC less than 15 ml / min);

• severe liver dysfunction;

• age up to 18 years (efficacy and safety have not been established);

• pregnancy, lactation.

Trade name : PredizinЃ

International Non-Proprietary Name (INN) : Trimetazidine

Dosage form : prolonged-release film-coated tablets

Composition :
1 tablet of prolonged action film-coated contains:

active substance: trimetazidine dihydrochloride 35 mg;
excipients: microcrystalline cellulose 88.22 mg, hypromellose 36.04 mg, pregelatinized starch 88.22 mg, colloidal silicon dioxide 1.26 mg, magnesium stearate 1.26 mg; shell: Opadry II 85G24057 - 7.50 mg (polyvinyl alcohol 3.30000 mg, talc 1.50000 mg, titanium dioxide 1.46025 mg, macrogol 3350 - 0.92625 mg, soy lecithin 0.26250 mg, iron dye red oxide 0.02775 mg, iron dye yellow oxide 0.01950 mg, iron dye black oxide 0.00375 mg).

Description : Pink, round biconvex film-coated tablets, without an inscription.

Pharmacotherapeutic group : antihypoxic agent
ATX code —01?¬15

Pharmacological properties
Pharmacodynamics
Trimetazidine has an antihypoxic effect. By directly affecting the cardiomyocytes and neurons of the brain, it optimizes their metabolism and function.
The cytoprotective effect is due to an increase in energy potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (increased aerobic glycolysis and blockade of fatty acid oxidation).
Supports myocardial contractility, prevents a decrease in the intracellular content of adenosine triphosphate (ATP) and phosphocreatine. Under conditions of acidosis, it normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium ions in cardiomyocytes, and normalizes the intracellular content of potassium ions.
Reduces intracellular acidosis and increased phosphate levels caused by myocardial ischemia and reperfusion. It prevents the damaging action of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the ischemic zone, increases the duration of the electric potential, reduces the release of creatine phosphokinase from cells and the severity of ischemic damage to the myocardium.
With angina pectoris, it reduces the frequency of attacks and the need to use nitroglycerin, after 2 weeks of treatment, exercise tolerance increases, improves the contractile function of the left ventricle in patients with ischemic dysfunction, decreases blood pressure (BP) drops.
Reduces dizziness and tinnitus. In case of vascular pathology of the eye, it improves the functional activity of the retina.

Pharmacokinetics
After oral administration, trimetazidine is rapidly and almost completely absorbed in the gastrointestinal tract, bioavailability is 90%.
The time to reach the maximum plasma concentration is approximately 5 hours. After 24 hours, the concentration in the blood plasma remains at a level exceeding 75% of the concentration determined after 11 hours. The equilibrium state is reached after 60 hours. Food intake does not affect the pharmacokinetic properties of trimetazidine.
The apparent volume of distribution is 4.8 (l / kg-1), which explains the good diffusion in tissues (the connection with blood plasma proteins is low, about 16%); easily penetrates histohematogenous barriers.
Trimetazidine is excreted from the body mainly by the kidneys (about 60% - unchanged). The half-life in healthy volunteers is about 7 hours, in patients over 65 years of age - about 12 hours. Renal clearance of trimetazidine directly correlates with creatinine clearance (CC), hepatic clearance decreases with age.
An increase in the half-life of trimetazidine in elderly patients has no clinical significance.

Indications for use
Ischemic heart disease: prevention of angina attacks (in complex therapy)
Cochleo-vestibular disorders of an ischemic nature (dizziness, tinnitus, hearing impairment).

Contraindications

• hypersensitivity to any component of the drug;

• renal failure (CC less than 15 ml / min);

• severe liver dysfunction;

• age up to 18 years (efficacy and safety have not been established);

• pregnancy, lactation.

Pregnancy and lactation period
Pregnancy

There are no data on the safety of using the drug during pregnancy, therefore, the use of the drug PredizinЃ during pregnancy should be abandoned.
Lactation period There are no
data on excretion of trimetazidine in breast milk. If necessary, the use of the drug during lactation is recommended to stop breastfeeding.

Dosage and administration
Inside, 1 tablet 35 mg 2 times a day, morning and evening with meals.
The duration of the course is according to the doctor's recommendation.

Side effect
The frequency of adverse effects reported when receiving trimetazidine is provided in accordance with the WHO classifications: very often ( > 1/10), often ( > 1/100 and <1/10) infrequently ( > 1/1000 <1 / 100), rarely ( > 1/10000 and <1/1000), very rarely (<1/10000), including individual messages.

From the digestive system
Often: abdominal pain, diarrhea, dyspepsia, nausea, vomiting. General disorders Often: asthenia.
From the side of the central nervous system
Often: dizziness, headache.
Very rare: extrapyramidal disturbances (tremor, rigidity, akinesia), reversible after discontinuation of the drug.
On the part of the skin and subcutaneous fat
Often: skin rash, itching, urticaria.
On the part of the cardiovascular system
Rarely: orthostatic hypotension, 'hot flushes' of blood to the skin of the face.

Overdose
There is only limited information on an overdose of trimetazidine, in case of an overdose, symptomatic therapy should be carried out.

Interaction with other medicinal products
No information available.

Special instructions
Do not use PredizinЃ for relieving angina attacks! The drug is not indicated for the initial course of therapy for unstable angina pectoris or myocardial infarction.
If an attack of angina pectoris develops, therapy should be reviewed and adapted.

Influence on the ability to drive a car and other mechanisms
The use of PredizinЃ does not affect the ability to drive vehicles and perform work that requires a high speed of psychomotor reactions.

Release form
Tablets of prolonged action film-coated, 35 mg.
10 tablets in a PVC - aluminum foil blister. 6 blisters in a cardboard box along with instructions for use.

Storage conditions
In the original packaging at a temperature not exceeding 25 ? C.
Keep out of the reach of children!

Shelf life is
2 years.
Do not use after the expiration date printed on the package.

Pharmacy
Dispensing Conditions Prescription.

Manufacturer
1. OOO 'Gedeon Richter Poland'
05-825, Grodzisk Mazowiecki, st. book Y. Poniatowski, 5, Poland.
2. Gedeon Richter Romania A.O.
540306, Targu-Mures, st. Cuza Voda 99 - 105, Romania
3. JSC 'GEDEON RICHTER - RUS'
140342 Russia, Moscow region, Yegoryevsky district, village Shuvoe, st. Lesnaya, 40.

Consumer claims should be sent to the address:
Moscow Representative Office of OJSC 'Gedeon Richter'
119049 Moscow, 4th Dobryninsky per., 8