Instruction for use: Mildronate by Grindex

Tradename: Mildronate®

International Non-Proprietary Name (INN): Meldonium

Dosage Form: capsules

Structure 1 capsule contains:
Active ingredient: Meldonium Dihydrate - 500 mg;
Excipients: potato starch - 27.2 mg colloidal silicon dioxide - 10.8 mg, calcium stearate - 5.4 mg;
capsule (body and cap): titanium dioxide (E 171) - 2% gelatin - 98%.
Description
Hard gelatin capsules ¹ 00, and the cap body in white. Content - a white crystalline powder with a weak smell. Hygroscopic powder.

Pharmacotherapeutic group:
metabolic means

ATC code: Ñ01ÅÂ

Pharmacological properties

Pharmacodynamics
Meldonium - a synthetic analog of gamma-butyrobetaine - a substance that is in every cell of the human body. It inhibits gamma butyrobetainic hydroxycinase, reduces the synthesis of carnitine and transport of long-chain fatty acids across cell membranes, prevents the accumulation in the cells of the activated forms of unoxidized fatty acids - derivatives of acylcarnitine and acyl-coenzyme A.
Cardioprotecting means of normalizing myocardial metabolism. In conditions of ischemia Meldonium restores the balance between oxygen delivery and consumption processes in cells, prevents the transport violation of adenosine triphosphate (ATP); simultaneously activates glycolysis, which proceeds without the use of supplemental oxygen. As a result of reducing the concentration of carnitine is synthesized hard gamma-butyrobetaine, which has vasodilating properties. The mechanism of action determines the diversity of its pharmacological effects: increasing efficiency, reducing the symptoms of mental and physical stress, activation of tissue and humoral immunity, cardioprotective effect. In the case of acute ischemic myocardial injury Meldonium slows the formation of necrotic areas, shorten the rehabilitation period.In heart failure, increases myocardial contractility, increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic cerebrovascular disorders improves blood circulation in the ischemic focus, promotes redistribution of blood to the ischemic area.It is effective in the case of vascular and dystrophic pathology of retinal vessels. It is also characteristic toning effects on the central nervous system, elimination of functional disturbances of somatic and autonomic nervous system in patients with chronic alcoholism during abstinence syndrome.
Pharmacokinetics
Once inside Meldonium rapidly absorbed, bioavailability - 78%. The time to reach maximum plasma concentration - 1 - 2 hours after ingestion. Primarily metabolized in the liver with the formation of two major metabolites are excreted by the kidneys. The half-life (T1 / 2) when administered depends on the dose, it is 3-6 hours.

Indications
In the treatment of coronary heart disease (angina, myocardial infarction), congestive heart failure and cardiomyopathy dyshormonal, as well as in the treatment of subacute and chronic disorders of blood supply to the brain (a stroke, cerebrovascular insufficiency).Reduced working capacity; mental and physical overload (including the athletes).
abstinence syndrome in alcoholism (in combination with specific therapy).
Contraindications
Hypersensitivity to the active substance or other components of the drug, increased intracranial pressure (in violation of the venous outflow, intracranial tumors), age 18 years (effectiveness and safety have not been established), pregnancy, lactation.

With Caution:
in diseases of the liver and / or kidneys.

Dosing and Administration
In view of the possible development of stimulating effect, it is recommended to apply in the morning and no later than 17.00 at the reception several times a day.
1. Coronary heart disease (angina, myocardial infarction), congestive heart failure and cardiomyopathy dyshormonal
In the combined therapy at 500 mg - 1 g per day by mouth, using the entire dose at once or divide it by 2 times. The course of treatment - 4-6 weeks.
Dishormonal cardiomyopathy - in the complex therapy of 500 mg orally per day. The course of treatment - 12 days.
2. Subacute and chronic circulatory disorders of the brain (a stroke, cerebrovascular insufficiency)
In the combined therapy after completion of the injection therapy with Mildronate®, the drug continues to be taken orally at 500 mg - 1 g per day, using the entire dose at once or divide it by 2 times. The course of treatment - 4-6 weeks.
In chronic disorders - in the complex therapy of 500 mg orally per day. The total course of treatment - 4-6 weeks.
Repeated courses (usually 2-3 times a year) are possible after consultation with the doctor.
3. Reduced availability; mental and physical overload (including the athletes)
Adults - into 500 mg 2 times a day. The course of treatment - 10-14 days. If necessary, the treatment is repeated after 2-3 weeks.Athletes 500 mg - 1 g orally 2 times a day before training. Duration of the course in the preparatory training period - 14 - 21 days, in the period of the competition - 10 -14 days.
4. The withdrawal syndrome in chronic alcoholism (in combination with specific therapy)
Inside of 500 mg 4 times a day. The course of treatment - 7 - 10 days.

Side effect
Rarely - allergic reactions (redness and itching of the skin, skin rash, urticaria, angioedema), and - dyspepsia, tachycardia, decreased or increased blood pressure, irritability. Very rarely - eosinophilia, general weakness.
Overdose
Symptoms: reduced blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.
Treatment: symptomatic.

Interaction with other drugs
It increases the vasodilatig funds, some antihypertensive drugs, cardiac glycosides. It can be combined with the prolonged form of nitrates, other antianginal drugs, anticoagulants, antiplatelet agents, antiarrhythmics, diuretics, bronchodilators.
In view of the possible development tachycardia and hypotension, caution should be exercised when combined with nitroglycerin (sublingual) and antihypertensives (especially alpha blockers and nifedipine short-forms).

Special instructions
Patients with chronic diseases of the liver and kidneys should be careful with long-term use of the drug.There is insufficient data on the use of the drug Mildronate® in children under 18 years.
Pregnancy and lactation
The safety of the drug has not been established during pregnancy. To avoid possible adverse effects on the fetus during pregnancy Mildronate® use of the drug is not recommended.It is not known whether the breast milk Meldonium allocated. If treatment with Mildronate® mother is necessary, breast-feeding is stopped.
Effects on ability to drive and use machines
No information about adverse effects of the drug Mildronate® on ability to drive and use machines.
release Form
Capsules 500 mg. 10 capsules in blisters made of PVC film coated with polyvinylidene chloride and aluminum foil.
In 2 or 6 contour cell package together with instructions for use placed in a cardboard box.

Storage conditionsStore in a dry place at temperatures no higher than 25 ° C.
Keep out of the reach of children.

Shelf life4 years.
Do not use beyond the expiration date printed on the package.

Conditions of supply of pharmacies
On prescription.