Mildronate, capsules 250 mg 40 pcs

Pharmacological action

Metabolic agent.

Pharmacodynamics

. Meldonium is a precursor to carnitine, a structural analog of gamma-butyrobetaine (GBB), a substance found in every cell of the human body.

Meldonium restores the balance between cellular oxygen supply and demand, eliminates the accumulation of toxic products of metabolism in cells, protecting them from damage, and has a tonic effect. As a result of its use the body’s resistance to stress and the ability to quickly restore energy reserves increases.

The formula has a stimulating effect on the central nervous system (CNS), increasing motor activity and physical endurance. Thanks to these properties, MILDRONAT® is used for increasing physical and mental performance.

Pharmacokinetics

The drug is quickly absorbed after oral administration, bioavailability is 78 %. The maximum concentration (Cmax) in blood plasma is reached 1-2 hours after oral administration.

It is metabolized in body mainly in liver with forming of two main metabolites, which are excreted by kidneys. The half-life (T1/2) when administered orally depends on the dose and is 3-6 hours. Trace concentrations of the drug remain in the body for a long time.

Indications

Active ingredient

Composition

Capsules.

1 capsule contains:

active ingredient

meldonium dihydrate 250 mg;

excipients

potato starch,

colloidal silicon dioxide,

calcium stearate;

capsule (body and cap) – titanium dioxide (E 171),

gelatin.

How to take, the dosage

Ingestion.

The daily dose for adults is 500 mg (2 capsules). The whole dose is taken in the morning in one dose or divided into two doses.

The course of treatment is 10-14 days.

If necessary, the treatment is repeated in 2-3 weeks.

Because of the possible excitatory effect, it is recommended to use the drug in the morning.

Interaction

Meldonium may be used concomitantly with prolonged nitrates and other antianginal agents, cardiac glycosides and diuretics. It may also be combined with anticoagulants, antiaggregants, antiarrhythmic agents and other drugs that improve microcirculation.

Meldonium may increase the effect of nitroglycerin, nifedipine, beta-adrenoblockers, other hypotensive agents and peripheral vasodilators.

Simultaneous use of the drug with other meldonium preparations is not allowed, as there may be an increased risk of adverse reactions.

Special Instructions

Patients with chronic liver and kidney diseases should be careful with long-term use of the drug. If long-term (more than one month) use of the drug is necessary, a specialist should be consulted.

Influence on driving and operating ability

There are no data on adverse effects on the ability to drive a vehicle and perform potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

Synopsis

Contraindications

Hypersensitivity to meldonium or any other component of the drug.

Elevated intracranial pressure (with impaired venous outflow, intracranial tumors).

Pregnancy and breast-feeding.

Age less than 18 years (safety not confirmed).

With caution:in liver and/or kidney disease.

Side effects

Meldonium is generally well tolerated. However, adverse reactions may occur in susceptible patients and when the recommended dose is exceeded.

The undesirable drug reactions are grouped into systemic organ classes according to the following frequency gradation: Very common (≥1/10), common (≥1/100 and < 1/10), infrequent (≥1/1000 and < 1/100), rare (≥1/10 000 and < 1/1000), and very rare (< 1/10 000), frequency unknown – the frequency cannot be estimated from available data.

Blood and lymphatic system disorders

Frequency unknown: eosinophilia.

Immune system disorders

Often: allergic reactions (skin redness, rashes, itching, swelling).

Cardiac disorders

Very rare: tachycardia.

Vascular disorders

Very rare: decreased blood pressure.

Gastrointestinal tract disorders

Often: Dyspeptic phenomena

Nervous system disorders

Often: headaches;

Frequent unknown: agitation.

General disorders

Often unknown: general weakness.

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

No cases of meldonium overdose have been reported. The drug is mildly toxic and does not cause severe adverse reactions.

Symptoms: decreased blood pressure accompanied by headache, tachycardia, dizziness and general weakness.

Treatment: symptomatic.

In severe overdose, liver and kidney function should be monitored.

Pregnancy use

Safety of use in pregnant women has not been studied; therefore, to avoid possible adverse effects on the fetus, the use of the drug in pregnant women is contraindicated.

Elevation with milk and the effect on the health of the newborn have not been studied, so breast-feeding should be stopped if the drug has to be used.

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