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

Reduced performance, mental and physical overload.

Pharmacological effect

Pharmacological action

Metabolic agent.

Pharmacodynamics

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

Under conditions of increased stress, meldonium restores the balance between the supply and need of cells for oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; also has a tonic effect. As a result of its use, the body’s resistance to stress and the ability to quickly restore energy reserves increase.

The drug has a stimulating effect on the central nervous system (CNS) – increasing motor activity and physical endurance. Thanks to these properties, MILDRONATE® is used, among other things, to increase physical and mental performance.

Pharmacokinetics

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

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

Special instructions

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

Impact on the ability to drive vehicles and machinery

There is no data on adverse effects on the ability to drive a vehicle and perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Meldonium

Composition

Capsules.

1 capsule contains:

active substance

meldonium dihydrate 250 mg;

excipients

potato starch,

colloidal silicon dioxide,

calcium stearate;

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

gelatin.

Pregnancy

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

Excretion in milk and the effect on the health of the newborn have not been studied, therefore, if it is necessary to use the drug, breastfeeding should be stopped.

Contraindications

Hypersensitivity to meldonium or any other component of the drug.

Increased intracranial pressure (due to impaired venous outflow, intracranial tumors).

Pregnancy and breastfeeding period.

Age up to 18 years (safety not confirmed).

With caution: with liver and/or kidney diseases.

Side Effects

Meldonium is generally well tolerated. However, in susceptible patients, as well as in cases where the recommended dose is exceeded, adverse reactions may occur.

Adverse drug reactions are grouped into systemic organ classes according to the following frequency gradation: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥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 the available data.

From the blood and lymphatic system

Frequency unknown: eosinophilia.

From the immune system

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

From the side of the heart

Very rare: tachycardia.

From the side of blood vessels

Very rare: decreased blood pressure.

From the gastrointestinal tract

Common: dyspeptic symptoms

From the nervous system

Often: headaches;

Frequency unknown: excitation.

General violations

Frequency unknown: general weakness.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Meldonium can be used simultaneously with long-acting nitrates and other antianginal agents, cardiac glycosides and diuretics. It can also be combined with anticoagulants, antiplatelet agents, antiarrhythmic drugs and other drugs that improve microcirculation.

Meldonium may enhance the effect of nitroglycerin, nifedipine, beta-blockers, other antihypertensive drugs and peripheral vasodilators.

Concomitant use of the drug with other meldonium drugs is not allowed, as the risk of adverse reactions may increase.

Overdose

Cases of overdose with meldonium have not been reported. The drug is low-toxic and does not cause severe adverse reactions.

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

Treatment: symptomatic.

In case of severe overdose, it is necessary to monitor liver and kidney functions.

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

4 years.
Do not use after the expiration date stated on the package.

Manufacturer

Grindeks JSC, Latvia