Mildronate, capsules 250mg, 40pcs

Composition

Capsules.

1 capsule contains:

active ingredient

meldonium dihydrate 250 mg;

excipients

potato starch,

colloidal silicon dioxide,

calcium stearate;

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

gelatin.

Pharmacological action

Pharmacotherapy group:

A metabolic agent.

ATX code: C01EB

Pharmacological action

Pharmacodynamics

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

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

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

Pharmacokinetics

After oral use, the drug is rapidly absorbed, with a bioavailability of 78%. The maximum concentration (Cmax) in blood plasma is reached 1-2 hours after oral use.

It is metabolized in the body mainly in the liver with the formation of two main metabolites that are excreted by the kidneys. The oral half-life (T1/2) depends on the dose and is 3-6 hours.

Indications

Reduced working capacity, mental and physical overload.

Use during pregnancy and lactation

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 necessary, the use of the drug, you should stop breastfeeding.

Contraindications

Hypersensitivity to meldonium or any other component of the drug.

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

Pregnancy and breast-feeding period.

Under 18 years of age (security not confirmed).

With caution: for 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 by organ-system class 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 (

From the blood and lymphatic system

, the frequency is unknown: eosinophilia.

From the immune system

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

From the side of the heart

Very rare: tachycardia.

From the side of blood vessels

Very rare: low blood pressure.

From the gastrointestinal tract

Often: dyspeptic phenomena

Nervous system

disorders Common: headaches;

Frequency unknown: agitation.

General disorders

Frequency unknown: general weakness.

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

Interaction

Meldonium is allowed to be used simultaneously with prolonged-acting nitrates and other antianginal agents, cardiac glycosides and diuretics. It can also be combined with anticoagulants, antiplatelet agents, antiarrhythmics and other drugs that improve microcirculation.

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

Concomitant use of the drug together with other meldonium preparations is not allowed, since the risk of adverse reactions may increase.

How to take, course of use and dosage

Inside.

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

The course of treatment is 10-14 days.

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

Due to the possible stimulating effect, the drug is recommended to be used in the first half of the day.

Overdose

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

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

Treatment: symptomatic.

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

Special instructions

Patients with chronic liver and kidney diseases should exercise caution when using the drug for a long time. If you need a long-term (more than a month) use of the drug, you should consult a specialist.

Influence on the ability to drive vehicles and mechanisms

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

Form of production

Solid gelatin capsules No. 1 are white in color.

The contents are white crystalline powder with a faint odor.

The powder is hygroscopic.

Storage conditions

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

Shelf

life is 4 years. Do not use after the expiration date indicated on the package.

Active ingredient

Meldonium

Dosage form

Capsules

Description

For adults

Indications

Intense physical activity