MILDRONATE [Meldonium]

Instructions for MILDRONATE [Meldonium]

Active ingredient MILDRONATE
Meldonium (Meldonium)

Pharmacological group

Metabolic agent

Composition
Capsules 1 caps.
active substance: meldonium dihydrate 250 mg
excipients: dried potato starch; silicon dioxide;

Pharmacological action

metabolic, psychostimulating, antihypoxic

Pharmacodynamics
Meldonium is a structural analogue of the precursor of carnitine - gamma-butyrobetaine (GBB), a substance that is found in every cell of the human body.
Under conditions of increased load, 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; 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 increases.
Mildronate has a stimulating effect on the central nervous system - increasing physical activity and physical endurance. Due to these properties, MILDRONATE® is used incl. to improve physical and mental performance.

Pharmacokinetics
After oral administration, the drug is rapidly absorbed, bioavailability - 78%. Cmax in blood plasma is achieved within 1-2 hours after ingestion. It is metabolized in the body mainly in the liver with the formation of 2 main metabolites, which are excreted by the kidneys. T1 / 2 when taken orally depends on the dose, is 3–6 hours. Trace concentrations of the drug remain in the body for a long time.

Indications

Reduced performance, mental and physical overload.

Contraindications
hypersensitivity to meldonia or any other component of the drug;
increased ICP (with impaired venous outflow, intracranial tumors);
pregnancy;
period of breastfeeding;
age up to 18 years (safety not confirmed).
Precautions: liver and / or kidney disease.

Application 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 it is necessary to use Mildronate, breastfeeding should be stopped.

Method of administration and dosage
Due to the possible stimulating effect, the MILDRONATE is recommended to be used in the first half of the day.
The daily dose for adults is 500 mg (2 capsules). The entire dose is used in the morning in 1 dose or dividing it into 2 doses.
The course of treatment is 10-14 days.
If necessary, the treatment is repeated after 2-3 weeks.

Side effects

Meldonium is generally well tolerated. However, in susceptible patients, as well as in cases of exceeding the recommended dose, adverse reactions may occur.
Adverse drug reactions are grouped into systemic organ classes according to the following frequency gradation: very often (?1 / 10); often (?1 / 100 and <1/10); infrequently (?1 / 1000 and <1/100); rarely (?1 / 10000 and <1/1000); very rare (</ 10000); frequency unknown - frequency cannot be estimated from available data.
If any of the side effects indicated in the description are aggravated or the patient has noticed any other side effects not listed in the description, the doctor should be informed about it.
On the part of 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 rarely - tachycardia.
From the side of the vessels: very rarely - a decrease in blood pressure.
From the gastrointestinal tract: often - dyspeptic symptoms.
From the nervous system: often - headaches; frequency unknown - excitement.
General disorders: frequency unknown - general weakness.
If any of the side effects indicated in the instructions are aggravated or any other side effects not indicated in the instructions are noticed, you should inform 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, antiarrhythmics and other drugs that improve microcirculation.
Meldonium can enhance the action of nitroglycerin, nifedipine, beta-blockers, other antihypertensive drugs and peripheral vasodilators.
The simultaneous use of Mildronate together with other meldonium preparations is not allowed, since the risk of adverse reactions may increase.

Overdose
Cases of overdose of meldonium have not been reported. The drug is low-toxic and does not cause severe adverse reactions.
Symptoms: lowering blood pressure, accompanied by headache, tachycardia, dizziness and general weakness.
Treatment: symptomatic. In case of severe overdose, it is necessary to monitor the function of the liver and kidneys.

Special instructions
Patients with chronic liver and kidney diseases should be careful with prolonged use of Mildronate.
If you need a long (more than a month) use of the drug, you should consult a specialist.
Influence on the ability to drive vehicles and mechanisms. There is no evidence of an adverse effect on the ability to drive a vehicle and perform potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions MILDRONATE®
4 years
Keep out of reach of children.

Shelf life of the drug MILDRONATE®
In a dry place, at a temperature not higher than 25 ° C
Do not use after the expiration date indicated on the package.