Instruction for use: Mildronate by Grindex 250mg

Tradename:

Mildronate®

International Non-Proprietary Name (INN):

Meldonium

Dosage Form:
capsules

Structure1 capsule contains:
active ingredient - 250 mg of meldonium dihydrate;
Excipients - potato starch, colloidal silicon dioxide, calcium stearate; capsule (cap and body) - titanium dioxide (E 171), gelatin.
Description

Hard gelatin capsules ¹ 1 white. Content - a white crystalline powder with a weak smell. Hygroscopic powder.

Pharmacotherapeutic group:
metabolic means

ATC code: Ñ01ÅÂ

Pharmachologic effect

Pharmacodynamics
Meldonium is a precursor of carnitine, a structural analog of gamma-butyrobetaine (GBB), a substance that is in every cell of the human body.
In high load conditions Meldonium restores the balance between delivery and cellular oxygen demand, eliminating the accumulation of toxic products of metabolism in the cells, protecting them from damage; also has a tonic effect. As a result of its use increases the body's resistance to stress and ability to quickly restore energy reserves.
The drug has a stimulating effect on the central nervous system (CNS) - increase of motor activity and physical stamina. Because of these properties Mildronate® use including to enhance physical and mental performance.

Pharmacokinetics

After oral administration, the drug is rapidly absorbed, bioavailability - 78%. The maximum concentration (Cmax) in plasma is achieved in 1-2 hours after ingestion. It is metabolized in the body mainly 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
Decreased performance, mental and physical overload.

Contraindications
Hypersensitivity to meldonium or any other component of the drug.Increased intracranial pressure (in violation of the venous outflow, intracranial tumors).
Pregnancy and breast-feeding.
Age 18 years (safety is not confirmed).
Precautions: in diseases of the liver and / or kidneys.

Application of pregnancy and during breastfeeding

Health and Safety in pregnant women has not been studied, therefore, in order to avoid possible adverse effects on the fetus, use of the drug is contraindicated in pregnant women.Withdrawal of milk and effects on the health of the newborn have not been studied, therefore, if necessary, the drug should stop breastfeeding.

Dosing and Administration

Inside.
The daily dose for adults is 500 mg (2 capsules). All dose used in the morning at one time or dividing it into 2 doses.The course of treatment - 10-14 days.
If necessary, the treatment is repeated after 2-3 weeks.
In connection with a possible stimulating effect of the drug it is recommended in the morning.

Side effect

Meldonium usually well tolerated. However, in susceptible patients, as well as in cases of exceeding the recommended dose may cause undesirable reactions.
Adverse drug reactions are grouped by system-organ classes according to the following gradation frequency: 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), the frequency is not known - according to available data it is impossible to estimate the frequency.
From the blood and lymphatic system

Frequency unknown: eosinophilia.

On the part of the immune system

Common: allergic reactions (redness, rash, itching, swelling).

With the side of the heart
Very rare: tachycardia.

From the side of blood vessels

Very rare: decrease in blood pressure.

On the part of the gastrointestinal tract Common: dyspepsia

From the nervous system Common: headache;

Frequency unknown: excitement.

General disorders

Frequency unknown: weakness.

If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, inform your doctor.

Overdose

No cases of overdose were reported meldonium. The drug has low toxicity and does not cause severe adverse reactions.

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

Treatment: symptomatic.

In severe overdose need to monitor liver and kidney function.

Interaction with other drugs

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

Meldonium may increase the effects of nitroglycerin, nifedipine, beta-blockers, other antihypertensive agents and peripheral vasodilators. The simultaneous use of the drug with other drugs meldonium is not allowed because it can increase the risk of adverse reactions.

Special instructions

Patients with chronic diseases of the liver and kidneys should be careful with long-term use of the drug. If necessary, long-term (over a month) use of the drug should consult with a specialist.

Effects on ability to drive and use machines

No information about adverse effects on the ability to control the vehicle and the performance of potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Release Form

Capsules 250 mg.
10 capsules in blisters made of PVC film or PVC film coated with polyvinylidene chloride and aluminum foil. On 4 blisters with instruction on use is placed in a cardboard box.

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

Shelf life
4 years.

Do not use beyond the expiration date printed on the package.