Mildronate kaps. it is firm. 250 mg No. 40

Mildronate – the cardiological medicament used in complex therapy in the following cases:

• lowered working capacity, a physical and psychoemotional overstrain;
• during recovery after cerebrovascular violations, injuries of the head and encephalitis.

Structure

• active ingredient: meldonium;
• 1 solid capsule contains 250 mg of meldonium of a dihydrate;
• other components: potato starch, silicon dioxide, calcium stearate;
• capsule (body and lid): titanium dioxide (E 171), gelatin.

Side reactions

from the immune system – allergic reactions, hypersensitivity, including allergic dermatitis, urticaria, a Quincke's disease, anaphylactic reactions in shock.

from mentality – it is rare – excitement, sensation of fear, the notions of compulsion, a sleep disorder.

from nervous system – headaches, paresthesias, a tremor, a hypesthesia, sonitus, vertigo, dizziness, violation of gait, a preunconscious state, a syncope.

from heart – it is rare – change of a heart rhythm, heartbeat, tachycardia / sinus tachycardia, fibrillation of auricles, arrhythmia, feeling of discomfort in a breast/stethalgia.

Contraindication

• hypersensitivity to meldonium and/or any excipient of medicine;
• increase in intracranial pressure (at violation of venous outflow, intracranial tumors);
• a heavy liver and/or renal failure (there are no sufficient data on safety of application);
• children are younger than 18 years;
• pregnancy;
• feeding by a breast.

Route of administration

For application inside. Capsules are swallowed, washing down with water. To apply medicine inside to or after a meal. Due to the possible exciting effect the medicament is recommended to be taken in the first half of day.

Adult

Dose makes 500 mg/days (2 capsules on 250 mg). The daily dose can be applied at once or to divide into two single doses. The maximum daily dosage makes 500 mg.

Duration of a course of treatment is 4-6 weeks. It is possible to repeat a course of treatment 2–3 times a year.

Feature of application

Use during pregnancy or feeding by a breast

Pregnancy. For assessment of the impact of meldonium on pregnancy, development of an embryo/fruit, childbirth and postnatal development of researches on animals it is not enough. The potential risk for people is unknown therefore meldonium during pregnancy is contraindicated.

Feeding by a breast. Available data of researches on animals confirm penetration of meldonium into mother's milk. It is unknown whether meldonium gets into breast milk of the person. It is impossible to exclude risk of newborns/babies therefore during feeding by a breast meldonium is contraindicated.

Children

Are absent data on safety and efficiency of use of meldonium to children (up to 18 years) therefore use of meldonium of this category of patients is contraindicated.

Ability to influence speed of response at control of motor transport or other mechanisms

Researches for assessment of the impact on ability to steer transport and to serve mechanisms it was not carried out.

Overdose

it was not reported about meldonium overdose cases. Drug low-toxic also does not cause the menacing side effects.

. Symptomatic treatment.

At heavy overdose needs to control functions of a liver and kidneys.

Hemodialysis has no essential value at overdose of meldonium in connection with the expressed linking with blood proteins.

to Store

at a temperature not above 25 °C.

to Store

in original packing for protection against moisture.

to Store

out of children's reach.