MILDRONATE Capsules 500 mg

APPROVED

by Order of the Ministry of Health

of Ukraine

as of 01.12.05 No. 657

Registration Certificate

No. UA/3419/02/02

MILDRONATE

Capsules 500 mg

 

PACKAGE INSERT. INFORMATION FOR PATIENTS

Read carefully this insert before using the drug!

Keep this insert. You may need to reread it in future.

If You have any further questions, please, consult a doctor.

This drug was prescribed personally to You. Do not give it to other persons. This may cause harm to their health even if the symptoms of their disease is similar to those observed in You.

 

Drug Formulation:

active substance: 1 capsule contains 500 mg of 3-(2,2,2-trimethylhydrazinium) propionate dehydrate;

adjuvants: potato starch, colloid silicon dioxide, calcium stearate.

Capsule (shell and cap): titanium dioxide (E 171), gelatine.

 

Dosage Form. Capsules.

 

Pharmacotherapeutic Group. Drugs affecting cardiovascular system.

Pharmacological Properties. Mildronate is a structural analogue of gamma-butyrobetaine, a substance contained in every cell of human organism.

Under the conditions of excessive stress and oxygen deficiency (e.g., ischemia) Mildronate creates balance between oxygen supply and its demand in cells, and removes toxic metabolic products accumulated in cells protecting them from damage.

Mildronate also performs tonic action, and in the result of its application the organism receives the possibility to withstand stress and quickly restore its energy reserves.

Thanks to these properties, Mildronate is used for improvement of physical and intellectual working ability, treatment of various cardiovascular system disorders and brain circulation impairment. Moreover, the drug eliminates functional disturbances of nervous system in patients with chronic alcoholism in case of abstinence syndrome; positively acts on retina vessels and immune system activity (regulates cellular immunity).

Indications. The drug is prescribed for combined therapy of ischemic heart disease (stenocardia, myocardial infarction, chronic cardiac decompensation, and dyshormonal cardiopathy); as well as in cases of acute and chronic disturbances of brain blood supply (cerebral strokes, and chronic cerebral circulatory insufficiency); in case of haemophtalm and haemorrhages in retina of various aetiology (diabetic, hypertensive); in case of decreased working efficiency, physical overstress, including in sportsmen; in order to eliminate abstinence syndrome in case of chronic alcoholism (in combination with specific alcoholism therapy); in case of acute impairment of circulation in retina.

 

Contraindications. The drug should not be applied in case of hypersensitivity to any of its components.

Pregnancy and breast-feeding. There is no sufficient data about application of Mildronate for treatment of children under 12.

Increase in intracranial pressure (in case of impaired venous drainage, intracranial tumours).

Precautions in Course of Application. There is no data concerning application of Mildronate for treatment of children. Safety of drug application during the pregnancy period has not been proved. In order to avoid possible negative effect of the drug on foetus, it should not be applied during pregnancy. It is unknown whether the drug is secreted with breast milk. If mother requires treatment with Mildronate, breast-feeding shall be stopped.

Due to possible development of stimulating effect it is recommended to take Mildronate before noon.

Patients with chronic renal and liver diseases should be careful in case of long-term drug application.

 

Interaction with Other Drugs. On doctor’s order the drug may be combined with other drugs for treatment of cardiovascular diseases: with drugs for treatment of stenocardia; drugs that inhibit blood coagulation; antiarrhythmic and diuretic drugs, cardiac glycosides, and other drugs.

Mildronate may intensify vasorelaxant action of nitroglycerin, nifediphine, β-adrenoceptor blockers, drugs that decrease blood pressure or dilate vessels.

If You are taking other drugs, please, inform the doctor before applying Mildronate.

 

Method of Application and Dosage. Applied internally.

  1. Cardiovascular diseases. As part of combined therapy – 0.5-1.0 g (1-2 capsules) per day taken at a time (or divide the daily dose for 2 times).

Minimum course of treatment is 4-6 weeks.

Cardialgia against the background of dyshormonal myocardiodystrophy – 0.5 g per day taken at a time or divided for 2 takings. Course of treatment is 12 days.

  1. Disturbed cerebral circulation. Acute phase – 0.5-1.0 g per day taken at a time or divided for 2 takings. Course of treatment is 4-6 weeks.

Chronic disorders – 0.5 g per day taken internally at a time or divided for two takings. General course of treatment is 4-6 weeks.

Recurrent courses (usually 2-3 times a year) may be taken after consulting a doctor.

  1. Vascular pathology and dystrophic diseases of retina. The drug is applied in the form of injections.
  2. Intellectual and physical stress, including in sportsmen. 0.5 g twice a day. Course of treatment is 10-14 days. If necessary, the treatment is repeated in 2-3 weeks.

Sportsmen should take 0.5-1.0 g internally twice a day before training. Duration of treatment during preparatory period is 14-21 days, during the period of competition – 10-14 days.

  1. Chronic alcoholism. 0.5 g 4 times a day. Course of treatment is 7-10 days.

Note. If You have forgotten to take the regular dose of Mildronate, take it immediately! However, if the time of the next taking is coming, do not take the missed dose. Carry on applying the drug in accordance with doctor recommendations. Do not double the dose!

In case of overdosage there is possible risk of arterial blood changes, mainly towards hypotension. In such a case turn to the doctor without delay!

 

Side effects. Mildronate is usually well-tolerated. In rare cases itching, tachycardia, dyspepsia, or excitement are possible.

In case of allergy symptoms stop taking the drug and consult a doctor!

Sometimes possible are digestive disorders (e.g., nausea, vomiting), tachycardia (accelerated heartbeat), excitement, arterial pressure changes, mainly towards hypotension.

In case of such or any other side effects consult the doctor concerning the further application of the drug.

 

Effective Period. 4 years.

Do not apply the drug after the expiration date indicated on the packaging.

 

Storage Conditions. Store in dry place under the temperature below 25°C out of reach of children.

Packaging. Capsules 500 mg: 10 capsules in blister; 2 or 6 blisters in carton.

Category of Selling. On prescription.

Manufacturer Name and Address.

JSС «Grindeks».

Latvia, Riga, LV-1057, 53 Krustpils St.

Deputy Director of the State Pharmacological Centre of the Ministry of Health of Ukraine

 

/signature/                                                                                                    V.M. Lyzogub

 

Seal: State Enterprise of the Ministry of Health of Ukraine – Kyiv – State Pharmacological Centre – Identification Code 20015794.