250 mg capsules N60

MILDRONATE® 250 mg capsules

The active substance is 3-(2,2,2-trimethylhydrazinium)
propionate dihydrate.
Antiischaemic agent of a metabolic action Each capsule contains 250 mg of 3-(2,2,2-trimethylhydrazinium)propionate dihydrate.
The other ingredients are potato starch, silicon dioxide, calcium stearate. Gelatine capsule composition: titanium dioxide, E171, gelatine.

Package: 10 capsules per blister. 2 or 6 blisters in a cardboard box.

WHAT MILDRONATE IS AND WHAT IT IS USED FOR 3-(2,2,2-trimethylhydrazinium)propionate dihydrate (Mildronate)is a structural analogue of a precursor of carnitine —gamma-butyrobetaine (GBB). Mildronate inhibits the activity ofgamma-butyrobetain-hydroxylase, causing a decrease of carnitinebiosynthesis and long-chain fatty acids transport through cellmembranes. It prevents the accumulation of Acyl-CoA and Acyl-carnitine,the metabolites of long-chain fatty acids in cells, thus diminishingtheir adverse effects.
Under the conditions ofischemia, Mildronate activates the anaerobic glycolysis and stimulatesthe ATP production, and transport, restores the balance between oxygendelivery and consumption.
Decrease of carnitineconcentration results in activation of synthesis ofgamma-butyrobetaine, which possess vasodilatating activity.
Mildronateexerts cardio protective effect. In the case of chronic congestiveheart failure it augments myocardial contractility, increases thetolerance of the organism to physical overload. In patients with II—IIIstage stable angina pectoris Mildronate increases the physical capacityand decreases the number of angina pectoris attacks.
Inthe cases of acute and chronic ischemic cerebrovascular disturbancesMildronate ameliorates cerebral blood flow in the ischemic region,promoting redistribution of blood flow in favour of ischemic zone.
Mildronateis also characterised by a tonic effect. It prevents functionaldisturbances of somatic and vegetative nervous system.

Indications. Cardiovasculardiseases: chronic coronary heart disease, stable angina pectoris,chronic heart failure, functional cardiovascular disturbances,cardiomyopathy.
Acute and chronic ischemic cerebrovascular disturbances.
Mildronateis used also in the cases of decreased performance, physical and psychoemotional overload, and during recovery process.

BEFORE YOU USE MILDRONATE Do not take Mildronate: if you are hypersensitive to Mildronate or any of the other ingredients of the medicine.

You must tell your doctor before taking your medicine, if:
· you are pregnant or intend to become pregnant;
· are breast feeding.

Special care with Mildronate:Mildronate should be used with caution in patients with chronic liveror kidney diseases during long term therapy. Safety of Mildronateapplication in children less than 12 years age was not studied.

Pregnancy:No clinical data are available on the drug safety during pregnancy. Toavoid a possible undesirable action on the organism of mother andfetus, Mildronate is not given during pregnancy.

Breast-feeding:It is not known whether active substance is excreted in human milk. Ifmother needs to be treated with the drug, she has to stop breast-feeding.

Driving and using machines: The cases of Mildronate unfavorable effect on ability to drive or use machines are unknown.
Usingother medicines: Please inform your doctor or pharmacist if you aretaking or have recently taken any other medicines, even those notprescribed.
Mildronate could be combined with antianginal drugs,anticoagulants, antiagregants, antarrhythmic drugs, cardiac glycosides,diuretics etc.
Mildronate may intensify the actions of severalcardiovascular agents such as nitroglycerine, nifedipine,beta-adrenoblockers, hypotensive agents and peripheral vasodilators.

HOW TO USE MILDRONATE Usual adult daily dose – 2 to 4 capsules (500 to 1000 mg) by mouth. Itis given as a single dose in the morning or in two divided doses. Inview of a possible development of active substance exciting effect itis recommended to take in the first half of the day.
If you take more Mildronate than you should:
Nodata on Mildronate overdose are known. It is low toxic and does notcause severe side effects. If sharp changes of arterial blood pressureare observed, symptomatic therapy should be given as appropriate.
If you forget to take Mildronate: Do not take a double dose to make up for forgotten individual doses.

POSSIBLE SIDE EFFECTS In separate cases, allergic reactions, dyspeptic disturbances,tachycardia, changes in arterial pressure, headache, agitation,weakness may occur; eosinophylia has been reported (one case reported).

Patients should discontinue usage of medicine andconsult their doctor, if allergic reactions are developed. If younotice any side effects not mentioned in this leaflet, please informyour doctor or pharmacist.

STORING OF MILDRONATE Protect from moisture. Do not store above 25˚С.
Keep out of the reach and sight of children.
Do not use after expiratory date printed on package!
Prescription drug.