Valproky 500 Hrono – antiepileptic means. The main indication to medicament use Valproky 500 Hrono, it is desirable as monotherapy, primary generalized epilepsy is: small epileptic attacks / absansnaya epilepsy, massive bilateral myoclonic spasms, big attacks of epilepsy with a myoclonia or without it, photosensitive forms of epilepsy.

Also as monotherapy or in a combination with other antiepileptic medicaments it is effective in the following diseases:

• secondary generalized epilepsy, especially Vest's syndrome (spasms at children of early age) and Lennox-Gasto's syndrome;
• partial epilepsy with simple or complex symptomatology (psychosensorial forms, psychomotor forms);
• epilepsy with secondary generalization;
• mixed epilepsy forms (generalized and partial).

Treatment of the episodes of a mania associated with bipolar affective disorders. Prevention of a recurrence of dysthymic episodes at adult patients with bipolar disorders which at treatment of episodes of a mania have a therapeutic response to therapy by Valproatum.

Structure

• Valproatum sodium/valproic acid;
• 1 tablet supports Valproky 500 Hrono Valproatum of sodium of 333 mg and valproic acid of 145 mg (that corresponds to 500 mg of Valproatum of sodium on 1 tablet);
• other components: ethyl cellulose, ammonium and methacrylate copolymer (type B), silicon dioxide colloidal anhydrous, a covering for drawing a cover (a gipromeloza, glycerin, ammonium and methacrylate copolymer (type A), polyacrylate dispersion, polietilen0kol).

Contraindication

Pregnancy, except for cases when other methods of treatment are inefficient.

if conditions of "The program of prevention of pregnancy" are not satisfied.

Hypersensitivity to Valproatum, seven-sodium Valproatum, divalproatum, a valpromid or any of medicine components in the anamnesis.

Acute hepatitis.

Chronic hepatitis.

Cases of heavy hepatitis in the individual or family anamnesis of the patient which are especially caused by medicines.

Hepatic porphyria.

Combination with meflokhiny and St. John's wort drugs.

Valproatum is contraindicated to the patients with the mitochondrial disorders caused by mutations in a gene coding mitochondrial enzyme a polymerase scale, for example with Alpers's syndrome — Guttenlokhera, to children up to two years at which presence of disorder connected with disturbance of patients is suspected. an ornitinovy cycle in the anamnesis.

Insufficiency of enzymes of a cycle of urea.

Route of administration

Valproky 500 Hrono are a form of medicament with the slowed-down release of active ingredient which allows to lower maximum and provides more uniform concentration of active ingredient in plasma within a day. It is desirable to accept medicine inside at meal time. The daily dose should be accepted in one or two receptions. Single use is possible in well controlled epilepsy. To swallow of a tablet entirely, without crushing and without chewing, washing down with a half of a glass of water, milk or other soft drink. Because of process of the extended release of medicament and like excipients medicine the inert matrix is not soaked up in digestive tract - it is removed in the course of a chair after release of active ingredient.

Valproky 500 Hrono is a dosage form of medicament with the prolonged action which forms lower maximum concentration in blood plasma and provides more stable concentration in blood plasma within a day.

Considering the content of active ingredient, this medicine is intended for use only to adults and children with body weight more than 17 kg.

for use to children up to 6 years (risk of hit in airways when swallowing).

From dosage forms for oral administration for appointment to the children up to 11 years best are suitable syrup, solution for oral administration and a granule of the prolonged action.

Dosage.

Initial daily dose makes 10–15 mg/kg, then it should be raised to achievement of an optimum dose.

Average dosage of medicine makes 20–30 mg/kg of body weight a day. However if against the background of use of a dose of a spasm it is not possible to control, the dose can be increased, carrying out careful observation of patients.

Use during pregnancy or feeding by a breast

Valproatum is contraindicated to

Feature of use

• to women of reproductive age if conditions of "The program of prevention of pregnancy" are not satisfied.

in breast milk in the concentration making from 1 to 10% of its level in blood plasma of mother. At newborns/babies whose mothers received treatment by this drug, disturbances from blood were observed.

Decision on that to stop feeding by a breast or to stop/refrain from administration of medicament Valproky 500 Hrono, it is necessary to accept taking into account advantage of breastfeeding for the child and advantage of treatment for the woman.

Children

to children with body weight more than 17 kg. This dosage form is not recommended to be applied to children up to 6 years (there is a risk of hit in airways when swallowing).

From dosage forms for oral administration for appointment to the children up to 11 years best are suitable syrup, solution for oral administration and a granule of the prolonged action.

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

Because of possible undesirable effects medicament Valproky 500 Hrono can have negative effect on ability to run vehicles and to work with mechanisms.

Patients, especially it is necessary to warn those who drive the car or work with other mechanisms about risk of emergence of drowsiness, especially if they receive complex anticonvulsant therapy or simultaneous therapy by other medicines which can increase drowsiness.

to Store

in original packing out of children's reach at a temperature not above 25 °C. Not to cool and not to freeze!