Dibufelon® capsules

Registration number: LP-005332
Trade name: Dibufelon®
International non-proprietary name or grouping name: phenosanic acid

Dosage form: capsules
Composition: 1 capsule contains:
active substance: phenosanic acid 200.0 mg;
excipients: lactose monohydrate, croscarmellose sodium, povidone K-17, calcium stearate, solid gelatin capsules No. 1 (capsule composition: titanium dioxide, iron oxide yellow, gelatin).
Description: solid gelatin capsules No. 1 of a cylindrical shape with hemispherical ends of yellow color. Contents of capsules – granules of white color or white with a yellowish tint, or a mixture of granules and powder of white color or white with a yellowish tint.
Pharmacotherapeutic group: antiepileptic agent
ATX code: N03AX
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Pharmacological properties

Pharmacodynamics. Phenosanic acid is a synthetic antioxidant of the class of sterically hindered phenols. The drug stabilizes neuronal membranes by inhibiting the processes of peroxidation and changes in the composition of lipids in the cell membranes of the brain. It has a neuroprotective effect. By adjusting the microviscosity of the lipid component of the cell membrane, it regulates the activity of adenylate cyclase and protein kinase C. It normalizes the processes of excitation in the central nervous system (CNS), and has a neurotropic effect. It prevents the development of convulsive seizures, tonic extension, eliminates epileptiform activity. It improves intellectual-mnestic and cognitive functions in patients with epilepsy, helps reduce neurological deficits and improve daily motor activity.

Pharmacokinetics. The drug is rapidly absorbed into the systemic bloodstream from the gastrointestinal tract. The average maximum concentration Cmax is (178 ± 29) ng/ml, it is achieved in Tmax – (3.9 ± 0.5) h. The average value of the total clearance of the drug CLt is (824 ± 167) l/hour. The half-life T1/2 is (5.3 ± 0.8) hours. High values of the volume of distribution Vd - (5590 ± 1204) l indicate that the drug penetrates well into organs and tissues.

Indications
As a combined therapy in patients with partial epileptic seizures with or without secondary generalization.
Contraindications
• hypersensitivity to the components of the drug;
• severe liver function disorders;
• myasthenia;
• severe respiratory failure (respiratory rate greater than 22/min);
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
• age under 18;
• pregnancy and breast-feeding.

Use during pregnancy and lactation.
The safety of Dibufelon® during pregnancy and lactation has not been studied. Do not use during pregnancy or lactation.

Posology and method of administration.
Entire capsules shall be administered orally during meals BID: in the morning - up to 10 o-clock and in the evening - no later than at 18 o'clock.
As a combined therapy in patients with partial epileptic seizures with or without secondary generalization the recommended initial dose of the drug is 400 mg per day: 200 mg in the morning and 200 mg in the evening. If the drug is well-tolerated, the dose shall be increased by 200 mg per day at intervals of 5-7 days: first up to 600 mg (400 mg in the morning and 200 mg in the evening) and then up to 800 mg (400 mg in the morning and 400 mg in the evening). The maximum daily dose of the drug is 800 mg/day. The duration of the course of therapy is determined by the attending physician.
Cancel the drug gradually, reducing the dose by 200 mg per day at intervals of 5-7 days.

Side effect.
Adverse reactions observed in clinical studies of Dibufelon® are listed according to the damage to organs and systems and frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥ 1/100 and < 1/10), infrequently (≥ 1/1 000 and < 1/100), rarely (≥ 1/10 000 and < 1/1 000), very rarely (< 1/10 000).

Metabolic and nutritional disorders: infrequently - increase or decrease in body weight, appetite disorders.
Disorders of the nervous system: infrequently - headache, drowsiness.
Gastrointestinal disorders: often - nausea, infrequently - pain in the epigastric region, diarrhoea, dry mouth.
Skin and subcutaneous tissue disorders: infrequently - itching of the skin, skin rash (including small-point rash), redness, increased sweating.
Disorders of the reproductive system and mammary glands: infrequently - premature ejaculation.
General disorders and reactions at the injection site: infrequently - poor health, pronounced weakness.

Overdose
Overdose with phenosanic acid results in the aggravation of side effects of the drug.
Treatment: if symptoms of overdose occur, discontinue the drug, induce vomiting, take activated charcoal, or perform gastric lavage.

Interaction with other medications
The drug enhances the effect of anticonvulsants, neuroleptics, antidepressants, narcotic analgesics, alcohol.

Special instructions
During treatment, it is necessary to monitor the functional state of the liver.

Effects on ability to drive and use machines
During treatment with Dibufelon®, avoid activities that require concentration and speed of psychomotor reactions.

Presentation
200 mg capsules. Ten capsules in a contour cell package made of polyvinyl chloride film and aluminum foil.
Two or five contour cell packages together with the instructions for use are placed in a cardboard package.

Storage conditions
Do not store above 25°С.
Keep away from children.

Shelf life
3 years.
Do not use after the expiration date.

Dispensing conditions
Available on prescription.

Owner of the registration certificate
PIQ-PHARMA LLC, Russia, 125047, Russia, Moscow, Oruzheyniy per., dom 25, str.1, pomesch. I, etazh 1.

Manufacturer
PIQ-PHARMA LLC, Russia, 308010, Belgorodskaya obl., Belgorodskiy rayon, pgt. Severnyy, ul. Berezovaya, d. 1/19.

Organization that accepts consumer complaints
PIQ-PHARMA LLC, Russia, 125047, Moscow, Oruzheyniy per., dom 25, str.1, pomesch. I, etazh 1. Tel./fax: (495) 925-57-00
www.pikfarma.ru