Dibuphelon^® (Capsules) Instructions for Use

Marketing Authorization Holder

Pik-Pharma, LLC (Russia)

Manufactured By

Pik-Pharma Lek, LLC (Russia)

Contact Information

Pik-Pharma, LLC (Russia)

ATC Code

N03AX (Other antiepileptic drugs)

Active Substance

Phenosanic acid

Dosage Form

Dibuphelon®

Capsules 200 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin capsules No. 1 of cylindrical shape with hemispherical ends, yellow in color. The capsule contents are granules white or white with a yellowish tint or a mixture of granules and powder white or white with a yellowish tint.

Excipients: lactose monohydrate, croscarmellose sodium, povidone K-17, calcium stearate, hard gelatin capsules No. 1 (capsule composition: titanium dioxide, yellow iron oxide, gelatin).

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Clinical-Pharmacological Group

Antiepileptic drug

Pharmacotherapeutic Group

Antiepileptic drugs; other antiepileptic drugs

Pharmacological Action

Pharmacodynamics

Phenosanic acid is a synthetic antioxidant from the class of sterically hindered phenols.

The drug stabilizes neuronal membranes by inhibiting lipid peroxidation processes and changing the composition of lipids in the cell membranes of the brain.

It has a neuroprotective effect. By correcting the microviscosity parameters of the lipid component of the cell membrane, it regulates the activity of adenylate cyclase and protein kinase C.

It normalizes excitation processes in the CNS, has a neurotropic effect. It prevents the development of convulsive seizures, tonic extension, and eliminates epileptiform activity.

It improves intellectual-mnestic and cognitive functions in patients with epilepsy, helps reduce neurological deficits and improve daily motor activity.

Pharmacokinetics

Absorption and Distribution

The drug is rapidly absorbed into the systemic circulation from the gastrointestinal tract. The average C_max is 178±29 ng/ml, T_max is 3.9±0.5 h.

High V_d values (5590±1204 L) indicate that the drug penetrates well into organs and tissues.

Elimination

The mean value of the total clearance of the drug (Cl_t) is 824±167 L/h. T_1/2 is 5.3±0.8 h.

Indications

• As combination therapy in patients with partial epileptic seizures with or without secondary generalization.

ICD codes

Dosage Regimen

The drug is taken orally, during meals, 2 times/day: in the morning – before 10 a.m. and in the evening – no later than 6 p.m. Capsules should be swallowed whole.

As combination therapy in patients with partial epileptic seizures with or without secondary generalization, the recommended initial dose of the drug is 400 mg/day (200 mg in the morning and 200 mg in the evening).

With good tolerance, the dose of the drug is increased by 200 mg/day at intervals of 5-7 days: first to 600 mg (400 mg in the morning and 200 mg in the evening) and then 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.

The drug is discontinued gradually, reducing the dose by 200 mg/day at intervals of 5-7 days.

Adverse Reactions

Adverse reactions observed in clinical studies with the use of the drug Dibuphelon^® are listed according to the affected organs and systems and frequency of occurrence. Frequency is defined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000), very rare (<1/10000).

Metabolism and nutrition disorders uncommon – increase or decrease in body weight, appetite disorders.

Nervous system disorders uncommon – headache, drowsiness.

Gastrointestinal disorders common – nausea; uncommon – pain in the epigastric region, diarrhea, dry mouth.

Skin and subcutaneous tissue disorders uncommon – skin itching, skin rash (including pinpoint rash), redness, increased sweating.

Reproductive system and breast disorders uncommon – premature ejaculation.

General disorders and administration site conditions uncommon – malaise, pronounced weakness.

Contraindications

• Hypersensitivity to the components of the drug;
• Severe liver function disorders;
• Myasthenia;
• Severe respiratory failure (respiratory rate more than 22/min);
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
• Pregnancy;
• Breastfeeding period;
• Age under 18 years.

Use in Pregnancy and Lactation

The safety of the drug during pregnancy and breastfeeding has not been studied. Do not use Dibuphelon^® during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe liver function disorders.

Pediatric Use

Contraindicated for use under 18 years of age.

Special Precautions

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

Effect on ability to drive vehicles and operate machinery

During treatment with Dibuphelon^®, activities requiring concentration and speed of psychomotor reactions should be avoided.

Overdose

Overdose of phenosanic acid is manifested as an increase in the side effects of the drug.

Treatment if symptoms of overdose occur, discontinue the drug, induce vomiting, take activated charcoal, or perform gastric lavage.

Drug Interactions

The drug enhances the effect of anticonvulsants, neuroleptics, antidepressants, narcotic analgesics, and alcohol.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

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

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.