Pantogam^® active (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

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

D,L-hopantenic acid

D,L-hopantenic acid (Grouping name)

Dosage Form

Pantogam® active

Capsules 300 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, white; capsule contents – powder white or white with a yellowish tint.

* rac-hopantenic acid.

Excipients: microcrystalline cellulose – 20.97 mg, magnesium stearate – 1.53 mg.

Composition of hard gelatin capsules titanium dioxide – 2%, gelatin – up to 100%.

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug with anticonvulsant action

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

The action is associated with the presence of GABA in its structure, which directly affects the GABA_B receptor-channel complex. It is a racemic mixture of equal amounts of the R-form of hopantenic acid and its S-isomer. The presence of the isomer improves the transport and interaction of the drug with the GABA receptor. It has a more pronounced nootropic and anticonvulsant effect than first-generation hopantenic acid drugs.

It increases the brain’s resistance to hypoxia and the effects of toxic substances, stimulates anabolic processes in neurons, combines a moderate sedative effect with a mild stimulating effect. It has antiasthenic and mild anxiolytic action. Reduces motor excitability, normalizes behavior. Activates mental activity and performance. Causes inhibition of pathologically increased bladder reflex and detrusor tone.

Pharmacokinetics

Rapidly absorbed from the gastrointestinal tract. Penetrates the blood-brain barrier. It is not metabolized and is excreted unchanged within 48 hours: about 70% of the taken dose – with urine, about 30% – with feces.

Indications

Cognitive impairments in organic brain lesions (including consequences of neuroinfections and traumatic brain injuries) and neurotic disorders; cerebrovascular insufficiency caused by atherosclerotic changes in brain vessels; extrapyramidal hyperkinesias (myoclonus epilepsy, Huntington’s chorea, hepatolenticular degeneration, Parkinson’s disease and others), as well as for the treatment of neuroleptic-induced extrapyramidal syndrome; in epilepsy together with anticonvulsants; psychoemotional overload, decreased mental and physical performance, to improve concentration and memory; neurogenic urinary disorders (pollakiuria, imperative urges, urge urinary incontinence, enuresis); in schizophrenia as part of complex therapy.

ICD codes

Dosage Regimen

Take orally, 15-20 minutes after meals, 2-3 times/day. Administer doses preferably in the morning and daytime hours to minimize potential sleep disturbances.

The typical course of treatment is 1-4 months. For specific conditions, treatment may extend to 6-12 months based on physician assessment.

After a 3-6 month treatment-free interval, a repeated course of therapy is permissible.

Do not exceed the prescribed daily dosage. The total daily dose is determined by the treating physician based on the specific indication and patient response.

For cognitive impairments and cerebrovascular insufficiency, adhere strictly to the prescribed regimen for optimal nootropic effect.

When used for extrapyramidal hyperkinesias or as part of antiepileptic therapy, maintain consistent dosing schedules.

In cases of neurogenic urinary disorders, continue treatment for the full prescribed duration to achieve therapeutic effect on detrusor tone.

Do not discontinue therapy abruptly without consulting your physician.

Adverse Reactions

Allergic reactions rarely – rhinitis, conjunctivitis, skin rashes.

From the nervous system sleep disturbances or drowsiness, noise in the head.

Contraindications

Acute severe kidney diseases; first trimester of pregnancy; lactation; age under 18 years; hypersensitivity to the drug.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy and during lactation (breastfeeding).

Use in Renal Impairment

The drug is contraindicated for use in renal impairment.

Pediatric Use

Contraindicated in children under 18 years of age, because there are no clinical studies on the use of the drug in this age group.

Special Precautions

Simultaneous long-term use with other nootropic and CNS stimulating agents is not recommended.

Drug Interactions

Prolongs the action of barbiturates, enhances the effects of anticonvulsants, prevents the side effects of phenobarbital, carbamazepine, neuroleptics.

The effect is enhanced when combined with glycine, etidronic acid.

Potentiates the action of local anesthetics (procaine).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.