Hopatenord (Tablets) Instructions for Use

Marketing Authorization Holder

Zvezda Media, LLC (Russia)

Manufactured By

Severnaya Zvezda NAO (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Hopantenic acid (Rec.INN registered by WHO)

Dosage Forms

	Hopatenord	Tablets 250 mg: 20, 40, 50 or 60 pcs.
		Tablets 500 mg: 20, 40, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score on one side.

Excipients: hydroxypropyl methylcellulose (hypromellose) – 7.5 mg, magnesium carbonate hydroxide pentahydrate (basic magnesium carbonate hydrate) – 40.1 mg, talc – 9.3 mg, calcium stearate – 3.1 mg.

10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
20 pcs. – bottles (1) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score on one side.

Excipients: hydroxypropyl methylcellulose (hypromellose) – 15 mg, magnesium carbonate hydroxide pentahydrate (basic magnesium carbonate hydrate) – 80.2 mg, talc – 18.6 mg, calcium stearate – 6.2 mg.

10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
20 pcs. – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

A nootropic agent with neurometabolic, neuroprotective, and neurotrophic properties. It increases the brain’s resistance to hypoxia and exposure to toxic substances, stimulates anabolic processes in neurons, combines a moderate sedative effect with a mild stimulating effect, has an anticonvulsant effect, and reduces motor excitability while regulating behavior.

It increases mental and physical performance. It helps to normalize GABA levels in chronic alcohol intoxication and subsequent ethanol withdrawal. It exhibits an analgesic effect.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. T_max is 1 hour. The highest concentrations are found in the liver, kidneys, stomach wall, and skin. It penetrates the blood-brain barrier. It is not metabolized.

It is excreted unchanged within 48 hours: 67.5% of the administered dose is excreted in the urine, 28.5% in the feces.

Indications

Cerebrovascular insufficiency caused by atherosclerotic changes in the cerebral vessels, senile dementia (initial forms), residual organic brain lesions in adults and the elderly, cerebral organic insufficiency in patients with schizophrenia, extrapyramidal hyperkinesis in patients with hereditary diseases of the nervous system (including Huntington’s chorea, hepatocerebral dystrophy, Parkinson’s disease), residual effects of previous neuroinfections, post-vaccinal encephalitis, traumatic brain injury (as part of complex therapy); extrapyramidal neuroleptic syndrome (hyperkinetic and akinetic), as a corrector for the side effects of antipsychotic agents (neuroleptics) and for prophylactic purposes simultaneously as “cover therapy”; epilepsy (with mental slowness in combination with anticonvulsants).

Psycho-emotional overload, decreased mental and physical performance (improving concentration and memory). Urination disorders: enuresis, daytime urinary incontinence, pollakiuria, imperative urges (adults and children from 2 years).

Children: perinatal encephalopathy, intellectual disability (delay in mental, speech, motor development, or their combination), infantile cerebral palsy, stuttering (mainly clonic form), epilepsy (as part of combination therapy with anticonvulsants, especially in polymorphic seizures and minor epileptic fits).

ICD codes

Dosage Regimen

It is taken orally. A single dose for adults is 0.5-1 g, for children – 0.25-0.5 g; the daily dose for adults is 1.5-3 g, for children – 0.75-3 g. The course of treatment is 1-4 months, in some cases – up to 6 months. A repeated course of treatment can be carried out after 3-6 months.

For children with intellectual disability and oligophrenia – 0.5 g 4-6 times/day daily for 3 months; for delayed speech development – 0.5 g 3-4 times/day for 2-3 months.

As a corrector for neuroleptic syndrome, adults – 0.5-1 g 3 times/day, children – 0.25-0.5 g 3-4 times/day. The course of treatment is 1-3 months.

For epilepsy, children – 0.25-0.5 g 3-4 times/day, adults – 0.5-1 g 3-4 times/day, daily, for a long time (up to 6 months).

For tics, adults – 1.5-3 g/day, daily, for 1-5 months; children – 0.25-0.5 g 3-6 times/day daily for 1-4 months.

For urination disorders, adults – 0.5-1 g 2-3 times/day, daily dose – 2-3 g; for children, a single dose is 0.25-0.5 g, daily – 25-50 mg/kg. The course of treatment is 0.5-3 months.

Adverse Reactions

Allergic reactions rhinitis, conjunctivitis, skin rash.

Contraindications

Acute severe kidney diseases, first trimester of pregnancy.

Use in Pregnancy and Lactation

Use is contraindicated in the first trimester of pregnancy.

Use in Renal Impairment

The drug is contraindicated in acute severe kidney diseases.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Long-term therapy with hopantenic acid in combination with other nootropic and CNS stimulating agents is not recommended.

Drug Interactions

It prolongs the action of barbiturates, enhances the effects of anticonvulsants, nootropic and CNS stimulating agents, and the action of local anesthetics (procaine).

It prevents the side effects of phenobarbital, carbamazepine, and antipsychotic agents (neuroleptics).

The effect of hopantenic acid is enhanced in combination with glycine and xydiphone.

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.