Valoserdin^® TAB (Tablets) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Phenobarbital (Rec.INN registered by WHO)

Peppermint oil (BP British Pharmacopoeia)

Ethylbromisovalerinate (Group Grouping name)

Dosage Form

Valoserdin® TAB

Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat, with a bevel, with a characteristic odor; inclusions are allowed.

Excipients : oregano oil (Spanish hop oil) – 0.074 mg, betadex (calculated on dry substance) – 55.55 mg, potato starch – 13 mg, lactose monohydrate – 41.416 mg, microcrystalline cellulose – 12.78 mg, calcium stearate – 0.9 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Drug with sedative and antispasmodic action

Pharmacotherapeutic Group

Sedative

Pharmacological Action

A combined medicinal product, the action of which is due to the properties of its constituent substances. It has a sedative and antispasmodic action. Facilitates the onset of natural sleep.

Phenobarbital enhances the sedative effect of other components and has a mild hypotensive effect.

The ethyl ester of α-bromoisovaleric acid has a sedative (similar to the effect of valerian) and antispasmodic effect.

Peppermint oil has a reflex vasodilating and antispasmodic effect.

Indications

As a sedative and vasodilator: insomnia (difficulty falling asleep); cardialgia; sinus tachycardia; neurotic conditions; autonomic lability; irritability; hypochondriacal syndrome; arterial hypertension (early stages).

As an antispasmodic: spasm of the gastrointestinal tract musculature (intestinal and biliary colic).

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of liquid.

For adults, take one to two tablets two to three times daily.

Adjust the single dose and frequency of administration based on the clinical indication and severity of symptoms.

For insomnia with difficulty falling asleep, take a single dose 30-60 minutes before bedtime.

The maximum single dose is two tablets.

The maximum daily dose is six tablets.

The duration of the treatment course is determined by the physician individually, based on therapeutic response and tolerability.

Avoid prolonged use to prevent the risk of drug dependence and cumulative effects.

Do not exceed the recommended dosage.

Adverse Reactions

From the nervous system drowsiness, dizziness, decreased ability to concentrate.

Other allergic reactions.

With prolonged use chronic bromine poisoning (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements); drug dependence.

Contraindications

Severe hepatic and/or renal failure; hypersensitivity to the components of the combination.

With caution

Pregnancy, lactation (breastfeeding).

Use in Pregnancy and Lactation

Use with caution during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

The use of the drug is contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

The use of the drug is contraindicated in severe renal insufficiency.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Influence on the ability to drive vehicles and mechanisms

During the treatment period, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

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

Over-the-Counter

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.