Valocordin^® (Tablets, Drops) Instructions for Use

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Phenobarbital (Rec.INN registered by WHO)

Ethylbromisovalerinate (Grouping name)

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Sedative

Pharmacological Action

A combined drug, the action of which is determined by the properties of its constituent substances. It has a sedative and antispasmodic effect. It facilitates the onset of natural sleep.

Phenobarbital has a vasodilating, hypnotic (in appropriate doses) and mild hypotensive effect, and enhances the sedative effect of other components.

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

Peppermint oil, included in some combined drugs as an auxiliary component, has a reflex vasodilating and antispasmodic effect. Some drugs contain hop cone oil or oregano oil as auxiliary components.

Indications

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

As an antispasmodic agent for spasms of the gastrointestinal tract musculature (intestinal and biliary colic).

ICD codes

Dosage Regimen

Drops

Take orally, before meals, with a small amount of liquid. The dose is set individually.

Adults – 22-30 drops 3 times/day.

For difficulty falling asleep, the dose can be increased to 45 drops.

The duration of use of the drug is determined individually by the doctor.

Tablets

Take orally, before meals, after dissolving in a small amount (30-50 ml) of water.

Adults – 15-30 drops 2-3 times/day. A single dose, if necessary (for example, with tachycardia), can be increased to 40-50 drops.

Children – 3-15 drops/day (depending on age and clinical picture of the disease).

The duration of use is determined by the doctor individually.

Adverse Reactions

Possible drowsiness, dizziness, decreased ability to concentrate, allergic reactions.

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

Contraindications

Severe hepatic and/or renal impairment; lactation period; hypersensitivity to the components of the drug.

With caution pregnancy.

Use in Pregnancy and Lactation

Should be used with caution during pregnancy.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

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

Use in Renal Impairment

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

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Special Precautions

Effect 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.

Drug Interactions

Sedatives – enhancement of the effect.

Methotrexate – possible increase in methotrexate toxicity.

Neuroleptics and anxiolytics – possible enhancement of the drug’s action.

CNS stimulants – weakening of the action of each of the drug components.

Ethanol – enhancement of the drug’s effects and increase in its toxicity.

Antibiotics, sulfonamides – reduction of antibacterial activity due to the presence of phenobarbital in the drug composition.

Griseofulvin – reduction in the degree of absorption and, as a consequence, weakening of the antifungal action (due to the presence of phenobarbital in the drug composition).

Indirect anticoagulants, corticosteroids, doxycycline, estrogens and other drugs metabolized in the liver via oxidation – reduction in effectiveness, because Phenobarbital accelerates their destruction.

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.