Valosomnin (Capsules) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Extractum rhizomatum cum radicibus Valerianae officinalis (Grouping name)

Melissa (DAB German Pharmacopoeia)

Peppermint (USAN adopted for use in the USA)

Dosage Form

Valosomnin

Capsules: 20, 40, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 2, body and cap of reddish-brown color; the capsule contents are a powder or compressed mass of brown color with inclusions of darker and lighter shades, with a characteristic odor.

Excipients : magnesium oxide – 6 mg, lactose monohydrate – 85.5 mg, talc – 8.1 mg, colloidal silicon dioxide – 3.2 mg, magnesium stearate – 2.2 mg.

Composition of the hard gelatin capsule titanium dioxide (E171) – 1%, iron oxide red dye (E172) – 0.85%, iron oxide yellow dye (E172) – 0.25%, gelatin – up to 100%.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A combined herbal medicine with sedative and antispasmodic effects.

Extract of valerian rhizomes with roots has a sedative effect.

Melissa leaf extract has sedative and antispasmodic effects.

Peppermint leaf extract has an antispasmodic and moderate sedative effect.

Indications

Increased nervous excitability; insomnia; irritability.

ICD codes

Dosage Regimen

Administer orally. Take a single dose of 1-2 capsules two to three times daily.

Ingest the last dose 30-60 minutes before bedtime to facilitate sleep onset.

Do not exceed the maximum daily dose.

Swallow the capsules whole with a sufficient amount of water; do not chew.

Treatment duration is typically 2 to 4 weeks.

Do not use the drug continuously for more than 1.5 to 2 months without consulting a physician.

Discontinuation can be abrupt; no withdrawal syndrome develops upon cessation of therapy.

If no therapeutic effect is observed after a full treatment course, or if symptoms worsen, seek medical advice.

Exercise caution when engaging in activities requiring increased concentration and psychomotor speed, such as driving or operating machinery.

Adverse Reactions

Allergic reactions possible – hyperemia, skin rash, peripheral edema, allergic dermatitis), bronchospasm.

From the digestive system with prolonged use, constipation is possible.

Contraindications

Arterial hypotension; cholangitis, cholelithiasis and other diseases of the biliary tract; pregnancy, breastfeeding period; children under 12 years of age; hypersensitivity to the components of the drug.

With caution GERD.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Pediatric Use

The use of the drug in children under 12 years of age is contraindicated.

Special Precautions

In patients with GERD, symptoms may worsen.

If symptoms persist or worsen during the use of the drug, the patient should consult a doctor.

The drug should not be used continuously for more than 1.5-2 months.

Effect on the ability to drive vehicles and machinery

During treatment, patients should exercise caution when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving machinery, work of a dispatcher, operator).

Drug Interactions

With simultaneous use of the drug with other drugs that depress the central nervous system (including hypnotics, centrally acting antihypertensive drugs, analgesics), an enhancement of the effect on the central nervous system is possible (dose adjustment may be required).

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.