Valocorphytun (Tablets) Instructions for Use

Marketing Authorization Holder

Krewel Meuselbach, LLC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Extractum rhizomatum cum radicibus Valerianae officinalis (Grouping name)

Peppermint (USAN)

Melissa (DAB)

Dosage Form

Valocorphytun

Film-coated tablets 35 mg+17.5 mg+17.5 mg: 20, 40, 50, 60, or 80 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light green in color, round, biconvex.

Excipients : lactose monohydrate, potato starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.

Shell composition povidone K-17, sucrose, colloidal silicon dioxide, magnesium carbonate, “tarragon” dye, titanium dioxide, talc, wax (capol).

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
50 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 spasmolytic effects.

Extract of valerian rhizomes with roots has a sedative effect.

Extract of lemon balm leaves has sedative and spasmolytic effects.

Extract of peppermint leaves has spasmolytic and moderate sedative effects.

Indications

Increased nervous excitability; insomnia; irritability.

ICD codes

Dosage Regimen

Administer the drug orally.

Take a single dose of one to two tablets.

Adhere to a frequency of two to three times daily.

Ingest the last dose 30 minutes to one hour before bedtime to facilitate sleep onset.

Do not exceed the maximum daily dose of six tablets.

Swallow the tablet whole with a sufficient amount of water.

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

Discontinue use if no therapeutic benefit is observed after a treatment period of 2-4 weeks.

Be aware that withdrawal syndrome does not develop upon cessation of therapy.

For patients with GERD, monitor for potential worsening of symptoms.

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, a worsening of symptoms is possible.

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 mechanisms

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 mechanisms, 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.