Relaxosan^® Night (Extract) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Valerian (BP British Pharmacopoeia)

Peppermint (USAN United States Adopted Name)

Melissa (DAB German Pharmacopoeia)

Dosage Form

Relaxosan® Night

Extract for oral administration: 50 ml or 100 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Extract for oral administration is a liquid from brown to greenish-brown in color, with a characteristic odor; sediment precipitation is allowed during storage.

Excipients: ethanol (ethyl alcohol) 70% – a sufficient amount to obtain 1000 ml of the preparation.

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A combined herbal medicine with sedative and antispasmodic effects.

Valerian extract has a sedative effect.

Lemon balm leaf extract has a sedative and antispasmodic effect.

Peppermint leaf extract has an antispasmodic and moderate sedative effect.

Indications

Increased nervous excitability; insomnia; irritability.

ICD codes

Dosage Regimen

Administer the preparation orally.

Take a single dose two to three times per day.

Ensure the last dose is taken 30 to 60 minutes before bedtime.

Shake the bottle thoroughly before each use to resuspend any sediment.

Measure the dose using the provided measuring cup or dropper.

Do not use the preparation continuously for more than 1.5 to 2 months.

No withdrawal syndrome is expected upon treatment discontinuation.

If symptoms persist or worsen, discontinue use and consult a physician.

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 medicinal product.

With caution GERD.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Pediatric Use

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

Special Precautions

In patients with GERD, a worsening of symptoms is possible.

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

The preparation 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 the simultaneous use of the preparation with other drugs that depress the central nervous system (including hypnotics, centrally acting antihypertensive agents, 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.