Klosterfrau Melisana (Elixir) Instructions for Use

Marketing Authorization Holder

MCM Klosterfrau Vertriebs, GmbH (Germany)

Manufactured By

Klosterfrau Berlin, GmbH (Germany)

ATC Code

A03 (Drugs for the treatment of functional gastrointestinal disorders)

Dosage Form

Klosterfrau Melisana

Elixir: bottle 47 ml, 95 ml, 155 ml or 235 ml

Dosage Form, Packaging, and Composition

Elixir as a clear, colorless or slightly yellowish liquid with a characteristic odor.

* obtained by hydro-steam distillation.

Excipients : ethanol – 52.7 g (59% by weight).

47 ml – bottles (1) – cardboard packs.
95 ml – bottles (1) – cardboard packs.
155 ml – bottles (1) – cardboard packs.
235 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A herbal preparation with sedative and hypnotic effects; it has a weak antispasmodic, anti-inflammatory and analgesic action, and normalizes the functions of the autonomic nervous system.

Indications

Oral use: anxiety; sleep disorders; headache; gastrointestinal disorders associated with neurotic disorders ( flatulence, feeling of heaviness in the stomach); common cold.

External use: lumbago; sciatica; myalgia after physical exertion; gingivitis; asthenia.

ICD codes

Dosage Regimen

For oral administration, 5-15 ml of the concentrate is diluted with a double amount of liquid (water, juice, tea, etc.).

For nervousness, gastrointestinal disorders: 5-10 ml before meals; for common cold: at the first signs – 10 ml 3 times a day; for difficulty falling asleep before bedtime: 10-15 ml with hot tea, hot water, with sugar or honey.

Externally, undiluted, as a rub (for sensitive skin, dilute with a double amount of water). Rub into the painful area until the preparation has completely evaporated.

For gingivitis: 5 ml is diluted with 10 ml of water and the affected side of the mouth is rinsed for 2-3 minutes; for prolonged treatment, a cotton swab soaked in the diluted solution is applied to the affected area.

For asthenia: without dilution, rub into the temporal area, rub the forehead or inhale the vapors by soaking a handkerchief with the concentrate.

Adverse Reactions

Allergic reactions.

Contraindications

Hypersensitivity.

For oral use: peptic ulcer of the stomach and duodenum; ulcerative colitis; liver diseases; children under 18 years of age.

For external use: children under 12 years of age.

Use in Hepatic Impairment

Contraindication for oral use — liver diseases.

Pediatric Use

Oral administration of the drug is contraindicated in children under 18 years of age.

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

Special Precautions

Influence on the ability to drive vehicles and mechanisms

Persons whose profession requires quick mental and motor reactions should not take the drug during work.

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.