Doppelherz^® Melissa (Drops) Instructions for Use

Marketing Authorization Holder

Queisser Pharma, GmbH & Co. KG (Germany)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Doppelherz® Melissa

Oral and external drops: 15 ml, 50 ml, or 100 ml dropper bottle

Dosage Form, Packaging, and Composition

Drops for oral and external use in the form of a clear, colorless liquid with a spicy odor and a spicy, burning taste.

Excipients: ethanol 96% (the ethanol content in the preparation is about 71%), purified water.

15 ml – dropper bottle (1) – cardboard packs.
50 ml – dropper bottle (1) – cardboard packs.
100 ml – dropper bottle (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with sedative and antispasmodic action

Pharmacotherapeutic Group

Cardiotonic agent of plant origin

Pharmacological Action

Herbal preparation.

When taken orally, it has a sedative, antispasmodic effect and helps to enhance the secretory function of the digestive organs.

When applied externally, it has a counterirritant effect.

Indications

For oral administration

• Sleep disorders;
• Increased nervous excitability;
• Functional disorders of the gastrointestinal tract (to improve digestion).

For external use

• Headache;
• Pain in joints and muscles after physical exertion;
• Rheumatic pains.

ICD codes

Dosage Regimen

For increased nervous excitability, the drug is taken 1-2 times/day, 1-2 teaspoons (30-60 drops) with sugar or glucose, or diluted in a double amount of water.

For sleep disorders, it should be taken in the same dose before bedtime.

For digestive disorders, the drug is prescribed 1-2 teaspoons (30-60 drops) 1-2 times/day. Before taking, it should be diluted in a double amount of water.

For headache, the drug is rubbed into the temporal region; for muscle or joint pain – into the corresponding painful areas. When used externally, the drug is not diluted.

Adverse Reactions

Sometimes allergic reactions (including skin redness) associated with the cinnamon bark included in the preparation, photosensitization (associated with Angelica archangelica root and bitter orange peel), more pronounced in predisposed patients (with fair skin). Dermatitis is possible with UV irradiation.

Contraindications

• Liver diseases;
• Gastric and duodenal ulcer;
• Chronic alcoholism;
• Epilepsy;
• CNS diseases;
• Childhood;
• Pregnancy;
• Lactation period (breastfeeding);
• Skin lesions at the intended application sites (for external use);
• Hypersensitivity to the components of the drug and to Peruvian balsam.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in liver diseases.

Pediatric Use

The drug is contraindicated in childhood.

Special Precautions

1 teaspoon corresponds to 30 drops of the drug (this ratio is only maintained when using the bottle dropper cap).

The drug contains 71% vol. ethanol. When using the drug in the recommended doses, it should be taken into account that 2 teaspoons (average single dose) contain 6.35 g of ethanol.

When using preparations containing Angelica archangelica root, prolonged exposure to the sun and intensive UV irradiation should be avoided.

Effect on the ability to drive vehicles and machinery

When using the drug, a decrease in the speed of psychomotor reactions is possible, which should be taken into account by patients engaged in potentially hazardous activities.

Overdose

Data on drug overdose are not provided.

Drug Interactions

Drug interactions of the preparation have not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Pharmacy supply conditions

The drug is approved for use as an over-the-counter product.

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.