Bertalis Edas-155 (Drops) Instructions for Use

Marketing Authorization Holder

Edas Holding, OJSC (Russia)

Dosage Form

Bertalis Edas-155

Homeopathic oral drops: dropper bottle

Dosage Form, Packaging, and Composition

Excipients: ethanol about 30 %.

Dark glass bottles (1) complete with a dropper cap – cardboard packs.
Dark glass dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Homeopathic preparation used for chronic fatigue syndrome

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

Homeopathic preparation.

Indications

• As a symptomatic agent in the complex treatment of chronic fatigue syndrome.

ICD codes

Dosage Regimen

Take the preparation between meals.

Unless otherwise directed, administer one dose (5 drops) in a teaspoon of water.

Take the dose three times a day.

Continue the course of treatment for 42 days.

For administration, place the drops into a spoon with a small amount of water immediately before use.

Do not use the dropper if it is damaged.

Adhere strictly to the prescribed three-times-daily schedule to maintain consistent drug levels.

Complete the full 42-day course unless otherwise advised by a physician.

If a dose is missed, take it as soon as remembered; if it is nearly time for the next dose, skip the missed dose.

Do not double the dose to make up for a forgotten one.

Consult a physician if no improvement is observed after the initial period of treatment.

Adverse Reactions

To date, there is no information on the adverse effects of the drug.

If adverse effects occur, you should consult a doctor.

Allergic reactions to the components of the drug are possible.

Contraindications

• Increased individual sensitivity to individual components of the drug;
• Age under 18 years (due to the lack of special studies).

With caution liver diseases, alcoholism, traumatic brain injury, brain diseases.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible. It is necessary to consult a doctor.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated for children under 18 years of age.

Special Precautions

The drug acts faster and more effectively if used when the first symptoms of the disease occur.

The course of treatment depends on the stage of the disease.

No drug dependence or “withdrawal syndrome” was observed.

The maximum single dose of the drug contains 0.03 g of absolute ethyl alcohol.

The maximum daily dose of the drug contains 0.1 g of absolute ethyl alcohol.

It is possible to replace Bertalis Edas-155 homeopathic drops with Bertalis Edas-955(sl) granules, which are identical in the composition of active components.

Effect on the ability to drive vehicles and mechanisms

Due to the content of ethyl alcohol, caution should be exercised during the period of drug use when performing potentially hazardous activities that require special attention and rapid reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator, etc.).

Overdose

Cases of overdose have not been reported to date.

Drug Interactions

The use of homeopathic preparations does not exclude treatment with other medicines.

Storage Conditions

In a light-protected place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 5 years.

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.