Passiflora Edas-111 (Drops) Instructions for Use

Marketing Authorization Holder

Edas Holding, OJSC (Russia)

Dosage Form

Passiflora Edas-111

Homeopathic oral drops: 25 ml bottle or dropper bottle

Dosage Form, Packaging, and Composition

Homeopathic oral drops colorless, transparent, with a weak alcoholic odor.

Excipients : ethanol 30 % (by volume).

25 ml – dark glass bottles (1) – cardboard packs.
25 ml – dark glass dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Homeopathic preparation used for increased nervous excitability and sleep disorders

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

Homeopathic preparation.

Indications

Employ as part of a complex treatment regimen for the following conditions.

• Sleep disorders, specifically difficulty initiating sleep.
• Asthenic and asthenodepressive states.
• Various forms of neuroses.
• States of increased irritability and nervous excitability.

ICD codes

Dosage Regimen

Administer orally, holding the liquid in the mouth briefly before swallowing.

For adults, unless otherwise directed, take 5 drops three times daily. Place drops on a piece of sugar or dissolve in a teaspoon of water. Take doses between meals.

For pediatric patients, administer only as recommended by a physician. Adhere to the following age-based dosing schedule three times daily: up to 2 years – 1 drop; 2 to 5 years – 2 drops; 5 to 10 years – 3 drops; over 10 years – 4 drops.

Adverse Reactions

No adverse reactions have been observed or reported during the use of this preparation.

Despite the favorable safety profile, remain vigilant for any unexpected symptoms and discontinue use immediately if they occur, consulting a healthcare professional.

Contraindications

Do not administer under the following condition.

• Known hypersensitivity or previous allergic reaction to any of the drug’s components, including active homeopathic ingredients or excipients.

Use in Pregnancy and Lactation

Studies have not been conducted.

Pediatric Use

For children as recommended by a doctor: up to 2 years 1 drop, from 2 to 5 years – 2 drops, from 5 to 10 years – 3 drops, over 10 years – 4 drops 3 times a day.

Special Precautions

No drug dependence or “withdrawal syndrome” has been observed.

It is possible to replace the homeopathic drops Passiflora EDAS-111 with the homeopathic granules Passiflora EDAS-911; the preparations are identical in composition.

Drug Interactions

This preparation is considered compatible with other medicinal products.

No clinically significant pharmacodynamic or pharmacokinetic interactions have been identified. Concurrent therapy with other agents does not require specific dosage adjustments.

Storage Conditions

At a temperature not exceeding +25°C (77°F), in a place protected from light and out of reach of children.

Shelf Life

The shelf life is 3 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.