Psilo-Balsam^® (Gel) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

D04AA32 (Diphenhydramine)

Active Substance

Diphenhydramine (Rec.INN registered by WHO)

Dosage Form

Psilo-Balsam®

Gel for external use 1%: 20 g or 50 g tubes

Dosage Form, Packaging, and Composition

Gel for external use 1% colorless, transparent, homogeneous.

Excipients : cetylpyridinium chloride – 1 mg, macrogolglycerol caprylocaprate (softigen 767) – 150 mg, polyacrylic acid – 12 mg, trometamol – 22.2 mg, purified water – 804.8 mg.

20 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antiallergic action for external use

Pharmacotherapeutic Group

Antipruritic agents, including antihistamines, anesthetics, and others; antihistamines for topical use

Pharmacological Action

An antiallergic agent, a histamine H₁-receptor blocker. It has pronounced antihistamine activity, reduces increased capillary permeability, tissue swelling, and hyperemia. It has a local anesthetic effect.

Diphenhydramine has a pronounced antiallergic effect and quickly reduces itching.

Psilo-Balsam^® has a cooling effect. The special gel base protects the skin and does not leave a visible mark.

Pharmacokinetics

Data on the pharmacokinetics of Psilo-Balsam^® are not provided.

Indications

• Sunburns and first-degree burns;
• Insect bites;
• Urticaria;
• Skin itching of various origins;
• Pruritic eczema;
• Chickenpox;
• Allergic skin irritations (except for cholestatic pruritus);
• Contact dermatitis caused by contact with plants.

ICD codes

Dosage Regimen

Apply a thin layer of the gel, approximately 2-3 grams, to the affected skin areas.

Administer the gel three to four times daily or as directed by a physician.

Gently rub the preparation into the skin until fully absorbed.

Ensure hands are clean before and after application to prevent secondary infection.

Do not apply to extensive areas of the body, as systemic absorption may lead to adverse effects.

Avoid application to broken skin, deep wounds, or severe burns without medical supervision.

Discontinue use and consult a physician if skin irritation or allergic reactions occur.

The duration of treatment depends on the condition being treated and its severity.

Do not use occlusive dressings over the treated area unless instructed by a healthcare professional.

Adverse Reactions

Allergic reactions skin manifestations are possible.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug should be used with caution during pregnancy.

Breastfeeding is recommended to be suspended during treatment.

Special Precautions

The drug contains light fatty components; it can be used as a skin cream.

During treatment with Psilo-Balsam^®, the patient should avoid sun exposure and alcohol consumption.

Effect on the ability to drive vehicles and operate machinery

During treatment, the patient should exercise caution when engaging in activities requiring increased concentration and speed of psychomotor reactions.

Overdose

Symptoms when applying the drug to large surfaces, intoxication is possible – dry mouth, difficulty breathing, agitation, confusion.

Treatment symptomatic therapy against the background of careful monitoring of respiratory function and blood pressure.

Drug Interactions

Data on the drug interaction of Psilo-Balsam^® are not provided.

Storage Conditions

List B. The drug should be stored at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

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

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.