Kamagel (Gel) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

D02AX (Other dermatoprotectants)

Dosage Form

Kamagel

Gel for external use: tube 40 g

Dosage Form, Packaging, and Composition

Excipients: ethanol 96%, propylene glycol, methylparaben, propylparaben.

40 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and dermatoprotective action for external use

Pharmacotherapeutic Group

Dermatoprotective agent

Pharmacological Action

A combined drug that has a dermatoprotective effect.

Aluminium acetotartrate has a local anti-inflammatory and astringent effect, coagulating exudate proteins to form a film that protects the skin from external irritants.

Chamomilla recutita flower extract has anti-inflammatory, antimicrobial, wound-healing, and mild analgesic effects.

Indications

• Dermatitis, including cases caused by sunburn, UV radiation exposure, insect bites, and jellyfish stings, as well as skin irritation following shaving.
• Intertrigo resulting from excessive sweating.
• Bruises and dislocations for symptomatic relief.

ICD codes

Dosage Regimen

Apply a thin layer of the gel to the affected skin areas several times daily, as required for symptomatic relief.

For the management of dislocations and bruises, apply the gel to a compress and place it on the affected area, ensuring it is secured appropriately.

Adverse Reactions

Monitor for allergic reactions, which may include localized skin rash, pruritus, erythema, or urticaria at the application site.

Discontinue use immediately upon the appearance of any signs of hypersensitivity and seek medical advice for appropriate management.

Drug Interactions

No specific drug interactions with other medicinal products have been reported to date following topical application.

Exercise caution when applying the gel over large areas or under occlusive dressings, as systemic absorption of components, though unlikely, cannot be entirely ruled out.

Contraindications

• Hypersensitivity to aluminium acetotartrate, chamomilla recutita flower extract, or to any of the excipients, including parabens (methylparaben, propylparaben) and ethanol.
• Do not apply to impaired skin integrity, such as open wounds, deep cuts, or severe burns, due to the potential for increased systemic absorption and local irritation.

Overdose

Overdose from topical application is unlikely due to minimal systemic absorption; however, excessive application may lead to intensified local adverse effects such as skin irritation.

In case of accidental ingestion, seek immediate medical attention and provide symptomatic and supportive care, as the ethanol content and other components may cause systemic toxicity.

Special Precautions

Avoid contact with mucous membranes and eyes.

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

Rx Only

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.