Octenisept (Solution) Instructions for Use

Marketing Authorization Holder

Schülke & Mayr GmbH (Germany)

ATC Code

D08AX (Other antiseptics and disinfectants)

Active Substances

Octenidine (Rec.INN registered by WHO)

Phenoxyethanol (Ph.Eur. European Pharmacopoeia)

Dosage Form

Octenisept

Solution for topical and external use: fl. 50 ml with sprayer, fl. 250 ml, 450 ml or 1 l

Dosage Form, Packaging, and Composition

50 ml – polyethylene bottles (1) with a mechanical sprayer – cardboard boxes.
250 ml – polyethylene bottles (1) – cardboard boxes.
450 ml – polyethylene bottles (1) – cardboard boxes.
1 l – polyethylene bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

It is active against gram-positive and gram-negative bacteria, lipophilic viruses, for example, Herpes simplex virus and hepatitis B virus, as well as against yeast-like fungi and dermatophytes.

Indications

• Treatment of the skin and mucous membranes before diagnostic and surgical procedures in pediatric, surgical, and obstetric-gynecological practice, in traumatology, proctology, dermatovenereology, otorhinolaryngology, dentistry;
• For the treatment of wound and burn surfaces;
• For the prevention of foot mycosis and interdigital mycosis;

ICD codes

Dosage Regimen

Externally. Topically.

The area to be treated is alternately treated with 2 swabs generously soaked with the preparation. The affected surface must be completely treated. For easily accessible areas, the preparation can be applied by spraying. The exposure time is at least 1-2 minutes.

For mouth rinsing, 20 ml of the preparation is used; a repeated rinse is recommended after 20 seconds.

For the prevention of fungal diseases, the skin between the toes and the feet are treated with the preparation 2 times a day (morning and evening). The duration of treatment is up to 14 days.

In pediatric practice without age restrictions.

Adverse Reactions

A brief burning sensation at the application site is possible. A bitter taste is possible when rinsing the mouth.

Contraindications

• Hypersensitivity to the components of the preparation.

Pediatric Use

In pediatric practice without age restrictions.

Special Precautions

Do not swallow.

Drug Interactions

Do not use concomitantly with iodine-containing antiseptics.

Storage Conditions

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

Shelf Life

Shelf life – solution in 250 ml, 450 ml and 1 l bottles – 5 years; solution in 50 ml bottles with a mechanical sprayer – 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.