OCTENISEPT

OCTENISEPT solution

Important notes (mandatory information)

octenisept colourless, aqueous wound and mucous membrane antiseptic. Areas of application: for repeated, time-limited antiseptic treatment of mucous membranes and adjacent skin before diagnostic and surgical procedures - in the ano-genital area of the vagina, vulva, glans penis, also before catheterisation of the bladder - in the oral cavity. For time-limited supportive therapy for fungal infections of the skin between the toes as well as for supportive antiseptic wound treatment.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

octenisept colourless, aqueous wound and mucous membrane antiseptic

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this leaflet contains

1. WHAT IS OCTENISEPT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING OCTENISEPT?
3. HOW TO USE OCTENISEPT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE OCTENISEPT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS OCTENISEPT AND WHAT IS IT USED FOR?

octenisept is an antiseptic for repeated, time-limited antiseptic treatment of mucous membranes and adjacent skin before diagnostic and surgical procedures - in the ano-genital area of the vagina, vulva, glans penis, also before catheterisation of the bladder - in the oral cavity. For time-limited supportive therapy for fungal infections of the skin between the toes as well as for supportive antiseptic wound treatment.

2. WHAT SHOULD YOU CONSIDER BEFORE USING OCTENISEPT?

octenisept must not be used:

• if you are allergic to the active ingredients or any of the other ingredients of this medicine listed in section 6.
• The medicine should not be used for irrigation in the abdominal cavity (e.g. intraoperatively) and the bladder, nor should it be used on the eardrum.

Warnings and precautions

Do not swallow the medicine in large quantities or allow it to enter the bloodstream, e.g. by accidental injection! After irrigation of deep wounds using a syringe, persistent oedema, erythema and even tissue necrosis have been reported, some of which required surgical revision (see section 4).

Warning

To avoid tissue damage, the preparation must not be injected into the depth of the tissue using a syringe. The preparation is intended for superficial use only (application using swabs or spraying).

Use of octenisept together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Do not use with antiseptics (disinfectants) based on PVP-iodine on adjacent skin areas, as this can lead to severe brown to violet discolouration in the border areas.

Pregnancy and breast-feeding

Current experience with pregnant women does not indicate any risk. There are no sufficient animal experimental and clinical data on use during breast-feeding. Since octenidine dihydrochloride is not or only absorbed in very small amounts, it can be assumed that it does not pass into breast milk. Phenoxyethanol is rapidly and almost completely absorbed and excreted almost quantitatively as an oxidation product via the kidneys. Accumulation in breast milk is therefore unlikely. Driving and using machines No influence known.

3. HOW TO USE OCTENISEPT?

Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The preparation is intended for superficial use and must not be injected into the depth of the tissue using a syringe, for example. Rub the area to be treated thoroughly with at least 2 swabs soaked in the medicine one after the other. The wound must be completely wetted. Wait for the minimum contact time of 1 to 2 minutes before taking further measures, such as applying a wound dressing. Rinsing the oral cavity is possible, but should only be done if the entire oral cavity needs to be treated. Then 20 ml should be used over 20 seconds. For supportive therapy of fungal infections of the skin between the toes, the medicine should be sprayed onto the affected areas in the morning and evening. To achieve the desired effect, these instructions must be carefully followed. Since experience has only been gained with a continuous duration of use of approx. 14 days, the medicine should not be used for longer than 2 weeks without medical supervision.

If you have used more octenisept than you should

There is no knowledge of overdosage. However, an overdose is very unlikely with a topical preparation.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare	1 to 10 in 10,000 treated persons
Very rare	less than 1 in 10,000 treated persons
Not known	Frequency cannot be estimated from the available data.

Rare

Burning, redness, itching and a feeling of warmth

Very rare

Contact allergic reactions, such as temporary redness

Not known

After irrigation of deep wounds using a syringe, persistent oedema, erythema and even tissue necrosis have been reported, some of which required surgical revision (see section 2). When rinsing the oral cavity, the medicine temporarily causes a bitter taste.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OCTENISEPT?

Keep this medicine out of the reach of children. After opening, you may not use this medicine for longer than 3 years, but not beyond the expiry date stated on the packaging. This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What octenisept contains

The active ingredients in 100 g of octenisept solution are octenidine dihydrochloride (0.1 g) and phenoxyethanol (Ph.Eur.) (2.0 g). The other ingredients are 2-[(3-coconut fatty acid amide propyl)dimethylazaniumyl]acetate, sodium D-gluconate, glycerol 85%, sodium chloride, sodium hydroxide, purified water.

What octenisept looks like and contents of the pack

octenisept is a clear, colourless solution and is available in pack sizes of 250 ml, 250 ml (spray bottle), 500 ml, 1 l, AP 10 x 250 ml, AP 20 x 500 ml and AP 10 x 11.

Pharmaceutical entrepreneur and manufacturer

Schülke & Mayr GmbH
22840 Norderstedt
Tel.: +49 (40) 52100-0
info@schuelke.com

This leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for repeated, time-limited antiseptic treatment of mucous membranes and adjacent skin before diagnostic and surgical procedures - in the ano-genital area of the vagina, vulva, glans penis, also before catheterisation of the bladder - in the oral cavity. For time-limited supportive therapy for fungal infections of the skin between the toes as well as for supportive antiseptic wound treatment.