OCTENISEPT

OCTENISEPT solution

Important notes (mandatory information)

octenisept antiseptic before catheterization of the bladder, solution. Areas of application: for repeated, temporary antiseptic treatment of mucous membrane and adjacent skin, also before catheterization of the bladder.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

octenisept antiseptic before catheterization of the bladder, solution for application to the mucous membrane and adjacent skin
Active ingredients: 0.1 g octenidine hydrochloride, 2.0 g phenoxyethanol (Ph.Eur.) /100 g

1. WHAT IS OCTENISEPT ANTISEPTIC BEFORE CATHETERIZATION OF THE BLADDER AND WHAT IS IT USED FOR?

octenisept antiseptic before catheterization of the bladder is an antiseptic for repeated, temporary antiseptic treatment of mucous membrane and adjacent skin, also before catheterization of the bladder.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING OCTENISEPT ANTISEPTIC BEFORE CATHETERIZATION OF THE BLADDER?

octenisept antiseptic before catheterization of the bladder must not be used if you are hypersensitive (allergic) to the active ingredients or any of the other ingredients. The medicinal product must not be used for irrigation of the abdominal cavity (e.g. intraoperatively) and the bladder, nor must it be used on the eardrum.

Special care must be taken when using octenisept antiseptic before catheterization of the bladder:
Warning: Do not swallow the medicinal product in large quantities or allow it to enter the bloodstream, e.g. through accidental injection.

Pregnancy:
There is no experience with use during pregnancy. Animal studies have shown no evidence of teratogenic or other embryotoxic effects of octenidine hydrochloride and phenoxyethanol.

Breastfeeding

There are no sufficient animal or clinical data on use during breastfeeding. Since octenidine hydrochloride is not or only minimally absorbed, 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 operating machinery

No known influence.

When using octenisept antiseptic before catheterization of the bladder with other medicinal products

Please inform your doctor or pharmacist if you are using or have recently used other medicinal products, even if they are non-prescription products. 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.

3. HOW SHOULD OCTENISEPT ANTISEPTIC BEFORE CATHETERIZATION OF THE BLADDER BE USED?

Always use the medicinal product exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Rub the area to be treated thoroughly with at least 2 swabs soaked in the medicinal product, one after the other, and ensure that the area is completely wetted. Wait at least 1 to 2 minutes before taking any further measures, such as applying a wound dressing. These instructions must be carefully followed in order to achieve the desired effect. Since experience is only available for a continuous period of use of approx. 14 days, the medicinal product should not be used for longer than two weeks without medical supervision.

If you have used a larger amount of octenisept antiseptic before catheterization of the bladder than you should

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

As a subjective symptom, a temporary burning sensation may occur in rare cases. Contact allergic reactions, such as temporary redness at the treated site, are very rare.

The following frequency information is used to assess 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.

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 package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department 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 SHOULD OCTENISEPT ANTISEPTIC BEFORE CATHETERIZATION OF THE BLADDER BE STORED?

Keep out of reach of children. Do not use for more than 3 years after opening, but not beyond the expiry date stated on the packaging. No special storage conditions are required.

6. FURTHER INFORMATION

octenisept antiseptic before catheterization of the bladder contains the following in 100 g solution: Active ingredients: octenidine hydrochloride 0.1 g, phenoxyethanol (Ph.Eur.) 2.0 g. Other ingredients: (3-coconut fatty acid amide propyl)dimethylazaniumylacetate, sodium D-gluconate, glycerol 85%, sodium chloride, sodium hydroxide, purified water.

Dosage form and contents

octenisept antiseptic before catheterization of the bladder is a clear, colourless solution and is available as a 15 ml bottle.

Marketing Authorisation Holder and Manufacturer

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

This package leaflet was last revised in April 2015.

Source: Package leaflet information
Version: 05/2018
Areas of application: for repeated, temporary antiseptic treatment of mucous membrane and adjacent skin, also before catheterization of the bladder.