OCTENISEPT BRŪČU KOPŠANAS GĒLS 20ML

Code: D03AU 

Active substances: Octenidine+Phenoxyethanol

Vendor, principal: Schulke&mayr Gmbh,. 

OCTENISEPT 1MG/+20MG/1ML 50ML

Package leaflet: Information for the user

Octenisept 1 mg/20 mg/ml, cutaneous solution

Octenidine hydrochloride Phenoxyethanol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-   Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
-   Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice.
-   If any side effects occur, talk to a doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

What is in this leaflet

1.   What Octenisept is and what it is used for
2.   What you need to know before you use Octenisept
3.   How to use Octenisept
4.   Possible side effects
5.   How to store Octenisept
6.   Contents of the pack and other    information

1.   What Octenisept is and what    it    is used for

Octenisept is an antiseptic solution. The active ingredients of the solution, octenidine hydrochloride (1 mg/mL) and phenoxyethanol (20 mg/mL), have an antiseptic effect. Octenisept is used for
•   the short-term antiseptic preparation of mucous membranes and the surrounding skin before diagnostic and surgical procedures on reproductive or excretory organs, including the insertion of a urinary catheter; suitable for repeated use;
•   repeated short-term antiseptic treatment of small superficial wounds and for facilitating the healing of the wound.
The medicine can be used in all age groups.

2.   What you need to know before you use Octenisept Do not use Octenisept

-   if you are allergic to octenidine hydrochloride, phenoxyethanol or any of the other
ingredients of this medicine (listed in section 6).
-   Octenisept must not be used in the abdominal cavity (e.g. during surgery), in the urinary bladder or applied on the eardrum.

Warnings and precautions

Talk to a doctor, pharmacist or a nurse before using Octenisept.
To avoid potential tissue damage, do not apply pressure when applying the product (by using a syringe or topically). Ensure the drainage of the wound cavity (e.g. by using a flexible drainage tube).
•   Avoid ingesting Octenisept and prevent it from entering the circulation, e.g. as a result of an unintended injection.
•   If Octenisept comes into contact with anionic surfactants (soap, detergent), this can render the active ingredient octenidine hydrochloride ineffective.
•   Special care must be taken when using the medication on newborns, especially preterm babies. Octenisept can cause severe skin damage. Remove any surplus medication and ensure that the solution does not remain on the skin for longer than necessary (including solution that may have spilled on any materials that come into direct contact with the patient).
•   Use of Octenisept on the eyes must be avoided. If the medicine comes into contact with the eyes, rinse them with a generous amount of water.
Children and adolescents
Do not use for longer than a couple of days in children under 6 years of age without talking to a doctor.

Other medicines and Octenisept

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not use Octenisept near skin surfaces that have been treated with antiseptics based on povidone-iodine (disinfectants), as contact of the medicines can cause strong brown or purple discolouration.
Do not use Octenisept concomitantly with anionic surfactants (soap, detergent etc.), as these agents can reduce or cancel out its effect.

Pregnancy, breast-feeding and fertility

Current experience shows no harmful effect to people using Octenisept during pregnancy. There is insufficient data available on the use of Octenisept during breast-feeding. As a precaution, the application of Octenisept onto the breast area should be avoided during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are no data on the effect of Octenisept on fertility.

Driving and using machines

Octenisept has no influence on the ability to drive and use machines.

3.

How to use Octenisept

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure.

Method of application

Octenisept is applied onto the area to be treated once per day, completely moistening the area with the medicine.
The solution is for topical use only and it must not be delivered to tissues (e.g. with a syringe).
Carefully rub the treated area with at least 2 tampons soaked in the solution one after another, making sure that the area is completely moistened. Octenisept can be applied onto difficult-to-access mucous membranes, skin and wounds by using a spray. Application with a tampon is preferred.

Use in children and adolescents

The recommended dosage is identical in adults and children.

Efficacy

Please remember that to you should wait for at least 2 minutes after the application and before commencing with other procedures in order to ensure the complete effectivity of the solution. These instructions should be carefully followed in order to ensure the desired result.

Duration of treatment

Octenisept can only be used for a limited period of time, as research has currently indicated problems only with using the medicine for longer than approximately 14 days.

If you use more Octenisept than you should

No cases of overdose have been reported. An overdose is extremely unlikely in case of using the medicine by following the instructions.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or a nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The estimation of the incidence of side effects is based on the following categories.

Very common More than 1 in 10 treated patients Common 1 to 10 treated patients in 100 Uncommon 1 to 10 treated patients in 1,000 Rare 1 to 10 treated patients in 10,000 Very rare Less than 1 in 10,000 treated patients Unknown Cannot be estimated from the available data

Possible side effects:

Rale-burning sensation, redness, itching, and hot sensation in the application site
Very rare: reaction caused by contact dermatitis, e.g. temporary redness in the application site.

Children

The incidence, type, and severity of side effects occurring in children is identical to those occurring in adults.

Reporting of side effects

If any side effects occur, talk to a doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and external package. The expiry date refers to the last day of that month.
Expiry date after initial opening: up to 1 year if the medicine has been stored at a temperature of up to 25 °C. This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Octenisept contains

The active ingredients are octenidine hydrochloride (1 mg/mL) and phenoxyethanol (20 mg/ml).
The other ingredients are cocamidopropyl betaine, sodium gluconate, glycerol 85%, sodium chloride, sodium hydroxide, purified water.

What Octenisept looks like and contents of the pack

Octenisept is a clear colourless, nearly odourless cutaneous liquid available in packages of 50 mL, 250 mL, 500 mL, and 1,000 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Surgitech AS Pärnu mnt 148 11317 Tallinn,
Estonia
Phone +372 646 0660 E-mail: [email protected]

Manufacturer:

Schülke & Mayr GmbH Robert-Koch-Str. 2
D-22851 Norderstedt, Germany
Phone: +49 (0) 40 52100-0 Fax +49 (0) 40 52100-318 E-mail: [email protected]

This leaflet was last revised in November 2017