OCTENISEPT

OCTENISEPT vaginal therapeutic vaginal solution

Important notes (mandatory information)

octenisept Vaginal Therapeutic Vaginal Solution. Areas of application: Antiseptic for the treatment of vaginal infections. Relief of symptoms in the case of bacterial itching, burning and discharge in the vaginal area.

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


Instructions for use: Information for the user

octenisept Vaginal Therapeutic.
Please read these instructions for use carefully, as they contain important information on what you need to consider when using this medicine. If you have any questions, please contact your doctor or pharmacist.

Solution for spraying into the vagina with vaginal applicator
Active ingredients: 0.1 g octenidine hydrochloride, 2.0 g phenoxyethanol (Ph.Eur.)/100 g

1. WHAT IS OCTENISEPT VAGINAL THERAPEUTIC AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING OCTENISEPT VAGINAL THERAPEUTIC?
3. HOW TO USE OCTENISEPT VAGINAL THERAPEUTIC?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD OCTENISEPT VAGINAL THERAPEUTIC BE STORED?
6. FURTHER INFORMATION

1. WHAT IS OCTENISEPT VAGINAL THERAPEUTIC AND WHAT IS IT USED FOR?
octenisept Vaginal Therapeutic is an antiseptic for the treatment of vaginal infections. It is used to relieve symptoms in the case of bacterial itching, burning and discharge in the vaginal area.

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING OCTENISEPT VAGINAL THERAPEUTIC?
octenisept Vaginal Therapeutic must not be used if you are hypersensitive (allergic) to the active ingredients or any of the other ingredients.
There is not yet sufficient experience with the use in children under 8 years of age.

Special care must be taken when using octenisept Vaginal Therapeutic

Warning: Do not swallow the medicine 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. For reasons of special caution, the medicine should not be used in the first three months of pregnancy.

Breastfeeding:
There are no sufficient animal or clinical data on use during breastfeeding. Since octenidine hydrochloride is not or only absorbed in the smallest quantities, 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 influence known.

When using octenisept Vaginal Therapeutic with other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, even if they are non-prescription medicines.
Do not use with antiseptics (disinfectants) based on PVP-iodine for the treatment of vaginal infections, as this can lead to severe brown to violet discolouration in the border areas.

3. HOW TO USE OCTENISEPT VAGINAL THERAPEUTIC?
Always use the medicine exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed, insert the vaginal applicator deep into the vagina in the morning and evening on the first day of treatment, then once a day in the evening, and press down the spray cap of the applicator ten times in succession. The duration of treatment is seven days.
Before the first use, remove the protective and spray cap from the bottle and keep it safe, then take the applicator out of the sleeve and place it on the medicine bottle.
It is recommended to insert the applicator deep into the vagina while sitting on the toilet or lying in bed. Then press down the spray cap of the applicator ten times in succession. After use, the applicator should be wiped off on the outside and some medicine should be sprayed out with the applicator pointing downwards. Before reusing, spray one to two times with the applicator pointing downwards.
To prevent reinfection, the partner should also be included in the treatment. To do this, spray the medicine without the applicator and with the spray cap attached onto the male genitals until they are completely wet.
To achieve the desired effect, these instructions must be followed carefully.
If the symptoms persist or return after the end of treatment, a gynaecological examination is necessary.

If you have used more octenisept Vaginal Therapeutic than you should

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

If you forget to use octenisept Vaginal Therapeutic

If you forget to use it, do not use a larger amount of the medicine the next time, but continue the treatment as recommended.

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 area, are very rare.
If you notice any side effects that are not listed here, please tell your doctor or pharmacist.

The following categories are used as a basis for the frequency of 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.

5. HOW SHOULD OCTENISEPT VAGINAL THERAPEUTIC BE STORED?
Keep medicine out of reach of children. Do not use the medicine after the expiry date stated on the packaging. Any remaining solution left in the container must be discarded after the end of treatment. No special storage conditions are required.

6. FURTHER INFORMATION

octenisept Vaginal Therapeutic contains 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 Vaginal Therapeutic is a clear, colourless solution and is available as a 50 ml spray bottle with vaginal applicator.

Pharmaceutical entrepreneur and manufacturer

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

These instructions for use were last revised in May 2009

Source: Information from the package leaflet
Status: 10/2015
Areas of application: Antiseptic for the treatment of vaginal infections. Relief of symptoms in the case of bacterial itching, burning and discharge in the vaginal area.