VAGISAN

VAGISAN Myko Combo 3-day

Important notes (mandatory information)

Vagisan Myko Kombi 3 Tage. Active ingredient: Clotrimazole. Areas of application: for the treatment of yeast infections of the vagina and external genital area (mostly Candida albicans).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vagisan Myko Kombi 3 Tage 200 mg vaginal suppositories and 20 mg/g cream
Active ingredient: Clotrimazole

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

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What this package leaflet contains

1. WHAT IS VAGISAN MYKO KOMBI 3 TAGE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VAGISAN MYKO KOMBI 3 TAGE?
3. HOW IS VAGISAN MYKO KOMBI 3 TAGE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VAGISAN MYKO KOMBI 3 TAGE BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VAGISAN MYKO KOMBI 3 TAGE AND WHAT IS IT USED FOR?

Vagisan Myko Kombi 3 Tage is an anti-fungal agent (antimycotic) in the form of a combination of vaginal suppositories and a cream for application to the skin in the external genital area. Vagisan Myko Kombi 3 Tage is used to treat yeast infections of the vagina and external genital area (mostly Candida albicans).

2. WHAT SHOULD YOU CONSIDER BEFORE USING VAGISAN MYKO KOMBI 3 TAGE?

Vagisan Myko Kombi 3 Tage must not be used if you are allergic to clotrimazole or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Vagisan Myko Kombi 3 Tage. Redness, burning, itching and painful inflammation can also have causes for which Vagisan Myko Kombi 3 Tage is not effective. A reliable identification of the cause (diagnosis) is only possible by a doctor.

Vagisan Myko Kombi 3 Tage may only be used under medical supervision in the following cases:

• if the condition occurs for the first time.
• if the condition has occurred more than 4 times in the past 12 months.

When using deodorants or intimate hygiene products

During treatment, you should only use deodorants or intimate hygiene products after consulting your doctor, as a reduction in the effectiveness of Vagisan Myko Kombi 3 Tage cannot be ruled out.

In the case of medically diagnosed inflammation of the glans and foreskin of the partner due to a fungal infection, treatment should be carried out with medicines intended for this purpose. If Vagisan Myko Kombi 3 Tage and latex products (e.g. condoms, diaphragms) are used at the same time, the functional capacity of these products may be reduced and thus their safety may be impaired for the duration of the use of Vagisan Myko Kombi 3 Tage due to the auxiliary substances contained (in particular stearates).

Children and adolescents

Vagisan Myko Kombi 3 Tage is not intended for use in children and adolescents. The safety and efficacy of Vagisan Myko Kombi 3 Tage have not yet been studied in children and adolescents. Vagisan Myko Kombi 3 Tage should therefore only be used in this age group after consultation with a doctor and according to their instructions. Use of Vagisan Myko Kombi 3 Tage together with other medicines Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. The effectiveness of amphotericin B and other polyene antibiotics (nystatin, natamycin) may be reduced by clotrimazole.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Vagisan Myko Kombi 3 Tage should only be used during pregnancy and breast-feeding under medical supervision or guidance.

Driving and using machines

No special precautions are required.

Vagisan Myko Kombi 3 Tage contains cetyl stearyl alcohol

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).

3. HOW IS VAGISAN MYKO KOMBI 3 TAGE USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Since both the vagina and the labia are usually affected by a yeast infection, both areas should be treated. The complete treatment with Vagisan Myko Kombi 3 Tage therefore consists of vaginal suppositories and a cream for application to the skin in the external genital area. In general, it is sufficient to use the vaginal suppositories and the cream simultaneously over a period of 3 days. Please adhere to this period even if you are already feeling better. If necessary, a second treatment can be carried out over a further 3 days. However, if there is no improvement in symptoms within 3 days, contact your doctor. Wash your hands before and after inserting the vaginal suppository or applying the cream.

Vaginal suppositories

Insert 1 vaginal suppository 1 time daily for 3 consecutive days as deep as possible into the vagina. To remove the vaginal suppository from the foil strip, pull the two foils apart at the tip of the suppository. Insert the vaginal suppository as deep as possible into the vagina with one finger. This is best done lying on your back with your legs slightly bent. It is best to insert the vaginal suppository before going to bed. You should wear a panty liner during use to avoid grease stains on textiles. The treatment should preferably not be carried out during menstruation or should be completed before menstruation begins. You should not use tampons during treatment. Treatment during menstruation should only be carried out in the case of severe symptoms. Ask your doctor about this.

Cream

In addition, apply the cream 2 times daily for 3 consecutive days with your fingers to the external genital area from the vaginal opening to the anus and then rub it gently into the skin.

If you have used more Vagisan Myko Kombi 3 Tage than you should

No side effects are to be expected if more Vagisan Myko Kombi 3 Tage is used. Continue treatment next time with the normal amount. If you have accidentally swallowed Vagisan Myko Kombi 3 Tage, the following signs of poisoning are possible: loss of appetite, nausea, vomiting, stomach pain, liver dysfunction, fatigue, drowsiness, delusions, frequent urination and allergic skin reactions. In these cases, please consult a doctor immediately.

If you forget to use Vagisan Myko Kombi 3 Tage

Do not use twice the amount if you have forgotten the previous application. Continue treatment with the usual amount the next time you use it.

If you stop using Vagisan Myko Kombi 3 Tage

Discuss the further procedure with your doctor or pharmacist, as otherwise the success of the treatment may be jeopardised.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Occasionally (1 to 10 out of 1000 treated persons)

Skin irritations such as burning, stinging or temporary redness.

Not known (frequency cannot be estimated from the available data)

In individual cases, generalised (general) hypersensitivity reactions of varying severity may occur. These may affect: the skin (e.g. itching, redness), the respiratory system (e.g. shortness of breath), the circulatory system (e.g. treatable drop in blood pressure up to loss of consciousness) and the gastrointestinal tract (e.g. nausea, diarrhoea).

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, 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 SHOULD VAGISAN MYKO KOMBI 3 TAGE BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton, foil strip and tube after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not use this medicine if the consistency of the suppositories or cream has changed significantly. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vagisan Myko Kombi 3 Tage contains

The active ingredient is: Clotrimazole. 1 vaginal suppository contains 200 mg clotrimazole. 100 g cream contains 2 g clotrimazole. The other ingredients are:

Vaginal suppositories

Cetyl stearyl alcohol (Ph. Eur.) [vegetable], hard fat, macrogol-20-glycerol monostearate, sodium polyacrylate.

Cream

Benzyl alcohol, cetyl palmitate (Ph. Eur.), cetyl stearyl alcohol (Ph. Eur.) [vegetable], sodium citrate dihydrate (E331), octyldodecanol (Ph. Eur.), polysorbate 60, sorbitan stearate (E491), purified water.

What Vagisan Myko Kombi 3 Tage looks like and contents of the pack

Vagisan Myko Kombi 3 Tage is a combination of oblong, white vaginal suppositories in a foil strip and a white, smooth, easy-to-spread cream in an aluminium tube. The combination pack contains 3 vaginal suppositories and an aluminium tube with 20 g cream for application to the skin.

Pharmaceutical entrepreneur and manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstraße 56
33611 Bielefeld
Telephone: 0521 8808-05
Telefax: 0521 8808-334
E-mail: info@wolff-arzneimittel.de

This package leaflet was last revised in August 2018.

Source: Information from the package leaflet
Status: 01/2020
Active ingredient: Clotrimazole. Areas of application: for the treatment of yeast infections of the vagina and external genital area (mostly Candida albicans).