VAGISAN

VAGISAN Myko Kombi 1-day therapy

Important notes (mandatory information)

Vagisan Myko Kombi. Active ingredient: Clotrimazole. Areas of application: is used to treat yeast infections of the vagina and external genital area (mostly caused by 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, 500 mg vaginal suppositories and 10 mg/g cream
Active ingredient: Clotrimazole

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 package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience 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 7 days, contact your doctor.

What this package leaflet contains

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

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

Vagisan Myko Kombi contains the active ingredient clotrimazole. Clotrimazole is an imidazole derivative and belongs to the group of anti-fungal agents (antimycotics). Vagisan Myko Kombi is used to treat yeast infections of the vagina and external genital area (mostly caused by Candida albicans). Typical symptoms of yeast infections of the genital area are infectious vaginal discharge as well as itching and pain of the labia. Vagisan Myko Kombi is used in adults and adolescents over 16 years of age.

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

Vagisan Myko Kombi 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.

You must contact your doctor before treatment with Vagisan Myko Kombi:

• if this is the first time you have had the condition,
• if you have had more than 2 vaginal yeast infections in the past 6 months,
• if you or your partner have ever been diagnosed with a sexually transmitted disease,
• if you are over 60 years old,
• if you have pain in your lower abdomen or when urinating,
• if you have an unpleasant-smelling vaginal discharge,
• if you have bloody vaginal discharge,
• if you have excessive or irregular bleeding,
• if you have a wound, ulcer or blister in the area of the labia or vagina,
• if you have a fever or chills,
• if you are allergic to other anti-fungal agents for vaginal use.

Contact your doctor if you experience redness, irritation or swelling of the vagina or labia (in the external genital area) after treatment. If Vagisan Myko Kombi is used together with latex products (e.g. condoms, diaphragms), the functionality of these products may be reduced and thus their safety may be impaired for the duration of the use of Vagisan Myko Kombi.

Children and adolescents

Vagisan Myko Kombi is not intended for use in children and adolescents under 16 years of age. The safety and efficacy of Vagisan Myko Kombi have not yet been studied in children and adolescents under 16 years of age. Vagisan Myko Kombi should therefore only be used in this age group after consultation with a doctor and according to their instructions.

Use of Vagisan Myko Kombi together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. You can use Vagisan Myko Kombi during pregnancy and breast-feeding under medical supervision.

Driving and using machines

No special precautions are required.

Vagisan Myko Kombi contains cetyl stearyl alcohol

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

3. HOW TO USE VAGISAN MYKO KOMBI?

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 therefore consists of a vaginal suppository and a cream. During the use of Vagisan Myko Kombi, you should wear a panty liner to avoid grease stains in textiles. Wash your hands before and after inserting the vaginal suppository or applying the cream.

Vaginal suppositories

To remove a vaginal suppository from the foil, tear the foil open from top to bottom; use the opening aid (V-shaped cut in the foil). You can then push the suppository out of the foil. Insert the vaginal suppository as deeply 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 in the evening before going to bed, as the vaginal suppository can then take effect while you are lying down. A 1-day treatment is usually sufficient to treat a vaginal yeast infection. The treatment should not be carried out during menstruation. You should not use tampons during treatment.

Cream

Apply the cream thinly to the external genital area from the vaginal opening to the anus twice a day with your fingers and then rub it in gently. The cream should be used for one week. Please continue to use it for this period of time even if you are already feeling better. If necessary, the treatment can be continued for up to 2 weeks. However, if there is no improvement in symptoms within 7 days, contact your doctor.

If you have used more Vagisan Myko Kombi than you should

No side effects are to be expected if more Vagisan Myko Kombi is used. Continue treatment with the cream as recommended.

If you forget to use Vagisan Myko Kombi

Do not use twice the amount of cream if you forget the previous application. Continue treatment with the usual amount at the next application.

If you stop using Vagisan Myko Kombi

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?

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

Common (may affect up to 1 in 10 people)

Temporary mild to moderate burning and itching at the treated site.

Uncommon (may affect up to 1 in 100 people)

Skin irritations such as stinging, burning or temporary redness.

Very rare (may affect up to 1 in 10,000 people)

Persistent local allergic reactions such as itching; generalised hypersensitivity reactions, e.g. with rash, nausea, weakness, swelling of the face, drop in blood pressure, diarrhoea and shortness of breath.

If you react allergically in this way, the reaction will occur immediately after the start of treatment. In such a case, inform a doctor immediately.

Reporting of side effects

If you experience 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 to provide more information on the safety of this medicine.

5. HOW TO STORE VAGISAN MYKO KOMBI?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the foil of the vaginal suppository, the tube and the outer carton after "Use by" or "Usable until". The expiry date refers to the last day of the month indicated. Do not store above 25°C. After opening, the cream can be used until the expiry date stated on the tube. 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 contains

The active ingredient is: Clotrimazole. One vaginal suppository contains 500 mg clotrimazole. 1 g cream contains 10 mg clotrimazole. The other ingredients are:

Vaginal suppositories

Cetyl stearyl alcohol, hard fat, macrogol-20-glycerol monostearate, sodium polyacrylate.

Cream

Benzyl alcohol, cetyl palmitate, cetyl stearyl alcohol, sodium citrate, octyldodecanol, polysorbate 60, sorbitan stearate, purified water.

What Vagisan Myko Kombi looks like and contents of the pack

Vagisan Myko Kombi is a combination of a white, oblong vaginal suppository in a foil strip made of an Alu/PE film and a white, smooth, easy-to-spread cream in an aluminium tube with a screw cap. The combination pack contains 1 vaginal suppository and an aluminium tube with 20 g cream.

Pharmaceutical entrepreneur and manufacturer

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

This package leaflet was last revised in September 2017.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Clotrimazole. Areas of application: is used to treat yeast infections of the vagina and external genital area (mostly caused by Candida albicans).