MYKOFUNGIN

MYKOFUNGIN 3 Combi 200 mg vaginal tablet + 10 mg/g cre.

Important notes (mandatory information)

Mykofungin 3 Kombi 200 mg vaginal tablets and 10 mg/g cream. Active ingredient: Clotrimazole. Areas of application: for infectious discharge caused by yeast fungi; inflammation of the vagina and labia caused by fungi - mostly yeast fungi of the genus Candida - as well as superimposed infections (superinfections) with bacteria sensitive to clotrimazole.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mykofungin 3 Kombi 200 mg vaginal tablets and 10 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 get 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, contact your doctor.

What this package leaflet contains

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

1. WHAT IS MYKOFUNGIN 3 KOMBI AND WHAT IS IT USED FOR?

Mykofungin 3 Kombi is a medicine for treating fungal infections of the vagina. Clotrimazole, the active ingredient in Mykofungin 3 Kombi, inhibits the growth and reproduction of fungal cells such as budding fungi (yeasts) as well as a number of other fungi and some bacteria. Mykofungin 3 Kombi is used for infectious discharge caused by yeast fungi; inflammation of the vagina and labia caused by fungi - mostly yeast fungi of the genus Candida - as well as superimposed infections (superinfections) with bacteria sensitive to clotrimazole. If you do not feel better or if you feel worse, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MYKOFUNGIN 3 KOMBI?

Mykofungin 3 Kombi must not be used if you are allergic to clotrimazole, benzyl alcohol 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 Mykofungin 3 Kombi. The following describes when you should only use the medicine under certain conditions and only with special caution. If you have a fever (temperatures of 38°C and above), lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or associated with shoulder pain, you should consult a doctor. Please consult your doctor if you are experiencing the condition for the first time and/or if you have had more than four such fungal infections in the past 12 months.

Note

If Mykofungin 3 Kombi is used together with latex products (e.g. condoms, diaphragms), the functional capacity of these products may be reduced and their safety impaired due to the auxiliary substances contained (in particular stearates).

Use of Mykofungin 3 Kombi together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Clotrimazole reduces the effectiveness of amphotericin and other polyene antimycotics (e.g. nystatin, natamycin). Dexamethasone in high doses may possibly weaken the effectiveness of 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. Clotrimazole should not be used as a precaution in early pregnancy. In the 2nd and 3rd trimester of pregnancy, Mykofungin 3 Kombi can be used on the express instructions of a doctor. If treatment during pregnancy is essential, treatment should only be carried out as directed by a doctor and without an applicator. If treated with the applicator during pregnancy, there is a possibility that the amniotic sac or the unborn child could be injured. To reduce the risk of an ascending infection, you must wash your hands thoroughly before inserting the vaginal tablets. In the case of proven yeast fungal disease in the vagina, special attention should be paid to the sanitation of the birth canal under medical supervision, especially in the last 4-6 weeks of pregnancy. During breast-feeding, Mykofungin 3 Kombi can be used on the instructions of a doctor.

Driving and using machines

There is no experience regarding impairment of driving and the ability to operate machines.

Mykofungin 3 Kombi contains cetyl stearyl alcohol

The cetyl stearyl alcohol contained in the cream can cause local skin irritation (e.g. contact dermatitis).

Mykofungin 3 Kombi contains benzyl alcohol

This medicine contains 0.01 g benzyl alcohol per 1 g cream. Benzyl alcohol can cause mild local irritation.

3. HOW IS MYKOFUNGIN 3 KOMBI 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.

• Vaginal tablets: Vaginal use. Insert one vaginal tablet as deep as possible into the vagina once a day - in the evening - for 3 consecutive days. This is best done lying on your back with your legs slightly bent.
• Cream: Application to the skin. For infections of the labia (Candida vulvitis) and adjacent areas, apply the cream thinly to the affected skin areas (external genitalia to the anus) 2-3 times a day and rub in.

Application with applicator

The plunger of the applicator is pulled out to the stop; then the vaginal tablet is removed from the aluminium packaging and placed in the recess of the applicator. Lie on your back and then carefully insert the applicator as deep as possible into the vagina. By pressing on the plunger of the applicator, the previously inserted vaginal tablet is released and remains in the vagina. The applicator can now be removed. Stay relaxed for another 10 to 15 minutes so that the active ingredient of Mykofungin 3 Kombi can distribute itself well in the vagina. The applicator is intended for multiple use; it must therefore be cleaned thoroughly under running, warm (not boiling) water after each use. To do this, the plunger is pulled out of the applicator beyond the stop and both parts are cleaned separately. They are then dried with a clean cloth and reassembled as before.

Application without applicator

The vaginal tablet is carefully inserted as deep as possible into the vagina with a clean finger.

Note

If the vagina is dry, the vaginal tablet may not dissolve completely. This can be recognised by the fact that solid crumbs are excreted, e.g. in the underwear. Other products (e.g. vaginal cream) are available for this case.

Duration of use:

• Vaginal tablets: In general, a 3-day treatment is sufficient for vaginitis, especially caused by yeast fungi. If necessary, a second treatment over 3 days can be carried out. In general, the signs of vaginitis caused by fungi (such as itching, discharge, burning) recede significantly within the first four days after the start of treatment. If there is no significant improvement in symptoms after 4 days, please contact your doctor.
• Cream: The general duration of therapy for the cream is 1-2 weeks for infections of the labia and adjacent areas. Since the vagina (vagina) and vulva (labia) are usually affected, combination treatment (treatment of both areas) should be carried out.

Please note the following when using Mykofungin 3 Kombi

Treatment should preferably not be carried out during menstruation or should be completed before it begins. During and up to two days after treatment, only protected sexual intercourse with a condom should take place. In the case of simultaneous infection of the labia and adjacent areas or in the case of medically diagnosed inflammation of the glans and foreskin of the partner by yeast fungi, the partner should also be treated.

If you have used more Mykofungin 3 Kombi than you should

No cases of overdose have been reported to date.

If you forget to use Mykofungin 3 Kombi

If you forget to use it in the evening, you can make up for it in the course of the following morning. Then use only one vaginal tablet or the same amount of cream and continue treatment as recommended.

If you stop using Mykofungin 3 Kombi

In order to achieve complete healing of the infection and to prevent a relapse, you should not stop or interrupt treatment prematurely without consulting your doctor. If you do so, the symptoms are likely to recur because your fungal infection is probably not yet properly healed. You should therefore not stop treatment after the symptoms have subsided, but continue it consistently for 3 days.

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.

Occasionally (may affect up to 1 in 100 people)

Skin reactions (e.g. burning, stinging), slight burning in the vagina (vagina). If the sexual partner is also treated, irritation of the penis or urethra may occur.

Rarely (may affect up to 1 in 1,000 people)

Skin conditions such as erythema (redness), rashes, blistering, peeling, itching, hives (urticaria) and fluid retention in the tissue (oedema).

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

Contact allergies.

Additionally for vaginal tablets

General allergic reactions (with shortness of breath, treatable drop in blood pressure up to loss of consciousness as well as nausea and diarrhoea), abdominal cramps, increased urination.

Additionally for cream

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

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 MYKOFUNGIN 3 KOMBI 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 folding box and blister after "usable until:" or "use by:". The expiry date refers to the last day of the month indicated.

Storage conditions:

• Vaginal tablets: Do not store above 30°C.
• Cream: No special storage conditions are required.

Note on shelf life after opening

The cream is stable for 6 months after opening.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mykofungin 3 Kombi contains

The active ingredient is: Clotrimazole. One vaginal tablet contains 200 mg clotrimazole. 1 g cream contains 10 mg clotrimazole. The other ingredients are:

• Vaginal tablets: Lactose monohydrate, maize starch, adipic acid, sodium hydrogen carbonate, stearic acid [vegetable], magnesium stearate (Ph.Eur.) [vegetable], highly dispersed silicon dioxide, polysorbate 80.
• Cream: Octyldodecanol (Ph.Eur.), cetyl stearyl alcohol (Ph.Eur.) [vegetable], cetyl palmitate (Ph.Eur.), sorbitan stearate, polysorbate 60, benzyl alcohol, purified water.

How Mykofungin 3 Kombi looks like and contents of the pack:

• Vaginal tablets: White, biconvex, oblong tablets with a smooth, glossy surface.
• Cream: white, homogeneous cream.

Mykofungin 3 Kombi is available in a pack of 3 vaginal tablets with a vaginal applicator and 20 g cream.

Pharmaceutical entrepreneur and manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Phone: 034954/247-0
Fax: 034954/247-100

This leaflet was last revised in May 2019.

Source: Information from the package leaflet
Status: 11/2019
Active ingredient: Clotrimazole. Areas of application: for infectious discharge caused by yeast fungi; inflammation of the vagina and labia caused by fungi - mostly yeast fungi of the genus Candida - as well as superimposed infections (superinfections) with bacteria sensitive to clotrimazole.