CLOTRIGALEN

CLOTRIGALEN Cream

Important notes (mandatory information)

ClotriGalen Cream. Active ingredient: Clotrimazole. Areas of application: for fungal infections of the skin caused by thread fungi (dermatophytes), yeasts (e.g. Candida species), mould fungi and others, such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

ClotriGalen Cream 1% Cream
Active ingredient: Clotrimazole

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, ClotriGalen Cream must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 2 weeks, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS CLOTRIGALEN CREAM AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING CLOTRIGALEN CREAM?
3. HOW TO USE CLOTRIGALEN CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CLOTRIGALEN CREAM?
6. FURTHER INFORMATION

1. WHAT IS CLOTRIGALEN CREAM AND WHAT IS IT USED FOR?

ClotriGalen Cream contains clotrimazole, the most frequently used representative from the group of azole derivatives. Clotrimazole is a broad-spectrum antimycotic, i.e. the substance is effective against the most common human-pathogenic fungi, i.e. fungi that cause disease in humans. ClotriGalen Cream is used for fungal infections of the skin caused by thread fungi (dermatophytes), yeasts (e.g. Candida species), mould fungi and others, such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum. These can manifest as athlete's foot, fungi of the skin and skin folds, pityriasis versicolor, erythrasma and as superficial candidiasis.

2. WHAT DO YOU NEED TO KNOW BEFORE USING CLOTRIGALEN CREAM?

ClotriGalen Cream must not be used if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of ClotriGalen Cream. In case of hypersensitivity to cetyl stearyl alcohol, it is advisable to use a dosage form that is free of cetyl stearyl alcohol instead of ClotriGalen Cream.

Special care must be taken when using ClotriGalen Cream

Elderly people: In elderly people in particular, the corners of the mouth are often infected with yeast fungi, as are the oral cavity and dentures. A visit to the doctor should be made for their treatment.

When using ClotriGalen Cream with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.

How does ClotriGalen Cream affect the effects of other medicines?
Clotrimazole reduces the effectiveness of amphotericin and other polyene antibiotics (nystatin, natamycin). Please note that this information may also apply to medicines that have been used recently. When using ClotriGalen Cream together with cosmetics: Deodorants should not be used on skin folds to be treated during the use of ClotriGalen Cream.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine. ClotriGalen Cream should not be used as a precaution in early pregnancy. It should not be used on the nipples of nursing mothers or only after consulting a doctor.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of ClotriGalen Cream

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

3. HOW TO USE CLOTRIGALEN CREAM?

Always use ClotriGalen Cream exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, ClotriGalen Cream is applied thinly to the affected areas 2 - 3 times a day and rubbed in. A small amount of ClotriGalen Cream (approx. 14 cm length of strand) is usually sufficient for an area about the size of a hand.

Type and duration of use

For use on the skin. Regular and sufficiently long use of ClotriGalen Cream is important for the success of the treatment. The duration of treatment varies; it depends, among other things, on the extent and location of the disease. In order to achieve complete healing, treatment with ClotriGalen Cream should not be discontinued after the acute inflammatory symptoms or subjective complaints have subsided, but should be continued for a treatment period of at least 4 weeks. Pityriasis versicolor generally heals in 1 - 3 weeks and erythrasma in 2 - 4 weeks. In the case of athlete's foot, treatment should be continued for about 2 weeks beyond the disappearance of all signs of the disease in order to prevent relapse and despite rapid subjective improvement. After each wash, the feet should be dried thoroughly (between the toes).

If you have used more ClotriGalen Cream than you should

Remove excess amounts of medicine from the skin.

If you forget to use ClotriGalen Cream

Do not use a double dose to make up for a forgotten application. Apply ClotriGalen Cream as soon as possible and continue treatment as planned.

If you stop using ClotriGalen Cream

Premature discontinuation of the medicine may lead to a relapse of the disease, i.e. new fungal growth.

If you have any further questions about the use of ClotriGalen Cream, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, ClotriGalen Cream can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Local side effects

Skin reactions (e.g. temporary redness, burning, stinging) may occur frequently. Allergic reactions on the skin may occur in case of hypersensitivity to cetyl stearyl alcohol.

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 TO STORE CLOTRIGALEN CREAM?

Keep medicine out of reach of children. Do not use the medicine after the expiry date which is stated on the folding box and on the tube after "usable until". The expiry date refers to the last day of the month. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening or preparation: The cream can be stored for 1 year after opening the tube.

6. FURTHER INFORMATION

What ClotriGalen Cream contains

The active ingredient is: Clotrimazole. 1 g of cream contains 10 mg of clotrimazole. The other ingredients are: Sorbitan stearate, polysorbate 60, cetyl palmitate (Ph.Eur.), cetyl stearyl alcohol (Ph.Eur.), benzyl alcohol, octyl dodecanol (Ph.Eur.), purified water.

What ClotriGalen Cream looks like and contents of the pack

ClotriGalen Cream is a white, uniform cream, it is odourless or may have a faint inherent odour. ClotriGalen Cream is available in packs of 25 g (N1), 50 g (N2) and 100 g (N3).

Pharmaceutical entrepreneur

GALENpharma GmbH
Wittland 13
24109 Kiel

Postfach 3764
24036 Kiel

Manufacturer

Paul W. Beyvers GmbH

Schaffhausener Straße 26-34
12099 Berlin (Tempelhof)

This package leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 02/2017
Active ingredient: Clotrimazole. Areas of application: for fungal infections of the skin caused by thread fungi (dermatophytes), yeasts (e.g. Candida species), mould fungi and others, such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum.