CLOTRIGALEN

CLOTRIGALE pump spray

Important notes (mandatory information)

ClotriGalen Pumpspray 1 % solution. Active ingredient: Clotrimazole. Areas of application: 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. These can manifest as athlete's foot, fungi of the skin and skin folds, pityriasis versicolor and as superficial candidoses.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

ClotriGalen Pumpspray 1 % solution for application to the skin
Active ingredient: Clotrimazole

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

• 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 side effects listed here 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 PUMPSPRAY AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING CLOTRIGALEN PUMPSPRAY?
3. HOW TO USE CLOTRIGALEN PUMPSPRAY?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CLOTRIGALEN PUMPSPRAY?
6. FURTHER INFORMATION

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

ClotriGalen Pumpspray contains clotrimazole, the most frequently used representative from the group of azole derivatives. Clotrimazole is a broad-spectrum antifungal, i.e. the substance is effective against the most common human-pathogenic fungi, i.e. fungi that cause disease in humans. ClotriGalen Pumpspray 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. These can manifest as athlete's foot, fungi of the skin and skin folds, pityriasis versicolor and as superficial candidoses.

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

ClotriGalen Pumpspray must not be used if you are hypersensitive (allergic) to the active ingredient or any of the other ingredients of ClotriGalen Pumpspray. In case of hypersensitivity to propylene glycol, macrogol or sensitivity to 2-propanol, it is advisable to use a dosage form free of the above-mentioned substances (e.g. cream) instead of ClotriGalen Pumpspray.

When using ClotriGalen Pumpspray 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 Pumpspray 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 Pumpspray together with cosmetics: Deodorants should not be used on skin folds to be treated during the use of ClotriGalen Pumpspray.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using any medicine. ClotriGalen Pumpspray should not be used during early pregnancy as a precaution. 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 Pumpspray

Propylene glycol can cause skin irritation.

3. HOW TO USE CLOTRIGALEN PUMPSPRAY?

Always use ClotriGalen Pumpspray exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the solution is sprayed thinly onto the infected areas of skin 2 - 3 times a day. Press the spray head 1 - 2 times with each application; this is sufficient even for large-area fungal infections. Press the spray head 1 - 2 times before the first application; the preparation is then ready to use. The spray distance should be 10 to 30 cm.

Type and duration of use

For application to the skin. 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 the spray 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. Regular and sufficiently long use of ClotriGalen solution is important for the success of the treatment. Pityriasis versicolor generally heals within 1 - 3 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 - despite rapid subjective improvement. After each wash, the feet should be dried thoroughly (between the toes).

If you have used more ClotriGalen Pumpspray than you should

Remove excess amounts of medicine from the skin.

If you forget to use ClotriGalen Pumpspray

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

If you stop using ClotriGalen Pumpspray

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 Pumpspray, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, ClotriGalen Pumpspray can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

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 are possible in case of hypersensitivity to propylene glycol and macrogol.

In case of undesirable effects, please consult your doctor. Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice side effects that are not listed in this package leaflet.

5. HOW TO STORE CLOTRIGALEN PUMPSPRAY?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the folding box and on the bottle label after "use by". 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 solution is stable for 6 months after opening the pump spray.

6. FURTHER INFORMATION

What ClotriGalen Pumpspray contains

The active ingredient is: Clotrimazole. 1 ml solution for application to the skin contains 10 mg clotrimazole. The other ingredients are: Propylene glycol, macrogol 400, 2-propanol (Ph.Eur.).

What ClotriGalen Pumpspray looks like and contents of the pack

ClotriGalen Pumpspray is a colourless, clear and homogeneous liquid with a characteristic odour of isopropanol. ClotriGalen Pumpspray is available in packs of 40 ml (N2).

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 2011.

Source: Information from the package leaflet
Status: 10/2016
Active ingredient: Clotrimazole. Areas of application: 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. These can manifest as athlete's foot, fungi of the skin and skin folds, pityriasis versicolor and as superficial candidoses.