CLOTRIMAZOL AL

CLOTRIMAZOLE AL Spray 1%

Important notes (mandatory information)

Clotrimazole AL Spray 1%. Areas of application: for fungal infections of the skin caused by dermatophytes, yeasts (e.g. Candida species), mould and other fungi, such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum. These can manifest as athlete's foot, skin and skin fold mycoses, pityriasis versicolor, erythrasma, superficial candidiasis.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Clotrimazole AL Spray 1%, solution for application to the skin
Active ingredient: Clotrimazole 0.01 g/ml

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Clotrimazole AL Spray 1% 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, you must see a doctor in any case.
• If any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS CLOTRIMAZOLE AL SPRAY 1% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING CLOTRIMAZOLE AL SPRAY 1%?
3. HOW SHOULD CLOTRIMAZOLE AL SPRAY 1% BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CLOTRIMAZOLE AL SPRAY 1% BE STORED?
6. FURTHER INFORMATION

1. WHAT IS CLOTRIMAZOLE AL SPRAY 1% AND WHAT IS IT USED FOR?

Clotrimazole is an active ingredient from the group of broad-spectrum antimycotics (agents for the treatment of fungal infections). Clotrimazole AL Spray 1% is used for fungal infections of the skin caused by dermatophytes, yeasts (e.g. Candida species), mould and other fungi, such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum. These can manifest as athlete's foot, skin and skin fold mycoses, pityriasis versicolor, erythrasma, superficial candidiasis.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING CLOTRIMAZOLE AL SPRAY 1% ?

Clotrimazole AL Spray 1% must not be used if you are hypersensitive (allergic) to the active ingredient clotrimazole or any of the other ingredients of Clotrimazole AL Spray 1%. In the case of known hypersensitivity to propylene glycol, macrogol (polyethylene glycol) and sensitivity to 2-propanol (isopropyl alcohol), it is advisable to use a dosage form that is free of the above-mentioned substances (e.g. a cream).

Special care must be taken when using Clotrimazole AL Spray 1%

is required

You should only use deodorants or other cosmetics on the affected areas of skin after consulting your doctor, as a reduction in the effectiveness of Clotrimazole AL Spray 1% cannot be ruled out.

When using Clotrimazole AL Spray 1%

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. Clotrimazole reduces the effectiveness of amphotericin and other polyene antibiotics (nystatin, natamycin).

Pregnancy and

breastfeeding

Ask your doctor or pharmacist for advice before taking/using any medicine.

Pregnancy

Clotrimazole should not be used as a precaution in early pregnancy.

Breastfeeding

To prevent small amounts of the active ingredient from passing into breast milk, Clotrimazole AL Spray 1% must not be used in the breast area during breastfeeding.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Clotrimazole AL Spray 1%:
Propylene glycol can cause skin irritation.

3. HOW SHOULD CLOTRIMAZOLE AL SPRAY 1% BE USED?

Always use Clotrimazole AL Spray 1% 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 usual dose is: The solution is sprayed thinly onto the infected areas of skin 2 to 3 times a day. Each time you use it, press the spray head 1 to 2 times; this is sufficient even for large-area fungal infections.

Type of application

Before using for the first time, press the spray head 1 to 2 times; the preparation is then ready to use. The spraying distance should be 10 - 30 cm.

Duration of use

Regular and sufficiently long use of the solution 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 the solution 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 relapses - and despite rapid subjective improvement. After each wash, the feet should be dried thoroughly (between the toes).

Please talk to your doctor or pharmacist if you have the impression that the effect of Clotrimazole AL Spray 1% is too strong or too weak.

If you forget to use Clotrimazole AL Spray 1%

After a forgotten application, treatment is continued with the prescribed amount or the amount specified in the dosage instructions.

If you stop using Clotrimazole AL Spray 1%

Continue treatment as usual. Try to be consistent with the treatment, as premature termination may jeopardise the success of the treatment.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Clotrimazole AL Spray 1% can have side effects, although not everybody gets them. Occasionally, skin reactions (e.g. temporary redness, burning, stinging) may occur.

Countermeasures

Please inform your doctor about any side effects that occur so that he/she can treat them specifically if necessary. Please inform your doctor or pharmacist if any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this package leaflet.

5. HOW SHOULD CLOTRIMAZOLE AL SPRAY 1% BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and label after "Use by". The expiry date refers to the last day of the month. Do not store above + 25°C.

6. FURTHER INFORMATION

What Clotrimazole AL Spray 1%

contains

The active ingredient is clotrimazole. 1 ml solution for application to the skin contains 0.01 g clotrimazole. The other ingredients are: Macrogol 400, 2-propanol (Ph. Eur.), propylene glycol.

What Clotrimazole AL Spray 1%

looks like and contents of the pack

Colourless, clear solution. Clotrimazole AL Spray 1% is available in packs of 30 ml solution for application to the skin.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This package leaflet was last revised in April 2012.

Source: Information from the package leaflet
Status: 02/2018
Areas of application: for fungal infections of the skin caused by dermatophytes, yeasts (e.g. Candida species), mould and other fungi, such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum. These can manifest as athlete's foot, skin and skin fold mycoses, pityriasis versicolor, erythrasma, superficial candidiasis.