Fungidexan, 100 g

Instructions for use for Fungidexan, 100 g

Important notes (compulsory information):

Fungidexan ointment. Applications: applied to the treatment of fungal infections (mycoses) of the skin by dermatophytes, yeasts (eg Candida species), molds and others, such as Malassezia Furfur and bacterial infections by Corynebacterium Minutissimum.

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


LEAFLET: INFORMATION FOR THE USER

Fungidexan ointment
Active ingredients: Clotrimazole, urea

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always use this medicine as described in this leaflet or exactly as your doctor's or pharmacist instructions.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse after four weeks, contact your doctor.

What is in this leaflet

1. What is Fungidexan and what is she applied for?
2. What should you consider before using Fungidexan?
3. How is Fungidexan to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is Fungidexan to keep?
6. Content of the pack and more information

1. What is Fungidexan and what is she applied for?

Fungidexan is a locally applicable means against fungal diseases of the skin (antimycotic).
Fungidexan is used to treat fungal infections (Mycoses) of the skin by dermatophytes, yeasts (eg Candida species), molds and others, such as Malassezia Furfur and bacterial infections by Corynebacterium Minutissimum.
These can be: mycoses of the feet (foot mushrooms), mycoses of the rest of the skin and the skin folds, mushroom lens (PityRiasis Versisteror), Dwarf braid (erythrasma), superficial candidoses.

2. What should you consider before using Fungidexan?

Fungidexan must not be used if they are allergic to clotrimazole or urea or one of the other ingredients of this medicine mentioned in section 6.

Warnings and Precautions:
Please talk to your doctor or pharmacist before applying Fungidexan. Due to the irritative potential of the 10 % Needle of urea should you use an application to acute inflammatory-altered skin (characterized for example by burning, redness, bubbles / wetes) to prevent possible aggravation of skin diseases. Do not carry any other medicines or cosmetics during treatment with Fungidexan on the same skin. With the simultaneous application of Fungidexan in the genital or anal range and latex products (eg condoms, diaphragms), it can lead to a reduction in functionality and thus to impair the safety of these products because of the contained other component "White Vaselin.

Children:
Please consult with your doctor before applying Fungidexan to children.

Application of Fungidexan together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / applied other medicines. Clotrimazole reduces the effectiveness of polyene antimycotics such as Nystatin, Natamycin and Amphotericin B.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before applying this medicine. Fungidexan should be in pregnancy and Still time only after consulting with the doctor are applied. Fungidexan may not be applied to the chest of breastfeeding mothers.

Driving and ability to operate machines:
There are no special precautions required.

Fungidexan contains poly (oxyethylene) -25-hydrogenated castor oil:
Poly (oxyethylene) -25-hydrogenated castor oil can cause skin irritation.

3. How is Fungidexan to apply?

Always use this medicine as described in this leaflet or exactly after the arrangement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

The recommended dose is:
Apply Fungidexan to the infested skirts once a day. In general, the once daily use is sufficient.

Type of application:
Apply the ointment thin to the infested skin.

Duration of application:
The treatment time is usually up to four weeks and depends on the type of disease. Important for a success of the treatment is the regular and sufficiently long application of the ointment. Fort the treatment for a few days, even if you have the impression that the acute inflammation is over and let your complaints. Especially with fungal diseases of the feet, you should apply Fungidexan for about 2 weeks, even if your complaints have already graduated or disappeared after a short time. Please talk to your doctor or pharmacist if you have the impression that the effect of Fungidexan is too strong or too weak.

If you have used a larger amount of Fungidexan than you should:
No cases of overdose have been reported so far.

If you forget the application of Fungidexan:
Do not turn twice the amount if you forget the previous application.

If you cancel the application of Fungidexan:
If there is insufficient treatment, the fungal disease can replace or occur again (Relapse).

If you have further questions about the application of this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. The frequency information on side effects is based on the following categories:

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Possible side effects:
Occasionally irritative contact reactions may occur due to the 10% urea proportion, such as. B. burning and redness. In addition, contact algae reactions may occur, which may appear as itching, redness, bubbles also beyond the contact site (so-called streure reaction.

Additional side effects in children:
To apply Fungidexan in children, there are no secured experiences. Reports from the specialist literature indicate that the use of higher concentrated urea-containing products in children can lead to a most short-term burning on the skin.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also add side effects directly through the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Fungidexan?

Keep this medicine inaccessible to children. You must not use the drug after the expiry date specifiable on the folding box and tube to "usable until". The expiry date refers to the last day of the specified month.

Storage conditions:
This medicinal product does not require special storage conditions.

Note on durability after a break:
Do not use Fungidexan for more than 6 months after opening the tube.

6. Content of the pack and further information

What Fungidexan contains
The active ingredients are: cletrimazole and urea. 1 g ointment contains 10 mg clotrimazole and 100 mg of urea. The other ingredients are: white vaseline; Corn starch; Octyldodecanol (ph.eur.); Glyceroltridocosanoate; Palmitic acid; Sorbitan laurate; Poly (oxyethylene) -25-hydrogenated castor oil.

How to look for Fungidexan and content of the pack:
Fungidexan is a white to creamy ointment. Fungidexan is available in packs of 20 g and 100 g ointment.

Pharmaceutical entrepreneur and manufacturer:
Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Telephone: (040) 727 04-0
Fax: (040) 7229296
[email protected]
www.almirall.de

This leaflet was last revised in June 2013.

Source: Information of the leaflet
Status: 02/2016