CANIFUG

CANIFUG Cream

Important notes (mandatory information)

Canifug Cream. Active ingredient: Clotrimazole. Areas of application: For fungal infections (mycoses) of the skin and the external female genital area (Candida vulvitis).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER
Canifug Cream
1 g clotrimazole per 100 g cream

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

• Keep the package leaflet. You may want to read it again later.
• Ask your doctor or 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 here affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

The package leaflet contains

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

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

Canifug Cream is an antifungal cream for application to the skin and for application to the skin of the external female genital area.
Canifug Cream is used for fungal infections (mycoses) of the skin and the external female genital area (Candida vulvitis).

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

Canifug Cream must not be used,

• if you are hypersensitive (allergic) to clotrimazole, cetyl stearyl alcohol or any of the other ingredients of Canifug Cream (see section 6 "Further information").
• during breastfeeding in the breast area.

Special care is required when using Canifug Cream

• if Canifug Cream and latex products (e.g. condoms, diaphragms) are used at the same time. The functional capacity of these products may be reduced and thus their safety may be impaired due to the excipients contained (in particular stearates).

Use in children and the elderly

Special adjustments are not necessary, as no increased or intensified side effects have been reported with the use of Canifug Cream.

When using Canifug Cream with other medicines

Due to the active ingredient clotrimazole, Canifug Cream reduces the effectiveness of amphotericin and other polyene antibiotics (nystatin, natamycin).

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

Pregnancy and breastfeeding

Please consult your doctor for advice before using Canifug Cream in the external genital area if you are pregnant or breastfeeding. You can use Canifug Cream in the external genital area during pregnancy and breastfeeding, but only as directed by a doctor. However, Canifug Cream must not be used in the breast area during breastfeeding to prevent the infant from ingesting small amounts of the active ingredient with the breast milk.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Canifug Cream

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

3. HOW TO USE CANIFUG CREAM?

Always use Canifug Cream exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Canifug Cream is a cream for application to the skin.
Unless otherwise prescribed by your doctor, Canifug Cream is applied thinly to the affected skin 2 to 3 times a day.

For each application, please proceed as follows:

• Apply a small amount to the affected skin areas. For an area about the size of a hand, a cream strand about 1/2 cm long is usually sufficient.
• If there is a fungal infection of the external female genital area (Candida vulvitis), the cream should be applied thinly to the labia as well as to the skin of the adjacent areas up to the anus.
• Rub in the applied cream.

Duration of use

The duration of treatment varies and depends, among other things, on the extent and location of the disease.

For fungal infections of the skin

The average duration of treatment is 2-4 weeks. In order to achieve complete healing, treatment should not be discontinued after the acute inflammatory symptoms or subjective complaints have subsided, but should be continued for about 2 more weeks.

For fungal infections in the external genital area of women

The average duration of treatment is 1-2 weeks.

If you have used more Canifug Cream than you should

Continue treatment with the normal amount next time.

If you forget to use Canifug Cream

After forgetting a single dose, do not use double the amount of Canifug Cream, but resume treatment with the prescribed amount.

If you stop using Canifug Cream

Please discuss the further procedure with your doctor or pharmacist, as the success of the treatment is at risk. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Canifug Cream can have side effects, although not everybody gets them. Significant side effects or signs to watch out for, and what to do if you are affected: If you are affected by any of the following side effects, stop using Canifug Cream and see your doctor as soon as possible.

Very rarely (less than 1 in 10,000 patients), hypersensitivity to clotrimazole or the other ingredients of Canifug Cream may occur. Not known (frequency cannot be estimated from the available data): In individual cases, generalised (general) hypersensitivity reactions of varying severity may occur. These may affect: the skin (e.g. itching, redness), the respiratory system (e.g. shortness of breath), the circulatory system (e.g. blood pressure drop requiring treatment, up to and including loss of consciousness) and the gastrointestinal tract (e.g. nausea, diarrhoea).

Other possible side effects

Common (1 to 10 in 100 patients) are temporary itching and burning after application.

Occasionally (1 to 10 in 1,000 patients), skin irritations such as stinging or temporary redness may occur.

Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet.

5. HOW TO STORE CANIFUG CREAM?

Keep the medicine out of the reach of children.

Do not use the medicine after the expiry date which is stated on the carton and the tube. The expiry date refers to the last day of the month. Do not store above 25 °C.

Shelf life after opening

Until the expiry date stated on the carton and the tube.

6. FURTHER INFORMATION

The active ingredient is clotrimazole. 100 g cream contains 1 g clotrimazole.

The other ingredients are

Benzyl alcohol, cetyl palmitate (Ph. Eur.), cetyl stearyl alcohol (Ph. Eur.) [vegetable], sodium citrate dihydrate (E133) octyldodecanol (Ph. Eur.), polysorbate 60, sorbitan stearate (E491), purified water.

What Canifug Cream looks like and contents of the pack

Canifug Cream is a uniformly white cream in aluminium tubes.

The packs contain 10 g, 15 g, 20 g, 25 g, 35 g, 40 g and 50 g cream for application to the skin and for application to the skin of the external female genital area. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Dr. August Wolff GmbH & Co. KG
Arzneimittel
Sudbrackstraße 56
33611 Bielefeld
Telephone: (0521) 8808-05
Fax: (0521) 8808-334
E-mail: info@wolff-arzneimittel.de

This package leaflet was last revised in April 2012.

Source: Information from the package leaflet
Status: 03/2016
Active ingredient: Clotrimazole. Areas of application: For fungal infections (mycoses) of the skin and the external female genital area (Candida vulvitis).