CANESTEN

CANESTEN Cream

Important notes (mandatory information)

Canesten Cream. Active ingredient: Clotrimazole. Area of application: for the treatment of fungal infections (mycoses) of the skin and mucous membrane, caused by dermatophytes, yeasts, moulds and others, such as Malassezia furfur, as well as skin infections caused by Corynebacterium minutissimum. Also used for Candida vulvitis and Candida balanitis.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Canesten Cream, 1% cream
Active ingredient: Clotrimazole

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your condition worsens or does not improve after about 2 weeks, contact your doctor.

What this package leaflet contains

1. WHAT IS CANESTEN CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CANESTEN CREAM?
3. HOW TO USE CANESTEN CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CANESTEN CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Canesten Cream is a medicine for the treatment of fungal infections (mycoses) of the skin and mucous membrane. Clotrimazole, the active ingredient in Canesten Cream, penetrates the affected skin layers and attacks the fungus there. The result: the fungus dies or its growth is inhibited. Canesten Cream is used to treat fungal infections (mycoses) of the skin and mucous membrane, caused by dermatophytes, yeasts, moulds and others, such as Malassezia furfur, as well as skin infections caused by Corynebacterium minutissimum. Also used for Candida vulvitis and Candida balanitis. These infections can occur, for example, in the form of: mycoses of the feet (athlete's foot), between toes and fingers, on the nail fold (paronychia), also in connection with nail mycoses; skin diseases that are additionally infected with Canesten-sensitive pathogens (superinfection). Mycoses of the skin and skin folds, superficial candidiasis, pityriasis versicolor (tinea versicolor), infections with Corynebacterium minutissimum (erythrasma), seborrheic dermatitis only with microbial involvement of the above-mentioned pathogens. Infections of the labia and adjacent areas, caused by yeasts (Candida vulvitis); inflammations of the glans and foreskin of men caused by yeasts (Candida balanitis).

2. WHAT SHOULD YOU CONSIDER BEFORE USING CANESTEN CREAM?

Canesten Cream must not be used if you are allergic to clotrimazole or any of the other ingredients of Canesten Cream listed in section 6.

Using Canesten Cream with other medicines

No interactions have been reported to date.

Pregnancy, breastfeeding and fertility

Ask your doctor or pharmacist for advice before using this medicine. There is only a limited amount of data available on the use of clotrimazole in pregnant women. If you use Canesten Cream as described in this package leaflet or as recommended by your doctor or pharmacist, the active ingredient clotrimazole is absorbed into the body in very small amounts only; therefore, a systemic effect (effect on other organs) is not to be expected. As a precaution, clotrimazole must not be used during the first 3 months of pregnancy or when used in the vagina. Due to the low absorption when used topically, Canesten Cream can be used during breastfeeding as directed. Canesten Cream should not be used directly on the breast area during breastfeeding. There are no studies on the effect of clotrimazole on human fertility.

Driving and using machines

Canesten Cream has no or negligible influence on the ability to drive and use machines.

Important information about certain other ingredients of Canesten Cream

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis). Note: If Canesten Cream is used in the genital area at the same time as latex products (e.g. condoms, diaphragms), the functional capacity of these products may be reduced and their safety impaired due to the excipients contained (in particular stearates). The effect is temporary and occurs only during treatment.

3. HOW TO USE CANESTEN CREAM?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Apply Canesten Cream thinly to the affected skin areas 2 - 3 times a day and rub in. Usually, a cream strand of about ½ cm is sufficient for an area about the size of a hand. Before each application of Canesten Cream, you should wash the affected skin areas to remove loose skin flakes. Then you should dry the skin thoroughly. In case of infection of the labia (Candida vulvitis) and adjacent areas of the woman, apply the cream 2 - 3 times a day to the corresponding skin areas (external genitals to the anus). The cream is also recommended for the simultaneous treatment of inflammation of the glans and foreskin (Candida balanitis) of the partner caused by yeasts.

Duration of use

The duration of treatment depends, among other things, on the extent and location of the disease. In order to achieve complete healing, treatment should not be discontinued after the symptoms have subsided, but should be continued consistently for a treatment period of at least 4 weeks. Pityriasis versicolor usually heals within 1 - 3 weeks and erythrasma within 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. Candida vulvitis and Candida balanitis heal within 1 - 2 weeks. Please talk to your doctor or pharmacist if you have the impression that the effect of Canesten Cream is too strong or too weak.

If you have used more Canesten Cream than you should

The consequences of using too much Canesten Cream are not known; there are no reports of this.

If you forget to use Canesten Cream

Do not use a larger amount of Canesten Cream next time, but continue treatment as recommended.

If you stop using Canesten Cream

In order to achieve complete healing of the fungal infection and to prevent relapse, you should not stop or interrupt treatment prematurely without consulting your doctor. If you do so, the symptoms may recur because your fungal infection is probably not yet properly healed. You should not stop treatment after the symptoms have subsided, but continue it consistently (as recommended under "Duration of use").

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

What else can you do?
Change towels, laundry and socks that come into contact with the affected skin area daily. This simple measure alone supports healing and prevents transmission to other parts of the body and to other people.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

The following side effects have been identified in the course of the use of clotrimazole after approval. Since these reactions were reported voluntarily by patient groups of uncertain size, it is not possible to estimate the frequency on the basis of the available data.

Significant side effects or signs to watch out for, and measures to take if you are affected

If you are affected by any of the following side effects, stop using Canesten Cream and see your doctor as soon as possible.

Immune system disorders (frequency not known)

Allergic reactions (shortness of breath, fainting).

Skin and subcutaneous tissue disorders (frequency not known)

Blisters, oedema, skin peeling/scaling, discomfort/pain.

Other possible side effects

Immune system disorders (frequency not known)

Allergic reactions (hives, hypotension).

Skin and subcutaneous tissue disorders (frequency not known)

Itching, redness, stinging/burning, skin irritation, rash. In case of hypersensitivity to cetyl stearyl alcohol, allergic reactions may occur on the skin or mucous membrane. In this case, it is advisable to use a dosage form without cetyl stearyl alcohol (e.g. spray) instead of the cream.

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 CANESTEN CREAM?

Keep this medicine out of the reach of children! Do not use this medicine after the expiry date which is stated on the tube and carton. 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: Canesten Cream can be stored for 3 months after opening the tube. Do not dispose of the medicine in waste water (via toilet or sink). Any unused medicine can be disposed of in household waste. This helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Canesten Cream contains

The active ingredient is: Clotrimazole. 1 g cream contains 10 mg clotrimazole. The other ingredients are: Benzyl alcohol, octyldodecanol (Ph.Eur.), cetyl stearyl alcohol (Ph.Eur.), cetyl palmitate (Ph.Eur.), sorbitan stearate, polysorbate 60, purified water.

What Canesten Cream looks like and contents of the pack

Canesten Cream is a white, homogeneous cream. Canesten Cream is available in aluminium tubes containing 20 g and 50 g.

Pharmaceutical entrepreneur

Bayer Vital GmbH
51368 Leverkusen
Germany
Telephone: (0214) 301
Telefax: (0214) 30 57 209
E-mail address: bayer-vital@bayerhealthcare.com

Manufacturer

Kern Pharma, S.L.
Poligon Industrial Colon II, C/ Venus, 72
08228 Terrassa
Spain

This package leaflet was last revised in July 2013.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Clotrimazole. Area of application: for the treatment of fungal infections (mycoses) of the skin and mucous membrane, caused by dermatophytes, yeasts, moulds and others, such as Malassezia furfur, as well as skin infections caused by Corynebacterium minutissimum. Also used for Candida vulvitis and Candida balanitis.