CANESTEN

CANESTEN Extra Cream 10 mg/g

Important notes (mandatory information)

Canesten Extra Cream. Active ingredient: Bifonazole. Areas of application: for fungal infections (mycoses) of the skin caused by dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Canesten Extra Cream
Active ingredient: Bifonazole

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If your condition does not improve or gets worse after 7 days, contact your doctor.

What this package leaflet contains

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

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

Canesten Extra Cream is a broad-spectrum antifungal for the treatment of fungal infections (mycoses) of the skin. Bifonazole, the active ingredient in Canesten Extra Cream, penetrates the affected skin layers and kills the fungus there. It also has an anti-inflammatory effect. Canesten Extra Cream is used for fungal infections (mycoses) of the skin caused by dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum. These can be, for example, fungal infections of the feet and hands as well as the treatment of an exposed nail bed as part of nail fungus therapy; fungal infections of the rest of the skin and skin folds; so-called pityriasis versicolor, caused by Malassezia furfur (Pityriasis versicolor); skin disease caused by Corynebacterium minutissimum (erythrasma) and superficial candidiasis.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CANESTEN EXTRA CREAM?

Canesten Extra Cream must not be used if you are allergic to bifonazole or any of the other ingredients of Canesten Extra Cream listed in section 6. If you have a known hypersensitivity to cetyl stearyl alcohol, it is advisable to use a dosage form (e.g. spray) that does not contain this ingredient instead of the cream. Special care should be taken when using Canesten Extra Cream if you have reacted with hypersensitivity (allergy) to other antifungal medicines in the past (e.g. with the active ingredients econazole, clotrimazole, miconazole), you should only use Canesten Extra Cream with caution. Avoid eye contact with Canesten Extra Cream. Do not ingest. If symptoms persist after treatment, please consult a doctor. Antifungal treatment of the skin of the nail bed with Canesten Extra Cream can only be carried out as part of nail fungus therapy after prior keratolytic removal of the fungus-infected nail substance.

Children

Canesten Extra Cream should only be used under medical supervision in infants and toddlers. Please make sure that no cream gets into the mouth of the infant/toddler.

Interactions when using Canesten Extra Cream with other medicines

Limited data suggest that an interaction between topically applied bifonazole and warfarin is possible, with an increase in the blood clotting factor (INR value). Therefore, appropriate monitoring should be carried out if bifonazole and warfarin are used at the same time.

Pregnancy, breast-feeding and fertility

There are no adequate data for the use of bifonazole in pregnant women. Since bifonazole is an active ingredient that is only applied to the skin and therefore systemic effects (effects on other organs) are not to be expected, a risk is not to be expected. Nevertheless, as a precautionary measure, bifonazole should only be used during pregnancy after careful consideration of the benefits and risks by a doctor. Bifonazole should be avoided during the first 3 months of pregnancy. Breastfeeding should be discontinued during treatment with bifonazole. Studies on the effect of bifonazole on human fertility have not been conducted.

Driving and using machines

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

Canesten Extra Cream contains cetyl stearyl alcohol

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

3. HOW TO USE CANESTEN EXTRA CREAM?

Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Canesten Extra Cream should be applied once a day. Usually a small amount of cream (approx. 1 cm length of strand) is sufficient for an area about the size of a hand.

Type of application

It is best to apply Canesten Extra Cream thinly to the affected skin areas in the evening before going to bed and rub in the cream. Wash the affected skin areas before each application so that loose skin flakes and any residues from the last treatment are removed. Dry them thoroughly after washing, especially areas that are difficult to reach, e.g. between the toes.

Duration of application

To achieve a permanent cure, you should continue treatment with Canesten Extra Cream even after the symptoms, such as burning or itching, have subsided. Depending on the type of disease, you should carry out the treatment over the following periods

Foot mycoses, interdigital mycoses (Tinea pedis, Tinea pedum interdigitalis)	3 weeks
Mycoses on the body, hands and in skin folds (Tinea corporis, Tinea manuum, Tinea inguinalis)	2 – 3 weeks
Pityriasis versicolor, erythrasma	2 weeks
Fungal infections of the skin caused by yeasts (superficial candidiasis)	2 – 4 weeks

Instructions for using Canesten Extra Cream with CanesTouch Applicator

1. Remove the cap from the CanesTouch applicator.
2. To open the tube, turn the lower part of the CanesTouch applicator towards ON.
3. Squeeze the tube until a sufficient amount of cream is visible on the soft CanesTouch applicator tip.
4. Apply the cream thinly and evenly to the infected areas/between the toes. Gently massage in with the ribbed side of the soft CanesTouch applicator tip and allow to dry.
5. To close the tube, turn the lower part of the CanesTouch applicator towards OFF.
6. After use, clean the soft CanesTouch applicator tip with a damp cloth. Do not use detergents or chemicals for cleaning. Please do not remove the soft CanesTouch applicator tip.
7. Replace the cap on the CanesTouch applicator.

If you use Canesten Extra Cream with CanesTouch applicator for a follow-up treatment, first squeeze out the cream residue remaining in the applicator tip (approx. 1 cm) and discard it. This is not necessary after once-daily application during the treatment periods specified under "Duration of application". If your condition worsens or does not improve after about 1 week, you must see a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Canesten Extra Cream is too strong or too weak.

If you have used more Canesten Extra Cream than you should

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

If you forget to use Canesten Extra Cream

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

If you stop using Canesten Extra Cream

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

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

What else can you do?
Change towels and clothing that have come into contact with the affected areas daily. This will help you avoid spreading the fungal infection to other parts of your body or to other people.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been identified in the context of the use of bifonazole 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 what to do if you are affected

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

General disorders and administration site conditions - Not known (frequency not known)

Pain at the administration site, localised oedema (at the administration site)

Skin and subcutaneous tissue disorders - Not known (frequency not estimable from the available data)

Dry skin, skin irritation, skin softening, skin flaking, redness, burning, itching, rash, eczema, blisters, hives, contact dermatitis, allergic dermatitis.

These side effects are only temporary and will subside after the end of treatment.

Other possible side effects

Allergic skin reactions may occur in case of hypersensitivity to cetyl stearyl alcohol. In this case, it is advisable to use a dosage form (e.g. spray) that does not contain cetyl stearyl alcohol instead of the cream.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 EXTRA 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

This medicinal product does not require any special storage conditions.

Note on shelf life after opening:

• Canesten Extra Cream 20 g and 50 g: Can be used for 16 months after opening.
• Canesten Extra Cream 15 g (with applicator): Can be used for 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Canesten Extra Cream contains

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

What Canesten Extra Cream looks like and contents of the pack

Canesten Extra Cream is a white, homogeneous cream.

Canesten Extra Cream is available in the following pack sizes:

• Aluminium tubes with 20 g and 50 g of cream.
• Laminated tube with integrated applicator with 15 g of cream.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

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

Manufacturer

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

Alternatively (including laminated tube with integrated applicator)

GP Grenzach Produktions GmbH
Emil-Barell-Straße 7
79639 Grenzach-Whylen
Germany

This package leaflet was last revised in August 2018.

Source: Information from the package leaflet
Status: 10/2019
Active ingredient: Bifonazole. Areas of application: for fungal infections (mycoses) of the skin caused by dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur, as well as infections caused by Corynebacterium minutissimum.