BIFON

BIFON Cream

Important notes (mandatory information)

Bifon Cream 10 mg/g. Active ingredient: Bifonazole. Areas of application: for infections of the skin caused by dermatophytes, yeasts, moulds and other pathogens such as Malassezia furfur or Corynebacterium minutissimum, such as mycoses of the skin and skin folds (tinea corporis and tinea inguinalis), mycoses between the fingers and toes (tinea pedis, tinea manuum), pityriasis versicolor, superficial yeast infections (candidiasis) of the skin, erythrasma. Warning: Contains cetyl stearyl alcohol.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bifon Cream 10 mg/g, Bifon Cream is a broad-spectrum antifungal for the treatment of fungal infections (mycoses) of the skin
Active ingredient: Bifonazole

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

• 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 you do not feel better or if you feel worse after 7 days, contact your doctor.

What this package leaflet contains

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

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

Bifon Cream is a broad-spectrum antifungal for the treatment of fungal infections (mycoses) of the skin. Bifonazole, the active ingredient in Bifon Cream, penetrates the affected skin layers and kills the fungus there. It also has an anti-inflammatory effect.

Bifon Cream is used for fungal infections (mycoses) of the skin caused by dermatophytes, yeasts, moulds and other pathogens such as Malassezia furfur or Corynebacterium minutissimum, such as:

• Mycoses of the skin and skin folds (tinea corporis and tinea inguinalis)
• Mycoses between the fingers and toes (tinea pedis, tinea manuum)
• Pityriasis versicolor
• superficial yeast infections (candidiasis) of the skin
• Erythrasma

2. WHAT SHOULD YOU CONSIDER BEFORE USING BIFON CREAM?

Bifon Cream must not be used if you are allergic to bifonazole or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Bifon Cream.

If you have a history of hypersensitivity (allergy) to other antifungal medicines (e.g. with the active ingredients econazole, clotrimazole, miconazole), you should only use Bifon Cream with caution. Avoid eye contact with Bifon Cream. If symptoms persist after treatment, please consult a doctor. Antifungal treatment of the skin of the nail bed with Bifon Cream can only be carried out after prior (keratolytic) removal of the fungus-infected nail substance.

Children

You should only use Bifon Cream in infants and toddlers under medical supervision.
Please make sure that no cream gets into the mouth of the infant/toddler.

Use of Bifon Cream with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any 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 concomitantly.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There are insufficient data on the use of bifonazole in pregnant women.Since bifonazole is an active ingredient that is applied exclusively 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 medical benefit-risk assessment. Bifonazole should be avoided during the first 3 months of pregnancy.

Breast-feeding should be discontinued during treatment with Bifonazole.

Studies on the effect of bifonazole on human fertility do not exist.

Driving and using machines

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

Bifon Cream contains cetyl stearyl alcohol. Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE BIFON 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.

The recommended dose is

Apply Bifon Cream once a day to the affected areas of skin. A length of cream about 1 cm is generally sufficient to apply to an area the size of a palm. Wash the affected areas of skin before each application to remove loose skin flakes and any residue from the last treatment. Dry them thoroughly after washing, especially areas that are difficult to reach, e.g. between the toes.

Method of application

Bifon Cream is best applied thinly to the affected areas of skin in the evening before going to bed and gently rubbed in.

Duration of use

Regular and sufficiently long use of this medicine is important for the success of the treatment. The duration of treatment varies and depends, among other things, on the extent and location of the disease. In order to achieve complete healing, treatment with Bifon Cream should not be stopped immediately after the acute inflammatory signs of the disease or the subjective symptoms have subsided.
The duration of treatment is generally:

• Foot mycoses, interdigital mycoses (tinea pedis, tinea pedis interdigitalis): 3 weeks
• Mycoses on the rest of the body, on hands and in skin folds (tinea corporis, tinea manuum, tinea inguinalis): 2 - 3 weeks
• Pityriasis versicolor Erythrasma: 2 weeks
• superficial candidiasis of the skin: 2 - 4 weeks

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 Bifon Cream is too strong or too weak.

If you have used more Bifon Cream than you should

You can continue treatment with the dose prescribed for you. No adverse effects are to be expected in the event of short-term overdose.

If you forget to use Bifon Cream

Continue treatment as directed in the dosage instructions (e.g. do not apply the cream more frequently or in larger quantities).

If you stop using Bifon Cream

Please note that a sufficiently long period of application of Bifon Cream is important (see section 3 "Duration of application") to achieve complete healing and avoid relapses.
Therefore, talk to your doctor or pharmacist before interrupting or prematurely ending treatment - e.g. because of side effects!
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 have been reported voluntarily by patient groups of unknown size, it is not possible to estimate the frequency on the basis of the available data.

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

Not known (frequency cannot be estimated from the available data)

Pain at the site of administration, peripheral oedema at the site of administration. 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.

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 BIFON 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 after "use by". The expiry date refers to the last day of the month indicated. After first opening the tube, Bifon Cream can be stored for 8 weeks.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink).
Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Bifon Cream contains

The active ingredient is: Bifonazole. 1 g cream contains 10 mg bifonazole.

The other ingredients are

Chlorhexidine digluconate, 2-octyl-1-dodecanol, cetyl stearyl alcohol, cetyl palmitate, sorbitan stearate, polysorbate 60, purified water.

What Bifon Cream looks like and contents of the pack

Bifon Cream is a white cream and is available in tubes of 15g and 35g.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Phone: 089 / 64186-0
Fax: 089 / 64186-130
E-mail: service@dermapharm.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Str. 15
06796 Brehna
(a subsidiary of Dermapharm AG)

This package leaflet was last revised in January 2023

Source: Information from the package leaflet
Status: 11/2024
Active ingredient: Bifonazole. Areas of application: for infections of the skin caused by dermatophytes, yeasts, moulds and other pathogens such as Malassezia furfur or Corynebacterium minutissimum, such as mycoses of the skin and skin folds (tinea corporis and tinea inguinalis), mycoses between the fingers and toes (tinea pedis, tinea manuum), pityriasis versicolor, superficial yeast infections (candidiasis) of the skin, erythrasma. Warning: Contains cetyl stearyl alcohol.