CLODERM

CLODERM Powder

Important notes (mandatory information)

Cloderm Powder 10 mg/g. Active ingredient: Clotrimazole. Areas of application: Support for local treatment with cream or solution effective against fungi, or for after-treatment of fungal infections of the skin and skin folds.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cloderm Powder 10 mg/g, for application to the skin
Active ingredient: Clotrimazole

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 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 experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 14 days, contact your doctor.

What this leaflet contains

1. What is Cloderm Powder and what is it used for?
2. What should you consider before using Cloderm Powder?
3. How to use Cloderm Powder?
4. What side effects are possible?
5. How to store Cloderm Powder?
6. Contents of the pack and further information.

1. WHAT IS CLODERM POWDER AND WHAT IS IT USED FOR?

Cloderm Powder is a broad-spectrum antifungal, imidazole derivative. Cloderm Powder is used to support local treatment with cream or solution that is effective against fungi, or for after-treatment of fungal infections of the skin and skin folds.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CLODERM POWDER?

Cloderm Powder must not be used if you are allergic to clotrimazole 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 Cloderm Powder.

Children and adolescents

There is no data available.

Use of Cloderm Powder with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Clotrimazole reduces the effectiveness of amphotericin and other polyene antifungals (nystatin, natamycin).

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 Cloderm Powder as described in this 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 should only be used during pregnancy after consultation with and under the guidance of a doctor. Due to the low absorption with topical application, Cloderm Powder can be used during breastfeeding as directed. During breastfeeding, Cloderm Powder should not be applied directly to the breast area. There are no studies on the effect of clotrimazole on human fertility.

Driving and operating machinery

Cloderm Powder has no or negligible influence on the ability to drive and use machines.

3. HOW TO USE CLODERM POWDER?

Always use Cloderm Powder exactly as described in this 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

The affected skin areas are powdered 1 to 2 times a day. The powder should be used alternately with other dosage forms, such as cream or solution.

Type of application

For application to the skin.

Duration of application

The duration of treatment varies. It depends, among other things, on the extent and location of the disease. In order to achieve complete healing, treatment with the powder should not be discontinued after the acute inflammatory symptoms or subjective complaints have subsided, but should be continued for a treatment period of at least 4 weeks.

In the case of athlete's foot, treatment should be continued for about 2 weeks beyond the disappearance of the signs of the disease in order to avoid relapses despite rapid subjective improvement. A follow-up treatment should not exceed a treatment period of 4 to 5 weeks.

Please talk to your doctor or pharmacist if you have the impression that the effect of Cloderm Powder is too strong or too weak.

If you have used more Cloderm Powder than you should

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

If you forget to use Cloderm Powder

Do not use double the amount to make up for the forgotten application.

If you stop using Cloderm Powder

You could jeopardize the success of the treatment. Please talk to your doctor or pharmacist before stopping treatment with Cloderm Powder. 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 clotrimazole after approval. Since these were reported voluntarily by patient groups of uncertain size, their frequency cannot be reliably determined. If you are affected by any of the side effects listed below, stop using Cloderm Powder and see your doctor as soon as possible.

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

Hypersensitivity, swelling of the face, tongue and larynx (angioedema), anaphylactic reaction, hypotension, fainting, shortness of breath, itching, redness, stinging/burning, skin irritation, rash, blisters, skin peeling/scaling, contact dermatitis, paresthesia, hives, irritation at the site of application, allergic reactions at the site of application, edema, pain.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this 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 CLODERM POWDER?

Keep this medicine out of the reach of children. Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the label and carton after "use by". The expiry date refers to the last day of the month indicated.

Never dispose of this medicine 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. For more information, see: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION.

What Cloderm Powder contains

The active ingredient is clotrimazole. 1 g of powder contains 10mg of clotrimazole.

The other ingredients are

Zinc oxide, highly dispersed silicon dioxide and talc.

What Cloderm Powder looks like and contents of the pack Cloderm Powder is a white powder and is available in a 30g pack.

Pharmaceutical entrepreneur

Dermapharm AG
Lil-Dagover-Ring 7
82031 Grünwald
Phone: 089/641860
Fax: 089/64186130
E-mail: service@dermapharm.de

Manufacturer

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

This leaflet was last revised in March 2023.

Source: Information from the package leaflet
Status: 11/2024
Active ingredient: Clotrimazole. Areas of application: Support for local treatment with cream or solution effective against fungi, or for after-treatment of fungal infections of the skin and skin folds.