CLOTRIMAZOL AL

CLOTRIMAZOLE AL 1% Cream

Important notes (mandatory information)

Clotrimazole 1% Cream - 1A Pharma. Areas of application: Fungal infections (mycoses) of the skin caused by dermatophytes, yeasts (e.g. Candida species), mould fungi and others 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

Clotrimazole 1% Cream - 1A Pharma
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 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 your symptoms worsen or do not improve after about 2 weeks, contact your doctor.

What this package leaflet contains

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

1. WHAT IS CLOTRIMAZOLE 1% CREAM - 1A PHARMA AND WHAT IS IT USED FOR?

Clotrimazole 1% Cream - 1A Pharma is a medicine for fungal skin infections. Areas of application: Fungal infections (mycoses) of the skin caused by dermatophytes, yeasts (e.g. Candida species), mould fungi and others such as Malassezia furfur as well as infections caused by Corynebacterium minutissimum. These infections can occur as fungal infections of the feet, skin and skin folds, superficial yeast infections (candidiasis), pityriasis versicolor or erythrasma (a disease caused by certain bacteria).

2. WHAT SHOULD YOU CONSIDER BEFORE USING CLOTRIMAZOLE 1% CREAM - 1A PHARMA?

Clotrimazole 1% Cream - 1A Pharma must not be used if you are allergic to clotrimazole or related substances (imidazole derivatives) or to any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Clotrimazole 1% Cream - 1A Pharma. If you are known to be hypersensitive to cetyl stearyl alcohol, it is advisable to use a dosage form that is free of cetyl stearyl alcohol (e.g. a solution) instead of the cream. If Clotrimazole 1% Cream - 1A Pharma is used together with latex products (e.g. condoms, diaphragms), the functional capacity of these products may be reduced and thus their safety may be impaired due to the excipients contained (in particular paraffin).

Use of Clotrimazole 1%

Cream - 1A Pharma together 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. No interactions have been reported to date.

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.

Pregnancy

There is only a limited amount of data on the use of clotrimazole in pregnant women. If you use Clotrimazole 1% Cream - 1A Pharma 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 should not be used during the first 3 months of pregnancy or when used vaginally.

Breast-feeding

Due to the low absorption into the body when applied to the skin, Clotrimazole 1% Cream - 1A Pharma can be used during breast-feeding as directed. However, Clotrimazole 1% Cream - 1A Pharma should not be applied directly to the breast area during breast-feeding.

Driving and using machines

Clotrimazole 1% Cream - 1A Pharma has no or negligible influence on the ability to drive and use machines.

Clotrimazole 1%

Cream - 1A Pharma contains cetyl stearyl alcohol

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

3. HOW TO USE CLOTRIMAZOLE 1% CREAM - 1A PHARMA?

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. Recommended dose: Apply the cream thinly to the affected skin areas 2 to 3 times a day. A small amount of cream (approx. 1/2 cm length of strand) is usually sufficient for an area about the size of a hand.

Method of application

Rub the cream gently into the skin. If you are treating a fungal foot infection with the cream, your feet should be dried thoroughly after each wash (including between the toes).

Duration of use

The duration of treatment depends on the type of disease and varies in length. Regular and sufficiently long use of the cream is important for the success of the treatment. To achieve complete healing, you should continue treatment for at least 4 weeks, even if you have the impression that the acute inflammation has subsided and your symptoms are improving. Pityriasis versicolor usually heals within 1-3 weeks and erythrasma within 2-4 weeks. In the case of athlete's foot, you should continue to use the cream for about 2 weeks, even if your symptoms subside or disappear after a few days.

If you have used a larger amount of Clotrimazole 1%

Cream - 1A Pharma than you should

The consequences of using too much Clotrimazole 1% Cream - 1A Pharma are not known; there are no reports on this.

If you forget to use Clotrimazole 1%

Cream - 1A Pharma

Do not apply a larger amount of cream the next time, but continue treatment as recommended.

If you stop using Clotrimazole 1%

Cream - 1A Pharma

In order to achieve complete healing 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 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.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause 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 context of the use of clotrimazole after approval. Since these reactions were reported voluntarily from 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 be taken if affected

If you are affected by any of the following side effects, stop using Clotrimazole 1% Cream - 1A Pharma 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 that is free of cetyl stearyl alcohol (e.g. a solution) 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 CLOTRIMAZOLE 1% CREAM - 1A PHARMA?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "use by". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening: The shelf life after opening is 6 months. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Clotrimazole 1%

Cream - 1A Pharma contains

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

What Clotrimazole 1%

Cream - 1A Pharma looks like and contents of the pack

Clotrimazole 1% Cream - 1A Pharma is a soft, white cream with a slight odour of benzyl alcohol. Packs of 20 g and 50 g cream in aluminium tubes. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

1A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Phone: (089) 6138825-0

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This package leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 10/2017
Areas of application: Fungal infections (mycoses) of the skin caused by dermatophytes, yeasts (e.g. Candida species), mould fungi and others such as Malassezia furfur as well as infections caused by Corynebacterium minutissimum.