CORDES BPO

CORDES BPO 5% Gel

Important notes (mandatory information)

Cordes BPO 5% Gel. Active ingredient: Benzoyl peroxide. Areas of application: is used for all forms of endogenous acne (acne vulgaris).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cordes BPO 5% Gel
Active ingredient: Benzoyl peroxide

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 need 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 the mild skin irritation that may occur at the beginning of treatment worsens or does not subside after 5 days, the preparation should be discontinued and medical advice should be sought.

What this package leaflet contains

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

1. WHAT IS CORDES BPO 5% GEL AND WHAT IS IT USED FOR?

Cordes BPO 5% Gel is a medicine for acne (acne dermaticum) and contains the active ingredient benzoyl peroxide. Cordes BPO 5% Gel is used for all forms of endogenous acne (acne vulgaris).

2. WHAT SHOULD YOU CONSIDER BEFORE USING CORDES BPO 5% GEL?

Cordes BPO 5% Gel must not be used if you are known to be allergic to the active ingredient benzoyl peroxide or to any of the other ingredients.

Warnings and precautions

Please talk to your doctor or pharmacist before using Cordes BPO 5% Gel. Caution is advised in patients with a predisposition to allergic eczema (atopic dermatitis) when used on dry (sebostatic) skin. Note: Cordes BPO 5% Gel must not be applied to mucous membranes or in the area of the mouth, nose and corners of the eyes. Due to the high sensitisation rate, benzoyl peroxide should not be used on damaged (eroded) skin.

Use of Cordes BPO 5%

Gel together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Simultaneous use of other irritating topical agents and simultaneous intensive UV irradiation (sunbathing, solariums) of the skin areas treated with Cordes BPO 5% Gel should be avoided.

Pregnancy and breast-feeding

Cordes BPO 5% Gel should only be used during pregnancy and breast-feeding after careful consultation with a doctor. The preparation should not be used in the last month of pregnancy. There is no evidence of passage into breast milk after external treatment during pregnancy. Similarly, there is no evidence of the concentration in breast milk during external (external) treatment during lactation (time of milk production). For these reasons, not only during pregnancy but also during the lactation phase (breastfeeding), a strict assessment of the benefit/risk ratio by the treating physician and special caution when using benzoyl peroxide is required. There is no evidence to date of any harm to the unborn child.

Driving and using machines

Cordes BPO 5% Gel has no influence on the ability to drive and use machines.

Cordes BPO 5%

Gel contains propylene glycol

Propylene glycol can cause skin irritation.

3. HOW TO USE CORDES BPO 5% GEL?

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, Cordes BPO 5% Gel is applied to the affected skin areas once or twice a day. Before using Cordes BPO 5% Gel, the skin should be thoroughly cleansed. The gel is then applied thinly to the skin (do not massage in) and left on the skin. After application, wash your hands thoroughly. Cordes BPO 5% Gel should not be applied to healthy skin. Initially, the frequency of application should be adjusted according to the skin's sensitivity and, if necessary, the treatment should be continued with a single daily application, in the evening. For application to the skin. Cordes BPO 5% Gel should be used until the acne has improved or the skin symptoms have disappeared. Please ask your doctor about this. The average duration of treatment is 4 -10 weeks. The frequency of application depends on the type and severity of the clinical picture and on the skin reaction. Note: Due to its bleaching effect, Cordes BPO 5% Gel should not be used on the eyebrows, in the beard area or on the forehead hairline, nor should it come into contact with coloured textiles.

If you have used more Cordes BPO 5%

Gel than you should

If skin irritation occurs, therapy should be continued with lower concentrations or discontinued. No special countermeasures are required.

If you forget to use Cordes BPO 5%

Gel

Do not use double the amount if you have forgotten the previous application.

If you stop using Cordes BPO 5%

Gel

Please discuss the further procedure with your doctor, as the success of the treatment is at risk.

If you have any further questions about 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.

Rare (1 to 10 in 10,000 treated)

In rare cases, benzoyl peroxide can lead to contact allergic sensitisation. Allergic reactions are possible in case of hypersensitivity to propylene glycol. In these cases, the preparation should be discontinued and a doctor should be consulted.

Note: At the beginning of treatment, mild skin irritation such as redness, itching, tightness and burning may occur as the effect sets in. These symptoms usually subside after a few days. Drying out and moderate peeling of the skin are also part of the therapeutic effect. However, if these signs persist for more than 5 days or become more severe, the preparation should be discontinued and medical advice should be sought.

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, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: http://www.bfarm.de, by reporting side effects you can help to provide more information about the safety of this medicine.

5. HOW TO STORE CORDES BPO 5% GEL?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton or tube after "use by". The expiry date refers to the last day of the month indicated. After opening, you can use Cordes BPO 5% Gel until the expiry date. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cordes BPO 5%

Gel contains

The active ingredient is benzoyl peroxide. 1 g of gel contains 50 mg of benzoyl peroxide. The other ingredients are: propylene glycol 0.1 g, carbomer, sodium hydroxide, purified water.

What Cordes BPO 5%

Gel looks like and contents of the pack

Glassy white gel. Cordes BPO 5% Gel is available in tubes of 30 g (N1) and 100 g (N3).

Pharmaceutical entrepreneur and manufacturer

ICHTHYOL-GESELLSCÜAFT Cordes, Hermanni & Co. (GmbH & Co.) KG
Sportallee 85
22335 Hamburg
Tel.:040-50714-0
Fax: 040-50714-110
E-Mail: info@ichthyol.de

This leaflet was last revised in February 2014.

Source: Information from the package leaflet
Status: 10/2016
Active ingredient: Benzoyl peroxide. Areas of application: is used for all forms of endogenous acne (acne vulgaris).