BENZAKNEN

BENZAKNEN Wash 5% Suspension

Important notes (mandatory information)

Benzaknen Wash 5%, Suspension. Active ingredient: Benzoyl peroxide. Areas of application: for all forms of acne of mild severity and for supportive therapy for acne of moderate to severe severity.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Benzaknen Wash 5%, Suspension for cutaneous use
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 your doctor or pharmacist has told you.

• Keep the package leaflet. You may need 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 you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS BENZAKNEN WASH AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU KNOW BEFORE USING BENZAKNEN WASH?
3. HOW IS BENZAKNEN WASH USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BENZAKNEN WASH BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BENZAKNEN WASH AND WHAT IS IT USED FOR?

Benzaknen Wash is an acne medication for cutaneous use. Benzaknen Wash is used for all forms of acne of mild severity and for supportive therapy for acne of moderate to severe severity. Benzaknen Wash is used in adolescents (from 12 years of age) and adults.

2. WHAT SHOULD YOU KNOW BEFORE USING BENZAKNEN WASH?

Benzaknen Wash must not be used if you are allergic to benzoyl peroxide or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions:

• For cutaneous use only.
• Consult your doctor before using Benzaknen Wash if you are prone to hay fever, allergic asthma or neurodermatitis (atopy) and your skin is dry and produces little sebum (sebostasis).
• A slight burning sensation on the skin may occur during the first application and redness and peeling of the skin may occur within a few days.
• In the first few weeks of treatment, most patients notice a sudden increase in skin peeling. This is not harmful to health and usually subsides within a day or two if treatment is temporarily discontinued.
• If severe skin irritation occurs, a doctor should be consulted and the use of Benzaknen Wash should be temporarily discontinued or the treatment stopped altogether.
• Benzoyl peroxide can cause swelling and blistering of the skin. If any of these symptoms occur, you must stop treatment with Benzaknen Wash. In this case, consult a doctor.
• Do not use additional skin irritants, as this may increase skin irritation.
• Avoid intensive UV light exposure (sun, solariums), as this may increase skin irritation.
• Benzaknen Wash must not come into contact with eyes and mucous membranes and must not be applied in the area of the mouth, nose and corners of the eyes.
• Benzaknen Wash must not be used on damaged skin.
• Contact with the eyes causes redness and burning. If Benzaknen Wash accidentally comes into contact with the eyes, the eye should be rinsed with plenty of running water for about 15 minutes.
• Caution is advised when using Benzaknen Wash on the neck and other sensitive areas of the skin.
• Benzoyl peroxide, the active ingredient in Benzaknen Wash, can cause swelling (discoloration) or discoloration of hair (including eyebrows) and colored textiles (e.g. T-shirts, bed linen, pajamas, washcloths, towels) and thus damage them. These effects can occur on direct contact of the product with textiles or hair, but also on indirect contact, e.g. via the hands or the treated skin. The bleaching effect can persist even after the product has been absorbed into the skin or washed off the skin. To prevent possible damage, it is recommended to clean your hands thoroughly with soap and, if necessary, a nail brush after using Benzaknen Wash and to avoid contact of the product or treated skin with hair, e.g. by using hair ties or hair clips. It is advisable to use white textiles during the treatment period.

Children

The safety and efficacy of Benzaknen Wash have not been studied in children before puberty (under 12 years of age), as acne vulgaris is rare in this age group.

Use of Benzaknen Wash with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Interactions with other medicines that could be used on the skin together with Benzaknen Wash are not known. However, medicines with exfoliating, irritating or drying effects should not be used at the same time as Benzaknen Wash.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. There are no data on the use in pregnancy in humans. The decision on whether to use Benzaknen Wash during pregnancy and breast-feeding is made by the attending physician after careful benefit-risk assessment. There is no knowledge of the passage into breast milk after external treatment during breast-feeding. Breastfeeding mothers should not use Benzaknen Wash on or around the breast to avoid the infant coming into direct contact with Benzaknen Wash.

Driving and using machines

No special precautions are required.

3. HOW IS BENZAKNEN WASH USED?

Always use Benzaknen Wash exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Benzaknen Wash is only intended for use in adults and adolescents aged 12 years and over.

Unless otherwise prescribed by your doctor, the usual dose is

The affected areas of skin are treated with Benzaknen Wash once a day. In severe cases or to enhance the therapeutic effect, the dosage can be increased to twice a day. Moisten the affected areas of skin. Apply Benzaknen Wash to your hands and rub it into the affected area of skin. The contact time with the skin should be 1 to 5 minutes. Then rinse thoroughly with water and dry the skin. Avoid contact with eyes, nose and mouth mucous membranes; rinse with plenty of water if necessary. Additional cleansing of the affected areas of skin is not necessary and may reduce the therapeutic success. The preparation is intended for cutaneous use only. The average duration of use is 4 - 12 weeks.

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

If you have used more Benzaknen Wash than you should

Benzaknen Wash is only intended for cutaneous use. Using too much Benzaknen Wash will not produce faster or better results and may cause severe skin irritation. In such cases, discontinue use of Benzaknen Wash and consult a doctor.

If you forget to use Benzaknen Wash

Continue treatment according to the specified dosage instructions.

If you stop using Benzaknen Wash

No special measures are required.

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. All side effects observed in clinical studies affect the skin. The side effects subside when treatment is less frequent or discontinued.

Very common (may affect more than 1 in 10 people)

Redness (erythema), burning sensation on the skin, dryness and peeling of the skin.

Common (may affect up to 1 in 10 people)

Itching, skin irritation (irritative contact dermatitis), skin pain (stinging pain)

Uncommon (may affect up to 1 in 100 people)

Allergic contact dermatitis.

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

After the launch of Benzaknen, facial swelling and allergic reactions, including allergic reactions at the site of application and hypersensitivity reactions (allergy) of the entire body, have been reported.

Occasionally, benzoyl peroxide or other ingredients of Benzaknen Wash may cause hypersensitivity reactions (allergic contact dermatitis). In such cases, the preparation should be discontinued and a doctor consulted.

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 SHOULD BENZAKNEN WASH BE STORED?

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the carton and container after "Use by". The expiry date refers to the last day of the month indicated.

Storage conditions

Do not store above 25°C.

Note on shelf life after opening

The shelf life of Benzaknen Wash after opening is 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Benzaknen Wash contains

The active ingredient is: Benzoyl peroxide. 1 g suspension for cutaneous use contains 50 mg benzoyl peroxide. The other ingredients are carbomer 940, alpha-olefin (C14 - CJ sulfonic acids sodium salt, glycerol, acrylate copolymer, sodium hydroxide, purified water.

What Benzaknen Wash looks like and contents of the pack

Benzaknen Wash is a white to cream-colored suspension. Benzaknen Wash is available in the following pack sizes: Tube with 30 g, tube with 50 g, tube with 100 g and 2 tubes (double pack) with 100 g each suspension for cutaneous use. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Galderma Laboratorium GmbH
Toulouser Allee 23a
40211 Düsseldorf
Telephone: (0800) 5888850
Telefax: (0211) 63558270
E-mail: patientenservice@galderma.com

Manufacturer

Laboratoires Galderma Zone Industrielle - Montdesir
F-74540 Alby-sur-Cheran

This package leaflet was last revised in June 2018.

Source: Package leaflet information
Status: 10/2020
Active ingredient: Benzoyl peroxide. Areas of application: for all forms of acne of mild severity and for supportive therapy for acne of moderate to severe severity.