BENZAKNEN

BENZAKNEN 10% Gel

Important notes (mandatory information)

Benzaknen 10% Gel. Active ingredient: Benzoyl peroxide. Areas of application: for all forms of severe acne as well as acne conditions in which the use of a lower concentrated benzoyl peroxide preparation does not lead to therapeutic success.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Benzaknen 10% 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 your doctor or pharmacist has told you.

• Keep the package leaflet. You may want 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 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, contact your doctor.

What this package leaflet contains

1. WHAT IS BENZAKNEN 10% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BENZAKNEN 10%?
3. HOW TO USE BENZAKNEN 10%?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BENZAKNEN 10%?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BENZAKNEN 10% AND WHAT IS IT USED FOR?

Benzaknen 10% is an acne medication for use on the skin. Benzaknen 10% is used for all forms of severe acne as well as acne conditions in which the use of a lower concentrated benzoyl peroxide preparation does not lead to therapeutic success. Benzaknen 10% is used in adolescents (from 12 years of age) and adults.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BENZAKNEN 10%??

Benzaknen 10% 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 external use only.
• Ask your doctor before using Benzaknen 10% 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 after a day or two if treatment is temporarily discontinued.
• If severe skin irritation occurs, a doctor should be consulted and the use of Benzaknen 10% 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. 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 10% 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 10% must not be used on damaged skin.
• Contact with the eyes causes redness and burning. If Benzaknen 10% 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 10% on the neck and other sensitive skin areas.
• Benzoyl peroxide, the active ingredient in Benzaknen 10%, can cause swelling and blistering of the skin. If any of these symptoms occur, you must stop treatment with Benzaknen. In this case, consult a doctor.
• The active ingredient benzoyl peroxide contained in Benzaknen 10% can cause bleaching (discoloration) or color change of hair (including eyebrows) and colored textiles (e.g. T-shirts, bed linen, pajamas, washcloths, towels) and thus damage them. These effects can occur with direct contact of the product with textiles or hair, but also with 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 wash your hands thoroughly with soap and, if necessary, a nail brush after using Benzaknen 10% 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 10% have not been studied in children before puberty (under 12 years of age), as acne vulgaris is rare in this age group.

When using Benzaknen 10%

together 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 10% are not known. However, medicines with exfoliating, irritating or drying effects should not be used at the same time as Benzaknen 10%.

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 10% during pregnancy and breast-feeding is made by the attending physician after careful consideration of the benefits and risks. There is no knowledge of the passage into breast milk after external application during breast-feeding. Breastfeeding mothers should not use Benzaknen 10% on or around the breast to avoid direct contact of the infant with Benzaknen 10%.

Driving and using machines

No special precautions are required.

Benzaknen 10%

contains propylene glycol

Propylene glycol can cause skin irritation.

3. HOW TO USE BENZAKNEN 10%??

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. Benzaknen 10% is only intended for use in adults and adolescents aged 12 years and over. It is recommended to start treatment with a lower dose benzoyl peroxide preparation. If a satisfactory result is not achieved with a 5% benzoyl peroxide preparation, treatment with Benzaknen 10% can be started.

Unless otherwise prescribed by your doctor, the usual dose is

Benzaknen 10% is applied to the affected skin areas 1-2 times daily. If you have sensitive skin, it is recommended to apply once a day before going to bed. Cleanse the skin before using Benzaknen 10% - preferably with a medicated skin cleanser. After drying, apply the gel thinly. The preparation is intended for external use only. The average duration of use is 4-12 weeks.

If you do not feel better or if you feel worse, contact your doctor.

If you have used more Benzaknen 10%

than you should

Benzaknen 10% is intended for external use only. Using too much Benzaknen 10% will not lead to faster or better results and can cause severe skin irritation. In such cases, discontinue use of Benzaknen 10% and consult a doctor.

If you forget to use Benzaknen 10%

Continue treatment according to the specified dosage instructions.

If you stop using Benzaknen 10%

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 (irritant 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 10%, such as propylene glycol, can lead to hypersensitivity reactions (allergic contact dermatitis). In such cases, the preparation should be discontinued and a doctor should be consulted.

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 BENZAKNEN 10%??

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 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 10% after opening is 3 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Benzaknen 10%

contains

The active ingredient is: Benzoyl peroxide. 1 g gel contains 100 mg benzoyl peroxide. The other ingredients are carbomer 940, sodium edetate (Ph. Eur.), docusate sodium, highly dispersed silicon dioxide, propylene glycol, poloxamer 182, glycerol, acrylate copolymer, sodium hydroxide, purified water.

What Benzaknen 10%

looks like and contents of the pack

Benzaknen 10% is a white to off-white gel. Benzaknen 10% is available in the following pack sizes: Tubes with 15 g, 25 g, 5O g and 60 g content; Double pack with 2 x 50 g and 2 x 60 g content.

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 leaflet was last revised in July 2019.

Source: Information from the package leaflet
Status: 10/2020
Active ingredient: Benzoyl peroxide. Areas of application: for all forms of severe acne as well as acne conditions in which the use of a lower concentrated benzoyl peroxide preparation does not lead to therapeutic success.