Benzaknen 10% Gel

Benzaknen 10% Gel. Active ingredient: Benzoyl peroxide. Indications: For all forms of severe acne and acne conditions where the use of a lower concentration benzoyl peroxide preparation is not successful.

For risks and side effects, read the package leaflet and ask 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse, consult your doctor.

What this leaflet contains:

1. WHAT IS BENZAKNEN 10% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BENZAKNEN 10%?
3. HOW IS BENZAKNEN 10% APPLIED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BE BETANKEN 10%?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

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

Benzaknen 10% is an acne medication for topical application. Benzaknen 10% is used for all forms of severe acne, as well as acne conditions where the use of a lower concentration benzoyl peroxide preparation is not successful. Benzaknen 10% is used in adolescents (from 12 years of age) and adults.

2. WHAT SHOULD YOU KNOW 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.
• Consult 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).
• The first application may cause a slight burning sensation on the skin, and within a few days redness and peeling of the skin may occur.
• During the first few weeks of treatment, most patients notice a sudden increase in skin peeling. This is not harmful and usually subsides after a day or two if treatment is temporarily paused.
• If severe skin irritation occurs, a doctor should be consulted and the use of Benzaknen 10% should be temporarily suspended or the treatment discontinued altogether.
• Benzoyl peroxide can cause swelling and blistering of the skin. If either of these symptoms occurs, you must stop treatment with Benzaknen and consult a doctor.
• Do not apply any additional skin-irritating agents, as this may lead to increased skin irritation.
• Avoid intense UV light exposure (sun, tanning beds) as this can lead to increased skin irritation.
• Benzaknen 10% must not come into contact with the eyes and mucous membranes and must not be applied to the area of the mouth, nose and corners of the eyes.
• Benzaknen 10% should not be used on damaged skin.
• Contact with the eyes causes redness and burning. If Benzaknen 10% accidentally comes into contact with the eyes, rinse the eye thoroughly with plenty of running water for approximately 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 esophageal and stomach problems if accidentally ingested. Consult a doctor if Benzaknen 10% is accidentally ingested.
• The active ingredient benzoyl peroxide in Benzaknen 10% can bleach (discolor) or change the color of hair (including eyebrows) and colored textiles (e.g., T-shirts, bed linens, pajamas, washcloths, towels), potentially damaging them. These effects can occur through direct contact of the product with textiles or hair, as well as through indirect contact, such as via the hands or treated skin. The bleaching effect may persist even after the product has been absorbed into the skin or washed off. To prevent potential damage, it is recommended to thoroughly wash your hands with soap and, if necessary, a nail brush after applying Benzaknen 10%, and to avoid contact between the product or treated skin and hair, for example, by using hair ties or clips. Wearing white textiles is also recommended 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) because acne vulgaris is rare in this age group.

When using Benzaknen 10% with other medicines:
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. No interactions with other medicines that may be used on the skin together with Benzaknen 10% are known. However, medicines with exfoliating, irritating, or drying effects should not be used at the same time as Benzaknen 10%.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There are no data on the use of Benzaknen 10% in pregnant women. The use of Benzaknen 10% during pregnancy and breastfeeding will be decided by the treating physician after a careful benefit-risk assessment. There is no information available on the transfer of Benzaknen 10% into breast milk after external application during breastfeeding. Breastfeeding mothers should not apply Benzaknen 10% to or around the breast to avoid direct contact of the infant with Benzaknen 10%.

Driving and operating machinery:
No special precautions are necessary.

Benzaknen 10% contains propylene glycol:
Propylene glycol may cause skin irritation.

3. HOW TO USE BENZAKNEN 10%

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Benzaknen 10% is intended for use only 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 areas of skin once or twice daily. If you have sensitive skin, once-daily application before bedtime is recommended. Cleanse the skin before applying Benzaknen 10% – ideally with a medicated skin cleanser. After drying, apply the gel thinly. This product is for external use only. The average duration of treatment is 4–12 weeks.

If you do not feel better or even feel worse, consult your doctor.

If you have used more Benzaknen 10% than you should:
Benzaknen 10% is for external use only. Using too much Benzaknen 10% will not lead to faster or better results and can cause severe skin irritation. In these cases, discontinue use of Benzaknen 10% and consult a doctor.

If you forget to use Benzaknen 10%:
Continue treatment according to the 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. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. All side effects observed in clinical trials affect the skin. The side effects subside when treatment is less frequent or stopped.

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):
Facial swelling and allergic reactions, including application site reactions and systemic hypersensitivity reactions (allergy), have been reported following the marketing of Benzaknen.

Occasionally, benzoyl peroxide or other ingredients of Benzaknen 10%, such as propylene glycol, may cause hypersensitivity reactions (allergic contact dermatitis). In these cases, the product should be discontinued and a doctor consulted.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany, 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 sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and container after EXP. The expiry date refers to the last day of that month.

Storage conditions:
Do not store above 25°C.

Shelf life after first opening:
Benzaknen 10% has a shelf life of 3 months after first opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Benzaknen 10% contains:
The active ingredient is: Benzoyl peroxide. 1 g of gel contains 100 mg of benzoyl peroxide. The other ingredients are carbomer 940, sodium edetate (Ph. Eur.), docusate sodium, colloidal anhydrous silica, propylene glycol, poloxamer 182, glycerol, acrylate copolymer, sodium hydroxide, and purified water.

(Apo) Usually ship out within 3-5 business days