BENZAKNEN Wash 5% Suspension for Acne treatment

Benzaknen Wash 5%, Suspension. Active ingredient: Benzoyl peroxide. Indications: For all forms of mild acne and as adjunctive therapy for moderate to severe acne.

For risks and side effects, read the package leaflet and ask 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 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 WASH AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BENZAKNEN WASH?
3. HOW IS BENZAKNEN WASH USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BE BENZAKNEN WASH BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

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

Benzaknen Wash is an acne medication for application to the skin. Benzaknen Wash is used for all forms of mild acne and as adjunctive therapy for moderate to severe acne. 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 external 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).
• 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 within a day or two if treatment is temporarily paused.
• If severe skin irritation occurs, a doctor should be consulted and the use of Benzaknen Wash 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 using Benzaknen Wash and consult a doctor.
• Do not apply any additional skin-irritating agents, as this may lead to increased skin irritation.
• Report any intense UV light exposure (sun, tanning beds) as this can lead to increased 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 should not be used on damaged skin.
• Contact with the eyes will cause redness and burning. If Benzaknen Wash 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 Wash on the neck and other sensitive skin areas.
• Benzoyl peroxide, the active ingredient in Benzaknen Wash, can cause esophageal and stomach problems if accidentally ingested. Consult a doctor if Benzaknen Wash is accidentally swallowed.
• The active ingredient in Benzaknen Wash, benzoyl peroxide, 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 using Benzaknen Wash, 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.

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

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

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 Wash in pregnant women. The treating physician will decide on the use of Benzaknen Wash during pregnancy and breastfeeding after a careful benefit-risk assessment. There is no information available regarding the passage of Benzaknen Wash into breast milk after external treatment during breastfeeding. Breastfeeding mothers should not apply Benzaknen Wash to or around the breast to avoid direct contact between the infant and Benzaknen Wash.

Driving and operating machinery:
No special precautions are necessary.

3. HOW TO USE BENZAKNEN WASH

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

Unless otherwise prescribed by your doctor, the usual dose is:
Treat the affected skin areas once a day with Benzaknen Wash. In severe cases or to enhance the therapeutic effect, the dosage can be increased to twice a day. Moisten the affected skin areas. Apply Benzaknen Wash to your hands and rub it onto 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 the eyes, nose, and mucous membranes of the mouth; if necessary, rinse with plenty of water. Additional cleansing of the affected skin areas is not necessary and may reduce the effectiveness of the treatment. This product is intended for external use only. The average duration of use is 4 to 12 weeks.

Please talk to your doctor or pharmacist if you feel 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 for application to the skin only. Using too much Benzaknen Wash will not lead to faster or better results and may cause severe skin irritation. In these cases, stop using Benzaknen Wash and consult a doctor.

If you forget to use Benzaknen Wash:
Continue the treatment according to the dosage instructions.

If you stop using Benzaknen Wash:
No special measures are necessary.

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 involve 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):
Since Benzaknen was marketed, facial swelling and allergic reactions, including allergic reactions at the application site and systemic hypersensitivity reactions (allergy), have been reported.

Occasionally, benzoyl peroxide or other ingredients of Benzaknen Wash 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 also applies to 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, 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 WASH?

Keep 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 Wash can be stored for 6 months after first opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

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