Adapalene / Benzoyl Peroxide Zentiva 0.3% / 2.5% gel

Adapalene/Benzoyl Peroxide Zentiva 0.3%/2.5% gel

The name of your medicine is Adapalene/Benzoyl Peroxide Zentiva 0.3%/2.5% gel (called Adapalene/Benzoyl gel throughout this leaflet) and belongs to a group of medicines called “anti-acne preparation for topical use”. It is used for the treatment of acne vulgaris, when comedones (blackheads, whiteheads), numerous papules and pustules (inflammatory pimples) are present.

It combines two active ingredients, adapalene and benzoyl peroxide which work together but in different ways:

• Adapalene belongs to a group of products known as retinoids and acts specifically on the skin processes that cause acne.
• Benzoyl peroxide, the other active ingredient, works as an antimicrobial agent and by softening and peeling the outer layer of the skin.

This medicinal product should only be used in adults and adolescents aged 12 years and over.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

This medicinal product is only intended for use in adults, and adolescents aged 12 years and over. This medicine is for external use only.

The doctor will decide which strength of gel you need, depending on the severity and appearance of your acne. The doctor will also decide if you need any additional treatment.

• The skin should be clean and dry before application.
• Apply a thin film of gel evenly over the entire acne-affected areas of the face and/or the trunk, once a day at bedtime. Avoid contact with the eyes, lips, nostrils and mucous membranes.
• If used on the face: Wash and dry the face and use a pea size amount to cover each part of the face (such as forehead, chin, each cheek).
• Wash your hands thoroughly immediately after you have applied Adapalene/Benzoyl gel.

Your doctor will tell you how long you will need to use this medicinal product. If you do not see any improvement after 4 - 8 weeks you should discuss with your doctor the benefit of continuing the treatment.

If you experience persistent skin irritation during the first weeks when using this gel, contact your doctor. Your doctor may recommend you to apply a moisturiser, to use the gel less often, to stop for a short time, or to stop using the gel.

Do not apply cosmetics (such as other facial creams or make-up) before the daily application of the gel. These products can be used after the applied gel has dried.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Approximately 1 in 10 people using this medicine may experience adverse skin reactions.

Stop using this medicinal product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using it if you develop hives or itching of the face or body. The frequency with which these side effects occur is not known.

Common side effects (may affect up to 1 in 10 people):

• skin burning sensation
• irritation of the skin
• eczema
• reddening of the skin
• scaling

Uncommon side effects (may affect up to 1 in 100 people):

• redness of the eyelid
• tingling or sensation of pins and needles at the application site
• itching of the skin, allergic skin reaction
• rash
• dry skin.

In addition to the side effects described above, the following side effects have been reported with a lower strength of adapalene / benzoyl peroxide gel (0.1%/ 2.5%):

Uncommon side effects (may affect up to 1 in 100 people):

• sunburn.

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

• swelling of the eyelid
• tightness in the throat
• allergic contact reactions
• swelling face
• pain of skin (stinging pain)
• blisters (vesicles)
• difficulty in breathing
• skin discolouration (change in skin colour)
• application site burn.

Adverse reactions typically associated with use of Adapalene/Benzoyl include mild to moderate application site reactions, such as skin irritation with redness, dryness, scaling, stinging and or burning of the skin.

Application site burns are in general superficial, but more severe cases involving blistering, have been reported.

If you experience persistent skin irritation during the first weeks when using this medicinal product, contact your doctor. Adverse skin-reactions, such as skin irritation, are more frequent with the higher strength gel than with lower strength (adapalene/benzoyl peroxide 0.1%/2.5% gel). You may be asked to apply a moisturiser, to use the gel less often, to stop for a short time, or to stop using the gel. These reactions usually occur early in the treatment, and tend to gradually lessen over time.

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 tube. The expiry date refers to the last day of that month.

Do not store above 30°C.

After first opening of the tube, use the product within 6 months.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.