Epiduo 0.3% / 2.5% gel

adapalene / benzoyl peroxide

Epiduo gel belongs to a group of medicines called "anti-acne preparation for topical use" i.e. it is used for the treatment of acne vulgaris, when comedones (blackheads, whiteheads), numerous papules and pustules (inflammatory pimples) are present.

This gel 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, works as an antimicrobial agent and by softening and peeling the outer layer of the skin.

Epiduo 0.3% / 2.5% gel 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.

Epiduo 0.3% / 2.5% gel is only intended for use in adults and adolescents aged 12 years and over.

Epiduo is a gel, used on the skin.

The doctor will decide which strength of Epiduo 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 (e.g. forehead, chin, each cheek).
• Wash your hands thoroughly immediately after you have applied Epiduo gel.

Your doctor will tell you how long you will need to use Epiduo 0.3% / 2.5% gel. 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 Epiduo gel, contact your doctor. 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.

Do not apply cosmetics (such as other facial creams or make-up) before the daily application of Epiduo 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 Epiduo 0.3% / 2.5% gel may experience adverse skin reactions.

Stop using the 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 the product if you develop hives or itching of the face or body. The frequency with which these side effects occur is not known.

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

• Irritation of the skin
• Eczema
• Skin burning sensation
• Reddening of the skin
• Scaling

Uncommon (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 Epiduo gel (adapalene 0.1% / benzoyl peroxide 2.5%):

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

• Sunburn

Not known (frequency 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 Epiduo 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, mostly superficial but more severe cases involving blistering, have been reported.

If you experience persistent skin irritation during the first weeks when using Epiduo 0.3% / 2.5% gel, contact your doctor. Adverse skin-reactions, e.g. skin irritation, are more frequent with Epiduo 0.3% / 2.5 % gel than with lower strength Epiduo 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/pump after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Shelf-life after first opening: 3 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.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium, Cyprus, Czech Republic, Germany, Greece, Luxembourg, Poland and Slovakia: Epiduo Forte

Estonia, Denmark, Ireland, Latvia, Lithuania and Malta: Epiduo

Finland, France, Iceland, Italy, Norway, Sweden and United Kingdom (Northern Ireland): Epiduo 0.3% / 2.5% gel

Bulgaria and Spain: Epiduo Forte 3 mg/g + 25 mg/g Gel

Croatia and Portugal: Epiduo 3 mg/g + 25 mg/g Gel

Hungary and Netherlands: Effezel Forte

Romania: Epiduo Forte 3 mg/25 mg/g gel