Adzoy™ 0.3% / 2.5% 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.

Adzoy™ 0.3% / 2.5% gel should only be used in adults and adolescents aged 12 years and over.

Do not use Adzoy™ gel:

- If you are pregnant

- If you are planning a pregnancy

- If you are allergic to adapalene or benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Adzoy™ gel.

- You should not use Adzoy™ gel on areas where you have cuts, scrapes, sunburn or eczema.

- Make sure Adzoy™ gel does not get into your eyes, mouth or nostrils, or mucous membranes and other very sensitive areas of the body. Should this occur wash these areas immediately with plenty of warm water.

- Avoid excessive exposure to sunlight and UV lamps.

- Avoid getting Adzoy™ gel on your hair or coloured fabrics as it may bleach them and wash your hands thoroughly after you have used Adzoy™ gel.

If you experience persistent skin irritation when starting treatment with Adzoy™ gel contact your doctor (see section 3. How to use Adzoy™ gel).

Other medicines and Adzoy™ gel

• Do not use other acne products (containing benzoyl peroxide and / or retinoids) at the same time as Adzoy™ gel.

• Avoid using Adzoy™ gel at the same time as cosmetics that irritate, dry or exfoliate the skin.

Other medicines may have an effect on Adzoy™ gel, so tell your doctor or pharmacist

if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Pregnancy

DO NOT use Adzoy™ gel if you are pregnant or thinking to become pregnant. Your doctor can give you more information.

If you fall pregnant while taking Adzoy™ 0.3% / 2.5% gel, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up.

Breast-feeding

If you are breast-feeding ask your doctor for advice before using this medicine. Your doctor will advise you whether to discontinue breast-feeding or to abstain from treatment with Adzoy™ 0.3% / 2.5% gel.

If your doctor advises you to continue the treatment, avoid application of the gel to the chest in order to avoid contact exposure of the infant.

Driving and using machines

Adzoy™ gel has no or negligible effects on the ability to drive and use machines.

Adzoy™ 0.3% / 2.5% gel contains propylene glycol , an ingredient that may cause local skin irritation (e.g. contact dermatitis).

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

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

Adzoy™ is a gel, used on the skin.

The doctor will decide which strength of Adzoy™ 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 Adzoy™ gel. Your doctor will tell you how long you will need to use Adzoy™ 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 Adzoy™ 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 Adzoy™ gel. These products can be used after the applied gel has dried.

Use in children

Adzoy™ 0.3% / 2.5% gel should not be used by children below 12 years of age.

If you use more Adzoy™ gel than you should:

If you use more Adzoy™ gel than you should on your skin, you will not get rid of your acne any quicker, but your skin may become irritated and red.

Please contact your doctor or the hospital if:

- you have used more Adzoy™ gel than you should

- a child has accidentally taken this medicine

- you or someone else accidentally swallow this medicine.

Your doctor will advise you on what action needs to be taken.

If you forget to use Adzoy™ gel:

Do not apply a double dose to make up for a forgotten dose.

If you stop using Adzoy™ gel

The spots (comedones, papules and pustules) will be reduced only after several applications of this medicine. Continue using Adzoy™ gel as long as prescribed by your doctor.

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 Adzoy™ 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 side effect (may affect up to 1 in 10 people):

• Irritation of the skin • Eczema • Skin burning sensation

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 Adzoy™ 0.1% / 2.5% gel (adapalene 0.1% / benzoyl peroxide 2.5%):

Uncommon (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 Adzoy™ gel 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 Adzoy™ 0.3% / 2.5% gel, contact your doctor. Adverse skin-reactions, e.g. skin irritation, are more frequent with Adzoy™ 0.3% / 2.5% gel than with lower strength Adzoy™ 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help by providing more information on the safety of this medicine

Keep out of the sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date which is stated on the carton and tube.

Discard the tube 6 months after first opening.

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

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