Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Adapalene, Benzoyl peroxide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for This medicine is used for the treatment of acne. 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. The other active ingredient, benzoyl peroxide, works as an antimicrobial agent and by softening and peeling the outer layer of the skin. 2.
e Adapalene/ Benzoyl Peroxide
Do not use this medicine:
This medicine contains 40mg propylene glycol in 1g of gel. Talk to your doctor or pharmacist before using this medicine. Other medicines and Adapalene/ Benzoyl Peroxide Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time as this medicine. Avoid using this medicine at the same time as cosmetics that are irritant, drying or exfoliate the skin. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Pregnancy, breast-feeding and fertility DO NOT use this medicine if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information. If you fall pregnant while taking this medicine, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up. This medicine can be used during breast-feeding. To avoid contact exposure of the infant, application of this medicine to the chest should be avoided. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Not relevant. This medicine contains propylene glycol This medicine contains 40mg propylene glycol (E1520) in each gram which is equivalent to 4 % w/w. 3.
Adapalene/ Benzoyl Peroxide
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is only intended for use in adults, adolescents and children aged 9 years and over. This medicine is for external use only. Apply a thin film of gel evenly over acne affected areas once a day at bedtime, avoiding the eyes, lips and nostrils. The skin should be clean and dry before application. You should wash your hands thoroughly after you have used this medicine. Tube: One fingertip provides approximately 2.5cm of gel corresponding to an average gel weight around 0.5g. Bottle: One pump provides an average gel weight around 0.5 g. Your doctor will tell you how long you will need to use this medicine. If you feel that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist. If you experience persistent irritation when applying this medicine, contact your doctor. You may be asked to apply a moisturizer, to use the gel less often or to stop for a short time, or to stop using the gel altogether. If you use more Adapalene/ Benzoyl Peroxide than you should
If you use more of this medicine than you should on your skin, you will not get rid of your acne quicker, but your skin may become irritated and red. Please contact your doctor or the hospital:
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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 this medicine 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): Dry skin, local skin rash (irritative contact dermatitis), burning sensation, irritation of the skin, redness, scaling. Uncommon side effects (may affect up to 1 in 100 people): Itching of the skin (pruritus), sunburn. Not known (frequency cannot be estimated from the available data): Swelling of the face, allergic contact reactions, swelling of the eyelid, tightness in the throat, pain on the skin (stinging pain), blisters (vesicles), difficulty in breathing, skin discolouration (change in skin colour), application site burn. If skin irritation appears after application of this medicine, it is generally mild to moderate, with local signs such as redness, dryness, scaling, burning and pain on the skin (stinging pain), which peak during the first week and resolve without additional treatment. Application site burns, mostly superficial but more severe cases involving blistering, have been reported. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine. 5.
Adapalene/ Benzoyl Peroxide
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 after "EXP". The expiry date refers to the last day of that month.
Store below 30 C. After first opening this medicine can be used for 6 months, if stored below 25 C. 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. 6.
What this medicine contains The active substances are adapalene and benzoyl peroxide. One gram of gel contains 1mg of adapalene and 25mg of anhydrous benzoyl peroxide (as benzoyl peroxide, hydrous). The other ingredients are disodium edetate, docusate sodium, poloxamer 124, glycerol, propylene glycol (E1520), sorbitan oleate, sepineo P 600 (acrylamide/sodium acryloyldimethyl taurate copolymer in isohexadecane with polysorbate 80), purified water. What this medicine looks like and contents of the pack Adapalene/ Benzoyl Peroxide 0.1% + 2.5 % gel/Emobax 0.1% + 2.5% Gel is a white to very pale yellow opaque gel. Adapalene/ Benzoyl Peroxide 0.1% + 2.5% gel/Emobax 0.1% + 2.5% Gel can be packed as: 15g or 30g of gel in a laminated tube with aluminium barrier with protective membrane and a plastic polypropylene closure, in a carton. 30 g, 45g or 60g of gel in an airless, white, polypropylene bottle with airless plastic snap-on pump equipped with actuator and plastic cap, in a carton. Not all pack sizes may be marketed. Marketing Authorisation Holder Penlan Pharmaceuticals Ltd, 45-47 Monument Hill, Weybridge, KT13 8RN, UK Manufacturer BELUPO lijekovi i kozmetika, d.d. Danica 5 48 000 Koprivnica Croatia This leaflet was last revised in September 2025
Adapalene/Benzoyl Peroxide 0.1 %/ 2.5 % gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Adapalene/Benzoyl Peroxide 0.1 %/ 2.5 % gel is adapalene, benzoyl peroxide.
Medicines with the same active substance, strength and form include: Adawell 0.1%/2.5% Gel, Adawell Forte 0.3%/2.5% Gel, Epiduo 0.1%/2.5% Gel. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Adapalene/Benzoyl Peroxide 0.1 %/ 2.5 % gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Cutaneous treatment of acne vulgaris when comedones, papules and pustules are present (see section 5.1).
This medicine is indicated in adults, adolescents and children aged 9 years and over.
Posology
This medicine should be applied to the entire acne affected areas once a day in the evening on clean and dry skin. A thin film of gel should be applied, with the fingertips, avoiding the eyes and lips (see section 4.4).
Tube: One fingertip provides approximately 2.5 cm of gel corresponding to an average gel weight around 0.5 g.
Bottle: One pressure provides an average gel weight around 0.5 g.
If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether.
The duration of treatment should be determined by the Doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment.
The safety and effectiveness of this medicine have not been studied in children below 9 years of age.
Method of administration
For application to the skin.
- Hypersensitivity to the active substances of to any of the excipients listed in section 6.1
- Pregnancy (see section 4.6).
- Women planning a pregnancy (see section 4.6)
This medicine should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned.
This medicine should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water.
If a reaction suggesting sensitivity to any component of the formula occurs, the use of this medicine should be discontinued.
Excessive exposure to sunlight or UV radiation should be avoided.
This medicine should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.
No interaction studies have been performed.
From previous experience with adapalene and benzoyl peroxide, there are no known interactions with other medicinal products which might be used cutaneously and concurrently with this medicine. However, other retinoids or benzoyl peroxide or drugs with a similar mode of action should not be used concurrently. Caution should be exercised if cosmetics with desquamative, irritant or drying effects are used, as they may produce additive irritant effects with this medicine.
Absorption of adapalene through human skin is low (see section 5.2), and therefore interaction with systemic medicinal products is unlikely.
The percutaneous penetration of benzoyl peroxide in the skin is low and the drug substance is completely metabolised into benzoic acid which is rapidly eliminated. Therefore, the potential interaction of benzoic acid with systemic medicinal products is unlikely to occur.
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Pregnancy
This medicine is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy. There are no or limited amount of data from the use of adapalene topically in pregnant women.
Animal studies by the oral route have shown reproductive toxicity at high systemic exposure (see section 5.3).
Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Breastfeeding
No study on animal or human milk transfer was conducted after cutaneous application of fixed combination adapalene/benzoyl peroxide gel.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to adapalene and benzoyl peroxide is negligible. This medicine can be used during breast-feeding.
To avoid contact exposure of the infant, application of this medicine to the chest should be avoided when used during breastfeeding.
Fertility
No human fertility studies were conducted with fixed combination adapalene/benzoyl peroxide gel.
However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies (see section 5.3).
Not relevant.
This medicine may cause the following adverse reactions at the site of application:
System organ class (MedDRA)
Frequency
Adverse Drug Reaction
Eye disorders
Not known (cannot be estimated from the available data)*
Eyelid oedema
Immune system
Not known (cannot be estimated from the available data)*
Anaphylactic reactions
Respiratory, thoracic and mediastinal disorders
Not known (cannot be estimated from the available data)*
Throat tightness, dyspnoea
Skin and subcutaneous tissue disorders
Common (≥1/100 to <1/10)
Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation, erythema, skin exfoliation (scaling)
Uncommon (≥1/ 1000 to <1/100)
Pruritus, sunburn
Not known (cannot be estimated from the available data)*
Allergic contact dermatitis, swelling face, pain of the skin (stinging pain), blisters (vesicles), skin discolouration (hyperpigmentation and hypopigmentation), urticaria, application site burn**
*post marketing surveillance data
**most of the cases of “application site burn” were superficial burns but cases with second degree burn or severe burn reactions have been reported.
If skin irritation appears after application of this medicine, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling, burning and pain of skin (stinging pain)) peaking during the first week and then subsiding spontaneously.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal products. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
This medicine is for once-daily cutaneous use only.
In case of accidental ingestion, appropriate symptomatic measures should be taken.
Ask anything about Adapalene/Benzoyl Peroxide 0.1 %/ 2.5 % gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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