Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for
Adapalene/Benzoyl peroxide gel 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 medicines 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.
2.
What you need to know before you take it
e Adapalene/Benzoyl peroxide gel
Do not use Adapalene/Benzoyl peroxide gel • if you are allergic to adapalene or benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6) • if you are pregnant • if you are planning to have a baby Warnings and precautions Talk to your doctor or pharmacist before using the gel. • You should not use the gel on areas where you have cuts, scrapes, sunburn or eczema. • Make sure the gel does not get into your eyes, mouth or nostrils, and other very sensitive areas of the body. If this occurs, wash these areas immediately with plenty of warm water. • Avoid excessive exposure to sunlight and UV lamps. • Avoid getting the gel on your hair or coloured fabrics as it may bleach them. • Wash your hands thoroughly after you have used this medicine. Other medicines and Adapalene/Benzoyl peroxide gel Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 1
• •
Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time as Adapalene/Benzoyl peroxide gel. Avoid using this medicine at the same time as cosmetics that are irritant, drying or exfoliate the skin.
Pregnancy and breast-feeding Pregnancy Do not use Adapalene/Benzoyl peroxide gel if you are pregnant or if you are planning to have a baby. Your doctor can give you more information. If you become pregnant while using this medicine, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up. Breast-feeding Adapalene/Benzoyl peroxide gel can be used during breast-feeding. To avoid contact exposure of the infant, application of this gel to the chest should be avoided. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Not relevant Adapalene/Benzoyl peroxide gel contains propylene glycol which may cause skin irritation. This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel which is equivalent to 4.00% w/w. Adapalene/Benzoyl peroxide gel contains benzoic aicd, a degradation product of benzoyl peroxide, which can cause local irriration.
3.
How to take it
Adapalene/Benzoyl peroxide gel
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Adapalene/Benzoyl peroxide gel 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 the 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 the gel. Your doctor will tell you how long you will need to use the gel. 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 using this medicine, contact your doctor. Your doctor may recommend you to apply a moisturiser, 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 gel than you should If you use more gel 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: • If you have used more gel than you should. 2
• If a child has accidentally taken this medicine. • If you accidentally swallow this medicine. Your doctor will advise you on action to be taken. If you forget to use Adapalene/Benzoyl peroxide gel Do not apply a double dose to make up for forgotten individual doses.
4.
Possible side effects
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 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 effects (may affect up to 1 in 10 people): • dry skin • local skin rash (irritative contact dermatitis) • burning sensation • irritation of the skin • reddening of the skin • 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 face, allergic contact reactions • swelling of the eyelid • tightness in the throat • pain of skin (stinging pain) • blisters (vesicles) • difficulty in breathing • skin discolouration (change in skin colour) • application site burn.
If skin irritation appears after application of the gel, it is generally mild to moderate, with local signs as redness, dryness, scaling, burning and skin pain (stinging pain), which peak during the first week and resolve without additional treatment. Application site burns are in general superficial, but more severe cases involving blistering have been reported. 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. 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.
How to store it
Adapalene/Benzoyl peroxide gel
Keep this medicine out of the sight and reach of children. 3
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 the tube, use the gel 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.
6.
Contents of the pack and other information
What Adapalene/Benzoyl peroxide gel contains The active substances are adapalene and benzoyl peroxide. 1 g of gel contains 1 mg (0.1%) adapalene and benzoyl peroxide hydrous, equivalent to 25 mg (2.5% w/w) anhydrous benzoyl peroxide. The other ingredients are propylene glycol (E1520), glycerol, sepineo P600 (co-polymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, sorbitan oleate), poloxamer 124, disodium edetate, docusate sodium, purified water. What Adapalene/Benzoyl peroxide gel looks like and contents of the pack White to pale yellow, homogeneous, opaque gel. The gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE head, having an aluminium peel-off seal and closed with a white polypropylene screw-cap. Pack sizes: 1 tube of 30 g, 45 g or 60 g. Not all pack sizes may be marketed. Marketing Authorisation Holder Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germany Manufacturer Beltapharm S.p.A Via Stelvio 66 20095 Cusano Milanino Milan Italy
This leaflet was last revised in 06/2025.
4
Frequently asked questions about Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel
How do I take Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel?
Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel comes as gel containing 0.1% / 2.5%. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel?
The active substance in Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel is adapalene, benzoyl peroxide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w Gel without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: adapalene, benzoyl peroxide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Cutaneous treatment of Acne vulgaris when comedones, papules and pustules are present (see section 5.1).
Adapalene/Benzoyl peroxide gel is indicated in adults, adolescents and children aged 9 years and above.
4.2. Posology and method of administration
Adapalene/Benzoyl peroxide gel 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).
If irritation occurs, the patient should be directed to apply non-comedogenic moisturisers, 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 Adapalene/Benzoyl peroxide gel have not been studied in children below 9 years of age.
Method of administration
Cutaneous use only.
Patients should be instructed to wash their hands after applying the medicinal product.
4.3. Contraindications
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
• Pregnancy (see section 4.6)
• Women planning a pregnancy (see section 4.6)
4.4. Special warnings and precautions for use
Adapalene/Benzoyl peroxide gel should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned.
Adapalene/Benzoyl peroxide gel should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, it should be washed immediately with warm water.
If a reaction suggesting sensitivity to any component of the formula occurs, the use of Adapalene/Benzoyl peroxide gel should be discontinued.
Excessive exposure to sunlight or UV radiation should be avoided.
Adapalene/Benzoyl peroxide gel should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.
Excipients
This medicine contains 40 mg propylene glycol (E1520) in each gram of gel, which is equivalent to 4.00% w/w, that may cause skin irritation.
This medicine can contain up to 2.5 mg of benzoic acid per g of gel, as degradation product of benzoyl peroxide. Benzoic acid may cause local irritation.
4.5. Interaction with other medicinal products and other forms of interaction
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 the gel. However, other retinoids or benzoyl peroxide or medicinal products 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 Adapalene/Benzoyl peroxide gel.
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.
4.6. Fertility, pregnancy and lactation
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 into 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
Adapalene/Benzoyl peroxide gel is contraindicated in pregnancy or in women planning a pregnancy (see section 4.3).
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 using this medicinal product, treatment should be discontinued.
Breast-feeding
No study on animal or human milk transfer was conducted after cutaneous application of Adapalene/Benzoyl peroxide gel.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to this medicinal product is negligible. Adapalene/Benzoyl peroxide gel can be used during breast-feeding.
To avoid contact exposure of the infant, application of Adapalene/Benzoyl peroxide gel to the chest should be avoided when used during breast-feeding.
Fertility
No human fertility studies were conducted with Adapalene/Benzoyl peroxide peroxide gel.
However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies (see section 5.3).
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Adapalene/Benzoyl peroxide gel may cause the following adverse reactions at the site of application:
MedDRA System Organ Class
Frequency
Adverse drug reaction
Eye disorders
Not known (cannot be estimated from the available data)*
Eyelid oedema
Immune system disorders
Not known (cannot be estimated from the available data)*
Anaphylactic reaction
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 (≥1/1 000 to <1/100)
Pruritus, sunburn
Not known (cannot be estimated from the available data)*
Allergic contact dermatitis, swelling face, pain of 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 Adapalene/Benzoyl peroxide gel, 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 product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Adapalene/Benzoyl peroxide gel is for once-daily cutaneous use only.
In case of accidental ingestion, appropriate symptomatic measures should be taken.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Adapalene, Benzoyl peroxide. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Differin partial — not the same combinationAdapalenum
- Acnelec partial — not the same combinationAdapalenum
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Adapalene/Benzoyl peroxide 0.1 %w/w, 2.5 %w/w 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.