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.
Epiduo 0.1%/2.5% 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 Benzoyl peroxide, Adapalene 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 Epiduo 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.
What you need to know before you take it
e Epiduo Do not use Epiduo: If you are pregnant 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 You should not use Epiduo on areas where you have cuts, scrapes, sunburn or eczema. Make sure Epiduo does not get into your eyes, mouth or nostrils, 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 Epiduo on your hair or coloured fabrics as it may bleach them and wash your hands thoroughly after you have used the medicine. Talk to your doctor or pharmacist before using Epiduo. Other medicines and Epiduo
- Do not use other acne products (containing benzoyl peroxide and / or retinoids) at the same time as Epiduo. Avoid using Epiduo 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 and breast-feeding DO NOT use Epiduo if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information. If you fall pregnant while taking Epiduo, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up. Epiduo can be used during breast-feeding. To avoid contact exposure of the infant, application of Epiduo to the chest should be avoided. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Not relevant. WOT Epiduo contains propylene glycol equivalent to 4% This medicine contains 40 mg propylene glycol (E1520) in each gram aram which is equivalent Epiduo contains polysorbates Polysorbates can cause allergic reactions. –
How to take it
Epiduo Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Epiduo is only intended for use in adults, adolescents and children aged 9 years and over. This medicine is for external use 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 Epiduo. Your doctor will tell you how long you will need to use Epiduo. If you feel that the effect of Epiduo is too strong or too weak, talk to your doctor or pharmacist. If you experience persistent irritation when applying Epiduo, 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 Epiduo than you should If you use more Epiduo 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 Epiduo than you should. If a child has accidentally taken this medicine. If you accidentally swallow this medicine. Your doctor will advise you on action to be taken.
NOTICE VERSO 180×315 PLAN n°
If you forget to use Epiduo 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 Common (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 (may affect up to 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 Epiduo, it is generally mild to moderate, with local signs as redness, dryness, scaling, burning and pain of 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 at: www.mhra.gov.uk/yellowcard or search for MHRA in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. –
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to store Epiduo How ta 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. The expiry date refers to the last day of that month. Discard the tube or pump 6 months after first opening. Do not store above 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.
Contents of the pack and other information
What Epiduo contains The active substances are: Adapalene and benzoyl peroxide. 1 of gel contains 1 mg (0.1% w/w) adapalene and benzoyl peroxide hydrous, equivalent to 25 mg (2.5% anhydrous benzoyl peroxide. The other ingredients are: docusate sodium, disodium edetate, glycerol, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80 (E433), sorbitan oleate) and purified water. What Epiduo looks like and contents of the pack Epiduo is a white to very pale yellow opaque gel. Epiduo is available in: White plastic tubes with screw-cap containing 5g, 15g, 30g, 45g, 60g or 90g (not all pack sizes may be marketed). White pumps with snap on cap containing 15g,| 30g,| 45g or 60g (not all pack sizes may be marketed). Marketing Authorisation Holder Galderma UK Limited, Evergreen House North, Grafton Place, London NW1 2 DX, United Kingdom. Manufacturer Laboratoires Galderma 74540 Alby sur Chéran France This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Denmark: Epiduo Croatia, Czech Republic, Portugal, Slovakia, Spain: Epiduo 1 mg/g + 25 mg/g gel Hungary, Netherlands: Effezel 1 mg/g + 25 mg/g gel Bulgaria, Estonia, Latvia, Lithuania, Romania: Epiduo 1 mg/25 gel Slovenia: Epiduo 1 mg/25 mg v 1 g gel Other countries: Epiduo 0.1% / 2.5% gel This leaflet was last revised in August 2024 –
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Frequently asked questions about Epiduo 0.1%/2.5% Gel
How do I take Epiduo 0.1%/2.5% Gel?
Epiduo 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.
What is the active substance in Epiduo 0.1%/2.5% Gel?
The active substance in Epiduo 0.1%/2.5% Gel is benzoyl peroxide, adapalene.
Are there equivalent medicines to Epiduo 0.1%/2.5% Gel?
Medicines with the same active substance, strength and form include: Adawell 0.1%/2.5% Gel, Adawell Forte 0.3%/2.5% Gel, Epiduo 0.3% / 2.5% gel. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Epiduo 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.
Can I get Epiduo 0.1%/2.5% 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: benzoyl peroxide, adapalene
- 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).
Epiduo is indicated in adults, adolescents and children aged 9 years and over.
4.2. Posology and method of administration
Epiduo should be applied to the entire acne affected areas once a day in the evening on a 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 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 Epiduo have not been studied in children below 9 years of age.
4.3. Contraindications
• Pregnancy (see section 4.6)
• Women planning a pregnancy (see section 4.6)
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Epiduo Gel should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned.
Epiduo should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water.
This medicine contains 40 mg propylene glycol (E1520) in each gram which is equivalent to 4 % w/w.
This medicine contains polysorbate 80 (E433), which can cause allergic reactions.
If a reaction suggesting sensitivity to any component of the formula occurs, the use of Epiduo should be discontinued.
Excessive exposure to sunlight or UV radiation should be avoided.
Epiduo should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.
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 Epiduo. 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 Epiduo.
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
Epiduo 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 Epiduo (adapalene / benzoyl peroxide) Gel.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to Epiduo is negligible. Epiduo can be used during breast-feeding.
To avoid contact exposure of the infant, application of Epiduo to the chest should be avoided when used during breast-feeding.
Fertility
No human fertility studies were conducted with Epiduo 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
Epiduo 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 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 (≥1/1000 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 Epiduo, 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 at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Epiduo is for once-daily cutaneous use only.
In case of accidental ingestion, appropriate symptomatic measures should be taken.
💬 Ask about this leaflet
Ask anything about Epiduo 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.