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 0.3% / 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 a gel, used on the skin. Epiduo gel belongs to a group of medicines called "anti-acne preparation The doctor will decide which strength of Epiduo gel you need, depending on the topical use" it is used for the treatment of acne vulgaris, when severity and appearance of your acne. The doctor will also decide if you need (blackheads, whiteheads), numerous papules and pustules (inflammatory any additional treatment. pimples) are present. skin should be clean and dry before application. This gel combines two active ingredients, adapalene and benzoyl peroxide Apply a thin film of gel evenly over the entire acne-affected areas of the face work together but in different ways: the trunk, once a day at bedtime. Avoid contact with the eyes, lips, Adapalene belongs to a group of products known as retinoids and acts nostrils and mucous membranes. specifically on the skin processes that cause acne. If used on the face: wash and dry the face and use a pea size amount to cover Benzoyl peroxide, works as an antimicrobial agent and by softening and each part of the face (e.g. forehead, chin, each cheek). peeling the outer layer of the skin. Wash your hands thoroughly immediately after you have applied Epiduo gel. Epiduo 0.3% / 2.5% gel should only be used in adults and adolescents Your doctor will tell you how long you will need to use Epiduo 0.3% / 2.5% gel. years and over. |If you do not see any improvement after 4-8 weeks you YUU should discuss with your doctor the benefit of the treatment. continuing you need to know before you use Epiduo If you using you experience persistent skin irritation during the first weeks when using Do not use Epiduo gel: moisturiser, Epiduo may your gel, apply contact doctor. You be asked to to use a are pregnant often, time, stop stop gel gel. the less to for short or to using the a using are planning a pregnancy Do not apply cosmetics (such as other facial creams or make-up) before the daily If you are allergic to adapalene or benzoyl peroxide or any of the other application of Epiduo gel. These products can be used after the applied gel has ingredients of this medicine (listed in section 6). dried. Warnings and precautions Use in in children Talk to your doctor or pharmacist before using Epiduo gel. Epiduo 0.3% / 2.5% gel should not be used by children below 12 years of age. You should not use Epiduo gel on areas where you have cuts, scrapes, or eczema. If you use more Epiduo gel than you should you use more Epiduo gel than you should on your skin, you will not get rid of Make sure Epiduo gel does not get into your eyes, mouth or nostrils, or membranes and other very sensitive areas of the body. Should this occur wash acne any quicker, but your skin may become irritated and red. areas immediately with plenty of warm water. Please contact your doctor or the hospital if: Avoid excessive exposure to sunlight and UV lamps. you have used more Epiduo gel than you should Avoid getting Epiduo gel on your hair or coloured fabrics as it may bleach a child has accidentally taken this medicine and wash your hands thoroughly after you have used Epiduo gel. you or someone else accidentally swallow this medicine. you experience persistent skin irritation when starting treatment with Epiduo doctor will advise you on what action needs to be taken. gel contact your doctor (see section 3.How to use Epiduo). If you forget to use Epiduo gel Other medicines and and Epiduo gel apply a double dose Do not apply dose to make up for a forgotten dose peroxide and or retinoids) you stop using Epiduo gel Do not use other acne products (containing came time as Epiduo gel. at the same The spots (comedones, papules and pustules) will be reduced only after several Avoid using Epiduo gel at the same time as cosmetics that irritate, dry or applications of this medicine. Continue using Epiduo gel as long as prescribed by exfoliate the skin. your Tell your doctor or pharmacist if you are using, have recently used or might use If you have any further questions on the use of this medicine, ask your doctor or any other medicines. pharmacist. Pregnancy and breast-feeding
What you need to know before you take it
e Epiduo 3. How to use Epiduo 4. Possible side effects 5. How to store Epiduo 6. Contents of the pack and other information –
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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 Epiduo 0.3% / 2.5% gel. If your doctor advises you to continue the treatment, avoid application of the gel to the chest inin order to avoid contact exposure of the infant. Driving and using using machines Driving Epiduo gel has no or negligible effects on the ability to drive and use machines. machine Epiduo contains propylene glycol This medicine contains 40 mg propylene glycol (E1520) in each gram which is equivalent to 4% Epiduo contains polysorbates Polysorbates can cause allergic reactions.
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How to take it
Epiduo Always use this medicine exactly as your doctor has told you. Check with your
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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.
Possible side effects
Pregnancy all medicines, this medicine can cause side effects, although not everybody DO NOT use Epiduo if you are pregnant thinking to become pregnant. gets them. doctor can give you more information. 1 in 10 people using Epiduo 0.3% / 2.5% gel may experience you fall pregnant while taking Epiduo 0.3% / 2.5% gel, the treatment must discontinued and you should inform your doctor as soon as possible for a further adverse skin reactions. follow-up. –
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P Code: P27840-7 Description: EPIDUO 0.3 DS GEL 45GM
SGK
Market: GBR Article: Leaflet Designation: TBC Plan No:
Colours and Varnishes:
Dimensions: 180X315 Cutter Ref: Printer: N/A Print Process: N/A Print Spec: N/A
Service Order: 404100174 Version No: V8 Date: 10-07-2025 Operator: NS Barcode: 2826 Mag: 100% BWR: 0 mm
GALDERMA
PANTONE 432 U
Version No:
ARTWORK
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, Marketing Authorisation Holder difficulty breathing. Stop using the product if you develop hives or itching of Galderma UK Limited face or body. The frequency with which these side effects occur is not known. House North Grafton Place Common (may affect up to 1 in 10 people): of the skin London NW1 2DX United Kingdom. Eczema Skin burning sensation Manufacturer Reddening of the skin Laboratoires Galderma Sc aling Scaling Uncommon (may affect up to 1 in 100 people): 74540 Alby-sur-Chéran Redness of the eyelid France and at Tingling or sensation of pins and needles at the application site This medicine is authorised in the Member States of the European Economic Itching of the skin, allergic skin reaction Area and in the United Kingdom (Northern Ireland) under the following names: Rash Belgium, Cyprus, Czech Republic, Germany, Greece, Luxembourg, Poland and Dry skin Slovakia: Epiduo Forte In addition to the side effects described above, the following side effects have Estonia, Denmark, Ireland, Latvia, Lithuania and Malta: Epiduo been reported with a lower strength of Epiduo gel (adapalene 0.1% / benzoyl Finland, France, Iceland, Italy, Norway, Sweden and United Kingdom (Northern peroxide 2.5%): Ireland): Epiduo 0.3% / 2.5% gel Bulgaria and Spain: Epiduo Forte 3 mg/g + 25 mg/g Gel Uncommon (may affect up to 1 in 100 people): Sunburn Croatia and Portugal: Epiduo 3 mg/g + 25 mg/g Gel Hungary and Netherlands: Effezel Forte Not known (frequency cannot be estimated from the available data) Romania: Epiduo Forte 3 mg/25 mg/g gel Swelling of the eyelid Tightness in the throat This leaflet was last revised in July 2025. Allergic contact reactions Sw elling fac facee swelling 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% % 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. Reporting of side effects 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 at: 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. –
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How to store it
Epiduo 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 for pump: 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.
Contents of the pack and other information
What Epiduo 0.3% / 2.5% gel contains peroxide. One gram of The active substances are adapalene and adapalene and gel contains mg (0.3 % peroxide hydrous, equivalent to 25 mg (2.5% w/w) anhydrous benzoyl peroxide. The other ingredients are disodium edetate, docusate sodium, glycerol, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80 (E433), sorbitan oleate) and purified water. See end of section 2 for further information. What Epiduo 0.3% / 2.5% gel looks like and contents of the pack Epiduo gel is a white to very pale yellow opaque gel. Epiduo gel is available in: One plastic tube containing 2 or 5 grams One pump containing 15, 30, 45, or 60 grams. Not all pack sizes may be marketed. –
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GALDERMA
P Code: P27840-7 Description: EPIDUO 0.3 DS GEL 45GM
SGK
Market: GBR Article: Leaflet Designation: TBC Plan No:
Colours and Varnishes:
Dimensions: 180X315 Cutter Ref: Printer: N/A Print Process: N/A Print Spec: N/A
Service Order: 404100174 Version No: V8 Date: 10-07-2025 Operator: NS Barcode: 2826 Mag: 100% BWR: 0 mm
GALDERMA
PANTONE 432 U
Version No:
ARTWORK
Frequently asked questions about Epiduo 0.3% / 2.5% gel
How do I take Epiduo 0.3% / 2.5% gel?
Epiduo 0.3% / 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 0.3% / 2.5% gel?
The active substance in Epiduo 0.3% / 2.5% gel is benzoyl peroxide, adapalene.
Are there equivalent medicines to Epiduo 0.3% / 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 0.1%/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 0.3% / 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 0.3% / 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
Epiduo 0.3% / 2.5% gel is indicated for the cutaneous treatment of Acne vulgaris, when comedones, numerous papules and pustules are present (see sections 4.2 and 5.1).
Epiduo 0.3% / 2.5% gel is indicated in adults and adolescents aged 12 years and over.
4.2. Posology and method of administration
Posology
Epiduo 0.3% / 2.5% gel should be applied once a day in the evening to the entire acne affected areas of the face and the trunk on a clean and dry skin.
The duration of treatment should be determined by the doctor based on the overall clinical condition and on the therapeutic response to the treatment. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment. If no improvement is observed after 4-8 weeks of treatment, the benefit of continued treatment should be reconsidered.
A lower strength of Epiduo is available (Epiduo 0.1% / 2.5% gel) and this concentration should be considered in patients with moderate acne vulgaris (see section 5.1).
When the entire face is involved with numerous papulopustules, an increased clinical benefit was observed in the subjects treated with Epiduo 0.3% / 2.5% gel compared with the reference therapy (Epiduo 0.1% / 2.5% gel). Doctors may choose between the two concentrations based on the presenting patient's clinical condition and severity.
Special populations
Elderly
The safety and efficacy of Epiduo 0.3% / 2.5% gel in geriatric patients aged 65 years and above have not been established.
Renal and hepatic impairment
Epiduo 0.3% / 2.5% gel has not been studied in patients with renal and hepatic impairment.
Paediatric population
The safety and efficacy of Epiduo 0.3% / 2.5% gel have not been studied in children below 12 years of age.
Method of administration
Cutaneous use only.
Apply a thin layer of Epiduo 0.3% / 2.5% gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g. forehead, chin, each cheek), avoiding the eyes and lips (see section 4.4).
Patients should be instructed to wash their hands after applying the medicinal product.
Cosmetics may be applied after the medicinal product has dried.
If irritation occurs, the patient should be directed to apply non-comedogenic moisturisers as needed, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether.
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 0.3% / 2.5% gel should not be applied to damaged skin, either broken (cuts or abrasions), sunburn or eczematous skin.
The medicinal product should not come into contact with the eyes, lips, 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 Epiduo 0.3% / 2.5% gel should be discontinued.
Excessive exposure to sunlight or UV radiation should be avoided.
Epiduo 0.3% / 2.5% gel should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.
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.
The efficacy and safety of Epiduo 0.3% / 2.5% gel in patients with severe nodular or deep nodulocystic acne have not been studied. As patients with severe nodular / nodulocystic acne are at increased risk of permanent scarring secondary to acne lesions, the use of Epiduo 0.3% / 2.5% gel in these patients is not recommended due to the risk of insufficient therapeutic response.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been conducted with Epiduo 0.3% / 2.5% gel.
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 0.3% / 2.5% gel. 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 the medicinal product.
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 0.3%/2.5% gel 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.
Breast-feeding
No study on animal or human milk transfer was conducted after cutaneous application of Epiduo 0.3% / 2.5% gel. Available pharmacokinetic data in rats have shown excretion of adapalene in milk after oral or intravenous administration of adapalene.
A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Epiduo 0.3% / 2.5% Gel therapy weighting the benefit of breast-feeding for the child and the benefit of therapy for the woman.
To avoid contact exposure of the infant, application of Epiduo 0.3% / 2.5% gel to the chest should be avoided when used during breast-feeding.
Fertility
No human fertility studies were conducted with Epiduo 0.3% / 2.5% 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
Epiduo 0.3% / 2.5% gel has no or negligible effects on the ability to drive and use machines.
4.8. Undesirable effects
Summary of safety profile
Approximately 10% of patients can be expected to experience adverse skin reactions. Treatment-related adverse reactions typically associated with use of Epiduo 0.3% / 2.5% gel include mild to moderate application site reactions, such as skin irritation mainly characterized by scaling, dryness, erythema, and burning/stinging. Recommendation is to use moisturiser, temporarily reduce the application frequency to every other day, or temporarily discontinue its use until once daily schedule can be resumed.
These reactions usually occur early in the treatment, and tend to gradually lessen over time.
Tabulated summary of adverse reactions
The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to 1<100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data) and were reported with Epiduo 0.3% / 2.5% gel in vehicle-controlled Phase 3 clinical study (see Table 1).
Table 1: Adverse reactions
System Organ Class
Frequency
Adverse reactions
Eye disorders
Uncommon
Erythema of eyelid
Not known*
Eyelid oedema
Immune system
Not known*
Anaphylactic reaction
Nervous system disorders
Uncommon
Paresthesia (tingling at application site)
Respiratory, thoracic and mediastinal disorders
Not known*
Throat tightness, dyspnea
Skin and subcutaneous tissue disorders
Common
Atopic dermatitis, eczema, skin burning sensation, skin irritation, erythema, skin exfoliation (scaling)
Uncommon
Dry skin, pruritus, rash
Not known*
Allergic contact dermatitis, swelling face, pain of skin (stinging pain) and blisters (vesicles), skin discolouration (hyperpigmentation or hypopigmentation), urticaria, application site burn**
*Post-marketing surveillance data reported since the global launch of Epiduo 0.1%/2.5% gel, from a population of unknown size
**Most of the cases of “application site burn” were superficial burns but cases with second degree burn or severe burn reactions have been reported.
Skin-related adverse events were more frequent with Epiduo 0.3% / 2.5% gel than Epiduo gel (Adapalene 0.1% / Benzoyl peroxide 2.5%) as compared to vehicle. In the pivotal study (see section 5.1), 9.2% of subjects in the combined population treated with Epiduo 0.3% / 2.5% gel had skin-related adverse events and 3.7% in the population treated with Epiduo gel compared to Vehicle Gel group (2.9%).
In addition to some of the above, other adverse drug reactions were reported with Epiduo gel (Adapalene 0.1% / Benzoyl peroxide 2.5%), the previously approved fixed combination of adapalene and benzoyl peroxide:
- Clinical trials:
Other adverse drug reactions reported in clinical trials with Epiduo gel are irritative contact dermatitis (common) and sunburn (uncommon).
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 0.3% / 2.5% gel is for once-daily cutaneous use only. Excessive application of Epiduo 0.3% / 2.5% gel may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.
In case of accidental ingestion, appropriate symptomatic measures should be taken.
💬 Ask about this leaflet
Ask anything about Epiduo 0.3% / 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.