Patient Leaflet Updated 18-Oct-2024 | Galderma (U.K) Ltd
Epiduo 0.1%/2.5% Gel
Epiduo® 0.1% / 2.5% Gel
adapalene / benzoyl peroxide
GEL
cutaneous use
Epiduo 0.1% / 2.5% gel
Adapalene/Benzoyl Peroxide
1. What Epiduo is and what it is used for
2. What you need to know before you use Epiduo
3. How to use Epiduo
4. Possible side effects
5. How to store Epiduo
6. Contents of the pack and other information
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.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
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.
Not relevant.
This medicine contains 40 mg propylene glycol (E1520) in each gram which is equivalent to 4% w/w.
Polysorbates can cause allergic reactions.
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 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 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 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:
Your doctor will advise you on action to be taken.
Do not apply a double dose to make up for forgotten individual doses.
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 (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
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.
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.
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.
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).
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 mg/g 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
GALDERMA
P24569-18
Evergreen House North, Grafton Place, London, NW1 2DX, UK