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EPIDUO 0.1%/2.5% GEL

Active substance(s): ADAPALENE / BENZOYL PEROXIDE

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®

0.1% / 2.5% Gel
adapalene / benzoyl peroxide

GEL
cutaneous use

Package leaflet: Information for the user
Epiduo 0.1% / 2.5% gel
Adapalene/Benzoyl Peroxide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same
as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
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

1. What Epiduo is and what it is used 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.

2. What you need to know before you use Epiduo
Do not use Epiduo:
- if you are allergic to the active substances 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 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.
Pregnancy and breast-feeding
Epiduo should not be used during pregnancy.
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.
Epiduo contains propylene glycol (E1520), an ingredient that may cause skin irritation.

3. How to use 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 and adolescents aged 9 years and over.
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.

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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.
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.
Epiduo may cause the following side effects at the site of application.
Common side effects (occur in less than 1 in 10 patients)
- dry skin
- local skin rash (irritative contact dermatitis)
- burning sensation
- irritation of the skin
- redness
- scaling
Uncommon side effects (occur in less than 1 in 100 patients)
- itching of the skin (pruritus)
- sunburn
Unknown frequency of occurrence (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).
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.
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 www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store 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. 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.

6. Contents of the pack and other information

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What Epiduo contains
- The active substances are: Adapalene and benzoyl peroxide. One g of gel contains 1 mg (0.1 %) adapalene and 25 mg (2.5 %) benzoyl peroxide.
- The other ingredients are: docusate sodium, disodium edetate, glycerin, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (copolymer
of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, 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:
Plastic tubes containing 5g, 15g, 30g, 45g, 60g or 90g (not all pack sizes may be marketed).
Pumps containing 15 g, 30 g, 45 g or 60 g (not all pack sizes may be marketed).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Galderma (UK) Ltd.
Meridien House,
69-71 Clarendon Road,
Watford, Herts,
WD17 1DS, UK.
Manufacturer
Laboratoires Galderma
ZI – Montdésir
74 540 Alby sur Chéran
France
PL 10590/0057
This medicinal product is authorised in the Member States of the EEA under the following names :
Denmark, France: Epiduo, gel
Spain: Epiduo 1mg/g + 25 mg/g gel
Other countries: Epiduo 0.1% / 2.5% gel
This leaflet was last revised in February 2015

Product code: MOCK UP
Product description: EPIDUO GEL
Market: GBR
Article: Leaflet
Font size: 10 pt / Titles: 12 pt
Flat size: 180x315
Pharmacode: 772
Fold size: 180x26,25
Specification n° MT.09.MPS.1470

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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