EPIDUO 1 mg/g + 25 mg/g GEL

Introduction

Package Leaflet: Information for the User

Epiduo 1 mg/g + 25 mg/g 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.

Contents of the pack

1. What is Epiduo and what is it used for
2. What you need to know before you use Epiduo
3. How to use Epiduo
4. Possible side effects
5. Storage of Epiduo
6. Contents of the pack and other information

1. What is Epiduo and what is it used for

Epiduo is used for the treatment of acne.

This gel is a combination of two active substances, adapalene and benzoyl peroxide, which work together but have different mechanisms of action:

Adapalene belongs to a group of products known as retinoids and acts specifically on the skin processes that cause acne.

The other active substance, benzoyl peroxide, acts as an antimicrobial agent and softens and sheds the outermost layer of the skin.

2. What you need to know before you use Epiduo

Do not use Epiduo:

• If you are pregnant
• If you plan to become pregnant
• 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

• Do not use Epiduo on areas where you have cuts, scratches, sunburn, or eczema.

• Make sure Epiduo does not get into your eyes, mouth, or nasal passages, and other sensitive areas of the body. If this happens, rinse the areas immediately with plenty of warm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Avoid getting Epiduo on your hair or colored fabrics as it may discolor them, and wash your hands carefully after using this medicine.

Consult your doctor or pharmacist before using Epiduo

Using Epiduo and other medicines:

• Do not use other acne products (that contain benzoyl peroxide and/or retinoids) at the same time as Epiduo.
• Avoid using Epiduo at the same time as cosmetics that are irritating, drying, or shedding the skin.
• Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding:

Do not use Epiduo if you are pregnant or plan to become pregnant. Your doctor may give you more information. If you become pregnant while using Epiduo, treatment should be discontinued and you should inform your doctor as soon as possible for follow-up.

Epiduo can be used during breastfeeding. To avoid contact exposure to the infant, Epiduo should not be applied to the breast.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Not applicable

Epiduo contains propylene glycol

This medicine contains 40 mg of propylene glycol (E1520) in each unit dose equivalent to 40 mg/g.

Epiduo contains polysorbates

Polysorbates may cause allergic reactions.

3. How to use Epiduo

Follow exactly the instructions of administration of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Epiduo should only be used in adults, adolescents, and children from 9 years of age.

This medicine is for external use only.

Apply a thin layer of gel evenly over the affected areas of acne once a day before bedtime, avoiding the eyes, lips, and nostrils. The skin should be clean and dry before application. You should wash your hands carefully after using Epiduo.

Your doctor will indicate how long you need to use Epiduo.

If you think the action of Epiduo is too strong or too weak, tell your doctor or pharmacist.

If you suffer from persistent irritation when applying Epiduo, contact your doctor.

You may be advised to apply a moisturizing product, use the gel less frequently, stop using it for a short period, or stop using it altogether.

If you use more Epiduo than you should

If you use more Epiduo than you should on the skin, it will not cure your acne more quickly and your skin may become irritated and red.

Contact your doctor or hospital:

• If you have used more Epiduo than you should.
• If a child has taken this medicine accidentally.
• If you ingest this medicine accidentally

Your doctor will indicate what measures should 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.

Stop using the product and consult your doctor immediately if you develop tightness in the throat or swelling of the eyes, face, lips, or tongue, if you feel weak or have difficulty breathing. Stop using the product if you develop hives or itching on the face or body. These side effects occur with an unknown frequency.

Common(may affect up to 1 in 10 people).

• Dry skin
• Local skin rash (irritant contact dermatitis)
• Burning sensation
• Skin irritation
• Redness of the skin
• Peeling

Uncommon(may affect up to 1 in 100 people).

• Itching of the skin (pruritus)
• Sunburn

Frequency not known(frequency cannot be estimated from the available data): swelling of the face, allergic contact reactions, swelling of the eyelids, tightness in the throat, pain in the skin (stinging), blisters (vesicles), difficulty breathing, discoloration of the skin (change in skin color), burning at the application site.

If skin irritation occurs after applying Epiduo, it is usually mild to moderate, with local signs of redness, dryness, peeling, burning, and stinging, with a peak during the first week and resolving without additional treatment.

Burning at the application site has been reported, mostly superficial but also more severe cases involving the appearance of blisters.

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

Discard the tube or the multidose container with airless pump 6 months after first opening.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

Composition of Epiduo

The active substances are adapalene and benzoyl peroxide. 1 g of gel contains 1 mg (0.1%) of adapalene and benzoyl peroxide hydrate, equivalent to 25 mg (2.5%) of anhydrous benzoyl peroxide.

The other ingredients are sodium docusate, disodium edetate, glycerol, poloxamers, propylene glycol (E1520), Simulgel 600 PHA (acrylamide/sodium acryloyldimethyltaurate copolymer, isohexadecane, polysorbate 80 (E433), sorbitan oleate), and purified water.

Appearance and pack size of the product:

Epiduo is a white to very pale yellow opaque gel.

Epiduo is available in:

White plastic tubes with screw cap of 5g, 15g, 30g, 45g, 60g, or 90g (not all pack sizes may be marketed).

White airless pump multidose containers of 15g, 30g, 45g, and 60g (not all pack sizes may be marketed).

Marketing authorisation holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Laboratoires Galderma

Z.I.- Montdésir

74540, Alby-sur-Chéran

France

or

Galderma Laboratorium Gmbh

Toulouser Allee 23a

40211 Düsseldorf

Germany

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 in 1 g gel

Other countries: Epiduo 0.1%/2.5% gel

This leaflet was approved in: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es