Product Information for the User

Epiduo 1 mg/g + 25 mg/g Gel

Adapaleno /Peróxido de Benzoilo

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, inform your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Epiduo and for what it is used

2. What you need to know before using Epiduo

3. How to use Epiduo

4. Possible adverse effects

5. Storage of Epiduo

6. Contents of the package and additional information

Epiduo is used for the treatment of acne.

This gel is a combination of two active principles, adapaleno and peroxide of benzoil, which act jointly but by different mechanisms:

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

The other active principle, peroxide of benzoil, acts as an antimicrobial agent and softens and peels the outer layer of the skin.

Do not use Epiduo:

• If you are pregnant
• If you plan to become pregnant
• If you are allergic to adapalene or benzoyl peroxide or to any of the other ingredients in this medication (including in section 6).

Warnings and precautions

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

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

Consult your doctor or pharmacist before using Epiduo

Using Epiduo and other medications:

• 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 irritating, drying, or peeling the skin.
• Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding:

DO NOT use Epiduo if you are pregnant or plan to become pregnant. Your doctor may provide you with more information. If you become pregnant while using Epiduo, the 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 exposure to the infant, avoid applying Epiduo to the breast.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No information available

Epiduo contains propylene glycol

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

Epiduo contains polysorbates

Polysorbates may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

This medication is only for external use.

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

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

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

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

You may be advised to apply a moisturizer, 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 on your skin than you should, your acne will not clear up faster, 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 medication by accident.
• If you accidentally ingest this medication.

Your doctor will tell you what measures to take.

If you forgot to use Epiduo

Do not apply a double dose to make up for the missed doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

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

• Dry skin
• Local skin rash (irritative contact dermatitis)
• Burning sensation
• Skin irritation
• Skin redness
• Peeling

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

• Itching on the skin (pruritus)
• Sunburn

Unknown frequency(the frequency cannot be estimated from available data): swelling of the face, contact allergic reactions, swelling of the eyelids, throat constriction, skin pain (stabbing pain), blisters (vesicles), difficulty breathing, skin discoloration (change in skin color), burn at the application site.

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

Severe burns at the application site have been reported, mostly superficial but also more severe cases involving the appearance of blisters.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box.The expiration date is the last day of the month indicated.

Dispose of the tubeor the multi-dose container with pumping without air entryafter 6months after opening it for the first time.

Do not store at a temperature above25°C.

Medicines should not be thrown away through drains or in the trash. Deposit the containers and medicines that you do not need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. By doing so, you will help protect the environment.

Composition of Epiduo :

The active ingredients are: adapaleno and benzoyl peroxide. 1 g of gel contains 1 mg (0.1%) of adapaleno and hydrated benzoyl peroxide, equivalent to 25 mg (2.5%) of anhydrous benzoyl peroxide.

The other components are: docusate sodium, disodium edetate, glycerol, poloxamers, propylene glycol (E1520), Simulgel 600 PHA ( acrylamide copolymer and acryloidimethyltaurato sodium, isohexadecano, polisorbate 80 (E433), sorbitan oleate) and purified water .

Appearance of the product and contents of the package:

Epiduo is a pale yellow to white opaque gel.

Epiduo is available in:

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

Multi-dose containers with white pump without air intake caps of 15g, 30g, 45g and 60g (not all package sizes may be marketed).

Marketing authorization holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Laboratoires Galderma

Z.I.- Montdésir

74540, Alby-sur-Chéran

France

or

Galderma Laboratorium Gmbh

Toulouser Allee 23a

40211 Düsseldorf

Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Danish: 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 has been approved in: October 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es