Epiduo Forte 3 mg/g + 25 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Epiduo Forte 3 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, tell your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Epiduo Forte is and what it is used for

Epiduo Forte gel belongs to a group of medicines known as "anti-acne topical preparations", i.e. it is used for the treatment of acne vulgaris in the presence of comedones (blackheads and whiteheads), and numerous papules and pustules (inflamed pimples).

This gel contains two active substances, adapalene and benzoyl peroxide, which act together but through different mechanisms:

• Adapalene belongs to a group of medicines known as retinoids and acts specifically on the skin processes that cause acne.
• Benzoyl peroxide acts as an antimicrobial agent and softens and peels the outermost layer of the skin.

Epiduo Forte gel should only be used in adolescents aged 12 years and older, and in adults.

2. What you need to know before using Epiduo Forte

Do not use this medicine:

• 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 of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Epiduo Forte gel.

• Do not use this medicine on areas of skin with cuts, scratches, sunburn or eczema.
• Make sure this medicine does not come into contact with your eyes, mouth, nostrils, mucous membranes, or other sensitive areas of the body. If this occurs, wash the affected areas immediately with plenty of lukewarm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Avoid contact of this gel with your hair or coloured fabrics, as it may cause bleaching. Wash your hands thoroughly after applying this medicine.

If you experience persistent skin irritation when starting treatment with this medicine, consult your doctor (see section 3 How to use Epiduo Forte).

Other medicines and Epiduo Forte gel

• Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) at the same time as this medicine.
• Avoid using this medicine simultaneously with cosmetics that are irritating, drying, or exfoliating to the skin.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy and breastfeeding

Pregnancy

DO NOT use Epiduo Forte if you are pregnant or planning to become pregnant. Your doctor can provide further information.

If you become pregnant while using Epiduo Forte gel, you must stop treatment and inform your doctor as soon as possible for further follow-up.

Breastfeeding

If you are breastfeeding, consult your doctor before using this medicine. Your doctor will advise whether you should discontinue breastfeeding or avoid treatment with this medicine.

If your doctor advises continuing treatment, avoid applying the gel to the chest area to prevent contact exposure to the nursing infant.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

Epiduo Forte contains propylene glycol

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

Epiduo Forte contains polysorbates

Polysorbates may cause allergic reactions.

3. How to use Epiduo Forte

Follow exactly the instructions for using this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

This medicine is intended for use only in adults, adolescents, and children aged 12 years and older.

This medicine is a gel for use on the skin.

Your doctor will decide the dose you need, depending on the severity and appearance of your acne. Your doctor will also determine whether you require any additional treatment.

• The skin should be clean and dry before application.
• Apply a thin, even layer of gel to all affected acne-affected areas of the face and/or trunk once daily before bedtime. Avoid contact with the eyes, lips, nostrils, and mucous membranes.
• If used on the face: wash and dry the face, and use an amount the size of a pea to cover each area of the face (e.g., forehead, chin, cheeks).
• Wash your hands thoroughly after applying Epiduo Forte gel.

Your doctor will inform you how long you need to use this medicine. If you do not see any improvement after 4–8 weeks, discuss with your doctor whether continuing treatment is beneficial.

If you experience persistent skin irritation during the first few weeks of using this medicine, contact your doctor. They may recommend using a moisturizing cream, applying the gel less frequently, temporarily interrupting treatment, or discontinuing it altogether.

Do not apply cosmetics (such as other facial creams or makeup) before the daily application of this medicine. These products may be used after the applied gel has dried.

Use in children

This medicine must not be used in children under 12 years of age.

If you use more Epiduo Forte gel than you should

Using more gel than recommended will not cure your acne more quickly and may cause skin irritation and redness.

Contact your doctor or hospital if:

• you have used more gel than recommended,
• a child has accidentally taken this medicine,
• you or someone else has accidentally ingested this medicine.

Your doctor will advise on the necessary steps to take.

If you forget to use Epiduo Forte gel

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

If you stop using Epiduo Forte gel

Acne lesions (comedones, papules, and pustules) will only improve after several applications of this medicine. It is important that you continue using Epiduo Forte gel for as long as your doctor has prescribed.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Approximately 1 in every 10 people using Epiduo Forte gel may experience cutaneous adverse reactions.

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

Common (may affect up to 1 in 10 people)

• Skin irritation
• Eczema
• Burning sensation on the skin
• Skin redness
• Peeling

Uncommon (may affect up to 1 in 100 people)

• Eyelid redness
• Tingling or pins and needles sensation at the application site
• Itching of the skin, skin allergic reaction
• Rash
• Dry skin

In addition to the adverse effects described above, the following adverse effects have been reported with lower-dose Epiduo gel (adapalene 1 mg/g / benzoyl peroxide 25 mg/g):

Uncommon (may affect up to 1 in 100 people)

• Sunburn

Frequency not known (frequency cannot be estimated from available data)

• Eyelid inflammation
• Throat tightness
• Contact allergic reaction
• Facial swelling
• Skin pain (pricking pain)
• Blisters (vesicles)
• Difficulty breathing
• Skin discoloration (change in skin color)
• Burning at the application site

Adverse reactions typically associated with the use of Epiduo include mild to moderate reactions at the application site, such as skin irritation with redness, dryness, peeling, pricking pain, and/or burning of the skin.

Application site burns have been reported, mostly superficial, but also more severe cases involving blister formation.

If you experience persistent skin irritation during the first weeks of using Epiduo Forte gel, contact your doctor. Adverse reactions such as skin irritation are more frequent with Epiduo Forte gel than with lower-dose Epiduo gel. You may be advised to use a moisturizing cream, to apply the gel less frequently, or to interrupt treatment temporarily or permanently. These reactions usually occur at the beginning of treatment and tend to gradually decrease over time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Epiduo forte

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

Do not use this medicine after the expiry date stated on the carton and tube/multidose container. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Expiry date after first opening of the tube: 7 days.

Expiry date after first opening of the multidose container with airless pump: 6 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Epiduo Forte

• The active substances are: adapalene and benzoyl peroxide. One gram of gel contains 3 mg (0.3%) of adapalene and 25 mg (2.5%) of hydrated benzoyl peroxide, equivalent to 25 mg (2.5%) of anhydrous benzoyl peroxide.
• The other components are: disodium edetate, sodium docusate, glycerol, poloxamers, propylene glycol (E1520), Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyl taurate, isohexadecane, polysorbate 80 (E433), sorbitan oleate) and purified water. See end of section 2 for more information.

Nature of the product and pack contents

Epiduo Forte is an opaque white to very pale yellow gel.

Epiduo Forte gel is available in:

• A 2 g or 5 g plastic tube.

• A multidose container with an airless pump of 15, 30, 45 or 60 g.

• Not all pack sizes may be marketed.

Marketing Authorization Holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible:

Laboratoires Galderma

Zone Industrielle Montdésir

74540 Alby sur Chéran

France

or

Galderma Laboratorium GmbH

Toulouser Allee 23a

40211 Düsseldorf

Germany

This medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Belgium, Cyprus, Czech Republic, Germany, Greece, Luxembourg, Poland and Slovakia: Epiduo Forte

Estonia, Denmark, Ireland, Latvia, Lithuania and Malta: Epiduo

Finland, France, Iceland, Italy, Norway, Sweden and United Kingdom (Northern Ireland): Epiduo 0.3%/2.5% gel

Bulgaria and Spain: Epiduo Forte 3 mg/g + 25 mg/g gel

Croatia and Portugal: Epiduo 3 mg/g + 25 mg/g gel

Hungary and the Netherlands: Effezel Forte

Romania: Epiduo Forte 3 mg/25 mg/g gel

This leaflet was approved in: September 2025

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