EPIDUO FORTE 3 mg/g + 25 mg/g GEL

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, 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 Package Leaflet

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

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

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

This gel is a combination of two active substances, adapalene and benzoyl peroxide, which act jointly but by 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 sheds the outermost layer of the skin.

Epiduo Forte gel should only be used in adolescents from 12 years of age and in adults.

2. What you need to know before you use Epiduo Forte

Do not use this medicine:

• If you are pregnant
• If you are planning 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

Consult your doctor or pharmacist before using Epiduo Forte gel.

• Do not use this medicine on areas where you have cuts, scratches, sunburn, or eczema.
• Make sure this medicine does not get into your eyes, mouth, or nasal passages, or mucous membranes 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 this medicine gel in contact with your hair or colored tissues as it may discolor them, and wash your hands carefully after using this medicine.

If you experience persistent skin irritation when you start 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 products (containing benzoyl peroxide and/or retinoids) at the same time as this medicine.
• Avoid using this medicine at the same time as cosmetics that are irritating, drying, or exfoliating to the skin.

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

Pregnancy and breastfeeding

Pregnancy

DO NOT use Epiduo Forte if you are pregnant or plan to become pregnant. Your doctor may give you more information.

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

Breastfeeding

If you are breastfeeding, ask your doctor for advice before using this medicine. Your doctor will advise you whether to stop breastfeeding or avoid treatment with this medicine.

If your doctor advises you to continue treatment, you should avoid applying the gel to the breast to prevent contact exposure of the infant.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

Epiduo Forte contains propylene glycol

This medicine contains 40 mg of propylene glycol (E1520) per unit dose, 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 administration of this medicine given by your doctor. Consult your doctor or pharmacist if you are unsure.

This medicine should only be used in adults, adolescents, and children from 12 years of age.

This medicine is a gel to be used on the skin.

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

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

Your doctor will tell you how long you need to use this medicine. If you do not see any improvement after 4-8 weeks, you should discuss with your doctor the benefit of continuing treatment.

If you experience persistent skin irritation during the first few weeks when using this medicine, contact your doctor. You may be advised to apply a moisturizing cream, use the gel less frequently, interrupt for a short period, or stop treatment altogether.

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

Use in children

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

If you use more Epiduo Forte gel than you should

If you use more gel 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 gel than you should.
• a child has accidentally taken this medicine.
• you or someone else has accidentally ingested this medicine.

Your doctor will tell you what measures to take.

If you forget to use Epiduo Forte gel

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

If you stop treatment with Epiduo Forte gel

Spots (comedones, papules, and pustules) will only be reduced after several applications of this medicine. It is important that you continue using Epiduo Forte gel for as long as your doctor prescribes.

If you have any other questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

About 1 in 10 people using Epiduo Forte gel may experience skin reactions.

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)

• Skin irritation
• Eczema
• Burning sensation on the skin
• Redness of the skin
• Flaking

Uncommon (may affect up to 1 in 100 people)

• Redness of the eyelid
• Tingling or sensation of pins and needles at the application site
• Itching on the skin, allergic skin reaction
• Rash
• Dry skin

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

Uncommon (may affect up to 1 in 100 people)

• Sunburn

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

• Lid inflammation
• Tightness in the throat
• Contact allergic reaction
• Facial inflammation
• Skin pain (stabbing pain)
• Blisters (vesicles)
• Difficulty breathing
• Discoloration of the skin (change in skin color).
• Burning at the application site

The adverse reactions typically associated with the use of Epiduo include local reactions of mild to moderate severity, such as skin irritation with redness, dryness, flaking, stabbing pain, and/or burning of the skin.

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

If you experience persistent skin irritation during the first few weeks when using Epiduo Forte gel, contact your doctor. The adverse reaction, such as skin irritation, is more frequent with Epiduo Forte gel than with Epiduo gel of lower strength. You may be advised to apply a moisturizing cream, use the gel less frequently, interrupt for a short period, or stop treatment altogether. These reactions usually occur at the start of treatment and tend to decrease gradually over time.

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 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 Forte

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 and tube/multidose container. The expiry date is the last day of the month stated.

Do not store above 25°C.

Expiry date after first opening: 3 months.

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. Contents of the pack and other 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 benzoyl peroxide hydrate, equivalent to 25 mg (2.5%) of anhydrous benzoyl peroxide.
• The other ingredients are: disodium edetate, sodium docusate, glycerol, poloxamers, propylene glycol (E1520), Simulgel 600 PHA (acrylamide/sodium acryloyldimethyltaurate copolymer, isohexadecane, polysorbate 80 (E433), sorbitan oleate) and purified water. See the end of section 2 for more information.

Appearance of the product and contents of the pack

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

Epiduo Forte gel is available in:

A 2 or 5g plastic tube.

A 15, 30, 45, or 60g airless pump multidose container.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Laboratoires Galderma

Zone Industrielle 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:

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 the United Kingdom (Northern Ireland): Epiduo 0.3 %/ 2.5% gel

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

Croatia and Portugal: Epiduo 3mg/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: 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