Label: information for the patient

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

adapaleno / peróxido de benzoilo

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for 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 do not appear in this label. See section 4.

Epiduo Forte gel belongs to a group of medications known as “topical anti-acne preparations”, meaning it is used for the treatment of common acne, in the presence of blackheads and whiteheads, numerous papules and pustules (inflamed bumps).

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

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

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

Do not use this medication:

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

Warnings and precautions

Consult your doctor or pharmacist before using Epiduo Forte gel.

• Do not use this medication on areas where you have cuts, scratches, sunburns, or eczema.
• Ensure that this medication does not enter your eyes, mouth, or nasal passages, or sensitive areas of the body. If this occurs, immediately wash the areas with plenty of warm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Avoid allowing this medication gel to come into contact with your hair or colored fabrics, as it may discolor them. Wash your hands carefully after using this medication.

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

Other medications and Epiduo Forte gel

• Do not use other acne products (containing benzyl peroxide and/or retinoids) at the same time as this medication..
• Avoid using this medication at the same time as cosmetics that are irritating, drying, or exfoliating 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

Pregnancy

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

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

Breastfeeding

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

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Epiduo Forte contains propylene glycol

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

Epiduo Forte contains polysorbates

Polysorbates may cause allergic reactions.

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

This medication should only be used in adults, adolescents, and children 12 years of age or older.

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

Your doctor will decide on the 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 must be clean and dry before application.
• Apply a thin layer of gel uniformly over all affected areas of acne on the face and/or trunk, once a day 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 (for example, forehead, chin, cheeks).
• Wash your hands carefully after using Epiduo Forte gel.

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

If you experience persistent skin irritation during the first weeks of using this medication, contact your doctor. You may be asked to apply a moisturizing cream, to use the gel less frequently, interrupt use for a short period of time, or discontinue use permanently.

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

Use in children

This medication should not be used by children under 12 years of age.

Using more Epiduo Forte gel than prescribed

If you use more gel than you should on your skin, 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 gel than you should.
• A child has taken this medication accidentally.
• You or someone else has ingested this medication accidentally.

Your doctor will tell you what measures to take.

Missing a dose of Epiduo Forte gel

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

Stopping treatment with Epiduo Forte gel

The pimples (comedones, papules, and pustules) will only decrease after several applications of this medication. It is essential to continue using Epiduo Forte gel for as long as your doctor prescribes.

If you have any other doubts about using this medication, consult your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Stop using the product and consult your doctor immediately if you develop a tight sensation in your 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 your face or body. These side effects occur at an unknown frequency.

Frequent (may affect up to 1 in 10 people)

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

Rare (may affect up to 1 in 100 people)

• Eye redness
• Itching or prickling sensation at the application site
• Itching on the skin, skin allergic reaction
• Rash
• Dry skin

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

Rare (may affect up to 1 in 100 people)

• Sunburn

Unknown frequency (the frequency cannot be estimated from the available data)

• Swollen eyelid
• Tight sensation in the throat
• Contact allergy reaction
• Swollen face
• Burning sensation on the skin (prickling pain)
• Blisters (vesicles)
• Difficulty breathing
• Change in skin color (skin discoloration)
• Burn at the application site

The typical reactions associated with the use of Epiduo include mild to moderate reactions at the application site, such as skin irritation with redness, dryness, peeling, prickling pain, and/or burning sensation on the skin.

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

If you experience persistent skin irritation during the first weeks of 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 at a lower dose. You may be asked to apply a moisturizing cream, to use the gel less frequently, to interrupt use for a short period of time, or to discontinue use permanently. These reactions usually occur at the beginning of treatment and tend to decrease gradually over time.

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the box and multi-dose tube/container. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Expiration date after first opening: 3 months.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment..

Composition of Epiduo Forte

• The active principles are: adapaleno and benzoyl peroxide. One gram of gel contains 3 mg (0.3%) of adapaleno and 25 mg (2.5%) of hydrated benzoyl peroxide. Equivalent to 25 mg (2.5%) of anhydrous benzoyl peroxide.
• The other components are: sodium edetate, sodium docusate, glycerol, poloxamers, propylene glycol (E1520), Simulgel 600 PHA ( acrylamide copolymer and sodium acryloyldimethyltaurate, isohexadecano, polisorbate 80 (E433), sorbitan oleate) and purified water . See the end of section 2 for more information.

Appearance of the product and contents of the packaging

Epiduo Forte is a pale yellow to white opaque gel.

Epiduo Forte gel is available in:

A plastic tube of 2 or 5g.

A multi-dose container with an airless pump of 15, 30, 45 or 60 g.

Not all packaging sizes may be marketed.

Marketing Authorization Holder:

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Laboratoires Galderma

Zone Industrielle Montdésir

74540 Alby sur Chéran

France

or

Galderma Laboratorium GmbH

Toulouser Allee 23a

40211 Düsseldorf

Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with 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 3mg/g + 25 mg/g gel

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

Hungary and Netherlands: Effezel Forte

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

This leaflet has been approved in: October 2024

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