Epiduo forte

Leaflet attached to the packaging: patient information

Epiduo Forte, 0.3% + 2.5%, gel
Adapalene + Benzoyl peroxide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Epiduo Forte and what is it used for
• 2. Important information 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 is Epiduo Forte and what is it used for

Epiduo Forte gel belongs to a group of medicines called "topical anti-acne medicines" meaning it is used to treat acne with blackheads, many pimples and pustules.
This gel contains two active substances, adapalene and benzoyl peroxide, which work together but in different ways.

• -Adapalene belongs to a group of medicines called retinoids and acts specifically on the processes in the skin that cause acne.
• -Benzoyl peroxide has an antibacterial effect and also softens and peels off the outer layer of the skin.

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

2. Important information before using Epiduo Forte

When not to use Epiduo Forte:

• In pregnant women
• In women planning to become pregnant
• If the patient is allergic to adapalene, benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Epiduo Forte, discuss it with your doctor or pharmacist.

• -Do not use Epiduo Forte on areas of the skin where there are cuts, abrasions, sunburn or eczema.
• -Be careful not to get Epiduo Forte in your eyes, mouth, nose or other very sensitive areas of the body. If this happens, rinse the area with plenty of warm water.
• -Avoid excessive exposure to sunlight and UV lamps.
• -Avoid contact between Epiduo Forte and hair or dyed surfaces, as it may discolour them. Wash your hands carefully after using Epiduo Forte.

If you experience persistent skin irritation after starting to use Epiduo Forte gel, contact your doctor (see section 3. How to use Epiduo Forte).

Epiduo Forte and other medicines

• -Do not use other anti-acne medicines (containing benzoyl peroxide and/or retinoids) at the same time as Epiduo Forte.
• -Avoid using Epiduo Forte and cosmetics that cause irritation, dryness or peeling of the skin at the same time.

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about medicines you plan to take.

Pregnancy and breastfeeding

Pregnancy
DO NOT USE Epiduo Forte during pregnancy, or if you are planning to become pregnant.
More information can be obtained from your doctor.
If you become pregnant while using Epiduo Forte, stop the treatment and inform your doctor as soon as possible for further monitoring.
Breastfeeding
If you are breastfeeding, consult your doctor before using this medicine. The doctor will decide whether to stop breastfeeding or not to use Epiduo Forte treatment.
If the doctor recommends continuing treatment, avoid applying the gel to the breast area to prevent the baby from coming into contact with the medicine.

Driving and using machines

Epiduo Forte has no influence or negligible influence on the ability to drive and use machines.

Epiduo Forte contains propylene glycol

This medicine contains 40 mg of propylene glycol (E1520) per gram, which is equivalent to 4% w/w.

Epiduo Forte contains polysorbates

Polysorbates may cause allergic reactions.

3. How to use Epiduo Forte

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Epiduo Forte is intended for use in adults and children from 12 years of age.
Epiduo Forte is a gel for use on the skin.
Your doctor will decide which strength of Epiduo Forte to use, depending on the severity of your acne and its appearance. Your doctor will also decide whether to use additional treatment.

• The skin should be clean and dry before applying the gel.
• -Apply a thin layer of gel evenly to the entire affected area of the face and/or trunk once a day, before bedtime. Avoid contact with the eyes, mouth, nostrils and mucous membranes.
• -When using on the face: wash and dry the face and apply a pea-sized amount to each area of the face (e.g. forehead, chin, each cheek)
• -After applying Epiduo Forte, wash your hands immediately and thoroughly.

Your doctor will tell you how long to use Epiduo Forte. If there is no improvement after 4-8 weeks, discuss the benefits of continuing treatment with your doctor.
If you experience persistent skin irritation after starting to use Epiduo Forte gel, contact your doctor. The doctor may ask you to use a moisturizing cream, use the medicinal product less frequently, temporarily stop using it or stop using the gel altogether.
Do not use cosmetics (such as facial creams or other makeup products) before daily application of Epiduo Forte. These products can be applied after the gel has dried.

Use in children

Epiduo Forte should not be used in children under 12 years of age.

Using more than the recommended dose of Epiduo Forte

Using more than the recommended dose of Epiduo Forte will not get rid of acne any quicker, but may cause irritation and redness of the skin.
Please contact your doctor or hospital:

• -if you have used more Epiduo Forte than recommended,
• -if a child has accidentally used the medicine,
• -if you or someone else has accidentally swallowed the medicine.

Your doctor will advise what to do next.

Missing a dose of Epiduo Forte

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

Stopping use of Epiduo Forte

Blackheads, pimples and pustules will only decrease after several applications of this medicine.
Continue to use Epiduo Forte for as long as your doctor tells you to.
If you have any further 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 side effects on the skin.
Stop using the medicine and seek immediate medical attention if you experience throat tightness or swelling of the eyes, face, lips or tongue, weakness or difficulty breathing. Stop using the medicine if you experience hives or itching of the face or body.
The frequency of these side effects is not known.
Common( may affect up to 1 in 10 people):

• skin irritation,
• eczema,
• burning sensation of the skin,
• redness of the skin,
• peeling of the skin.

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

• eyelid redness,
• tingling or stinging sensation at the application site,
• itching of the skin, skin allergic reaction,
• rash,
• dryness of the skin.

Besides the side effects listed above, the following side effects have also been reported with the use of a lower strength of Epiduo Forte (adapalene 0.1% + benzoyl peroxide 2.5%):
Uncommon (may affect up to 1 in 100 people):

• sunburn

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

• eyelid swelling,
• feeling of throat tightness,
• allergic contact dermatitis,
• facial swelling,
• skin pain (stinging pain),
• blisters,
• breathing difficulties,
• skin colour changes (changes in skin colour),
• irritation at the application site.

Typical side effects associated with the use of Epiduo Forte include mild to moderate reactions at the application site, such as redness, dryness, peeling, burning sensation of the skin and/or stinging sensation of the skin.
Irritation at the application site is usually superficial, but more severe cases with blisters have been reported.
If you experience persistent skin irritation during the first few weeks of using Epiduo Forte gel, contact your doctor. Skin-related side effects such as skin irritation occur more frequently with Epiduo Forte (0.3% + 2.5%) than with the lower strength Epiduo gel 0.1% + 2.5%. Your doctor may ask you to use a moisturizing cream, use the medicinal product less frequently, temporarily stop using it or stop using the gel altogether. The above reactions usually occur during the initial treatment period and tend to decrease over time.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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, tube or pump pack after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Shelf-life 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. This will help protect the environment.

6. Contents of the pack and other information

What Epiduo Forte contains

• Active substancesare: adapalene and benzoyl peroxide. One gram of gel contains 3 mg (0.3% w/w) adapalene and benzoyl peroxide hydrate, equivalent to 25 mg (2.5% w/w) anhydrous benzoyl peroxide.
• Other ingredientsare: disodium edetate, sodium docusate, glycerol, poloxamer 124, propylene glycol (E1520), Simulgel 600 PHA (acrylamide and acryloyldimethyltaurine copolymer dispersion 40% in isohexadecane, polysorbate 80 (E433), sorbitan oleate) and purified water. More detailed information is given at the end of section 2.

What Epiduo Forte looks like and contents of the pack

Epiduo Forte is a white or very pale yellow, opaque gel.
Epiduo Forte is available in:
pump packs containing 15 or 30 grams of the medicine.
Not all pack sizes may be marketed.

Marketing authorization holder

Galderma Poland Sp. z o.o.
Puławska 145 Street
02-715 Warsaw
Poland
phone: +48 22 331 21 80

Manufacturer/Importer

Laboratoires Galderma
Z.I. 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) 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 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
Date of last revision of the leaflet: 17.10.2024.
Detailed information on the use of this medicine is available by scanning the QR code on the patient leaflet and packaging using a smartphone. The same information is also available at the following address: https://www.galderma-epiduo.info.pl/
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