Epiduo forte

Package leaflet: Information for the patient

Epiduo Forte, 0.3% + 2.5%, gel
Adapalene + Benzoyl peroxide
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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 agents", meaning it is used in the treatment of acne with comedones, numerous papules 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 specifically affects skin processes that cause acne.
• Benzoyl peroxide has antimicrobial action and softens and desquamates the outer layer of the skin. Epiduo Forte should only be used in adults and adolescents aged 12 years and older.

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 treatment with Epiduo Forte, discuss this with your doctor or pharmacist.
• Do not use Epiduo Forte on skin areas with cuts, abrasions, sunburn, or rash (eczema).
• Take care to avoid contact of Epiduo Forte with eyes, mouth, nose, or other sensitive areas of the body. If contact occurs, rinse the area thoroughly with plenty of warm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Avoid contact of Epiduo Forte with hair and dyed surfaces, as it may cause bleaching. Hands should be washed carefully after applying Epiduo Forte. If persistent skin irritation occurs after starting treatment with 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 medications (containing benzoyl peroxide and/or retinoids) at the same time as Epiduo Forte.
• Avoid using Epiduo Forte together with cosmetics that may irritate, dry, or exfoliate the skin. Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used. Pregnancy and breastfeeding Pregnancy DO NOT use Epiduo Forte during pregnancy or if the patient is planning to become pregnant. For further information, consult your doctor. If pregnancy occurs while using Epiduo Forte, treatment must be discontinued immediately and the doctor should be informed promptly for further monitoring. Breastfeeding If the patient is breastfeeding, she should consult her doctor before using this medicine. The doctor will decide whether to discontinue breastfeeding or avoid treatment with Epiduo Forte. If the doctor recommends continuing treatment, avoid applying the gel to the chest area to prevent the infant’s exposure to the medicine. Driving and operating machinery Epiduo Forte has no effect or has a negligible effect on the ability to drive and operate machinery. Epiduo Forte contains propylene glycol. This medicine contains 40 mg of propylene glycol (E1520) per gram, 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 directed by the doctor. If in doubt, consult a
doctor or pharmacist.
Epiduo Forte is intended for use in adults and children aged 12 years and older.
Epiduo Forte is a gel for topical use on the skin.
The doctor will decide which strength of Epiduo gel is appropriate, depending on the severity and appearance
of acne. The doctor will also determine whether additional treatment is necessary.

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

The doctor will inform the patient how long to continue using Epiduo Forte. If no improvement is observed after 4–8
weeks, discuss with the doctor whether continuing treatment is beneficial.
If persistent skin irritation occurs after starting Epiduo Forte gel, contact the doctor. The doctor may
advise using a moisturizing cream, reducing the frequency of application, temporarily discontinuing use, or permanently stopping the gel.
Do not use cosmetics (such as facial creams or other makeup products) before the daily application of Epiduo Forte. These products may be used after the applied gel has dried.
Use in children
Epiduo Forte must not be used in children under 12 years of age.
Use of more than the recommended dose of Epiduo Forte
Using more Epiduo Forte than recommended will not make acne clear up faster and may cause skin irritation and redness.
Please contact a doctor or hospital:

• if more Epiduo Forte has been used than recommended,
• if a child has accidentally used the medicine,
• if the patient or someone else has accidentally swallowed the medicine. The doctor will advise on the necessary steps. Missed dose of Epiduo Forte Do not apply a double dose to make up for a missed dose. Stopping Epiduo Forte Skin lesions (comedones, papules, and pustules) will improve only after several applications of this medicine. Continue using Epiduo Forte for as long as directed by the doctor. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Skin-related adverse reactions may be expected in approximately 1 in 10 people using Epiduo Forte gel.
Discontinue use and seek immediate medical attention if the patient experiences throat tightness or swelling of the eyes, face, lips, or tongue, weakness, or difficulty breathing. Discontinue use if the patient develops hives or itching of the face or body.
The frequency of these adverse reactions is unknown.

Common (may affect up to 1 in 10 people):

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

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

• eyelid redness,
• tingling or pricking sensation at the application site,
• skin itching, skin allergic reaction,
• eruption,
• dry skin.

In addition to the adverse reactions listed above, the following adverse reactions have also been reported after using the lower-dose product Epiduo gel (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 available data):

• eyelid swelling,
• sensation of throat tightness,
• allergic contact dermatitis,
• facial swelling,
• skin pain (burning pain),
• blisters,
• breathing difficulties,
• skin discoloration (changes in skin color),
• application site burn.

Typical adverse reactions associated with the use of Epiduo include mild to moderate local reactions such as redness, dryness, peeling, skin burning, and/or stinging sensation. Application site burns are usually superficial, but more severe cases with blister formation have been reported. If persistent irritation occurs during the first weeks of using Epiduo Forte gel, the patient should contact their doctor. Skin-related adverse reactions 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%). The doctor may advise the patient to use a moisturizing cream, reduce the frequency of application, temporarily discontinue use, or completely stop using the gel. The aforementioned reactions usually occur during the initial treatment period and tend to gradually diminish over time.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration 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. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps 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 stated on the cardboard box, tube, or on the multidose container with pump after the abbreviation EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Period of validity after first opening of the tube: 7 days
Period of validity after first opening of the container with pump: 6 months.
Medicines must not be disposed of via the sewage system 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

What Epiduo Forte contains

• The active substances are: adapalene and benzoyl peroxide. One gram of gel contains 3 mg (0.3% w/w) of adapalene and hydrated benzoyl peroxide equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• Other ingredients are: disodium edetate, sodium docoglycol, glycerol, poloxamer 124, propylene glycol (E1520), Simulgel 600 PHA (acrylamide and acryloyldimethyltaurate copolymer dispersion 40% in isohexadecane, polysorbate 80 (E433), sorbitan oleate) and purified water. More detailed information is provided 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 tubes containing 2 or 5 grams of gel and in multi-dose packages with a pump containing 15 or 30 grams of gel.

Not all pack sizes may be available on the market.

Marketing Authorisation Holder
Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warszawa
Poland
Tel.: +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 authorised for marketing in the European Economic Area countries 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

Detailed information on the use of this medicinal product is available by scanning the QR code located on the patient leaflet and on the packaging using a smartphone. The same QR information is also available at the following address: https://www.galderma-kod-epiduo.info.pl/