Patient Information Leaflet

Epiduo
Adapalene + Benzoyl Peroxide
0.1% + 2.5%, gel
Please read all of this leaflet carefully before using the medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

What Epiduo is and what it is used for
What you need to know before using Epiduo
How to use Epiduo
Possible side effects
How to store Epiduo
Contents of the pack and other information

1. What Epiduo is and what it is used for

Epiduo is used for the treatment of acne vulgaris.
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.
The other active ingredient, benzoyl peroxide, has antibacterial properties and softens and exfoliates the outer layer of the epidermis.

2. Important information before using Epiduo

When not to use Epiduo:

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

Warnings and precautions

Do not apply Epiduo to areas of skin that are cut, abraded or affected by eczema (dermatitis).
Take care to avoid contact of Epiduo with the eyes, mouth, nose or other sensitive areas. If contact occurs, rinse thoroughly with plenty of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of Epiduo with hair and dyed fabrics, as it may cause bleaching. After applying the medicine, hands should be thoroughly washed. Discuss this with your doctor before starting treatment with Epiduo.

Epiduo and other medicines

Do not use other acne medications (containing benzoyl peroxide and/or retinoids) at the same time as Epiduo.
Avoid using cosmetic products that irritate, dry out or exfoliate the skin while using Epiduo. Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to use.

Pregnancy and breastfeeding
DO NOT use Epiduo during pregnancy or if the patient is planning to become pregnant.
Further information should be obtained from the treating physician.
If pregnancy occurs during treatment with Epiduo, treatment must be discontinued immediately and the doctor informed as soon as possible for further monitoring.
Epiduo may be used during breastfeeding. To avoid exposing the infant to the medicine, do not apply Epiduo to the chest area.
Before using any medicine, consult a doctor or pharmacist.
Driving and operating machinery
No effects observed.
Epiduo contains propylene glycol.
This medicine contains 40 mg of propylene glycol (E1520) per gram, equivalent to 4% w/w.
Epiduo contains polysorbates.
Polysorbates may cause allergic reactions.

3. How to use Epiduo

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Epiduo is intended for use in adults, adolescents, and children aged 9 years and older.
This medicine is for topical use only.
Apply a thin layer of the medicine evenly to the skin area affected by acne once daily, before
bedtime, avoiding contact with the eyes, mouth, and nostrils. The skin should be clean and dry
before application. After applying Epiduo, hands should be washed thoroughly.
Your doctor will decide how long you should use Epiduo.
If you feel that the effect of Epiduo is too strong or too weak, consult your doctor or pharmacist.
If persistent irritation occurs during treatment with Epiduo, contact your doctor.
Your doctor may recommend using moisturizing creams, less frequent application of the gel,
temporarily discontinuing treatment, or completely stopping treatment.

Use of more Epiduo than recommended
Using more Epiduo than recommended will not make acne clear up faster and may cause skin
irritation and redness.
Please contact your doctor or hospital:

if more Epiduo has been used than recommended,
if the medicine has been used by a child by accident,
if the medicine has been swallowed accidentally. The doctor will advise what further steps should be taken.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop using the medicine and seek immediate medical help if the patient develops throat tightness or swelling of the eyes, face, lips or tongue, weakness or difficulty breathing. Discontinue use of the medicine if the patient develops hives or itching of the face or body. The frequency of these adverse effects is unknown.

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

dry skin,
localised rash (contact dermatitis due to irritation),
burning sensation,
skin irritation,
redness of the skin,
peeling of the skin.

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

itching of the skin,
sunburn.

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

itching of the face,
allergic contact reactions,
itching of the eyelids,
sensation of throat tightness,
skin pain (burning pain),
blisters on the skin,
breathing difficulties,
skin colour changes (changes in skin colour),
burning at the application site.

Skin irritation following application of Epiduo is usually mild or moderate in severity, with local symptoms such as redness, dryness, peeling, burning sensation and skin pain (pricking pain), most pronounced during the first week of treatment and resolving without additional therapy.
Burning at the application site is usually superficial; however, more severe cases with blistering have been reported.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Epiduo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Shelf life after first opening: 6 months.
Do not store above 25°C.
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 contains:

The active substances are: adapalene and benzoyl peroxide. 1 g of gel contains 1 mg (0.1% w/w) of adapalene and hydrated benzoyl peroxide equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
The other ingredients are: simulgel 600 PHA (acrylamide and sodium acryloyldimethyltaurate copolymer dispersion 40% in isohexadecane, polysorbate 80 (E433), sorbitan oleate), sodium docosanoate, disodium edetate, glycerol, poloxamer 124, propylene glycol (E1520), purified water.

What Epiduo looks like and contents of the pack:
Epiduo is a white or slightly yellow, opaque gel.
Epiduo is available in two types of packaging:
White plastic tubes (made of HDPE), with a neck made of HDPE, closed with a cap made of PP, containing 15 g, 30 g, or 60 g of gel, in a cardboard carton.
White, multi-dose, hermetically sealed containers with a pump, with a cap, made of PP, LDPE and HDPE, containing 15 g, 30 g, 45 g or 60 g of gel, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warszawa
Poland
tel.: +48 22 331 21 80

Manufacturer
Laboratoires Galderma
Z.I. Montdésir
74 540 Alby sur Chéran
France
or
Galderma Laboratorium GmbH
Toulouser Allee 23a
40211 Düsseldorf
Germany

This medicinal product is authorised in the European Economic Area and Great Britain (Northern Ireland) under the following names:
Denmark: Epiduo
Croatia, Czech Republic, Portugal, Slovakia, Spain: Epiduo 1 mg/g + 25 mg/g gel
Hungary, Netherlands: Effezel 1 mg/g + 25 mg/g gel
Bulgaria, Estonia, Latvia, Lithuania, Romania: Epiduo 1 mg/25 mg/g gel
Slovenia: Epiduo 1 mg/25 mg v 1 g gel
Other countries: Epiduo 0.1% / 2.5% 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 information is also available at the following website: https://www.galderma-epiduo.info.pl/
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