EPIDUO 0.1% + 2.5% Gel

Contents of the leaflet

7. What is Epiduo and what is it used for
8. Important information before using Epiduo
   1. When not to use Epiduo:
   2. Warnings and precautions
   3. Epiduo and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Epiduo contains propylene glycol
   7. This medicine contains 40 mg of propylene glycol (E1520) per gram, which corresponds to 4%
   8. Epiduo contains polysorbates
9. How to use Epiduo
   1. Using more than the recommended dose of Epiduo
   2. Missing a dose of Epiduo
10. Possible side effects
    1. Reporting side effects
11. How to store Epiduo
12. Contents of the packaging and other information
    1. What Epiduo contains:
    2. What Epiduo looks like and what the pack contains:
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

1.

What is Epiduo and what is it used for

2.

Important information before using Epiduo

3.

How to use Epiduo

4.

Possible side effects

5.

How to store Epiduo

6.

Contents of the packaging and other information

1. What is Epiduo and what is it used for

Epiduo is used to treat acne vulgaris.
The 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 works specifically on the processes in the
skin that cause acne.
The second active substance of the medicine, benzoyl peroxide, has antibacterial effects and softens and
exfoliates the outer layer of the skin.

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

• Epiduo should not be used on skin areas with cuts, abrasions, or eczema (dermatitis).
• Be careful not to get Epiduo in your eyes, mouth, nose, or other 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 and hair or dyed fabrics, as it may discolor them. After applying the medicine, wash your hands thoroughly. Before starting treatment with Epiduo, discuss this with your doctor.

Epiduo and other medicines

• Do not use other anti-acne medicines (containing benzoyl peroxide and/or retinoids) at the same time as Epiduo.
• Avoid using Epiduo and cosmetics that cause irritation, dryness, or exfoliation of the skin. Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to use.

Pregnancy and breastfeeding

DO NOT use Epiduo during pregnancy or if you are planning to become pregnant.
For more information, consult your doctor.
If you become pregnant while using Epiduo, stop treatment and inform your doctor as soon as possible for further monitoring.
Epiduo can be used during breastfeeding. To avoid exposing the baby to the medicine, do not apply Epiduo to the breast area.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

No effects have been observed.

Epiduo contains propylene glycol

This medicine contains 40 mg of propylene glycol (E1520) per gram, which corresponds to 4%

w/w.

Epiduo contains polysorbates

Polysorbates may cause allergic reactions.

3. How to use Epiduo

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Epiduo is intended for use in adults, adolescents, and children from 9 years of age.
The medicine is for use on the skin only.
Apply a thin layer of the medicine evenly to the affected skin area once a day, before bedtime, avoiding contact with the eyes, mouth, and nostrils. Before applying the medicine, the skin should be clean and dry. After applying the medicine, wash your hands 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, talk to your doctor or pharmacist.
If you experience persistent irritation while using Epiduo, contact your doctor.
Your doctor may recommend using moisturizing creams, applying the gel less frequently, interrupting treatment for a while, or stopping treatment altogether.

Using more than the recommended dose of Epiduo

Using more Epiduo than recommended will not make acne disappear faster, but may cause irritation and redness of the skin.
Please contact your doctor or hospital:

Missing a dose of Epiduo

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

4. Possible side effects

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

• dry skin,
• local rash (irritant contact dermatitis),
• burning sensation,
• skin irritation,
• redness of the skin,
• peeling of the skin.

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

• itching of the skin,
• sunburn.

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

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

Skin irritation that may occur after using Epiduo is usually mild or moderate, with local symptoms such as redness, dryness, peeling, or burning of the skin, and skin pain (prickling pain), most pronounced in the first week of use and resolving without additional treatment.
Burns at the application site are usually superficial, but more severe cases with blisters have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this 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

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 packaging 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 benzoyl peroxide, equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• The other ingredients are: Simulgel 600 PHA (acrylamide and sodium acryloyldimethyltaurine copolymer dispersion 40% in isohexadecane), polysorbate 80 (E433), sorbitan oleate, disodium edetate, glycerol, poloxamer 124, propylene glycol (E1520), purified water.

What Epiduo looks like and what the pack contains:

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

Marketing authorization holder

Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warsaw
Poland
phone: +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 authorized in the Member States of the European Economic Area and the United Kingdom (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 in 1 g gel
Other countries: Epiduo 0.1% / 2.5% gel
Date of 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: https://www.galderma-epiduo.info.pl/
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