Epiduo 1 mg/g + 25 mg/g gel
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Epiduo 1 mg/g + 25 mg/g gel
Adapalene / Benzoyl Peroxide
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse reactions, inform your doctor or pharmacist, even if they are not listed in this leaflet. 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.
This gel is a combination of two active substances, adapalene and benzoyl peroxide, which work together but through different mechanisms:
Adapalene belongs to a group of medicines known as retinoids and specifically targets the skin processes that cause acne.
The other active substance, benzoyl peroxide, acts as an antimicrobial agent and softens and peels the outermost layer of the skin.
2. What you need to know before using Epiduo
Do not use Epiduo:
- If you are pregnant
- If you plan to become pregnant
- If you are allergic to adapalene or benzoyl peroxide, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
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Do not use Epiduo on areas with cuts, scrapes, sunburn or eczema.
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Make sure Epiduo does not come into contact with your eyes, mouth, nostrils, or other sensitive areas of the body. If this occurs, wash the areas immediately with plenty of lukewarm water.
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Avoid excessive exposure to sunlight and UV lamps.
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Avoid contact of Epiduo with your hair or colored fabrics, as it may cause bleaching. Wash your hands thoroughly after using this medicine.
Consult your doctor or pharmacist before using Epiduo.
Use of Epiduo with other medicines:
- Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) at the same time as Epiduo.
- Avoid using Epiduo together with cosmetics that are irritating, drying, or exfoliating to the skin.
- Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding:
DO NOT use Epiduo if you are pregnant or planning to become pregnant. Your doctor can provide further information. If you become pregnant while using Epiduo, treatment must be stopped immediately and you should inform your doctor as soon as possible for follow-up.
Epiduo may be used during breastfeeding. To avoid contact exposure to the infant, avoid applying Epiduo to the breast area.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Not applicable
Epiduo contains propylene glycol
This medicine contains 40 mg of propylene glycol (E1520) in each dose unit, equivalent to 40 mg/g.
Epiduo contains polysorbates
Polysorbates may cause allergic reactions.
3. How to use Epiduo
Follow exactly the instructions for administration of this medicine given by your doctor. If you have any doubts, consult your doctor or pharmacist.
Epiduo should only be used in adults, adolescents, and children aged 9 years and older.
This medicine is for external use only.
Apply a thin, even layer of gel to the affected acne areas once daily before bedtime, avoiding the eyes, lips, and nostrils. The skin should be clean and dry before application. Wash your hands thoroughly after using Epiduo.
Your doctor will advise you on how long you need to use Epiduo.
If you think that the effect of Epiduo is too strong or too weak, inform your doctor or pharmacist.
If you experience persistent irritation when applying Epiduo, contact your doctor.
You may be advised to apply a moisturizer, use the gel less frequently, stop using it for a short period, or stop using it altogether.
If you use more Epiduo than you should
Using more Epiduo than recommended will not cure your acne more quickly and may cause skin irritation and redness.
Contact your doctor or hospital:
- If you have used more Epiduo than you should.
- If a child has accidentally taken this medicine.
- If you accidentally ingest this medicine.
Your doctor will advise you on the necessary steps to take.
If you forget to use Epiduo
Do not apply a double dose to make up for a missed dose.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Stop using the product and consult your doctor immediately if you develop throat tightness or swelling of the eyes, face, lips, or tongue, or if you feel weak or have difficulty breathing. Stop using the product if you develop hives or itching on the face or body. These side effects occur with an unknown frequency.
Frequent (may affect up to 1 in 10 people):
- Dry skin
- Localized skin rash (irritant contact dermatitis)
- Burning sensation
- Skin irritation
- Skin redness
- Peeling
Uncommon (may affect up to 1 in 100 people):
- Itching of the skin (pruritus)
- Sunburn
Frequency not known (frequency cannot be estimated from available data): facial swelling, contact allergic reactions, eyelid swelling, throat tightness, skin pain (pricking pain), blisters (vesicles), difficulty breathing, skin discoloration (change in skin color), burning at the application site.
If skin irritation occurs after application of Epiduo, it is generally mild to moderate, with local signs of redness, dryness, peeling, burning, and skin pain (pricking pain), peaking during the first week and resolving afterward without additional treatment.
Application site burns have been reported, mostly superficial, but also more severe cases involving blister formation.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Epiduo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.
Discard the tube or the multidose pump container without air entry 6 months after first opening.
Do not store above 25°C.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Additional information
Composition of Epiduo:
The active substances are: adapalene and benzoyl peroxide. 1 g of gel contains 1 mg (0.1%) of adapalene and hydrated benzoyl peroxide equivalent to 25 mg (2.5%) of anhydrous benzoyl peroxide.
The other components are: sodium docusate, disodium edetate, glycerol, poloxamers, propylene glycol (E1520), Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyldimethyl taurate, isohexadecane, polysorbate 80 (E433), sorbitan oleate) and purified water.
Appearance of the product and contents of the container:
Epiduo is an opaque white to very pale yellow gel.
Epiduo is available in:
White plastic tubes with screw cap of 5 g, 15 g, 30 g, 45 g, 60 g or 90 g (not all pack sizes may be marketed).
Multidose containers with airless pump in white with press cap of 15 g, 30 g, 45 g and 60 g (not all pack sizes may be marketed).
Marketing Authorization Holder:
Laboratorios Galderma, S.A.
Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer responsible:
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 European Economic Area Member States and in 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 v 1 g gel
Other countries: Epiduo 0.1%/2.5% gel
This patient information leaflet has been approved in: October 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es