0.1% / 2.5% gel 
adapalene / benzoyl peroxide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Epiduo is and what it is used for 
2. What you need to know 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 Epiduo is and what it is used for

Epiduo is for the treatment of acne.

This gel combines two active substances, adapalene and benzoyl peroxide, which work together but in different ways:

Adapalene belongs to a group of medicines called retinoids and they act specifically on the processes in the skin that cause acne.

The other active ingredient, benzoyl peroxide, acts as a bactericide and by softening and flaking the outer layer of skin.

The adapalene and benzoyl peroxide contained in Epiduo may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Epiduo

Do not use Epiduo

  • If you are pregnant
  • If you are planning to become pregnant
  • If you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

  • You should not use Epiduo in areas where you have cuts, abrasions, sunburn, or eczema.
  • Make sure that Epiduo does not get into the eyes, mouth or nostrils, or other very sensitive areas of the body. Should this occur, immediately rinse these areas with plenty of warm water.
  • Avoid excessive exposure to sunlight and UV radiation.
  • Avoid getting Epiduo in your hair or on colored fabrics as the gel can cause bleaching. Also, wash your hands thoroughly after using the medicine.

Talk to your doctor or pharmacist before using Epiduo.

Other medicines and Epiduo

  • Do not use other acne products (which contain benzoyl peroxide and/or retinoids ) at the same time as Epiduo.
  • Avoid using Epiduo at the same time as irritating cosmetics, dehydrating, or cause scaling of the skin.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

DO NOT use Epiduo if you are pregnant or planning to become pregnant. Your doctor can give you more information.

If you become pregnant while taking Epiduo, treatment must be stopped and you should inform your doctor as soon as possible for further follow-up.

Epiduo can be used during breast-feeding. To avoid exposing the baby, you should avoid applying Epiduo to your chest.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Not relevant.

Epiduo contains propylene glycol (E1520), an ingredient that may cause skin irritation.

3. How to use Epiduo

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Epiduo is only intended for the treatment of adults, adolescents, and children aged 9 years and up. This medicine is for topical use only.

Apply gel one in a thin layer on the acne-affected areas once daily at bedtime. Avoid eyes, lips,s, and nostrils. The skin should be clean and dry before application. You should wash your hands thoroughly after using Epiduo.

Your doctor will tell you how long you need to use Epiduo.

If you have the impression that the effect of Epiduo is too strong or too weak, talk to your doctor or pharmacist.

If you experience any persistent irritation when applying Epiduo, consult a doctor. You may be asked to apply a moisturizer, use gel less often or discontinue treatment for a short period, or discontinue treatment altogether.

If you use more Epiduo than you should 

If you use more Epiduo on your skin than you need, you will not get rid of your acne faster but your skin may become irritated and red.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Epiduo

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

4. Possible side effects

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

Stop using the product and contact your healthcare provider immediately if you develop a feeling of tightness in the throat or swelling of the eyes, face, lips, or tongue, feel weak, or have difficulty breathing. Stop using the product if you get hives or itching on your face or body. The frequency with which these side effects occur is not known.

Common side effects are (may affect up to 1 in 10)

  • Dry skin
  • Local skin rash (irritating contact dermatitis )
  • Burning sensation in the skin
  • Skin irritation
  • Redness
  • Peeling

Less common side effects are (may affect up to 1 in 100)

  • Itching of the skin ( pruritus )
  • Solved

Has been reported (occurs in an unknown number of users): swollen face, allergic contact dermatitis, swelling of the eyelids, feeling of tightness in the throat, pain in the skin (stabbing pain), blisters (vesicles, difficulty breathing, discoloration of the skin (change in skin color), burns at the application site.

If skin irritation occurs after application of Epiduo, it is usually mild to moderate, with local symptoms such as redness, dryness, scaling, burning sensation, and pain in the skin (stabbing pain), and is greatest during the first week and then subsides without further treatment.

Burns at the application site, most superficial but also more severe cases of blistering have been reported.

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 which is stated on the carton. The expiration date is the last day of the specified month.

The tube or multi-dose container with the pump should be discarded 6 months after it was first opened.

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. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are adapalene and benzoyl peroxide. 1 g of gel contains 1 mg (0.1%) of adapalene and 25 mg (2.5%) of benzoyl peroxide.
  • The other ingredients are docusate sodium, disodium edetate, glycerol, poloxamer, propylene glycol (E1520), Simulgel 600PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, sorbitan oleate), and purified water.

What the medicine looks like and the contents of the pack

Epiduo is a white to very pale yellow, opaque gel.

Epiduo is provided in

White plastic tubes with screw caps containing 5 g, 15 g, 30 g, 45 g, 60 g, or 90 g (not all pack sizes may be marketed).

White multi-dose containers with pump with lids containing 15 g, 30 g, 45 g, and 60 g (not all pack sizes may be marketed).

Manufacturer

Galderma Laboratories

ZI – Montdésir

74 540 Alby sur Chéran

France

This medicinal product is authorized under the European Economic Area under the 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

Belgium, Finland, France, Greece, Iceland, Italy, Luxembourg, Norway, Poland, UK, Germany, Austria: Epiduo 0.1% / 2.5% gel

Muhammad Nadeem

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