Epiduo

Patient Information Leaflet: Information for the User

Epiduo 0.1%/2.5% gel

Adapalene/Benzoyl peroxide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 pack and other information

1. What Epiduo is and what it is used for

Epiduo is indicated for the treatment of acne.
Epiduo gel contains two active substances, adapalene and benzoyl peroxide, which act together but in different ways:
adapalene belongs to a group of substances known as retinoids and acts specifically on the skin processes that cause acne.
The other active substance, benzoyl peroxide, acts as an antibacterial agent and exerts a soothing and exfoliating effect on 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 are planning a pregnancy
• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Do not use Epiduo on areas where wounds, cuts, sunburn or eczema are present.
• Avoid contact of Epiduo with the eyes, mouth, nostrils and other highly sensitive areas of the body. If contact occurs, rinse the affected area immediately with plenty of lukewarm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Avoid contact of Epiduo with hair or coloured fabrics, as it may cause bleaching. Wash your hands thoroughly after using the medicine. Consult your doctor or pharmacist before using Epiduo.

Other medicines and Epiduo
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concomitantly with Epiduo.
Avoid using Epiduo together with cosmetic products that have irritating, drying or exfoliating effects on the skin.
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.

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, stop treatment immediately and inform your doctor as soon as possible for further advice.
Epiduo may be used during breastfeeding. To avoid contact exposure to the infant, do not apply Epiduo to the chest area.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Not applicable.

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

3. How to use Epiduo

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Epiduo is indicated for use only in adults, adolescents, and children aged 9 years and older. This medicine is for external use only.
Apply a thin layer of gel to the acne-affected areas once daily at bedtime, avoiding contact with the eyes, lips, and nostrils. Wash and dry the skin before each application. After applying the product, wash your hands thoroughly.
Your doctor will inform you for how long you should use Epiduo.
If you notice that the effect of Epiduo is too strong or too weak, consult your doctor or pharmacist.
If application of Epiduo causes persistent irritation, contact your doctor.
Your doctor may advise you to use a moisturizing cream, to apply the gel less frequently, to interrupt treatment for a short period, or to discontinue treatment permanently.
If you use more Epiduo than you should:
If you apply more Epiduo than recommended, your acne will not clear faster, but your skin may become irritated and red.
Please contact your doctor or hospital if:

• You have used more Epiduo than intended.
• A child has accidentally ingested the product.
• You have accidentally swallowed the product.

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 missed applications.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop using the product and contact your doctor immediately if you experience throat tightness or swelling of the eyes, face, lips or tongue, if you feel faint or have difficulty breathing.
Stop using the product if you develop hives or feel itching on your face or body. The frequency with which these adverse events may occur is unknown.

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

• Dry skin
• Localised skin rash (irritant contact dermatitis)
• Burning sensation
• Skin irritation
• Redness
• Desquamation

Uncommon side effects (may affect up to 1 in 100 people)

• Skin itching
• Sunburn

Frequency not known (cannot be estimated based on available data): facial swelling, contact allergic reactions, eyelid swelling, throat tightness, skin pain (pricking pain), blisters (vesicles), difficulty breathing, changes in skin colour, burning at the application site

If skin irritation occurs following application of Epiduo, it is generally mild or moderate, with local signs such as redness, dryness, desquamation, burning and skin pain (pricking pain), which usually peak during the first week and then resolve without additional treatment.
Cases of burning at the application site have been reported, mostly superficial, but also more severe cases with blistering.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help 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 pack. The expiry date refers to the last day of that month.
Discard the tube or the multi-dose container with airtight pump 6 months after first opening.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Epiduo contains

• 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 components are: docusate sodium, edetate disodium, glycerol, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyl-dimethyl taurate, isohexadecane, polysorbate 80, sorbitan oleate) and purified water.

Description of the appearance of Epiduo and contents of the pack
Epiduo is an opaque gel, white to pale yellow in colour.
Epiduo is available 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 multidose containers with an airtight pump containing 15 g, 30 g, 45 g and 60 g (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Galderma Italia S.p.A. – Registered office: Via dell’Annunciata 21 – Milan, Italy
Manufacturer
Laboratoires Galderma
ZI – Montdésir
74 540 Alby sur Chéran
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Epiduo, gel
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

More detailed information on this medicinal product is available by scanning the QR code on the package leaflet using a smartphone. The same information can also be accessed at the following URL: https://galdermainfo.it/epiduo/.

Patient Information Leaflet

Epiduo 0.3%/2.5% gel

adapalene/benzoyl peroxide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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 pack and other information

1. What Epiduo is and what it is used for

Epiduo gel belongs to a group of medicines called "anti-acne topical preparations".
It is used for the treatment of acne vulgaris when comedones (blackheads,
whiteheads) and numerous papules and pustules (inflamed pimples) are present.
This gel combines two active substances, adapalene and benzoyl peroxide, which act
together but in different ways:

• Adapalene belongs to a group of substances known as retinoids and acts specifically on the skin processes that cause acne.
• Benzoyl peroxide acts as an antibacterial agent and exerts a softening and keratolytic (exfoliating) effect on the outermost layer of the skin. Epiduo 0.3%/2.5% gel should only be used in adult and adolescent patients aged 12 years and older.

2. What you should know before using Epiduo

Do not use Epiduo gel:

• if you are pregnant
• if you are planning 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
Talk to your doctor or pharmacist before using Epiduo gel.

• Do not use Epiduo gel on areas of skin with cuts, abrasions, sunburn or eczema.

Avoid contact of Epiduo gel with eyes, mouth, nostrils, mucous membranes and other highly sensitive areas of your body. If contact occurs, rinse the affected area immediately with plenty of lukewarm water.

• Avoid excessive exposure to sunlight and UV lamps.
• Avoid contact of Epiduo gel with your hair or coloured fabrics, as it may cause bleaching. Wash your hands thoroughly after using Epiduo gel.

If you experience persistent skin irritation as soon as you start treatment with Epiduo gel, contact your doctor (see section 3 - How to use Epiduo gel).
Other medicines and Epiduo gel

• Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concurrently with Epiduo gel.
• Avoid using Epiduo gel together with cosmetic products that irritate, dry or exfoliate the skin. Other medicines may interact with Epiduo gel. Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
Pregnancy
DO NOT USE Epiduo 0.3%/2.5% if you are pregnant or planning to become pregnant. Your doctor can provide further information.
If you become pregnant while using Epiduo 0.3%/2.5% gel, stop treatment immediately and inform your doctor as soon as possible for further advice.
Breastfeeding
If you are breastfeeding, consult your doctor before using this medicine. Your doctor will advise whether you should discontinue breastfeeding or avoid treatment with Epiduo 0.3%/2.5% gel.
If your doctor advises you to continue treatment, do not apply the gel on the chest area in order to avoid contact exposure to the infant.
Driving and using machines
Epiduo gel has no or negligible effect on the ability to drive and operate machinery.
Epiduo 0.3%/2.5% gel contains propylene glycol (E1520), an ingredient which may cause local skin irritation (e.g. contact dermatitis).

3. How to use Epiduo

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Epiduo 0.3%/2.5% gel is intended for use only in adults and adolescents aged 12 years and older.
Epiduo is a gel for application to the skin.
Your doctor will decide which concentration of Epiduo gel is appropriate for you, depending on the severity and appearance of your acne. Your doctor will also determine whether you need additional treatment.

• The skin must be clean and dry before application.
• Apply a thin, uniform layer of gel once daily in the evening, before going to bed, over the entire acne-affected area (face and/or trunk). Avoid contact with the eyes, lips, nostrils, and mucous membranes.
• When used on the face: wash and dry your face, then apply an amount the size of a pea to each area of the face (for example, forehead, chin, each cheek).
• Wash your hands thoroughly immediately after applying Epiduo gel.

Your doctor will inform you how long you should use Epiduo 0.3%/2.5% gel. If you do not see any improvement after 4–8 weeks, contact your doctor to discuss whether continuing treatment is beneficial.
If persistent skin irritation occurs during the first weeks of using Epiduo gel, contact your doctor. You may be advised to use a moisturizing cream, to apply the medicine less frequently, to temporarily suspend treatment, or to discontinue it altogether.
Do not apply cosmetics (such as facial creams or makeup products) before the daily application of Epiduo gel. These products may be used after the gel has dried following application.

Use in children
Epiduo 0.3%/2.5% gel must not be used in children under 12 years of age.

If you use more Epiduo gel than you should
If you apply more Epiduo gel than recommended, your acne will not clear faster, but your skin may become irritated and red.
Contact your doctor or hospital if:

• you have used more Epiduo gel than intended;
• a child has accidentally ingested the product;
• you or someone else has accidentally swallowed this medicine.

Your doctor will advise you on the necessary steps to take.

If you forget to use Epiduo gel
Do not apply a double dose to make up for a missed application.

If you stop using Epiduo gel
Pimples (comedones, papules, and pustules) will only improve after several applications of this medicine. Continue using Epiduo gel for the duration prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
About 1 in 10 patients using Epiduo 0.3%/2.5% gel may experience adverse skin reactions.
Stop using the product and contact your doctor immediately if you notice throat tightness or swelling of the eyes, face, lips or tongue, if you feel faint or have difficulty breathing.
Stop using the product if you develop hives or feel itching on your face or body. The frequency of these adverse events is unknown.

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

• Skin irritation
• Eczema
• Sensation of skin burning

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

• Eyelid redness
• Stinging or prickling sensation at the application site
• Skin itching, skin allergic reaction
• Skin rash
• Skin dryness

In addition to the side effects listed above, the following side effects have been reported with a lower dosage of Epiduo gel (adapalene 0.1%/benzoyl peroxide 2.5%):
Uncommon (may affect up to 1 in 100 people)

• Sunburn
  Unknown (frequency cannot be estimated from the available data)
• Swelling of the eyelids
• Throat constriction
• Contact allergic reaction
• Facial swelling
• Skin pain (stinging pain)
• Blisters (vesicles)
• Difficulty breathing
• Change in skin colour
• Burning at the application site

Adverse reactions typically associated with the use of Epiduo include mild to moderate reactions at the application site, such as skin irritation with redness, dryness, peeling, stinging and/or burning of the skin.
Cases of burning at the application site have been reported, mostly superficial, but also more severe cases with blistering.
If persistent skin irritation occurs during the first few weeks of using Epiduo 0.3%/2.5% gel, contact your doctor. Cutaneous adverse reactions, for example skin irritation, are more frequent with Epiduo 0.3%/2.5% gel compared to the lower dosage Epiduo 0.1%/2.5% gel. You may be advised to apply a moisturising cream, to use the gel less frequently, to interrupt treatment for a short period or to stop treatment altogether. These reactions usually occur at the beginning of treatment and tend to gradually decrease over time.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help 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 carton and on the tube/pump container after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Usable life after first opening: 3 months.
Do not dispose of unused Epiduo 0.3%/2.5% gel via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Epiduo 0.3%/2.5% gel contains

• The active substances are adapalene and benzoyl peroxide. One gram of gel contains 3 mg (0.3%) of adapalene and 25 mg (2.5%) of benzoyl peroxide.
• The other components are disodium edetate, sodium docusate, glycerol, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (copolymer of acrylamide and sodium acryloyl-dimethyl taurate, isohexadecane, polysorbate 80, sorbitan oleate), and purified water. See the end of section 2 for further information.

Description of the appearance of Epiduo 0.3%/2.5% gel and package contents
Epiduo gel is a white to pale yellow opaque gel.
Epiduo gel is available in:
A plastic tube containing 2 or 5 grams.
A multidose container with an airtight pump containing 15, 30, 45, or 60 grams.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Galderma Italia S.p.A. – Registered office Via dell’Annunciata 21 – Milano (MI)
Manufacturer
Laboratoires Galderma
Z.I. Montdésir
74540 Alby-sur-Chéran
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Belgium, Germany, Greece, Luxembourg, Poland: Epiduo Forte
Denmark: Epiduo
Finland, France, Iceland, Italy, Norway, Sweden, and United Kingdom: Epiduo 0.3%/2.5% gel
Spain: Epiduo Forte 3 mg/g + 25 mg/g gel
Portugal: Epiduo 3 mg/g + 25 mg/g gel

Detailed and up-to-date information on this medicinal product is available by scanning the QR code provided on the package leaflet and outer packaging with a smartphone. The same information is also available at the following URL: https://galdermainfo.it/epiduo0.3/