EPIDUO 0.1%/2.5% Gel

Зміст інструкції

1. Epiduo 0.1%/2.5%, gel
   1. What is Epiduo and what is it 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
2. Epiduo 0.3%/2.5% gel
   1. What is Epiduo and what is it 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

Epiduo 0.1%/2.5%, gel

Adapalene/Benzoyl peroxide
Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Epiduo and what is it used for

Epiduo is indicated for the treatment of acne.
Epiduo gel contains two active ingredients, 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 ingredient, benzoyl peroxide, acts as an antibacterial and exerts a soothing
and exfoliating action 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 ingredients or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Do not use Epiduo on areas where there are wounds, scratches, sunburn or eczema.
• Avoid contact of Epiduo with the eyes, mouth, nostrils and with other very sensitive areas of the body. If it comes into contact with one of these areas, immediately rinse the affected area with plenty of lukewarm water.
• Avoid excessive exposure to sunlight and UV lamps.
• Avoid contact of Epiduo with hair or colored fabrics as it may discolor them, and wash your hands thoroughly after using the medicine. Consult your doctor or pharmacist before using Epiduo.

Other medicines and Epiduo
Do not use other products for acne (containing benzoyl peroxide and/or retinoids) at the same time as
Epiduo .
Avoid using Epiduo at the same time as cosmetic products that have irritating, drying
or exfoliating effects on the skin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.

Pregnancy and breastfeeding
DO NOT USE Epiduo if you are pregnant, or if you are planning a pregnancy. Your doctor will be able to give
you more information.
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 exposure to the infant through contact, do not apply Epiduo to the chest area.
Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery
Not applicable.

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

3. How to use Epiduo

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Epiduo is indicated for use only in adults and adolescents and children aged 9 years and over.
This medicine is for external use only.
Apply a thin layer of gel to the areas affected by acne once a day 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 tell you how long you will need to use Epiduo.
If you should notice that the effect of Epiduo is too strong or too weak, consult your doctor or
pharmacist.
If the application of Epiduo should cause persistent irritation, contact your doctor.
Your doctor may ask you to apply a moisturising cream, to use the gel less
frequently, to suspend treatment for a short period or to stop it permanently.

If you use more Epiduo than you should:
If you apply more Epiduo than you should to the skin, your acne will not disappear faster but your
skin may become irritated and red.
Please, contact your doctor or hospital if:

• You have used more Epiduo than you should.
• A child has accidentally taken the product.
• You have accidentally swallowed the product.

The doctor will advise you on the measures to be taken.

If you forget to use Epiduo:
Do not apply a double dose to compensate for missed applications.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the product and seek medical attention immediately if you experience tightness of the throat 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 an itching sensation on your face or body. The frequency with which these adverse events may occur is not known.

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

• dry skin
• local skin rash (irritant contact dermatitis)
• burning sensation
• skin irritation
• redness
• scaling Uncommon side effects(may affect up to 1 in 100 people)
• itchy skin
• sunburn

Frequency not known(cannot be estimated from available data): facial swelling,
allergic contact reactions, eyelid swelling, throat constriction, skin pain
(stinging pain), blisters (vesicles), difficulty breathing, change in skin color, burning in
application site
If skin irritation occurs following application of Epiduo, this is
generally mild to moderate, with local signs such as redness, dryness, scaling,
burning and skin pain (stinging pain), which peak during the first week
and then disappear without additional treatment.
Cases of burning at the application site have been reported, mostly superficial but also
more severe cases with blisters.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the pack. The expiry date refers to the last day of that month.
Dispose of the tube or multi-dose container with airless pump 6 months after its first
opening.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Epiduo contains

• The active ingredients 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: sodium docusate, disodium edetate, glycerol, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (acrylamide and sodium acryloyl-dimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate) and purified water.

Description of Epiduo and contents of the pack
Epiduo is an opaque gel from white to pale yellow.
Epiduo is available in
White plastic tubes with a screw cap 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 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

Manufacturer
Laboratoires Galderma
ZI – Montdésir
74 540 Alby sur Chéran
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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 in 1 g gel
Other Countries: Epiduo 0.1%/2.5% gel
More detailed information on this medicinal product is available by scanning the following QR code
URL: https://galdermainfo.it/epiduo/.

Epiduo 0.3%/2.5% gel

adapalene/benzoyl peroxide

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Epiduo and what is it used for

Epiduo gel belongs to a group of medicines called “topical anti-acne preparations”,
meaning it is used for the treatment of common acne, when comedones (blackheads,
whiteheads), numerous papules and pustules (inflamed pimples) are present.
This gel combines two active ingredients, 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 exfoliating action 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 need to know before using Epiduo

Do not use Epiduo gel:

• if you are pregnant
• if you are planning a pregnancy
• 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 where there are cuts, abrasions, sunburn or eczema.

Avoid contact of Epiduo gel with your eyes, mouth or nostrils, or mucous membranes and other very
sensitive areas of your body. If it comes into contact with any of these areas, immediately rinse the
affected area with plenty of lukewarm water.

• Avoid excessive exposure to sunlight and UV lamps.
• Avoid contact of Epiduo gel with your hair or colored fabrics as it may discolor them, and 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 products (containing benzoyl peroxide and/or retinoids) at the same time as Epiduo gel.
• Avoid using Epiduo gel in conjunction with cosmetic products that irritate, dry or exfoliate the skin. Other medicines may have effects on Epiduo gel, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Pregnancy and breastfeeding
Pregnancy
DO NOT USE Epiduo 0.3%/2.5% if you are pregnant or planning a pregnancy. Your doctor can
give you more information.
If you become pregnant while using Epiduo 0.3%/2.5% gel, stop treatment and inform your
doctor as soon as possible for further monitoring.
Breastfeeding
If you are breastfeeding, ask your doctor for advice before using this medicine. Your
doctor will advise you whether to stop breastfeeding or to refrain from treatment with Epiduo
0.3%/2.5% gel.
If your doctor advises you to continue treatment, do not apply the gel to the chest in order to avoid
contact exposure to the infant.

Driving and using machines
Epiduo gel has no or negligible effects on the ability to drive and use machines.

Epiduo 0.3%/2.5% gel contains propylene glycol (E1520),an ingredient that may cause
local skin irritation (e.g. contact dermatitis).

3. How to use Epiduo

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Epiduo 0.3%/2.5% gel is indicated exclusively for use in adults and adolescents aged
12 years or older.
Epiduo is a gel, used on the skin.
The doctor will decide which concentration of Epiduo gel you need, depending on the severity and appearance
of your acne. The doctor will also decide if you need additional treatment.

• The skin must be clean and dry before application.
• Apply a thin layer of gel evenly over the entire area affected by acne (face and/or trunk), once a day in the evening before bedtime. Avoid contact with eyes, lips, nostrils and mucous membranes.
• If used on the face: wash and dry your face and use an amount equal to the size of a pea and apply it to each part of the face (e.g. forehead, chin, each of the two cheeks).
• Wash your hands thoroughly immediately after applying Epiduo gel.

The doctor will tell 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 the benefit of continuing the
treatment.
If you experience persistent skin irritation during the first weeks of using Epiduo gel,
contact your doctor. They may ask you to apply a moisturizer, use the medicine less
frequently, temporarily stop therapy or discontinue it.
Do not apply cosmetics (such as face creams or make-up products) before
the daily application of Epiduo gel. These products can be used after the gel,
once applied, has dried.

Use in children
Epiduo 0.3%/2.5% gel should 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 you should to the skin, your acne will not disappear faster but
your skin may become irritated and red.
Contact your doctor or hospital if:

• a child has accidentally taken the product;
• you or someone else has accidentally swallowed this medicine.

The doctor will advise you on the measures 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 decrease after several applications of this
medicine. Continue to use Epiduo gel for the period prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Approximately 1 in 10 patients using Epiduo 0.3%/2.5% gel may experience adverse skin reactions.
Stop using the product and seek immediate medical attention if you experience tightness of the throat 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 an itching sensation 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):

• Skin irritation
• Eczema
• Burning sensation of the skin

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

• Redness of the eyelid
• Pins and needles or tingling at the application site
• Itchy skin, allergic skin reaction
• Rash
• Dry skin

In addition to the side effects described 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 based on available data)
• Swelling of the eyelids
• Constriction of the throat
• Allergic contact reaction
• Swelling of the face
• Skin pain (stinging pain)
• Blisters (vesicles)
• Difficulty breathing
• Change in skin color
• Burning at the application site

Adverse reactions typically associated with the use of Epiduo include application site reactions
ranging from mild to moderate, such as skin irritation with redness, dryness, scaling,
tingling and/or burning sensation of the skin.
Cases of burns at the application site have been reported, mostly superficial but also
more severe cases with blisters.
If you experience persistent skin irritation during the first few weeks when using Epiduo
0.3%/2.5% gel, contact your doctor. Skin 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 asked to apply a moisturizer, use the gel less frequently, suspend treatment for a short period of
time or discontinue it. These reactions usually occur at the beginning of treatment, and tend to decrease
gradually over time.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 which is stated on the package and on the tube/container
with pump after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Validity after first opening: 3 months.
Do not dispose of unused Epiduo 0.3%/2.5% gel in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Epiduo 0,3%/2,5% gel contains

• The active ingredientsare 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 ingredientsare disodium edetate, sodium docusate, glycerol, poloxamer, propylene glycol (E1520), Simulgel 600 PHA (acryl amide and sodium acryloyl-dimethyl taurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate) and purified water. See the end of paragraph 2for further information.

Description of the appearance of Epiduo 0,3%/2,5% gel and contents of the pack
Epiduo gel is an opaque gel from white to pale yellow.
Epiduo gel is available in:
A plastic tube containing 2 or 5 grams.
A multi-dose 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 – Milan (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 with 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
information is also available at the following URL: https://galdermainfo.it/epiduo0.3/