Adapalene and benzoyl peroxide Medgen: detailed information

Patient Information Leaflet: Information for the User

Adapalene/Benzoyl Peroxide Medgen 1 mg/g + 25 mg/g Gel
Adapalene/Benzoyl Peroxide
Generic Medicine
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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g gel is and what it is used for
What you need to know before using adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g gel
How to use adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g gel
Possible side effects
How to store adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g gel
Contents of the pack and other information

1. What adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g gel is and what it is used for

Adapalene/benzoyl peroxide Medgen is used for the treatment of acne.
The 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 specifically acts on the skin processes that cause acne.
Benzoyl peroxide, the other active substance, 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 adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g

gel
Do not use adapalene/benzoyl peroxide Medgen

if you are allergic to adapalene or benzoyl peroxide or to any of the other ingredients of this medicine (listed in section 6).
if you are pregnant
if you are planning a pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
Do not use this gel on areas of skin with cuts, abrasions, sunburn or eczema.
Make sure the gel does not come into contact with your eyes, mouth, nostrils or 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 the gel with your hair or coloured fabrics, as it may cause bleaching.
Wash your hands thoroughly after using this medicine.
Other medicines and adapalene/benzoyl peroxide Medgen
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concurrently with this gel.
Avoid using adapalene/benzoyl peroxide Medgen together with cosmetic products that irritate, dry or exfoliate the skin.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breastfeeding
Pregnancy
DO NOT USE adapalene/benzoyl peroxide Medgen if you are pregnant or planning to become pregnant. Your doctor can provide further information.
If you become pregnant while using adapalene/benzoyl peroxide Medgen, stop treatment immediately and inform your doctor as soon as possible for further advice.
Breastfeeding
This gel may be used during breastfeeding. To avoid contact exposure to the nursing infant, application of this medicine to the chest area should be avoided.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Not applicable
Adapalene/benzoyl peroxide Medgen contains propylene glycol which may cause skin irritation.
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, equivalent to 4.00% w/w.
Adapalene/benzoyl peroxide Medgen contains polysorbates which may cause allergic reactions.
This medicine contains 3 mg of polysorbate 80 per gram of gel, equivalent to 0.3% w/w.
Adapalene/benzoyl peroxide Medgen contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.

3. How to use adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g gel

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
This medicine is intended for use only in adults, adolescents, and children aged 9 years and older. This medicine is for external use only.
Apply a thin, even layer of the gel once daily in the evening before going to bed, to the acne-affected areas, avoiding contact with the eyes, lips, and nostrils. The skin should be clean and dry before application. Wash your hands thoroughly after applying this gel.
Your doctor will inform you how long you should use this medicine.
If you notice that the effect of adapalene/benzoyl peroxide Medgen is too strong or too weak, consult your doctor or pharmacist.
If persistent skin irritation occurs while using this medicine, contact your doctor.
Your doctor may advise you to apply a moisturizing cream, to use the gel less frequently, or to temporarily or permanently discontinue treatment.
If you use more adapalene/benzoyl peroxide Medgen than you should
If you apply more gel than recommended, your acne will not clear up faster, but your skin may become irritated and red.
Contact your doctor or hospital:

If you have used more adapalene/benzoyl peroxide Medgen than you should have.
If a child has accidentally ingested this medicine.
If you have accidentally swallowed this medicine.

Your doctor will advise you on the necessary steps to take.
If you forget to use adapalene/benzoyl peroxide Medgen
Do not apply a double dose to make up for the missed application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Stop using the medicine 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 medicine if you develop hives or experience itching of the face or body. The frequency of these side effects 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
peeling

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

skin itching
sunburn

Unknown frequency (frequency cannot be estimated from the available data):

facial swelling, allergic contact reactions,
eyelid swelling,
throat constriction,
skin pain (pricking pain),
blisters (vesicles),
breathing difficulties,
skin colour changes,
burning at the application site

If skin irritation occurs after applying this medicine, it is generally mild or moderate, with local signs such as redness, dryness, peeling, burning, and skin pain (pricking pain), which usually 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 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 the following website: https://www.aifa.gov.it/content/segnalazioni-reazioniavverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store adapalene/benzoyl peroxide Medgen 1 mg/g + 25 mg/g gel

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 tube. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening of the tube, use the medicine within 3 months.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What adapalene/benzoyl peroxide Medgen contains

The active substances are: adapalene and benzoyl peroxide. 1 g of gel contains 1 mg (0.1% w/w) of adapalene and 25 mg (2.5%) of benzoyl peroxide hydrate, equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
The other components are: propylene glycol (E1520), glycerol, Sepinov EHP 10 (copolymer of acrylamide and sodium acryloyldimethyl taurate (1:1)), isohexadecane, polysorbate 80, sorbitan oleate), poloxamer 124, disodium edetate, sodium docusate, purified water.

Description of the appearance of adapalene/benzoyl peroxide Medgen and pack contents

Homogeneous, opaque gel, white to very pale yellow in colour.
Pack sizes: 1 tube of 30 g, 45 g or 60 g.
The gel is packaged in white HDPE/LLDPE plastic tubes with a white HDPE cap, sealed with an aluminium seal and closed with a white polypropylene screw cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Laboratoires MEDGEN
24 rue Erlanger
75016 Paris
FRANCE

Manufacturers:
BELTAPHARM S.p.A
Via Stelvio 66, – 20095 Cusano Milanino
Milan,
ITALY
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4,
Sir Temi Zammit Buildings,
San Gwann, SGN 3000,
MALTA

This medicinal product is authorised in the European Economic Area Member States under the following names:
France: Casarenel 0.1%/2.5%, gel
Netherlands: Aknadue 1 mg/g + 25 mg/g gel
Spain: Aceduo 1 mg/g + 25 mg/g gel

Package leaflet: Information for the user

Adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel
Adapalene/benzoyl peroxide
Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel is and what it is used for
What you need to know before using adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel
How to use adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel
Possible side effects
How to store adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel
Contents of the pack and other information

1. What adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel is and what it is used for

Adapalene/benzoyl peroxide Medgen 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 skin processes that cause acne.
benzoyl peroxide acts as an antibacterial agent and exerts a soothing and keratolytic effect on the outermost layer of the skin.

This medicine should only be used in adult and adolescent patients aged 12 years and older.

2. What you need to know before using adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g

gel
Do not use Adapalene/benzoyl peroxide Medgen

if you are allergic to adapalene or benzoyl peroxide, or to any of the other ingredients of this medicine (listed in section 6).
if you are pregnant
if you are planning a pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
Do not use this gel on areas of skin with cuts, abrasions, sunburn or eczema.
Make sure the gel does not come into contact with your eyes, mouth, nostrils, or other particularly sensitive areas of the body. If contact occurs, rinse the affected area immediately with abundant lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of the gel with your hair or coloured fabrics, as it may bleach them.
Wash your hands thoroughly after using this medicine.
If you experience persistent skin irritation as soon as you start treatment with this gel, contact your doctor. (See section 3 How to use Adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel).
Other medicines and Adapalene/benzoyl peroxide Medgen
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concurrently with this gel.
Avoid using Adapalene/benzoyl peroxide Medgen concurrently with cosmetic products that irritate, dry out or exfoliate the skin.
Other medicines may interact with Adapalene/benzoyl peroxide Medgen gel. Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Pregnancy and breastfeeding
Pregnancy
DO NOT USE Adapalene/benzoyl peroxide Medgen if you are pregnant or planning a pregnancy. Your doctor can provide further information.
If you become pregnant while using this medicine, stop treatment immediately and inform your doctor as soon as possible for further evaluation.
Breastfeeding
If you are breastfeeding, consult your doctor before using this medicine. Your doctor will advise you whether to discontinue breastfeeding or to avoid treatment with this gel.
If your doctor advises you to continue treatment, do not apply the gel to the chest area in order to avoid exposing the infant to contact with the product.
Driving and using machines
Adapalene/benzoyl peroxide Medgen gel has no or negligible effects on the ability to drive and use machinery.
Adapalene/benzoyl peroxide Medgen contains propylene glycol, which may cause skin irritation.
This product contains 40 mg of propylene glycol (E1520) in each gram of gel, equivalent to 4.00% w/w.
Adapalene/benzoyl peroxide Medgen contains polysorbates, which may cause allergic reactions.
This medicine contains 3 mg of polysorbate 80 in each gram of gel, equivalent to 0.3% w/w.
Adapalene/benzoyl peroxide Medgen contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.

3. How to use Adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for topical use only in adults and adolescents aged 12 years and older. This medicine is for external use only.
Your doctor will decide which gel concentration is appropriate for you, depending on the severity and type 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, even layer of gel once daily in the evening before going to bed, over the entire acne-affected area of the 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 of gel the size of a pea to each area of the face (e.g., forehead, chin, each cheek).
Wash your hands thoroughly immediately after applying the gel.

Your doctor will inform you how long you should use this medicine. 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 Adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel, contact your doctor. Your doctor may advise you to use a moisturizing cream, to use the medicine less frequently, or to temporarily or permanently discontinue treatment.
Do not apply cosmetics (such as facial creams or makeup products) before applying the gel daily. These products may be used after the gel has dried.

Use in children
This medicine must not be used in children under 12 years of age.

If you use more Adapalene/benzoyl peroxide Medgen than you should
If you apply more gel than directed, your acne will not clear up faster, but your skin may become irritated and red.
Contact your doctor or hospital:

If you have used more Adapalene/benzoyl peroxide Medgen than recommended;
If a child has accidentally ingested this medicine;
If you or someone else has accidentally swallowed this medicine.

Your doctor will advise you on the necessary steps.

If you forget to use Adapalene/benzoyl peroxide Medgen
Do not apply a double dose to make up for a missed application.
Pimples (comedones, papules, and pustules) will only begin to reduce after several applications of this medicine. Continue using this treatment for the duration prescribed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Approximately 1 in 10 patients using this medicine may experience skin adverse reactions.
Stop using this medicine 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. Discontinue use of the medicine if hives develop or if you feel itching on the face or body. The frequency of these adverse effects is unknown.

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

skin burning sensation
skin irritation
eczema
redness
peeling

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
dry skin

In addition to the side effects listed above, the following adverse reactions have been reported with a lower dose of adapalene/benzoyl peroxide gel (1 mg/g + 25 mg/g):

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

sunburn

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

eyelid swelling
throat constriction
contact allergic reaction
facial swelling
skin pain (stinging pain)
blisters (vesicles)
breathing difficulty
skin colour changes
burning at the application site

Adverse reactions typically associated with the use of Adapalene/benzoyl peroxide Medgen 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 this medicine, contact your doctor. Cutaneous adverse reactions, such as skin irritation, are more frequent with the higher-dose gel compared to the lower-dose gel (adapalene/benzoyl peroxide 1 mg/g + 25 mg/g gel). You may be advised to apply a moisturising cream, to use the gel less frequently, to suspend treatment for a short period, or to discontinue 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:
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 adapalene/benzoyl peroxide Medgen 3 mg/g + 25 mg/g gel

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 tube. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening the tube, use within 3 months.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What adapalene/benzoyl peroxide Medgen contains

The active substances are adapalene and benzoyl peroxide. One gram of gel contains 3 mg of adapalene (0.3% w/w) and hydrated benzoyl peroxide, equivalent to 25 mg of anhydrous benzoyl peroxide (2.5% w/w).
The other components are Propylene glycol (E1520), Glycerol, Sepineo P600 (copolymer of acrylamide and sodium acryloyldimethyltaurate (1:1), isohexadecane, polysorbate 80, sorbitan oleate), Poloxamer 124, Disodium edetate, Sodium docusate, Purified water.

Description of the appearance of adapalene/benzoyl peroxide Medgen and pack contents
Homogeneous, opaque gel, white to very light yellow in colour.
The gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE cap, equipped with an aluminium removable seal and closed with a white polypropylene screw cap.
15 g tube
30 g tube
45 g tube
60 g tube
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratoires MEDGEN
24 rue Erlanger
75016 Paris
FRANCE

Manufacturer
BELTAPHARM S.p.A
Via Stelvio 66 – 20095 Cusano Milanino
Milan,
ITALY
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4,
Sir Temi Zammit Buildings,
San Gwann, SGN 3000,
MALTA

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Casarenel 0.3%/2.5%, gel
Netherlands: Aknadue 3 mg/g + 25 mg/g gel
Spain: Aceduo 3 mg/g + 25 mg/g gel