Adalain

Patient Information Leaflet: Information for the User

Adalain 1 mg/g + 25 mg/g gel

Adapalene/benzoyl peroxide
Generic medicine
Please read this entire leaflet carefully before 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 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Adalain is and what it is used for
2. What you need to know before using Adalain
3. How to use Adalain
4. Possible side effects
5. How to store Adalain
6. Contents of the pack and other information

1. What Adalain is and what it is used for

Adalain is indicated for the treatment of acne.
This gel combines two active ingredients, adapalene and benzoyl peroxide, which work 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, the other active ingredient, 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 Adalain

Do not use Adalain

• 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 discoloration.
Wash your hands thoroughly after using this medicine.

Other medicines and Adalain
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) at the same time as this gel.
Avoid using Adalain together with cosmetic products that irritate, dry out, or exfoliate the skin.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Pregnancy
DO NOT use Adalain if you are pregnant or planning to become pregnant. 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 advice.

Breastfeeding
This gel may be used during breastfeeding. To avoid contact exposure to the nursing infant, application of this medicine on the chest area should be avoided.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Not applicable.

Adalain 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.

Adalain 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.

Adalain contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.

3. How to use Adalain

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended only for use 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 acne-affected areas once daily in the evening before going to bed, 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 tell you how long you should use this medicine.
If you feel that the effect of Adalain is too strong or too weak, consult your doctor or pharmacist.
If you experience persistent skin irritation while using this medicine, contact your doctor.
Your doctor may advise you to apply a moisturizing cream, to use the gel less frequently, to temporarily suspend treatment, or to discontinue it altogether.
If you use more Adalain than you should
If you apply more gel than you should, your acne will not clear up any faster, but your skin may become irritated and red.
Contact your doctor or hospital:

• If you have used more Adalain 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 Adalain
Do not apply a double dose to make up for a missed application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
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 you develop hives or feel itching on 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

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

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

In cases where 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 may 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 Adalain

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening 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. Package contents and other information

What Adalain contains

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

Description of the appearance of Adalain and contents of the pack
Opaque, homogeneous gel, white to very pale yellow in colour.
Pack sizes: 1 tube of 30 g, 45 g or 60 g.
The gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE cap, fitted with
an aluminium removable seal and closed with a white polypropylene screw cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8 – 10
Berlin, Germany

Manufacturer
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4,
Sir Temi Zammit Buildings, San Gwann, SGN 3000, Malta
BELTAPHARM SPA
Via Stelvio 66,
20095 Cusano Milanino
Milan, Italy

This medicinal product is authorised in the European Economic Area countries under the
following names:
Netherlands Adapaleen/benzoylperoxide Aristo 1 mg/g + 25 mg/g Gel
Croatia Arelma
Italy Adalain
Poland Adalain

Package leaflet: Information for the user

Adalain 3 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Adalain is and what it is used for
2. What you need to know before using Adalain
3. How to use Adalain
4. Possible side effects
5. How to store Adalain
6. Contents of the pack and other information

1. What Adalain is and what it is used for

Adalain 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, the other active ingredient, acts as an antibacterial agent and provides a soothing and exfoliating effect on the outermost layer of the skin.

This medicine should only be used in adults and adolescents aged 12 years and older.

2. What you need to know before using Adalain

Do not use Adalain

• 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 where cuts, abrasions, sunburn or eczema are present.
Make sure that 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 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 cause discoloration.
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 Adalain).

Other medicines and Adalain
Do not use other acne treatments (containing benzoyl peroxide and/or retinoids) concurrently with this gel.
Avoid using Adalain concurrently with cosmetic products that irritate, dry out, or exfoliate the skin.
Other medicines may affect your treatment with this 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 Adalain if you are pregnant or planning to become pregnant. 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 whether you should discontinue breastfeeding or avoid treatment with this gel.
If your doctor advises continuing treatment, do not apply the gel to the chest area to avoid contact exposure to the infant.

Driving and using machines
Adalain gel has no or negligible effects on the ability to drive and operate machinery.

Adalain 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.

Adalain 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.

Adalain contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.

3. How to use Adalain

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
This medicine is intended only for use 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 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, 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 the face, then apply an amount about the size of a pea to each facial area (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 there is no improvement after 4–8 weeks, consult your doctor to discuss whether continuing treatment is beneficial.
If persistent skin irritation occurs during the first weeks of using this gel, contact your doctor. Your doctor may recommend applying a moisturizing cream, using the medicine less frequently, temporarily suspending treatment, or discontinuing it altogether.
Do not apply cosmetics (such as facial creams or makeup products) before the daily application of the gel. 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 Adalain 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 Adalain than you should have.
• If a child has accidentally taken this medicine.
• If you or someone else has accidentally ingested this medicine.

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

If you forget to use Adalain
Do not apply a double dose to make up for a missed application.
Acne lesions (comedones, papules, and pustules) will improve only 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 experiences them.
Approximately 1 in 10 patients using this medicine may experience skin-related 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 you develop hives or feel itching on the face or body. The frequency of these side 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 effects 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 available data):

• eyelid swelling
• throat constriction
• contact allergy
• facial swelling
• skin pain (stinging pain)
• blisters (vesicles)
• difficulty breathing
• skin colour change
• burning at the application site

Adverse reactions typically associated with the use of Adalain include mild to moderate application site reactions 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, for example skin irritation, are more frequent with the higher gel dose compared to the lower dose (adapalene/benzoyl peroxide 1 mg/g + 25 mg/g gel). You may be advised to apply a moisturizing cream, to use the gel less frequently, to suspend treatment temporarily, or to discontinue it. These reactions usually occur at the beginning of treatment and tend to gradually diminish 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 Adalain

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 and on the tube after Exp..
The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening 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 in use. This will help protect the environment.

6. Package contents and other information

What Adalain contains

• The active substances are: adapalene and benzoyl peroxide. 1 g of gel contains 3 mg of adapalene (0.3% w/w) and hydrated benzoyl peroxide, equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• The other components are: propylene glycol (E1520); glycerol; Sepineo P600 (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 Adalain and package contents
Homogeneous opaque gel, white to very pale yellow in colour.
The gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE cap, fitted 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 Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8 – 10
Berlin, Germany

Manufacturer
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4,
Sir Temi Zammit Buildings, San Gwann, SGN 3000, Malta
BELTAPHARM SPA
Via Stelvio 66,
20095 Cusano Milanino
Milan, Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Adapaleen/benzoylperoxide Aristo 3 mg/g + 25 mg/g Gel
Croatia: Arelma
Italy: Adalain