Adalain

Patient Information Leaflet

Adalain, 3 mg/g + 25 mg/g, gel
Adapalene + Benzoyl peroxide
Please read all of 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 "topical anti-acne agents" and is used in the treatment of acne vulgaris with comedones, numerous papules and pustules.
This gel contains two active substances, adapalene and benzoyl peroxide, which work together but in different ways:

• Adapalene belongs to a group of medicines called retinoids and specifically affects skin processes involved in the development of acne.
• The other active ingredient, benzoyl peroxide, has antibacterial action and softens and exfoliates the outer layer of the skin.

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

2. Important information before using Adalain

When not to use Adalain

• if the patient is allergic to adapalene or benzoyl peroxide, or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is pregnant
• if the patient plans to become pregnant.

Warnings and precautions
Before starting to use Adalain, discuss this with your doctor or pharmacist.
Do not apply the gel to areas where the skin is cut, abraded, sunburned, or affected by eczema (dermatitis).
Take care to avoid getting the gel into the eyes, mouth, nose, or other highly sensitive areas of the body. If this occurs, immediately rinse the affected area thoroughly with large amounts of lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of the gel with hair and dyed fabrics, as it may cause bleaching.
After applying this medicine, wash your hands thoroughly.
If persistent skin irritation occurs after starting treatment with this gel, contact your doctor (see section 3. How to use Adalain).

Adalain and other medicines
Do not use other anti-acne medications (containing benzoyl peroxide and/or retinoids) at the same time as this gel.
Avoid using products that irritate, dry out, or exfoliate the skin while using Adalain.
Other medicines may affect treatment and/or this gel. Therefore, inform your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use.

Pregnancy and breastfeeding
Pregnancy
DO NOT use Adalain during pregnancy or if the patient plans to become pregnant. For further information, consult your doctor.
If pregnancy occurs while using Adalain, discontinue treatment immediately and inform your doctor as soon as possible for further monitoring.

Breastfeeding
If the patient is breastfeeding, she should consult her doctor before using this medicine. The doctor will advise whether breastfeeding should be discontinued or whether to refrain from using this gel.
If the doctor recommends continuing treatment, do not apply the gel to the chest area to prevent the child from being exposed to the medicine through contact.

Driving and operating machinery
Adalain 3 mg/g + 25 mg/g gel has no effect or negligible effect 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 (E 1520) in each gram of gel, corresponding to 0.4% w/w.

Adalain contains polysorbates, which may cause allergic reactions.
This medicine contains 3 mg of polysorbate 80 in each gram of gel, corresponding to 0.3% w/w.

Adalain contains benzoic acid, resulting from the breakdown of benzoyl peroxide, which may cause local irritation.

3. How to use Adalain

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
This medicine is intended for use only in adults and adolescents aged 12 years and older.
This medicine is for topical use on the skin only.

Depending on the severity and appearance of acne, the doctor will decide which gel strength is
appropriate for the patient. The doctor will also determine whether additional treatment is needed.

• The skin should be clean and dry before applying the gel.
• Apply a thin, even layer of gel to the entire affected facial and/or trunk area once daily, before bedtime. Avoid contact with eyes, mouth, nostrils, and mucous membranes.
• When applying to the face: wash and dry the face, then apply a pea-sized amount of gel to each area of the face (e.g., forehead, chin, each cheek).
• Hands should be washed thoroughly immediately after applying the gel.

The treating doctor will decide how long Adalain should be used. If no improvement is seen after 4 to 8 weeks, discuss with your doctor whether continuing treatment is beneficial.
If persistent skin irritation occurs during the first weeks of using this gel, contact your doctor. The doctor may recommend using moisturizing creams, less frequent application of the gel, a temporary interruption of treatment, or complete discontinuation of Adalain therapy.
Do not apply cosmetics (such as facial creams or other makeup products) before the daily application of the gel. These products may be used after the applied gel has dried.

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

Use of more than the recommended dose of Adalain
Using more Adalain than recommended will not speed up acne clearance and may cause skin irritation and redness.
Contact your doctor or hospital:

• If more Adalain has been used than recommended.
• If a child has accidentally ingested the medicine.
• If the patient or someone else has accidentally swallowed the medicine.

The doctor will advise on the necessary steps.

Missed dose of Adalain
Do not use a double dose to make up for a missed dose.

Stopping Adalain treatment
Skin lesions (comedones, papules, and pustules) will only improve after several applications of this medicine. Continue treatment for as long as directed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse skin reactions may be expected in approximately 1 in 10 people using this medicine.
Stop using this medicine and seek immediate medical help if the patient experiences a sensation of throat tightness or swelling of the eyes, face, lips or tongue, weakness or difficulty breathing. Discontinue use of the medicine if the patient develops hives or itching of the face or body. The frequency of these adverse reactions is unknown.

Common (may occur in up to 1 in 10 people):

• burning sensation of the skin
• skin irritation
• eczema (rash)
• redness of the skin
• skin peeling

Uncommon (may occur in up to 1 in 100 people):

• eyelid redness
• tingling or pricking sensation at the application site
• itching of the skin, skin allergic reaction
• rash
• dry skin

In addition to the adverse reactions listed above, the following adverse reactions have also been reported after application of a gel containing adapalene and benzoyl peroxide at a lower strength (1 mg/g + 25 mg/g):

Uncommon (may occur in up to 1 in 100 people):

• sunburn

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

• eyelid swelling
• sensation of throat tightness
• contact allergic reactions
• facial swelling
• skin pain (pricking pain)
• blisters (vesicles)
• breathing difficulties
• skin discolouration (change in skin colour)
• burning at the application site

Typical adverse reactions associated with the use of Adalain include mild to moderate local reactions at the application site, such as skin irritation with redness, dryness, peeling, pricking sensation and/or burning sensation of the skin.
Burning at the application site is usually superficial, but more severe cases with blister formation have been reported.
If persistent skin irritation is experienced during the first weeks of using this medicine, the patient should contact a doctor. Skin-related adverse reactions such as skin irritation occur more frequently with higher strength gels than with lower strength gels (1 mg/g + 25 mg/g). The doctor may advise the patient to use a moisturizing cream, reduce the frequency of application, temporarily interrupt treatment or completely discontinue the gel. The aforementioned reactions usually occur during the initial phase of treatment and tend to gradually diminish over time.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 carton and tube label after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Shelf life after first opening the tube: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Adalain contains

• The active substances are: adapalene and benzoyl peroxide. Each 1 g of gel contains 3 mg (0.3% w/w) of adapalene and benzoyl peroxide with water equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• The other ingredients are: propylene glycol (E 1520), glycerol, Sepineo P600 (copolymer of acrylamide and sodium acryloyldimethyltaurate (1:1), isohexadecane, polysorbate 80, sorbitan oleate), poloxamer 124, disodium edetate, sodium docecylbenzenesulfonate, purified water.

What Adalain looks like and contents of the pack
Adalain is a white or slightly yellow, opaque gel.
The gel is packed in white plastic tubes made of HDPE/LLDPE with a white HDPE neck and an aluminium "peel-off" seal, fitted with a white polypropylene cap, placed in a cardboard carton.
Pack sizes:
1 tube containing 15 g of gel.
1 tube containing 30 g of gel.
1 tube containing 45 g of gel.
1 tube containing 60 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Poland
Tel: +48 22 855 40 93

Manufacturer:
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings
SGN 3000 San Gwann
Malta
Beltapharm S.p.A.
Via Stelvio 66
20095 Cusano Milanino
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Adapalene/Benzoyl Peroxide Aristo 0.3%/2.5% Gel
Czech Republic: Arelma 0.3%/2.5% Gel
Spain: Adapaleno+peróxido de benzoilo Aristo 0.3% + 2.5% Gel
Italy: Arelma 0.3%/2.5% Gel
Poland: Adalain