Package leaflet: Information for the user

Adalain, 1 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, as you may need to read it again.
If you have any further 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 adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Adalain is and what it is used for
Important information before using Adalain
How to use Adalain
Possible side effects
How to store Adalain
Contents of the pack and other information

1. What Adalain is and what it is used for

Adalain is used in the treatment of acne vulgaris.
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 also softens and exfoliates the outer layer of the skin.

2. Important information before using Adalain

When not to use Adalain

if the patient is allergic to adapalene or benzoyl peroxide or 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 treatment with 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 particularly 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, hands should be washed thoroughly.
Adalain and other medicines
Do not use other anti-acne medications (containing benzoyl peroxide and/or retinoids) at the same time as Adalain.
Avoid using Adalain simultaneously with cosmetics that cause skin irritation, drying, or exfoliation.
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or 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
Adalain may be used during breastfeeding. To avoid exposing the infant to the medicine, do not apply Adalain to the chest area.
Before using any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Not applicable.
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 as a breakdown product of benzoyl peroxide, which may cause local irritation.

3. How to use Adalain

This medicine should always be used exactly as recommended by the doctor. In case of 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, on the skin.
Apply a thin, even layer of gel to the acne-affected skin area once daily, before bedtime, avoiding contact with the eyes, mouth, and nostrils. The skin should be clean and dry before applying the medicine. Hands should be thoroughly washed after application.
Your doctor will decide how long you should continue treatment with Adalain.
If you feel that the effect of Adalain is too strong or too weak, consult your doctor or pharmacist.
If you experience persistent irritation during treatment with Adalain, contact your doctor. The doctor may recommend using moisturizing creams, less frequent application of the gel, temporarily interrupting treatment, or completely discontinuing treatment.
Use of more Adalain than recommended
Using more Adalain than recommended will not result in faster acne improvement and may cause skin irritation and redness.
Contact your doctor or hospital:

If you have used more Adalain than recommended.
If a child accidentally ingests the medicine.
If the medicine is accidentally swallowed.

Your doctor will advise what steps to take next.
Missed dose of Adalain
Do not apply a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Treatment should be discontinued and immediate medical help sought 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 affect up to 1 in 10 people):

dry skin
local rash (irritant contact dermatitis)
burning sensation
skin irritation
redness
skin peeling

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

skin itching (pruritus)
sunburn

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

facial swelling, allergic contact reactions
eyelid swelling
sensation of throat tightness
skin pain (pricking pain)
blisters (vesicles)
breathing difficulties
skin discoloration (change in skin color)
application site burn.

If skin irritation occurs after applying Adalain, it is usually mild to moderate in severity, with local symptoms such as redness, dryness, peeling, burning, and skin pain (pricking pain). These symptoms are typically most intense during the first week of treatment and resolve without additional therapy.
Application site burns are usually superficial; however, more severe cases with blister formation have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the outer carton and tube label after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Period of use after first opening of the tube: 3 months.
Medicines should not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Adalain contains

The active substances are: adapalene and benzoyl peroxide. 1 g of gel contains 1 mg (0.1% w/w) of adapalene and benzoyl peroxide monohydrate equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
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, and placed in a cardboard carton.
Pack size: 1 tube containing 30 g of gel.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
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 European Economic Area countries under the following names:
Netherlands: Adapalene/Benzoyl Peroxide Aristo 0.1%/2.5% Gel
Czech Republic: Arelma 0.1%/2.5% Gel
Spain: Adapaleno+peróxido de benzoilo Aristo 0.1% + 2.5% Gel
Italy: Arelma 0.1%/2.5% Gel
Poland: Adalain