Package leaflet: Information for the patient

Arsifast, 1 mg/g + 25 mg/g, gel
Adapalene + Benzoyl peroxide
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

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

1. What Arsifast is and what it is used for

Arsifast is used in the treatment of acne vulgaris.
This gel contains two active substances, adapalene and benzoyl peroxide, which act together but in different ways.
Adapalene belongs to a group of medicines called retinoids and specifically affects skin processes that cause acne.
The other active substance in the medicine, benzoyl peroxide, has antibacterial action and softens and exfoliates the outer layer of the epidermis.

2. Important information before using Arsifast

When not to use Arsifast

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 to use this medicine, discuss it with your doctor or pharmacist.
Do not apply this gel to areas with cuts, abrasions, sunburns, or eczema.
Take care to avoid getting the gel into the eyes, mouth, nose, or other highly sensitive areas of the body. If this occurs, rinse the area thoroughly with plenty of warm 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 the medicine, wash your hands thoroughly.
Arsifast and other medicines
Do not use other anti-acne medications (containing benzoyl peroxide and/or retinoids) at the same time as Arsifast gel.
Avoid using Arsifast together with cosmetics that cause skin irritation, drying, or peeling.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.
Pregnancy and breastfeeding
Pregnancy
DO NOT use Arsifast during pregnancy or if the patient plans to become pregnant. For further information, consult your doctor.
If pregnancy occurs during treatment with this medicine, treatment must be stopped immediately and the doctor should be informed as soon as possible for further monitoring.
Breastfeeding
This gel may be used during breastfeeding. To avoid exposing the infant to the medicine, do not apply Arsifast to the chest area.
Before using any medicine, consult your doctor or pharmacist.
Driving and operating machinery
No effects observed.
Arsifast contains propylene glycol, which may cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, corresponding to 4.00% w/w.
Arsifast contains polysorbate, which may cause allergic reactions.
This medicine contains 3 mg of polysorbate 80 in each gram of gel, corresponding to 0.3% w/w.
Arsifast contains benzoic acid, a breakdown product of benzoyl peroxide, which may cause local irritation.

3. How to use Arsifast

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
This medicine is intended 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 the gel to the skin area affected by acne once daily, before bedtime, avoiding contact with the eyes, mouth, and nostrils. The skin should be clean and dry before application. After applying the gel, hands should be thoroughly washed.
Your doctor will decide how long you should use this medicine.
If you feel that the effect of Arsifast is too strong or too weak, consult your doctor or pharmacist.
If you experience persistent irritation during treatment with Arsifast, contact your doctor. The doctor may recommend using moisturizing creams, applying the gel less frequently, taking a temporary break from treatment, or discontinuing treatment altogether.
Use of more Arsifast than recommended
Using more gel than recommended will not speed up acne improvement and may cause skin irritation and redness.
Please contact your doctor or hospital:

if more Arsifast has been used than recommended,
if the medicine has been accidentally used by a child,
if the medicine has been accidentally swallowed.

The doctor will advise on the necessary steps to take.
Missed dose of Arsifast
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and immediate medical help should be sought if the patient develops
throat tightness or swelling of the eyes, face, lips or tongue, weakness or difficulty breathing.
Treatment should be discontinued if the patient develops hives or itching of the face or body.
The frequency of these adverse reactions is unknown.

Common (affects less than 1 in 10 people):

dry skin,
local rash (contact dermatitis due to irritation),
burning sensation of the skin,
skin irritation,
redness of the skin,
peeling of the stratum corneum.

Uncommon (affects less than 1 in 100 people):

skin itching,
sunburn.

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

facial swelling,
allergic contact reactions,
eyelid swelling,
sensation of throat tightness,
skin pain (burning pain),
blisters on the skin,
breathing difficulties,
skin discolouration (changes in skin colour),
burning at the application site.

Skin irritation following the use of this medicine is usually mild or moderate, with local symptoms such as redness, dryness, peeling, burning sensation or skin pain (pricking pain), most pronounced during the first week of treatment and resolving without additional therapy.
Burning at the application site is usually superficial, although more severe cases with blister formation have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 Warszawa
Tel.: + 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 responsible entity.
Reporting adverse reactions allows the collection of further information on the safety of using the medicine.

5. How to store the medicine Arsifast

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
Do not store above 30°C.
Shelf life after first opening the tube: 6 months.
Medicines must not be disposed of via wastewater 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 Arsifast contains

The active substances are: adapalene and benzoyl peroxide. Each 1 g of gel contains 1 mg (0.1% w/w) of adapalene and benzoyl peroxide with water, corresponding to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
Other ingredients 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 docecynate, purified water.

What Arsifast looks like and contents of the pack
A uniform, opaque gel ranging in colour from white to very light yellow.
The gel is contained in a white plastic tube made of HDPE/LLDPE with a white HDPE neck and an aluminium "peel-off" seal, closed with a white polypropylene cap.
Pack sizes: 1 tube containing 30 g, 45 g or 60 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
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 authorised in the European Economic Area countries under the following names:
Netherlands: Adapaleen/Benzoylperoxide Polpharma 1 mg/g + 25 mg/g Gel