ARSIFAST 1 mg /G + 25 Mg/G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Arsifast, 1 mg/g + 25 mg/g, gel
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Arsifast and what is it used for
4. Important information before using Arsifast
   1. When not to use Arsifast
   2. Warnings and precautions
   3. Arsifast and other medicines
   4. Pregnancy and breastfeeding Pregnancy
   5. Driving and using machines
   6. Arsifast contains propylene glycol, which may cause skin irritation
   7. Arsifast contains polysorbate, which may cause allergic reactions.
   8. Arsifast contains benzoyl peroxide, which may cause local irritation.
5. How to use Arsifast
   1. Using more than the recommended dose of Arsifast
   2. Missing a dose of Arsifast
6. Possible side effects
   1. Reporting side effects
7. How to store Arsifast
8. Contents of the packaging and other information
   1. What Arsifast contains
   2. What Arsifast looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Arsifast, 1 mg/g + 25 mg/g, gel

Adapalene + Benzoyl peroxide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Arsifast and what is it used for
• 2. Important information before using Arsifast
• 3. How to use Arsifast
• 4. Possible side effects
• 5. How to store Arsifast
• 6. Contents of the packaging and other information

1. What is Arsifast and what is it used for

Arsifast is used to treat common acne.
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 acts specifically on the processes in the skin that cause acne.
The second active substance of the medicine, benzoyl peroxide, has antibacterial effects and softens and exfoliates the outer layer of the skin.

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, scratches, sunburn, or eczema.
Be careful not to get the gel into your eyes, mouth, nose, or other sensitive areas of the body. If this happens, rinse the area with a large amount of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact between the gel and hair or dyed fabrics, as it may discolor them.
After using the medicine, wash your hands thoroughly.

Arsifast and other medicines

Do not use other anti-acne medicines (containing benzoyl peroxide and/or retinoids) at the same time as Arsifast gel.
Avoid using Arsifast and cosmetics that cause irritation, dryness, or exfoliation of the skin.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding Pregnancy

DO NOT USE Arsifast during pregnancy or if you plan to become pregnant. For more information, consult your doctor.
If you become pregnant while using this medicine, stop treatment immediately and inform your doctor as soon as possible for further monitoring.
Breastfeeding
This gel can be used during breastfeeding. To avoid exposing the baby to the medicine, do not apply Arsifast to the breast area.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

No effects have been observed.

Arsifast contains propylene glycol, which may cause skin irritation

This medicine contains 40 mg of propylene glycol (E1520) per gram of gel, which corresponds to 4.00% w/w.

Arsifast contains polysorbate, which may cause allergic reactions.

This medicine contains 3 mg of polysorbate 80 per gram of gel, which corresponds to 0.3% w/w.

Arsifast contains benzoyl peroxide, which may cause local irritation.

may cause local irritation.

3. How to use Arsifast

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is for use in adults, adolescents, and children from 9 years of age.
The medicine is for external use only.
Apply a thin layer of the gel evenly to the affected skin area once a day, before bedtime, avoiding contact with the eyes, mouth, and nostrils. Before applying the medicine, the skin should be clean and dry. After applying the gel, wash your hands thoroughly.
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 while using Arsifast, contact your doctor. Your doctor may recommend using moisturizing creams, applying the gel less frequently, interrupting treatment for a while, or stopping treatment altogether.

Using more than the recommended dose of Arsifast

Using more gel than recommended will not make acne disappear faster, but may cause irritation and redness of the skin.
Please contact your doctor or hospital:

• if you have used more Arsifast than recommended,
• if a child has used the medicine by mistake,
• if the medicine has been swallowed by mistake.

Your doctor will advise you what to do.

Missing a dose of Arsifast

Do not use a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the medicine and seek immediate medical attention if you experience throat tightness or swelling of the eyes, face, lips, or tongue, weakness, or difficulty breathing. Stop using the medicine if you experience hives or itching of the face or body.
The frequency of these side effects is not known.
Common(occurring in less than 1 in 10 patients):

• dry skin,
• local rash (irritant contact dermatitis),
• burning sensation of the skin,
• skin irritation,
• redness of the skin,
• peeling of the skin.

Uncommon(occurring in less than 1 in 100 patients):

• itching of the skin,
• sunburn.

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

• facial swelling,
• allergic contact reactions,
• eyelid swelling,
• feeling of throat tightness,
• skin pain (burning pain),
• blisters on the skin,
• breathing difficulties,
• skin discoloration (changes in skin color),
• burning at the application site.

Skin irritation that may occur after using this medicine is usually mild or moderate, with local symptoms such as redness, dryness, peeling, or burning of the skin, and skin pain (stinging pain), most pronounced in the first week of use and resolving without additional treatment.
Burns at the application site are usually superficial, but more severe cases with blisters have been reported.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store 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 month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Do not store above 30°C.
Shelf life after first opening the tube: 6 months.
Medicines should 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 packaging 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 in an amount equivalent to 25 mg (2.5% w/w) of anhydrous benzoyl peroxide.
• The other ingredients are: propylene glycol E1520, glycerol, sepineo P600 (copolymer of acrylamide and sodium acryloyldimethyltaurinate (1:1)), isohexadecane, polysorbate 80, sorbitan oleate), poloxamer 124, disodium edetate, sodium docusate, purified water.

What Arsifast looks like and contents of the pack

Homogeneous, non-transparent gel, white to very light yellow in color.
The gel is in a white HDPE/LLDPE plastic tube with a white HDPE neck and a peel-off type aluminum seal, with a white PP cap.
Pack size: 1 tube containing 30 g, 45 g, or 60 g.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +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 medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Adapaleen/Benzoylperoxide Polpharma 1 mg/g + 25 mg/g Gel
Date of last revision of the leaflet:June 2025