ARSIFAST 3 mg /G + 25 Mg/G Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Arsifast, 3 mg/g + 25 mg/g, Gel
   1. Read the package 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. Use in children
   2. Using more than the recommended dose of Arsifast
   3. Missing a dose of Arsifast
6. Possible side effects
   1. Reporting side effects
7. How to store Arsifast
8. Contents of the pack 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:

Package Leaflet: Information for the Patient

Arsifast, 3 mg/g + 25 mg/g, Gel

Adapalene + Benzoyl Peroxide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your 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 pack and other information

1. What is Arsifast and what is it used for

Arsifast belongs to a group of medicines called "topical anti-acne medicines". It is used to treat common acne (blackheads, whiteheads, pimples).

• Adapalene belongs to a group of medicines called retinoids and acts specifically on the skin processes that cause acne.
• Benzoyl peroxide, the second active substance of the medicine, has antibacterial properties and softens and peels off the outer layer of the skin.

This medicine should only be used in adults and adolescents from 12 years of age.

2. Important information before using Arsifast

When not to use Arsifast

Warnings and precautions

Before starting to use this medicine, discuss it with your doctor or pharmacist.

Do not use this gel on areas where there are cuts, scrapes, sunburn, or eczema.

Be careful not to get the gel in your eyes, mouth, nose, or other sensitive areas of the body. If this happens, rinse the area with plenty of warm water.

Avoid excessive exposure to sunlight and UV lamps.

Avoid contact between the gel and hair or dyed fabrics, as it may discolour them.

After using the medicine, wash your hands thoroughly.

If you experience persistent skin irritation after starting to use this gel, contact your doctor (see section 3 "How to use Arsifast").

Arsifast and other medicines

Do not use other anti-acne medicines (containing benzoyl peroxide and/or retinoids) at the same time as this gel.

Avoid using Arsifast and cosmetics that cause irritation, dryness, or peeling of the skin at the same time.

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, as other medicines may affect your treatment.

Pregnancy and breastfeeding Pregnancy

DO NOT use Arsifast during pregnancy or if you are planning 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

If you are breastfeeding, consult your doctor before using this medicine. Your doctor will decide whether to stop breastfeeding or not to use this medicine.

If your doctor recommends continuing treatment, avoid applying the gel to the breast area to prevent the baby from coming into contact with the medicine.

Driving and using machines

Arsifast has no or negligible influence on the ability to drive and use machines.

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

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.

Arsifast is for use in adults, adolescents, and children from 12 years of age. The medicine is for external use only.

Your doctor will decide on the strength of the gel, depending on the severity of the acne and its appearance.

Your doctor will also decide whether to use additional treatment.

• The skin should be clean and dry before applying the gel.
• Apply a thin layer of gel evenly to the entire affected area of the skin (face and/or trunk) once a day, before bedtime. Avoid contact with the eyes, mouth, nostrils, and mucous membranes.
• When using on the face: wash and dry the face, then apply an amount of gel equivalent to a grain of rice to each area of the face (e.g., forehead, chin, each cheek).
• After applying the gel, wash your hands thoroughly.

Your doctor will tell you how long to use Arsifast. If there is no improvement after 4-8 weeks, discuss the benefits of continuing treatment with your doctor.

If you experience persistent skin irritation during the first few weeks of using this gel, contact your doctor. Your doctor may ask you to use a moisturizing cream, use the medicine less frequently, temporarily stop using it, or stop using the gel altogether.

Do not use cosmetics (such as face creams or other makeup products) before applying this gel daily. These products can be applied after the gel has dried.

Use in children

Arsifast should not be used in children under 12 years of age.

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:

Your doctor will advise on what actions to take.

Missing a dose of Arsifast

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

Lesions (blackheads, pimples) will decrease only after repeated use of this medicine.

Continue to use the treatment for as long as your doctor has told you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

About 1 in 10 people using Arsifast may experience side effects on the skin.

Stop using this 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(affects less than 1 in 10 people):

• burning sensation of the skin,
• skin irritation,
• eczema,
• redness of the skin,
• peeling of the skin.

Uncommon(affects less than 1 in 100 people):

• redness of the eyelids,
• tingling or prickling sensation at the application site,
• itching of the skin, allergic skin reaction,
• rash,
• dryness of the skin.

Besides the above-mentioned side effects, the following side effects have also been reported with the use of a lower-strength version of this medicine - Arsifast, gel (adapalene + benzoyl peroxide 1 mg/g + 25 mg/g):

Uncommon(affects less than 1 in 100 people):

• sunburn.

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

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

Typical side effects of using Arsifast include mild to moderate reactions at the application site, such as redness, dryness, peeling, burning sensation of the skin, and/or a feeling of skin burning.

Burning at the application site is usually superficial, but more severe cases with blistering have been reported.

If you experience persistent irritation during the first few weeks of using this medicine, contact your doctor. Skin-related side effects such as skin irritation occur more frequently with the use of a higher-strength gel than with a lower-strength gel (adapalene and benzoyl peroxide 1 mg/g + 25 mg/g). Your doctor may ask you to use a moisturizing cream, use the medicine less frequently, temporarily stop using it, or stop using the gel altogether. The above-mentioned reactions usually occur during the initial treatment period and tend to decrease over time.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Arsifast

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 packaging. The expiry date refers to the last day of the month stated on the packaging.

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 pack and other information

What Arsifast contains

• The active substances are adapalene and benzoyl peroxide. Each gram of gel contains 3 mg (0.3% 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 acryloyldimethyltaurine (1:1)), isohexadecane, polysorbate 80, sorbitan oleate, poloxamer 124, disodium edetate, sodium docusate, purified water.

What Arsifast looks like and contents of the pack

Arsifast is a homogeneous, opaque gel with a colour from white to very light yellow.

The gel is in a white plastic tube with HDPE/LLDPE and a white HDPE neck and a peel-off aluminium seal, with a white PP cap.

Pack sizes: 1 tube containing 15g, 30g, 45g, or 60g.

Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Adapaleen/Benzoylperoxide Polpharma 3 mg/g + 25 mg/g Gel

Date of last revision of the leaflet:June 2025