Arsifast

Package leaflet: Information for the user

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

Contents of the leaflet

1. What Arsifast is and what it is used for
2. What you need to know before you use 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 Arsifast is and what it is used for

Arsifast belongs to a group of medicines called "topical anti-acne agents". It is used in the treatment of acne vulgaris with comedones (blackheads and whiteheads) and numerous papules and pustules (inflammatory pimples).
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 that cause acne.
• Benzoyl peroxide, the second active ingredient, has antibacterial action and softens and desquamates the outer layer of the epidermis.

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

2. Important information before using the medicine Arsifast

When not to use the medicine Arsifast

• 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 this medicine, discuss it with your doctor or pharmacist.
Do not apply this gel to areas where there are cuts, scratches, sunburns, or eczema.
Take care to avoid getting the gel into the eyes, mouth, nose, or other particularly sensitive areas of the body. If this occurs, rinse the affected area thoroughly with plenty 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 the medicine, hands should be washed thoroughly.
If persistent skin irritation occurs after starting to use this gel, contact your doctor (see section 3 "How to use the medicine Arsifast").

Arsifast 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 the medicine Arsifast simultaneously with cosmetics that cause skin irritation, drying, or peeling.
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use, because other medicines may affect treatment.

Pregnancy and breastfeeding
Pregnancy
DO NOT use the medicine Arsifast during pregnancy or if the patient plans to become pregnant. Further information should be obtained from your doctor.
If pregnancy occurs during treatment with this medicine, treatment must be stopped immediately and the doctor must be informed 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 decide whether to discontinue breastfeeding or not to use treatment with this medicine.
If the doctor recommends continuing treatment, avoid applying the gel to the chest area to prevent the child's exposure to the medicine.

Driving and operating machinery
The gel Arsifast has no effect or has a negligible effect on the ability to drive and operate machinery.

Arsifast contains propylene glycol, which may cause skin irritation
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel, equivalent 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, equivalent to 0.3% w/w.

Arsifast contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.

3. How to use Arsifast

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

The doctor will decide which strength of gel to use, depending on the severity and appearance of the acne lesions. The doctor will also determine whether additional treatment is necessary.

• 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 of the medicine with eyes, mouth, nostrils, and mucous membranes.
• When applying to the face: wash and dry the face, then apply an amount of gel corresponding to the size of a pea to each area of the face (e.g., forehead, chin, each cheek).
• Hands should be washed thoroughly immediately after applying the gel.

Your doctor will inform you how long you should use Arsifast. If there is no improvement after 4–8 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 advise you to use a moisturizing cream, reduce the frequency of application, temporarily interrupt treatment, or discontinue the gel completely.
Do not use cosmetics (such as facial creams or other makeup products) before daily application of this gel. These products may be used after the applied gel has dried.

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

Use of more than the recommended dose of Arsifast
Using more gel than recommended will not make acne clear up faster and may cause skin irritation and redness.
Please contact your doctor or hospital:

• if more Arsifast has been used than recommended,
• if a child accidentally uses the medicine,
• if you or someone else accidentally swallows the medicine.

Your doctor will advise on the necessary actions.

Missed dose of Arsifast
Do not use a double dose to make up for a missed dose.
Skin lesions (comedones, papules, and pustules) will improve only after repeated applications of this medicine. Continue treatment for as long as directed by your doctor.
If you have any further doubts regarding 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.
Skin-related adverse reactions may be expected in approximately 1 out of 10 patients using Arsifast gel.
Treatment with this medicine should be discontinued and immediate medical help should be sought if the patient experiences throat tightness or swelling of the eyes, face, lips, or tongue, weakness, or difficulty breathing.
The medicine should be discontinued if the patient develops hives or itching of the face or body. The frequency of these adverse reactions is unknown.

Common (occur in less than 1 out of 10 patients):

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

Uncommon (occur in less than 1 out of 100 patients):

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

In addition to the adverse reactions listed above, the following adverse reactions have also been reported after use of a lower strength formulation - Arsifast gel (adapalene + benzoyl peroxide 1 mg/g + 25 mg/g):
Uncommon (occur in less than 1 out of 100 patients):

• sunburn.

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

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

Typical adverse reactions associated with the use of Arsifast include mild to moderate local reactions such as redness, dryness, peeling, skin burning, and/or skin stinging.
Application site burns are usually superficial, but more severe cases with blister formation have been reported.
If persistent irritation occurs during the first weeks of treatment with this medicine, the patient should contact a physician. Skin-related adverse reactions such as skin irritation occur more frequently with the higher strength gel than with the lower strength gel (adapalene and benzoyl peroxide 1 mg/g + 25 mg/g). The physician may advise the patient to use a moisturizing cream, to reduce the frequency of application, to temporarily interrupt treatment, or to completely discontinue use of 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 reactions occur, including any 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 Drug Reactions, 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 the medicine.

5. How to store the medicinal product Arsifast

Keep the medicine out of the sight and reach of children.
Do not use this medicinal product 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.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Arsifast contains

• The active substances in this medicine are: adapalene and benzoyl peroxide. Each 1 g of gel contains 3 mg (0.3% w/w) of adapalene and benzoyl peroxide with water in an amount equivalent 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 docecylbenzenesulfonate, purified water.

What Arsifast looks like and contents of the pack
Homogeneous, opaque gel, white to very pale yellow in colour.
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 15 g, 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: Adapalene/Benzoyl Peroxide Polpharma 3 mg/g + 25 mg/g Gel