Benzacne

Package leaflet: Information for the user

Benzacne, 50 mg/g, gel
Benzacne, 100 mg/g, gel
Benzoyl peroxide
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 4 to 6 weeks of treatment, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

1. What Benzacne is and what it is used for

Benzacne is an anti-acne gel intended for topical application to the skin.
The medicine contains the active substance benzoyl peroxide. When applied to the skin, benzoyl peroxide readily penetrates the stratum corneum and inhibits the growth of anaerobic bacteria Propionibacterium acnes, which are one of the causes of acne vulgaris.
It also has a keratolytic effect on the epidermis and reduces the number of comedones.
Benzacne is indicated for the treatment of various forms of acne vulgaris (Acne vulgaris).

2. Important information before using Benzacne

When not to use Benzacne

• If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has skin eruptions (eczema), chronic skin inflammation, or skin burns, including those caused by excessive exposure to sunlight.

Warnings and precautions
Before starting to use Benzacne, discuss it with your doctor or pharmacist.

• Avoid contact of the medicine with eyes, lips, and mucous membranes. Do not apply the medicine to irritated skin, open wounds, or to the breast area during breastfeeding. In case of accidental contact with these areas, rinse thoroughly with water.
• If using Benzacne together with other topical anti-acne medicines, it is recommended to apply them at different times of the day (e.g. one in the morning and one in the evening) to reduce the risk of skin irritation.
• Use with caution on sensitive skin areas, such as the neck or other sensitive areas.
• Avoid exposure to UV radiation (e.g. sunlamps, tanning beds) and direct sunlight.
• The medicine may cause bleaching of hair and fabrics.

Benzacne and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Concurrent use of Benzacne with:

• other topical anti-acne medicines containing: tretinoin, isotretinoin, resorcinol, salicylic acid, sulfur, or ethyl alcohol applied to the same skin area may increase the risk of skin irritation and dryness;
• topical antibiotics (e.g. clindamycin, erythromycin) or medicines containing retinoids (e.g. adapalene, tretinoin) may reduce their effectiveness.

If it is necessary to use any other medicines concurrently, consult your doctor to determine any required adjustments in the use of Benzacne.

Children and adolescents
Do not use in children under 12 years of age.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not apply the medicine to the breast area during breastfeeding.

Driving and operating machinery
Benzacne has no influence on the ability to drive or operate machinery.

3. How to use Benzacne

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and children over 12 years of age
Apply once or twice daily.
During the first 2 to 3 weeks of treatment, the product containing 50 mg/g of benzoyl peroxide is usually used, and if necessary, treatment may be continued with the product containing 100 mg/g of benzoyl peroxide.
Method of administration
The medicine is intended for topical application to the skin.
After washing and drying the skin, apply a small amount of the medicine sufficient to cover the affected areas and gently rub in.
After applying the medicine, wash your hands.
If you feel that the medicine's effect is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Benzacne
Symptoms of excessive use of Benzacne include redness or swelling of the skin. If these occur, discontinue use immediately and contact your doctor.
Cold compresses may be applied to irritated areas.
Missed dose of Benzacne
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 everybody will experience them.
During treatment with Benzacne the following may occur:

• dryness or excessive peeling of the skin;
• redness of the skin;
• sensation of warmth or mild stinging at the site of application. These symptoms may appear during the first week of treatment and do not require discontinuation of Benzacne. If they occur, the frequency of applying Benzacne should be reduced.

If any of the following symptoms occur, stop using the medicine and contact your
doctor:

• allergic contact dermatitis or painful skin irritation;
• burning of the skin;
• skin rash.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Benzacne

The medicine should be stored at a temperature below 25°C. Do not freeze.
The medicine should be stored in a place out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the tube and outer carton following
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system 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 Benzacne contains

• The active substance is benzoyl peroxide. 1 g of gel contains 50 mg or 100 mg of benzoyl peroxide.
• The other ingredients are: carbomer, sodium hydroxide, purified water.

What Benzacne looks like and contents of the pack
Benzacne is a white, odourless gel.
50 mg/g: The medicinal product is available in a tube containing 30 g of gel, placed in a cardboard box.
100 mg/g: The medicinal product is available in a tube containing 20 g of gel, placed in a cardboard box.
Marketing Authorisation Holder:
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]
Manufacturer:
50 mg/g:
Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland
100 mg/g:
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares,
Rua Outeiro da Armada, No 5,
Condeixa-a-Nova 3150-194
Portugal