BENZACNE 50 mg /G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Benzacne, 50 mg/g, gel
3. Benzacne, 100 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
4. What is Benzacne and what is it used for
5. Important information before using Benzacne
   1. When not to use Benzacne
   2. Warnings and precautions
   3. Benzacne and other medicines
   4. Children and adolescents
   5. Pregnancy and breastfeeding
   6. Driving and using machines
6. How to use Benzacne
   1. Using more than the recommended dose of Benzacne
   2. Missing a dose of Benzacne
7. Possible side effects
   1. Reporting side effects
8. How to store Benzacne
9. Package contents and other information
   1. What Benzacne contains
   2. What Benzacne looks like and what the package contains
   3. Marketing authorization holder:
   4. Manufacturer:

Leaflet attached to the packaging: patient information

Benzacne, 50 mg/g, gel

Benzacne, 100 mg/g, gel

Benzoyl peroxide

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

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 4 to 6 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Benzacne and what is it used for
• 2. Important information before using Benzacne
• 3. How to use Benzacne
• 4. Possible side effects
• 5. How to store Benzacne
• 6. Package contents and other information

1. What is Benzacne and what is it used for

Benzacne is a gel medicine with anti-acne action, intended for local application to the skin.
The medicine contains the active substance benzoyl peroxide. Benzoyl peroxide, when applied to the skin, easily penetrates the stratum corneum and inhibits the growth of anaerobic bacteria Propionibacterium acnes, which are one of the causes of common acne.
It also has a peeling effect on the skin, reducing the number of comedones.
Benzacne is indicated for the treatment of various forms of common acne (Acne vulgaris).

2. Important information before using Benzacne

When not to use Benzacne

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

Warnings and precautions

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

• Protect your eyes, mouth, and mucous membranes from contact with the medicine. Do not apply the medicine to irritated skin and open wounds, and to the breast area during breastfeeding. If these areas come into contact with the medicine, rinse them thoroughly with water.
• In case of concurrent use of Benzacne with other anti-acne medicines for topical use, it is recommended to use them at different times of the day, e.g. in the morning or evening, to reduce the risk of skin irritation.
• Use with caution on sensitive skin, e.g. on the neck or other sensitive areas.
• Avoid exposure to UV radiation (quartz lamps, solarium) and sun.
• The medicine may cause discoloration of hair and fabrics.

Benzacne and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Concurrent use of Benzacne with:

• other anti-acne medicines for topical use containing: tretinoin, isotretinoin, resorcinol, salicylic acid, sulfur, ethanol on the same skin surface may increase skin irritation and dryness;
• topically applied antibiotics (e.g. clindamycin, erythromycin) or medicines containing retinoids (e.g. adapalene, tretinoin) leads to a weakening of their action.

In case of necessity to use any other medicines at the same time, consult your doctor to determine possible changes in the use of Benzacne.

Children and adolescents

Do not use in children under 12 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not apply the medicine to the breast area during breastfeeding.

Driving and using machines

Benzacne does not affect the ability to drive and use machines.

3. How to use Benzacne

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Recommended dose
Adults and children over 12 years old
Apply once or twice a day.
Usually, within the first 2 to 3 weeks of treatment, a medicine with a benzoyl peroxide content of 50 mg/g is used, and if necessary, treatment is continued with a medicine with a benzoyl peroxide content of 100 mg/g.
Method of administration
The medicine is intended for local application to the skin.
After washing and drying the skin, apply a small amount of the medicine to the affected areas and gently rub it in.
After applying the medicine, wash your hands.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using more than the recommended dose of Benzacne

A symptom of excessive use of Benzacne is redness or swelling of the skin. If they occur, stop using the medicine and contact your doctor.
Cold compresses can be applied to the irritated areas.

Missing a dose of Benzacne

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

4. Possible side effects

Like all medicines, Benzacne can cause side effects, although not everybody gets them.
During treatment with Benzacne, the following may occur:

• dryness or excessive peeling of the skin;
• redness of the skin;
• a feeling of warmth or slight stinging at the site of application. These symptoms may appear in the first week of treatment and do not indicate a need to discontinue the medicine. If they occur, reduce the frequency of application of Benzacne.

If 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 side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. 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 181 C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Benzacne

Store the medicine at a temperature below 25°C. Do not freeze.
Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after EXP. The expiry date refers to the last day of the month.
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. Package contents and other information

What Benzacne contains

• The active substance of the medicine 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 what the package contains

Benzacne is a white, odorless gel.
50 mg/g: The medicine is available in a tube containing 30 g of gel, placed in a cardboard box.
100 mg/g: The medicine is available in a tube containing 20 g of gel, placed in a cardboard box.

Marketing authorization holder:

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization 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
Date of last update of the leaflet:08/2024