Patient Information Leaflet

Akneroxid 10
Benzoyl peroxide
100 mg/g, gel
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 leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 4 weeks of treatment, or if your condition worsens, consult your doctor.

Leaflet Contents:

What Akneroxid 10 is and what it is used for
Important information before using Akneroxid 10
How to use Akneroxid 10
Possible side effects
How to store Akneroxid 10
Contents of the pack and other information

1. What Akneroxid 10 is and what it is used for

Akneroxid 10 is a gel. It is an anti-acne medicine for topical application to the skin.
The medicine contains the active substance benzoyl peroxide, which, when applied to the skin, inhibits the growth of anaerobic bacteria Propionibacterium acnes, one of the causes of acne vulgaris.
Indications
Acne vulgaris, particularly on the chest and back.

2. Important information before using Akneroxid 10

When not to use Akneroxid 10

if the patient is allergic to benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6),
on damaged skin,
in the eyes,
on mucous membranes,
around the mouth, nose or eyes,
on dry skin with limited sebum secretion, in patients with atopic dermatitis.

Warnings and precautions

Before starting treatment with Akneroxid 10, discuss this with your doctor or pharmacist. This medicine should be used on the skin only.

Care should be taken to avoid Akneroxid 10 getting into the eyes.
Accidental contact with the eyes may cause redness and a burning sensation. If the medicine comes into contact with the eyes, rinse immediately with plenty of water.
Particular caution is required when applying the medicine to sensitive areas of the skin, e.g. the neck.
Contact of Akneroxid 10 with the mouth and mucous membranes should be avoided.
During treatment with Akneroxid 10, treated areas of skin should not be exposed to UV radiation (sunlight, sunbeds).
Due to the bleaching properties of the medicine, application should be avoided around the eyebrows, beard, at the hairline, and contact with clothing should be prevented.

Akneroxid 10 and other medicines

Tell your doctor or pharmacist about all medicines currently used, recently used or which you plan to use.
Akneroxid 10 should not be used simultaneously with dermatological medicines that irritate the skin, dry it out, cause peeling, or contain reducing agents.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Akneroxid 10 should not be used in women during the last month of pregnancy.
The doctor will decide whether Akneroxid 10 can be used during the remaining months of pregnancy and during breastfeeding, after carefully weighing the benefits of therapy against the potential risks.

Driving and operating machinery

Akneroxid 10 has no effect on the ability to drive or operate machinery.

3. HOW TO USE THE MEDICINAL PRODUCT AKNEROXID 10

This medicinal product should always be used exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicinal product is intended for topical application to the skin.
Unless otherwise advised by a physician, Akneroxid 10 is usually applied once or twice daily.
Treatment may initially start with a medicinal product containing 50 mg/g of benzoyl peroxide (Akneroxid 5).
Patients with particularly sensitive skin should initially apply Akneroxid 10 once daily, before bedtime.
After thoroughly cleansing the skin, Akneroxid 10 should be applied in a thin layer to the affected skin areas. Do not apply the product to healthy skin. After application, hands should be washed thoroughly.
The usual duration of treatment is between 4 and 10 weeks.
If you feel that the effect of Akneroxid 10 is too strong or too weak, inform your doctor or pharmacist.
Use of more than the recommended dose of Akneroxid 10
In case of accidental ingestion, the patient should immediately contact a doctor or pharmacist.
If the product is used incorrectly, e.g. too frequently, in excessive amounts, or applied to damaged skin, severe irritation symptoms may occur.
Missed dose of Akneroxid 10
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Akneroxid 10 can cause adverse reactions, although not everybody experiences them.
After starting treatment with Akneroxid 10, a feeling of skin tightness and slight redness may occur during the first days of treatment, which usually resolves during continued use.
Moderate peeling of the epidermis may persist throughout the treatment period.
If excessive redness or a burning sensation persists for more than five days, treatment should be discontinued and medical advice should be sought. Once these symptoms have resolved, treatment can often be continued, either with longer intervals between applications or by switching to Akneroxid 5, which contains 50 mg/g of the active substance – benzoyl peroxide.
Use of Akneroxid 10 may uncommonly (less frequently than in 1 out of 100 people) cause increased skin dryness.
In rare cases (less frequently than in 1 out of 1,000 people), contact allergy may occur.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Akneroxid 10

Store the medicine below 25°C.
The shelf-life after first opening the tube is 6 months.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after: EXP.
The expiry date refers to the last day of the stated month.
The batch number is indicated on the tube as Lot.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Akneroxid 10 contains
The active substance is benzoyl peroxide.
1 g of gel contains 100 mg of benzoyy peroxide.
The other ingredients (excipients) are: macrogol lauryl ether, carbomer 940, sodium hydroxide, edetic acid, purified water.

What Akneroxid 10 looks like and contents of the pack
Akneroxid 10 is a white gel.
The medicinal product is available in a polyethylene tube (HDPE with a polypropylene cap) containing 20 g or 50 g of gel, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstr. 3
D-21465 Reinbek
Germany

For further information, please contact the representative of the Marketing Authorisation Holder:
Almirall Sp. z o.o.
Pileckiego 63 Street
02-781 Warsaw
Phone: 22 330 02 57
Fax: 22 313 01 57

Date of the latest revision of the leaflet: