Package leaflet: Information for the patient

Akneroxid 5
Benzoyl peroxide
50 mg/g, gel
Please read the entire 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
physician or pharmacist.

Keep this leaflet for future reference.
If advice or additional information is needed, please consult a pharmacist.
If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 4 weeks of treatment, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

What Akneroxid 5 is and what it is used for
Important information before using Akneroxid 5
How to use Akneroxid 5
Possible side effects
How to store Akneroxid 5
Contents of the pack and other information

1. What Akneroxid 5 is and what it is used for

Akneroxid 5 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

2. Important information before using Akneroxid 5

When not to use Akneroxid 5

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 reduced sebum secretion, in patients with atopic dermatitis.

Warnings and precautions

Before starting treatment with Akneroxid 5, consult your doctor or pharmacist. The medicine should be used on skin only.

Care should be taken to avoid getting Akneroxid 5 into the eyes.
Accidental contact with the eyes may cause redness and a burning sensation. In case of
contact with the eyes, rinse immediately with plenty of water.
Particular caution should be exercised when applying the medicine to sensitive skin areas, e.g. the neck.
Avoid contact of Akneroxid 5 with the mouth and mucous membranes.
During treatment with Akneroxid 5, avoid exposing treated skin areas to UV radiation (sunlight, solarium).
Due to the bleaching properties of the medicine, avoid applying it near the eyebrows, beard, at the hairline, and avoid contact with clothing.

Akneroxid 5 and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Do not use Akneroxid 5 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 have a baby, she should consult her doctor or pharmacist before using this medicine.
Akneroxid 5 should not be used in women during the last month of pregnancy.
The doctor will decide whether Akneroxid 5 may 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 5 has no effect on the ability to drive or operate machinery.

3. How to use Akneroxid 5

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
This medicine is intended for topical application to the skin.
Unless otherwise directed by a physician, Akneroxid 5 is usually applied once or twice daily.
Patients with particularly sensitive skin should initially use Akneroxid 5 once daily,
before bedtime.
After thoroughly cleansing the skin, apply Akneroxid 5 in a thin layer to the affected areas of skin.
Do not apply the medicine to healthy skin. After using the medicine, hands should be washed thoroughly.
The usual duration of treatment is from 4 to 10 weeks.
If you feel that the effect of Akneroxid 5 is too strong or too weak, inform your physician or pharmacist.
Use of more than the recommended dose of Akneroxid 5
If the medicine is accidentally ingested, the patient should immediately contact a physician
or pharmacist.
If the medicine is used incorrectly, for example too frequently, in excessive amounts,
or on damaged skin, severe irritation symptoms may occur.
Missed dose of Akneroxid 5
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your physician
or pharmacist.

4. Possible adverse reactions

Like all medicines, Akneroxid 5 can cause adverse reactions, although not everybody experiences them.
After starting treatment with Akneroxid 5, a feeling of skin tightness and mild redness may occur during the first few days of treatment, which usually resolves during continued use. Moderate peeling of the skin 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 by applying the medicine less frequently.
Use of Akneroxid 5 may uncommonly (in fewer than 1 out of 100 people) cause increased skin dryness.
In rare cases (in fewer than 1 out of 1000 people), contact allergy may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected] .
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Akneroxid 5

Store the medicine at a temperature below 25°C.
Shelf life after first opening the tube – 6 months.
Keep out of the sight and reach of children.
Do not use the 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Akneroxid 5 contains
The active substance is benzoyl peroxide.
1 g of gel contains 50 mg of benzoyl peroxide.
The other ingredients (excipients) are: macrogol lauryl ether, carbomer 940, sodium hydroxide, edetic acid, purified water.

What Akneroxid 5 looks like and contents of the pack
Akneroxid 5 is a white gel.
The available pack is a polyethylene tube (HDPE with a polypropylene cap) containing 50 g of gel, placed in a cardboard box.

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.
ul. Pileckiego 63
02-781 Warsaw
tel.: 22 330 02 57
fax: 22 313 01 57