AKNEROXID 100 mg /G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Akneroxid 10
   1. Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Akneroxid 10 and what is it used for
   1. Indications
4. Important information before using Akneroxid 10
   1. When not to use Akneroxid 10
   2. Warnings and precautions
   3. Akneroxid 10 and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
5. HOW TO USE AKNEROXID 10
   1. Using more than the recommended dose of Akneroxid 10
   2. Missing a dose of Akneroxid 10
6. Possible side effects
   1. Reporting side effects
7. How to store Akneroxid 10
8. OTHER INFORMATION
   1. What Akneroxid 10 contains
   2. What Akneroxid 10 looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

Akneroxid 10

Benzoyl peroxide
100 mg/g, gel

Please read carefully the contents of the leaflet 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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Akneroxid 10 and what is it used for
• 2. Important information before using Akneroxid 10
• 3. How to use Akneroxid 10
• 4. Possible side effects
• 5. How to store Akneroxid 10
• 6. Contents of the packaging and other information

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

Akneroxid 10 is a gel. It is a topical anti-acne medicine for use on 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 common acne.

Indications

Common acne, especially 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 production, in patients with atopic dermatitis.

Warnings and precautions

Before starting to use Akneroxid 10, the patient should discuss it with their doctor or pharmacist.
The medicine should only be used on the skin.
Caution should be exercised to avoid getting Akneroxid 10 in the eyes.
Accidental contact of the medicine with the eyes may cause redness and a burning sensation. In case of contact with the eyes, they should be rinsed immediately with a large amount of water.
The medicine should be used with particular caution on sensitive areas of the skin, e.g. on the neck.
Contact of Akneroxid 10 with the mouth and mucous membranes should be avoided.
During treatment with Akneroxid 10, the treated skin areas should be avoided from exposure to UV radiation (sunlight, solarium).
Due to the bleaching properties of the medicine, it should be avoided to apply it around the eyebrows, beard, at the border of the skin with hair, and contact with clothing should be avoided.

Akneroxid 10 and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
Akneroxid 10 should not be used at the same time as dermatological medicines that irritate the skin, dry it, or have reducing properties.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Akneroxid 10 should not be used in women in the last month of pregnancy.
The doctor will decide whether Akneroxid 10 can be used in other months of pregnancy and during breastfeeding, after careful consideration of the benefit-risk ratio.

Driving and using machines

Akneroxid 10 has no influence on the ability to drive or use machines.

3. HOW TO USE AKNEROXID 10

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use on the skin.
Unless otherwise directed by the doctor, Akneroxid 10 is usually applied once or twice a day.
Treatment can be started with a medicine containing 50 mg/g of benzoyl peroxide (Akneroxid 5).
Patients with particularly sensitive skin should initially use Akneroxid 10 once a day, before bedtime.
After thorough skin cleansing, Akneroxid 10 is applied in a thin layer to the affected skin areas. The medicine should not be applied to healthy skin. After use, the hands should be washed thoroughly.
The usual treatment period is from 4 to 10 weeks.
If the patient feels that the effect of Akneroxid 10 is too strong or too weak, they should inform their doctor or pharmacist.

Using more than the recommended dose of Akneroxid 10

In case of accidental ingestion of the medicine, the patient should immediately contact their doctor or pharmacist.
In case of using the medicine not in accordance with the recommendations, e.g. too frequently, in excessive doses, or on damaged skin, severe irritation symptoms may occur.

Missing a dose of Akneroxid 10

A double dose should not be used to make up for a missed dose.
In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Akneroxid 10 can cause side effects, although they may not occur in every patient.
After starting to use Akneroxid 10, in the first days of treatment, a feeling of tension and slight redness of the skin may occur, which usually subsides during treatment. Moderate peeling of the skin persists throughout the treatment period.
If excessive redness or a burning sensation persists for more than five days, the use of the medicine should be discontinued and the doctor consulted. After the symptoms have subsided, treatment can often be continued, using the medicine at longer intervals or using Akneroxid 5, which contains 50 mg/g of the active substance - benzoyl peroxide.
The use of Akneroxid 10 may not very often (less than 1 in 100 people) cause increased dryness of the skin.
In rare cases (less than 1 in 1000 people), contact allergy may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. 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 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected].
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Akneroxid 10

The medicine should be stored at a temperature below 25°C.
The shelf life after first opening the tube is 6 months.
The medicine should be kept out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging, after: EXP.
The expiry date refers to the last day of the given month.
The batch number is indicated on the tube as Lot.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. OTHER INFORMATION

What Akneroxid 10 contains

The active substance of the medicine is benzoyl peroxide.
1 g of gel contains 100 mg of benzoyl peroxide.
The other ingredients (excipients) are: laureth-9, carbomer 940, sodium hydroxide, edetic acid, purified water.

What Akneroxid 10 looks like and what the packaging contains

Akneroxid 10 is a white gel.
The available packaging of the medicine is 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 authorization holder and manufacturer

Almirall Hermal GmbH
Scholtzstr. 3
D-21465 Reinbek
Germany
For more detailed information, please contact the representative of the marketing authorization holder:
Almirall Sp. z o.o.
ul. Pileckiego 63
02-781 Warsaw
phone: 22 330 02 57
fax: 22 313 01 57
Date of last revision of the leaflet: