AKNEROXID 50 mg /G Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Akneroxid 5
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Akneroxid 5 and what is it used for
   1. Indications
4. Important information before using Akneroxid 5
   1. When not to use Akneroxid 5
   2. Warnings and precautions
   3. Akneroxid 5 and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
5. How to use Akneroxid 5
   1. Using more than the recommended dose of Akneroxid 5
   2. Missing a dose of Akneroxid 5
6. Possible side effects
   1. Reporting side effects
7. How to store Akneroxid 5
8. Contents of the pack and other information
   1. What Akneroxid 5 contains
   2. What Akneroxid 5 looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer

Package Leaflet: Information for the Patient

Akneroxid 5

Benzoyl peroxide
50 mg/g, gel

Read the package 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 package leaflet for the patient or as advised 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 there is no improvement after 4 weeks or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

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

Akneroxid 5 is a gel. It is a medicine with anti-acne action for topical 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

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 limited sebum production, in patients with atopic dermatitis.

Warnings and precautions

Before starting to use Akneroxid 5, the patient should discuss it with their doctor or pharmacist.
The medicine should be used only on the skin.
Caution should be exercised to avoid getting Akneroxid 5 into 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 5 with the mouth and mucous membranes should be avoided.
During the use of Akneroxid 5, the treated skin areas should be avoided from being exposed 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 5 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 5 should not be used at the same time as dermatological medicines that irritate the skin, dry it, peel it, or contain substances with 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 5 should not be used in women in the last month of pregnancy.
The doctor will decide whether Akneroxid 5 can be used in other months of pregnancy and during breastfeeding, after careful consideration of the benefit-risk ratio.

Driving and using machines

Akneroxid 5 has no influence on the ability to drive or use machines.

3. How to use Akneroxid 5

This medicine should always be used exactly as described in the package leaflet for the patient or as advised 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 the doctor advises otherwise, Akneroxid 5 is usually applied once or twice a day.
Patients with particularly sensitive skin should initially use Akneroxid 5 once a day, before bedtime.
After thoroughly cleaning the skin, Akneroxid 5 is applied in a thin layer to the affected skin areas. The medicine should not be applied to healthy skin. After using the medicine, the hands should be washed thoroughly.
The treatment period is usually from 4 to 10 weeks.
If the patient feels that the effect of Akneroxid 5 is too strong or too weak, they should inform their doctor or pharmacist.

Using more than the recommended dose of Akneroxid 5

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 5

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 5 can cause side effects, although they may not occur in every patient.
After starting to use Akneroxid 5, in the first days of treatment, a feeling of tension and slight redness of the skin may occur, which usually disappears 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 stopped and the doctor consulted.
After the disappearance of these symptoms, treatment can often be continued, using the medicine at longer intervals.
The use of Akneroxid 5 may occasionally (less often than in 1 in 100 people) cause increased dryness of the skin.
In rare cases (less often than in 1 in 1000 people), contact allergy may occur.

Reporting side effects

If any side effects occur, including any possible 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 will allow for the collection of more information on the safety of the medicine.

5. How to store Akneroxid 5

The medicine should be stored at a temperature below 25°C.
The shelf life after first opening the tube is 6 months.
Store in a place 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 specified 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. Contents of the pack and other information

What Akneroxid 5 contains

The active substance of the medicine is benzoyl peroxide.
1 g of gel contains 50 mg of benzoyl peroxide.
The other ingredients (excipients) are: laureth-9, 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 packaging of the medicine 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
To obtain more detailed information, the patient should contact the representative of the Marketing Authorisation 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: