Aknemicin

Package Leaflet: Information for the Patient

Aknemycin,20 mg/g, skin solution
Erythromycin

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Aknemycin and what is it used for

Aknemycin skin solution contains the active substance - the antibiotic erythromycin.
Erythromycin acts on microorganisms that are important in the development of common acne,
particularly on Propionibacterium acnes. Additionally, erythromycin used locally inhibits the breakdown
of skin sebum lipids.

Indications

All forms of common acne, especially inflammatory forms, with the presence of papules and pustules.

2. Important information before using Aknemycin

When not to use Aknemycin

• if the patient is allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6);
• during breastfeeding, Aknemycin should not be used in the breast area to avoid contact with the infant.

Warnings and precautions

Before starting to use Aknemycin, the doctor or pharmacist should be consulted.
The medicine should not come into contact with the eyes.

Aknemycin and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking
or has recently taken, as well as any medicines the patient plans to use.
Interactions with other medicines are not known.

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.
If the doctor decides that the medicine should be used during breastfeeding, to avoid oral ingestion of erythromycin by the infant, the infant's mouth should not come into contact with the treated skin area.

Driving and using machines

Aknemycin does not affect the ability to drive or use machines.

Aknemycin contains ethanol.

This medicine contains 759 mg of alcohol (ethanol) per ml of solution. Aknemycin may cause
burning of damaged skin.
Flammable product. Keep away from fire and do not use near an open flame, lit cigarette, or certain devices (e.g., hair dryers).

3. How to use Aknemycin

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The medicine is intended for local use on the skin.
Aknemycin skin solution is usually applied to the skin areas where the disease changes occur, twice a day (e.g., morning and evening).
In most patients, a significant improvement is observed within 4 weeks of using the medicine. The treatment period
should not exceed 4 to 6 weeks.
A special applicator is attached to the medicine bottle. Aknemycin can be applied directly to the skin using the applicator.
Applicator instructions:
To prepare the bottle with the applicator for use, the cap should be pressed on the applicator before each use. This will release the safety mechanism, and the medicine can be applied to the skin.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Using more than the recommended dose of Aknemycin

In case of accidental overdose, the doctor or pharmacist should be consulted immediately.

Missing a dose of Aknemycin

A double dose should not be used to make up for a missed dose.

Stopping the use of Aknemycin

In case of any further doubts about using the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Aknemycin can cause side effects, although not everybody gets them.
Very rarely (in no more than 1 in 10,000 people), drying, redness, burning sensation, and skin itching may occur.
In such cases, treatment with Aknemycin ointment can be continued. These medicines can also be used alternately.
In individual cases, the above-mentioned symptoms may occur as part of an allergic reaction (contact allergic dermatitis).
Prolonged use of the medicine may lead to worsening of the disease due to the development of bacterial resistance and (or) the occurrence of folliculitis caused by Gram-negative bacteria.
If the patient experiences a severe skin reaction: red, scaly rash with nodules under the skin and blisters (pustular psoriasis), they should contact their doctor immediately. The frequency of these side effects is unknown (cannot be determined from available data).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. 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, tel.: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Aknemycin

Store at a temperature below 25°C.
Flammable product. Keep away from fire and do not use near an open flame, lit cigarette, or certain devices (e.g., hair dryers).
The medicine should be stored out of sight and reach of children.
Aknemycin should not be used after the expiration date stated on the packaging, after: Expiration date. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Aknemycin contains

• -The active substance of the medicine is erythromycin. 1 g of skin solution contains 20 mg of erythromycin.
• The other ingredients (excipients) are: ethanol, lauryl polyglycol phosphate, glycerol, povidone.

What Aknemycin looks like and what the package contains

The medicine is a skin solution.
The package contains a bottle with an applicator containing 25 ml or 50 ml of skin solution, placed in a cardboard box.
Not all package sizes may be marketed.
Marketing authorization holder and manufacturer:
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
Date of last update of the leaflet: