Aknemicin

LEAFLET INCLUDED WITH THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Aknemycin(Aknemycin Solution)

20 mg/g, liquid for the skin

Erythromycin
Aknemycin and Aknemycin Solution are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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. Contents of the packaging and other information

1. What is Aknemycin and what is it used for

Aknemycin, in the form of a liquid for the skin, contains the active substance - an antibiotic - erythromycin.
Erythromycin acts on microorganisms that are important in the development of common acne,
especially on Propionibacterium acnes. Additionally, erythromycin used locally inhibits
the breakdown of sebum lipids on the skin's surface.

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 drug (listed in section 6);
• during breastfeeding, Aknemycin should not be used in the area of the breast, to avoid contact with the infant.

Warnings and precautions

Before starting to use Aknemycin, you should discuss it with your doctor or pharmacist.
The drug should not come into contact with the eyes.

Aknemycin and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
Interactions with other drugs are not known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this drug.
If, in the doctor's opinion, the drug 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 operating machinery

Aknemycin does not affect the ability to drive and operate machinery.

Aknemycin contains ethanol

This drug contains 752 mg of alcohol (ethanol) per ml of liquid. Aknemycin may cause burning of damaged skin.
Flammable product. Store 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 drug should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The drug is intended for local use on the skin.
Aknemycin, in the form of a liquid for the skin, is usually applied to the skin areas where the disease changes occur, twice a day (e.g., in the morning and evening).
In most patients, a significant improvement is observed within 4 weeks of using the drug. The treatment period should not exceed 4 to 6 weeks.
A special applicator is attached to the bottle with the drug. Aknemycin can be applied directly to the skin using the applicator.

Instructions for using the applicator

To prepare the bottle with the applicator for use, you should press the cap on the applicator before each use. This will release the safety mechanism and allow you to apply the drug to the skin.
If you feel that the effect of the drug is too strong or too weak, you should consult a doctor or pharmacist.

Using a higher dose of Aknemycin than recommended

In case of accidental overdose, you should immediately consult a doctor or pharmacist.

Missing a dose of Aknemycin

You should not use a double dose to make up for a missed dose.

Stopping the use of Aknemycin

In case of any further doubts related to the use of the drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like any drug, Aknemycin can cause side effects, although they may not occur in everyone.
Very rarely (in no more than 1 in 10,000 people), dryness, redness, burning sensation, and itching of the skin may occur.
In such cases, you can continue treatment with Aknemycin in the form of an ointment. These drugs can also be used alternately.
In individual cases, the above-mentioned symptoms may occur as part of an allergic reaction (allergic contact dermatitis).
Long-term use of the drug may lead to an exacerbation 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 acne), they should contact their doctor immediately. The frequency of these side effects is unknown (it cannot be determined based on available data).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Aknemycin

Do not store above 25°C.
The drug should be stored in a place that is out of sight and reach of children.
Aknemycin should not be used after the expiration date stated on the packaging.
The expiration date is the last day of the specified month.
Shelf life after first opening - 6 months.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.
Flammable product. Store away from fire and do not use near an open flame, lit cigarette, or certain devices (e.g., hair dryers).

6. Contents of the packaging and other information

What Aknemycin contains

• The active substance of the drug is erythromycin. 10 g of liquid for the skin contains 0.2 g of erythromycin. (1 g of liquid for the skin contains 20 mg of erythromycin).
• The other ingredients (excipients) are: ethanol, lauryl polyglycol phosphate, glycerol, povidone K 30.

What Aknemycin looks like and what the packaging contains

The drug is a liquid for the skin.
The packaging of the drug is a glass bottle containing 25 ml of liquid for the skin, with an applicator and cap in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Germany

Manufacturer:

Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 2684.00.00
Parallel import authorization number: 74/20

Date of approval of the leaflet: 19.02.2025

[Information about the trademark]