Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Aknemycin (Aknemycin Salbe)
20 mg/g, ointment
Erythromycinum
Aknemycin and Aknemycin Salbe are different trade names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Aknemycin is and what it is used for

Aknemycin ointment contains the active substance – the antibiotic erythromycin. Erythromycin acts against microorganisms involved in the development of acne vulgaris, particularly Propionibacterium acnes. In addition, topically applied erythromycin inhibits the breakdown of sebum lipids on the skin surface.

Indications
All forms of acne vulgaris, especially inflammatory forms with 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 must not be applied to the breast area to avoid contact of the medicine with the infant.

Aknemycin and other medicines
Tell your doctor or pharmacist if you are currently taking, have recently taken, or plan to take any other medicines.
Interactions with other medicines are not known.

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.
If, in the doctor's opinion, the use of this medicine is necessary during breastfeeding, contact between the infant's mouth and the treated skin area must be avoided to prevent oral intake of erythromycin by the infant.

Driving and operating machinery
Aknemycin has no influence on the ability to drive or operate machinery.

Aknemycin ointment contains cetostearyl alcohol and butylated hydroxytoluene – components of white soft paraffin.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Butylated hydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

This medicine contains fragrance with allergens. These allergens (benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, limonene, linalool) may cause allergic reactions.

Benzyl alcohol (a component of the fragrance) may cause allergic reactions and mild local irritation.

3. How to use Aknemycin

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Aknemycin ointment is usually applied to the affected areas of skin twice daily (e.g. in the morning and evening).
In most patients, noticeable improvement occurs within 4 weeks of treatment. The treatment period should not
exceed 4 to 6 weeks.
Before applying the ointment, you should:

Wash the skin with lukewarm water to remove any residue from the previous application.
Thoroughly dry the skin.

If you feel that the medicine's effect is too strong or too weak, please consult your doctor or pharmacist.
Use of more than the recommended dose of Aknemycin
In case of accidental overdose, seek immediate medical advice from your doctor or pharmacist.
Missed dose of Aknemycin
Do not apply a double dose to make up for a missed dose.
Stopping the use of Aknemycin
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Aknemycin ointment for topical use may cause adverse effects, although not everyone experiences them.

Very rarely (in no more than 1 in 10,000 people), mild erythema or slight desquamation of the stratum corneum may occur at the beginning of treatment. These symptoms subside with prolonged use of the medicine.

In isolated cases, the above symptoms may occur as part of a hypersensitivity reaction (allergic contact dermatitis).

Long-term use of the medicine may lead to worsening of lesions due to development of bacterial resistance and/or to the occurrence of Gram-negative folliculitis.

If a severe skin reaction occurs in the patient—such as red, peeling rash with subcutaneous nodules and blisters (vesiculobullous eruption)—medical advice should be sought immediately. The frequency of these adverse effects is unknown (cannot be estimated from available data).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aknemycin

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
The medicine should be used within 6 months after opening the packaging.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of abbreviations appearing on the immediate packaging:
Ch.-B./Verwendbar bis: see tube fold – Batch number/Expiry date: see tube fold
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Aknemycin contains

The active substance is erythromycin. 1 g of the ointment contains 20 mg of erythromycin.
The other components (excipients) are: titanium dioxide, talc, white soft paraffin (containing butylhydroxytoluene), hard paraffin, liquid paraffin, polyglyceryl cetyl stearyl phosphate, oleyl oleate, cetostearyl alcohol, polyglyceryl lauryl phosphate, liquid sorbitol, non-crystallising, fragrance oil (containing benzyl benzoate, propylene glycol, benzyl alcohol, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, limonene, linalool), purified water.

What Aknemycin looks like and contents of the pack
Aknemycin is an ointment.
The packaging consists of an aluminium tube containing 25 g of ointment, placed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Germany, the country of export:
Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Schleswig-Holstein
Germany
Manufacturer:
Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Schleswig-Holstein
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
German marketing authorisation number, country of export: 2684.00.01
Parallel import authorisation number: 326/25