PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Aknemycin
20 mg/g, ointment
Erythromycinum
Please read carefully the entire leaflet 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 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 other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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, topical 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 infant with the medicine.

Aknemycin and other medicines
Tell your doctor or pharmacist if you are 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 become pregnant, 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 contains cetostearyl alcohol and butylated hydroxytoluene (E 321) – a component of white soft paraffin.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Butylated hydroxytoluene (E 321) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

This medicine contains fragrance oil with allergens. These allergens (benzyl alcohol; benzyl benzoate; benzyl salicylate; cinnamaldehyde; cinnamyl alcohol; citral; citronellol; eugenol; farnesol; geraniol; hydroxycitronellal; isoeugenol; linalool) may cause allergic reactions.
Benzyl alcohol (a component of the fragrance oil) may cause allergic reactions and mild local irritation.

3. How to use Aknemycin medicine

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

Wash the skin with lukewarm water to remove any residue of the previous dose of ointment.
Dry the skin thoroughly.

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

4. Possible adverse reactions

Like all medicines, Aknemycin topical ointment may cause adverse reactions, although they do not occur in everyone.
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 resolve with continued use of the medicine.
In isolated cases, the above symptoms may occur as part of hypersensitivity reactions (allergic contact dermatitis).
Prolonged use of the medicine may lead to worsening of skin lesions due to development of bacterial resistance and (or) to the occurrence of Gram-negative bacterial folliculitis.
If a severe skin reaction occurs in the patient: red, peeling rash with subcutaneous nodules and blisters (bullous eruption), medical advice should be sought immediately. The frequency of these adverse reactions is unknown (cannot be estimated from available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Aknemycin

Do not store above 25 °C.
After first opening, use within 6 months.
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.
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. Each 1 g of ointment contains 20 mg of erythromycin.
The other ingredients (excipients) are: fragrance oil Gardenia PH 0/060927 (benzyl benzoate, propylene glycol (E 1520), benzyl alcohol, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citronellol, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, linalool), purified water, cetostearyl alcohol, liquid non-crystallizing sorbitol, cetyl-stearyl polyglycol phosphate, oleyl oleate, lauryl polyglycol phosphate, titanium dioxide (E 171), white paraffin, talc, white soft paraffin (contains butylated hydroxytoluene (E 321)), liquid paraffin.

What Aknemycin looks like and contents of the pack
Aknemycin is a white or pale yellow, homogeneous, slightly perfumed ointment.
The packaging consists of an aluminum tube with a protective cap 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 Hungary, country of export:
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
Manufacturer:
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Hungary Marketing Authorisation Number (country of export): OGYI-T-2373/01
Parallel Import Licence Number: 388/19