AKNEMYCIN 20 mg /G Ointment

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT
2. Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!
3. Aknemycin
4. 20 mg/g, ointment
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Aknemycin and what is it used for
   1. Indications
6. Important information before using Aknemycin
   1. When not to use Aknemycin
   2. Aknemycin and other medicines
   3. Pregnancy and breastfeeding
   4. Driving and using machines
   5. Aknemycin contains cetostearyl alcohol and butylhydroxytoluene (E 321) - a component of white petrolatum.
7. How to use Aknemycin
   1. Using a higher dose of Aknemycin than recommended
   2. Missing a dose of Aknemycin
   3. Stopping the use of Aknemycin
8. Possible side effects
   1. Reporting side effects
9. How to store Aknemycin
10. Contents of the packaging and other information
    1. What Aknemycin contains
    2. What Aknemycin looks like and what the packaging contains
    3. Marketing authorization holder in Hungary, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Date of leaflet approval: 01.10.2024

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

Aknemycin

20 mg/g, ointment

Erythromycin

You should carefully read the contents of the leaflet before using the medicine, 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 medicine has been prescribed to 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, pharmacist, or nurse. 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 ointment contains the active substance - the antibiotic erythromycin. Erythromycin acts on microorganisms that are important in the development of common acne, in particular on Propionibacterium acnes. Additionally, erythromycin used locally inhibits the breakdown of lipids in sebum on the skin 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

• during breastfeeding, Aknemycin should not be used in the area of the breast to avoid contact with the infant.

Aknemycin 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 take. 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, the patient should avoid contact between the infant's mouth and the treated skin area to prevent oral ingestion of erythromycin.

Driving and using machines

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

Aknemycin contains cetostearyl alcohol and butylhydroxytoluene (E 321) - a component of white petrolatum.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis). Butylhydroxytoluene (E 321) may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation. This medicine contains a fragrant oil with allergens. These allergens (benzyl alcohol; benzyl benzoate; benzyl salicylate; cinnamal; cinnamyl alcohol; citral; citronellol; eugenol; farnesol; geraniol; hydroxycitronellal; iso-eugenol; linalol) may cause allergic reactions. Benzyl alcohol (a component of the fragrant oil) may cause allergic reactions and mild local irritation.

3. How to use Aknemycin

This medicine should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. The medicine is intended for local use on the skin. Aknemycin ointment 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, significant improvement is observed within 4 weeks of using the medicine. The treatment period should not exceed 4 to 6 weeks. Before applying the ointment, the patient should:

• 1. Wash the skin with lukewarm water to remove any remaining previous dose of ointment.
• 2. Dry the skin thoroughly.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Using a higher dose of Aknemycin than recommended

In case of accidental overdose, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Aknemycin

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

Stopping the use of Aknemycin

In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aknemycin ointment for local use on the skin may cause side effects, although not everybody gets them. Very rarely (in no more than 1 in 10,000 people), at the beginning of treatment, mild redness or slight peeling of the skin may occur. These symptoms disappear with longer use of the medicine. In individual cases, the above-mentioned symptoms may occur as part of an allergic reaction (allergic contact dermatitis). Prolonged use of the medicine may lead to an increase in disease changes 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, peeling 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 based on available data).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered 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 specified month. Medicines should not be disposed of via wastewater or household waste containers. 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 packaging and other information

What Aknemycin contains

• The active substance of the medicine is erythromycin. 1 g of ointment contains 20 mg of erythromycin.
• The other ingredients (excipients) are: fragrant oil Gardenia PH 0/060927 (benzyl benzoate, propylene glycol (E 1520), benzyl alcohol, benzyl salicylate, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, farnesol, geraniol, hydroxycitronellal, iso-eugenol, linalol), purified water, cetostearyl alcohol, liquid, non-crystallizing sorbitol, cetyl-stearyl polyglycol phosphate, oleic acid oleinate, lauryl polyglycol phosphate, titanium dioxide (E 171), solid paraffin, talc, white petrolatum (contains butylhydroxytoluene (E 321)), liquid paraffin.

What Aknemycin looks like and what the packaging contains

Aknemycin is a white or light yellow, homogeneous, slightly fragrant ointment. The packaging of the medicine is an aluminum tube with a protective cap, containing 25 g of ointment, placed in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Hungary, the 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 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorization number in Hungary, the country of export: OGYI-T-2373/01
Parallel import authorization number: 388/19

Date of leaflet approval: 01.10.2024

[Information about the trademark]