Aknemicin

Package Leaflet: Information for the Patient

Aknemycin

20 mg/g, ointment
Erythromycin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack and other information

1. What is Aknemycin and what is it used for

Aknemycin ointment contains the active substance erythromycin, an antibiotic. 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 sebum lipids 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

• if you are allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6);
• during breastfeeding, do not use Aknemycin in the breast area to avoid contact with the infant.

Aknemycin and other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If your doctor thinks you should use the medicine while breastfeeding, to avoid oral ingestion of erythromycin by the infant, do not let the infant's mouth come into contact with the treated skin area.

Driving and using machines

Aknemycin has no influence on the ability to drive and use machines.

Aknemycin ointment contains cetostearyl alcohol and butylhydroxytoluene (E321) - a component of white petrolatum.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis). Butylhydroxytoluene (E321) 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; limonene; linalool) 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

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The medicine is for use on the skin only. Aknemycin ointment is usually applied to the areas of skin where the disease occurs, twice a day (e.g., morning and evening). In most patients, a noticeable improvement is observed within 4 weeks of using the medicine. The treatment period should not exceed 4 to 6 weeks. Before applying the ointment:

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

If you feel that the effect of the medicine is too strong or too weak, talk to your doctor or pharmacist.

Using more Aknemycin than you should

If you have used more than the recommended dose, contact your doctor or pharmacist immediately.

Forgetting to use Aknemycin

Do not use a double dose to make up for a forgotten dose.

Stopping using Aknemycin

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aknemycin ointment can cause side effects, although not everybody gets them. Very rarely (in less than 1 in 10,000 people) at the beginning of treatment, a mild redness or slight peeling of the skin may occur. These symptoms disappear with continued use of the medicine. In isolated 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 exacerbation of the disease due to the development of bacterial resistance and/or the occurrence of folliculitis caused by Gram-negative bacteria. If you experience a severe skin reaction: red, peeling rash with bumps under the skin and blisters (pustular psoriasis), contact your doctor immediately. The frequency of these side effects is not known (cannot be estimated from the available data). Reporting of side effects If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aknemycin

Store below 25°C. Keep the medicine out of the sight and reach of children. Do not use the medicine after the expiry date stated on the packaging, after "Expiry date". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aknemycin contains

• The active substance is erythromycin. 1 g of ointment contains 20 mg of erythromycin.
• The other ingredients (excipients) are: titanium dioxide; talc; white petrolatum, containing butylhydroxytoluene (E321); solid paraffin; liquid paraffin; cetyl-stearyl polyglycol phosphate; oleic acid oleinate; cetostearyl alcohol; lauryl polyglycol phosphate; sorbitol 70%; fragrant oil (perfume oil Gardenia, containing substances: benzyl benzoate; propylene glycol (E1520); benzyl alcohol; benzyl salicylate; cinnamal; cinnamyl alcohol; citral; citronellol; eugenol; farnesol; geraniol; hydroxycitronellal; iso-eugenol; limonene; linalool); purified water.

What Aknemycin looks like and contents of the pack

Aknemycin is an ointment. The pack contains an aluminum tube with 25 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
GermanyAlmirall Sp. z o. o.
ul. Pileckiego 63
02-781 Warsaw
tel.: 22 330 02 57
fax: 22 313 01 57
Date of last revision of the leaflet: