Aknemycin
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Aknemycin (Aknemycin Lösung)
20 mg/g, topical solution
Erythromycinum
Aknemycin and Aknemycin Lösung 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 to be able to read it again if necessary.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:
- What Aknemycin is and what it is used for
- What you need to know 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 is a topical solution containing the active substance – an antibiotic – erythromycin.
Erythromycin acts against microorganisms involved in the development of acne vulgaris, particularly Propionibacterium acnes. Additionally, 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 to 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.
Warnings and precautions
Before starting treatment with Aknemycin, discuss this with your doctor or pharmacist.
Avoid contact of the medicine with the eyes.
Aknemycin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
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 a doctor or pharmacist before using this medicine.
If, in the doctor's opinion, the use of the medicine during breastfeeding is necessary, 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 effect on the ability to drive and operate machinery.
Aknemycin contains ethanol
This medicine contains 752 mg of alcohol (ethanol) per ml of solution. Aknemycin may cause a stinging sensation on damaged skin.
The product is flammable. Keep away from fire and do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
3. How to use Aknemycin
This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Aknemycin, in the form of a skin solution, is usually applied to the affected skin areas twice daily (e.g. morning and evening).
In most patients, a noticeable improvement is observed within 4 weeks of treatment. The treatment period should not exceed 4 to 6 weeks.
The medicine bottle is supplied with a special applicator. 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, press and turn the cap of the applicator before each use. This releases the safety lock, allowing the medicine to be applied to the skin.
If you feel the medicine's effect is too strong or too weak, consult your doctor or pharmacist.
Using more Aknemycin than recommended
In case of accidental overdose, seek immediate advice from your doctor or pharmacist.
Missing a dose of Aknemycin
Do not apply a double dose to make up for a missed dose.
Stopping Aknemycin
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 may cause adverse reactions, although not everyone experiences them.
Very rarely (in no more than 1 in 10,000 people), skin dryness, redness, burning sensation, and itching may occur.
In such cases, treatment with Aknemycin ointment may be continued. These medicines may also be used alternately.
In isolated cases, the above symptoms may occur as part of a hypersensitivity reaction (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 folliculitis.
If a severe skin reaction occurs, such as red, peeling rash with subcutaneous nodules and blisters (erythema multiforme), contact a doctor immediately. The frequency of these adverse reactions is unknown (cannot be estimated based on available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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.: + 48 22 49 21 301, fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of using this medicine.
5. How to store Aknemycin
Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use Aknemycin after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Shelf-life after first opening – 6 months.
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.
Flammable product. Store away from fire and do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
6. Contents of the packaging and other information
What Aknemycin contains
- The active substance is erythromycin. 10 g of the topical solution contains 0.2 g of erythromycin. (1 g of the topical solution contains 20 mg of erythromycin).
- The other ingredients (excipients) are: ethanol, lauryl polyglycol phosphate, glycerol, povidone K 30.
What Aknemycin looks like and contents of the pack
The medicine is a topical solution.
The packaging consists of a glass bottle containing 25 ml of topical solution, with an applicator and cap, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Germany, 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Germany, country of export: 2684.00.00
Parallel import licence number: 74/20