Aknemicin

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Aknemycin (Aknemycin Salbe), 20 mg/g, Ointment

Erythromycin
Aknemycin and Aknemycin Salbe are different trade names for the same drug.

Read the Leaflet Carefully Before Using the Medication

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms 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. Package contents 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 significant in the development of common acne, in particular on Propionibacterium acnes. Additionally, topical erythromycin 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

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

Aknemycin and other medications

Tell your doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Interactions with other medications 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 medication.
If the doctor decides that the medication should be used during breastfeeding, to avoid oral ingestion of erythromycin by the infant, contact between the infant's mouth and the treated skin area should be avoided.

Driving and using machines

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

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

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.
This medication contains fragrances with allergens.These allergens (benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, limonene, linalol) 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 medication should always be used as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
The medication is intended for topical use on the skin.
Aknemycin ointment is usually applied to the skin areas with lesions, twice a day (e.g., morning and evening).
In most patients, significant improvement is observed within 4 weeks of using the medication.
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 thoroughly.

If you feel that the medication is too strong or too weak, consult your doctor or pharmacist.

Using more than the recommended dose of Aknemycin

In case of accidental overdose, consult your doctor or pharmacist immediately.

Missing a dose of Aknemycin

Do 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 medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Aknemycin ointment for topical use 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 continued use of the medication.
In individual cases, the above-mentioned symptoms may occur as part of an allergic reaction (allergic contact dermatitis).
Prolonged use of the medication may lead to worsening of the disease 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 eruption), they should contact their doctor immediately. The frequency of these side effects is unknown (cannot be determined from available data).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, inform your 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Aknemycin

Keep the medication out of sight and reach of children.
Do not store above 25°C.
Use the medication within 6 months of opening the package.
Do not use the medication after the expiration date stated on the package. The expiration date refers to the last day of the specified month.

Translation of abbreviations on the immediate packaging:

Ch.-B./Verwendbar bis: see tube fold - Batch number/Expiration date: see tube fold
Medications should not be disposed of in wastewater or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Aknemycin contains

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

What Aknemycin looks like and what the package contains

Aknemycin is an ointment.
The package is an aluminum tube with an HDPE cap containing 25 g of ointment, placed in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Almirall Hermal GmbH, Scholtzstraße 3, 21465 Reinbek, Germany

Manufacturer:

Almirall Hermal GmbH, Scholtzstraße 3, 21465 Reinbek, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German export permit number: 2684.00.01

Parallel import permit number: 73/23 Date of leaflet approval: 07.04.2023

[Information about the trademark]