Package leaflet: Information for the user

WARNING! Keep the leaflet, information on the immediate packaging in a foreign language.
Aknemycin Plus
(40 mg + 0.25 mg)/g, solution for skin application
Erythromycinum + Tretinoinum
Please read the entire leaflet carefully 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Aknemycin Plus is and what it is used for
Important information before using Aknemycin Plus
How to use Aknemycin Plus
Possible side effects
How to store Aknemycin Plus
Contents of the pack and other information

1. What Aknemycin Plus is and what it is used for

Aknemycin Plus is a topical solution used for the treatment of acne. The active substances in this medicine are erythromycin and tretinoin.
Erythromycin is a macrolide antibiotic that acts against Gram-positive bacteria and some Gram-negative bacteria, including Propionibacterium acnes, which plays an important role in the development of acne.
Tretinoin belongs to the group of medicines known as retinoids. It promotes skin desquamation, inhibits keratinization of the epidermis, and helps remove comedones.
Indications
All forms of acne, including non-inflammatory forms with comedones and inflammatory forms with pustular lesions, particularly in patients with excessive sebum production.

2. Important information before using Aknemycin Plus

When not to use Aknemycin Plus

if the patient is allergic to erythromycin and/or tretinoin, or to any of the other ingredients of this medicine (listed in section 6),
in acute acne,
in rosacea,
in acute inflammatory skin conditions, especially around the mouth (perioral dermatitis),
in pregnant women,
in women planning to become pregnant.

Warnings and precautions
Before starting treatment with Aknemycin Plus, discuss this with your doctor or pharmacist.
Take care to avoid contact of Aknemycin Plus with the eyes or under the eyelids.
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If the medicine comes into contact with the eyes, rinse them thoroughly with plenty of water.
Do not apply Aknemycin Plus around the lips or nostrils.
During the initial phase of treatment, acne lesions may temporarily worsen with increased inflammatory reaction – this is a sign that the medicine has started to work, and these symptoms are usually transient. This does not constitute a reason to discontinue treatment; however, your doctor may reduce the frequency of application.
The medicine should always be applied using the provided applicator. If, despite using the applicator, the medicine comes into contact with the fingers, wash hands thoroughly.
During treatment with Aknemycin Plus, the skin may become more sensitive (photosensitive) to ultraviolet (UV) radiation (sunlight, tanning lamps, or solarium).
Skin irritation occurring during treatment (see section 4) may intensify due to exposure to UV radiation, X-ray radiation, or bathing in salt or chlorinated water. This particularly applies to individuals who are exposed for prolonged periods to sunlight and to patients especially sensitive to solar radiation. During treatment with Aknemycin Plus, avoid direct exposure to sunlight or UV radiation from other sources (e.g. tanning lamps and solariums).
Before using Aknemycin Plus, any existing sunburns should be fully healed.

Aknemycin Plus and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to use.
Avoid simultaneous use of other topical medicines due to the risk of increased skin irritation.
Skin irritation occurring during treatment may intensify due to exposure to UV radiation (sunlight, tanning lamps, solarium), X-ray radiation, or bathing in salt or chlorinated water.

Effect on fertility, pregnancy, and lactation:
Consult your doctor before using any medicine.
DO NOT use Aknemycin Plus during pregnancy or if you are planning to become pregnant. More information is available from your treating physician.
Exercise particular caution if your doctor recommends using the medicine during breastfeeding.
To avoid direct contact of the medicine with the newborn's skin, do not apply Aknemycin Plus on the breast during breastfeeding.

Driving and operating machinery
Aknemycin Plus has no effect on the ability to drive or operate machinery.

Aknemycin Plus contains ethanol.
This medicine contains 754 mg of alcohol (ethanol) per ml of solution and may cause a stinging sensation on damaged skin.
Due to its alcohol (ethanol) content, the medicine is flammable. Store away from fire and do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Aknemycin Plus

This medicine should always be used exactly as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
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This medicine is intended for topical application on the skin.
Adults
Apply the medicine to the affected skin area once or twice daily, after cleansing the skin.
Aknemycin Plus should be applied directly to the skin using the provided applicator.
The applicator prevents contaminants from the skin entering the solution.
The duration of treatment must not exceed 12 weeks.
Use of a higher than recommended dose of Aknemycin Plus
No data available.
If more medicine has been used than recommended or if the medicine has been accidentally ingested, contact your doctor.
Missed dose of Aknemycin Plus
Do not apply a double dose to make up for a missed dose.
Stopping the treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Aknemycin Plus can cause adverse reactions, although not everyone experiences them.

Rarely (less frequently than in 1 out of 1,000 treated individuals), the medicine may cause skin depigmentation and skin irritation manifesting as redness, burning sensation, dryness, and peeling.

Very rarely (less frequently than in 1 out of 10,000 treated individuals), the above adverse reactions may be symptoms of hypersensitivity reactions (allergic contact dermatitis).

In the initial treatment period, an exacerbation of acne lesions with increased inflammatory response may occur.

If a severe skin reaction occurs in the patient—such as red, scaly rash with subcutaneous nodules and blisters (bullous eruption)—medical advice must be sought immediately. The frequency of these adverse effects is unknown (cannot be estimated based on available data).

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a 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, phone: +48 22 49-21-301, fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl.

Adverse reactions can also be reported to the marketing authorization holder or a parallel importer.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Aknemycin Plus

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Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine 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 of the bottle:

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 medicine. For additional information – see section 2.

6. Contents of the pack and other information

What Aknemycin Plus contains
The active substances in this medicinal product are erythromycin and tretinoin.
One gram of topical solution contains: 40 mg of erythromycin and 0.25 mg of tretinoin.
Other components (excipients) of the medicinal product are: ethanol 95%, glycerol 85%, copovidone.

What Aknemycin Plus looks like and contents of the pack
Aknemycin Plus is a topical solution.
The medicinal product is available in a 25 ml amber glass bottle with an applicator and a white screw cap, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Almirall Hermal GmbH, Scholtzstrasse 3, D-21465 Reinbek, Germany

Manufacturer:
Almirall Hermal GmbH, Scholtzstrasse 1, 3 and 6, D-21465 Reinbek, Schleswig-Holstein, Germany

Parallel importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Natur Produkt Zdrovit Sp. z o.o., ul. Nocznickiego 31, 01-918 Warsaw

Marketing Authorisation number in the Czech Republic, the country of export: 46/268/02-C
Parallel import licence number: 467/12
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