Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Aknemycin Plus
(40 mg + 0.25 mg)/g, solution for skin application
Erythromycinum + Tretinoinum
Please read this 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur, 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 solution for topical application to the skin and is an anti-acne medicine. The active substances are erythromycin and tretinoin.
Erythromycin is an antibiotic belonging to the macrolide group, which 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 retinoid medicines, which promote skin desquamation, inhibit keratinization of the epidermis, and help remove comedones.
Indications
All forms of acne, including non-inflammatory forms with comedones and inflammatory forms with pustular nodules, especially 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 pregnancy.

Warnings and precautions

Before starting treatment with Aknemycin Plus, consult a doctor or pharmacist.
Take care to avoid contact of Aknemycin Plus with eyes or under the eyelids.
If the medicine comes into contact with the eyes, rinse thoroughly with plenty of water.
Do not apply Aknemycin Plus around the lips or nose.
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 require discontinuation of treatment; however, the 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 fingers, wash hands thoroughly.
During treatment with Aknemycin Plus, the skin may become more sensitive (photosensitive) to ultraviolet (UV) radiation (sunlight, UV lamps, or tanning beds).
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 to sunlight for prolonged periods 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 sunbeds).
Any sunburn should be fully healed before starting treatment with Aknemycin Plus.

Aknemycin Plus and other medicines

Inform your doctor about all medicines currently used or recently used, as well as any medicines planned for use.
Avoid concomitant 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, UV lamps, tanning beds), X-ray radiation, or bathing in salt or chlorinated water.

Effect on fertility, pregnancy, and breastfeeding

Before using any medicine, consult a doctor.
DO NOT use Aknemycin Plus during pregnancy or if the patient plans to become pregnant. More information can be obtained from the attending physician.
Extreme caution is required if the doctor prescribes the medicine during breastfeeding.
To avoid direct contact of the medicine with the newborn's skin, do not apply Aknemycin Plus on the breasts during breastfeeding.

Driving and operating machinery

This medicine has no effect on the ability to drive or operate machinery.

Aknemycin Plus contains ethanol

This medicine contains 752 mg of alcohol (ethanol) per ml of solution and may cause stinging on damaged skin.
Due to its alcohol (ethanol) content, this medicine is flammable. Store away from fire and avoid 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 your doctor has instructed. If in doubt, consult your doctor or pharmacist.
This medicine is for topical use on the skin only.
Adults
Apply the medicine to affected areas of skin once or twice daily, after cleansing the skin.
Aknemycin Plus should be applied directly to the skin using the provided applicator.
The applicator helps prevent contamination of the solution by microorganisms from the skin.
The duration of treatment must not exceed 12 weeks.
Use of more than the 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 immediately.
Missed dose of Aknemycin Plus
Do not apply a double dose to make up for a missed application.
Stopping 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 loss of skin pigmentation 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 allergic reactions (allergic contact dermatitis).

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

If the patient develops a severe skin reaction: 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 from available data).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 enables the collection of further information on the safety of using the medicine.

5. How to store Aknemycin Plus

Store below 25°C.
The medicine is flammable. For additional information – see section 2.
Use within 6 months after first opening the bottle.
Keep the medicine out of the 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This practice helps protect the environment.

6. Contents of the package and other information

What Aknemycin Plus contains
The active substances in this medicine are erythromycin and tretinoin.
1 g of the solution contains 40 mg of erythromycin and 0.25 mg of tretinoin.
Other ingredients (excipients) are: ethanol 95%, glycerol 85%, copovidone.

What Aknemycin Plus looks like and contents of the pack
Aknemycin Plus is a solution for topical use.
The medicine is available in a 25 ml amber glass bottle with an applicator and a white screw cap, placed in a cardboard box.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 46/268/02-C
Parallel Import Licence Number: 893/12