PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Aknemycin Plus
(40 mg + 0.25 mg)/g, cutaneous solution
Erythromycinum + Tretinoinum
Please read the entire leaflet carefully before using this 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. This medicine may harm another person, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 liquid formulation and is a topical anti-acne medication intended for application to the skin. The active substances in this medicine are erythromycin and tretinoin.
Erythromycin is an antibiotic belonging to the macrolide group, which acts against Gram-positive bacteria and certain Gram-negative bacteria, including Propionibacterium acnes, which plays a significant role in the development of acne.
Tretinoin belongs to the group of retinoid drugs, 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 papulopustular 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 it with your doctor or pharmacist.
Care should be taken to avoid Aknemycin Plus entering the eyes or under the eyelids.
If the medicine comes into contact with the eyes, rinse thoroughly with plenty of water.
Aknemycin Plus should not be applied around the lips or inside the nose.
In the initial phase of treatment, acne lesions may temporarily worsen with increased inflammatory reaction – this indicates that the medicine has started to work, and these symptoms are usually transient. This is not 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 fingers, hands should be washed thoroughly.
During treatment with Aknemycin Plus, the skin may become more sensitive (photosensitive) to ultraviolet (UV) radiation (sunlight, quartz lamps, or solarium).
Skin irritation occurring during treatment (see section 4) may be intensified by exposure to UV radiation, X-rays, or bathing in salt or chlorinated water. This particularly applies to individuals who are exposed to sunlight for prolonged periods and to patients who are especially sensitive to sunlight. During treatment with Aknemycin Plus, direct exposure to sunlight or UV radiation from other sources (e.g. sunlamps or tanning beds) should be avoided.
Any sunburn should be fully healed before starting treatment with Aknemycin Plus.

Aknemycin Plus and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Concurrent use of other topical medicines should be avoided due to the risk of increased skin irritation.
Skin irritation during treatment may be intensified by exposure to UV radiation (sunlight, quartz lamps, solarium), X-ray radiation, or bathing in salt or chlorinated water.

Effects on fertility, pregnancy and breastfeeding
Consult your doctor before using any medicine.
DO NOT use Aknemycin Plus during pregnancy or if you are planning to become pregnant.
Further information is available from your doctor.
Special caution is required if your doctor recommends using the medicine during breastfeeding.
To avoid direct contact of the medicine with the newborn’s skin, Aknemycin Plus should not be applied to 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, the medicine is flammable. It should be stored away from fire and not used near open flames, lit cigarettes, or certain electrical devices (e.g. hair dryers).

3. How to use Aknemycin Plus

This medicine should always be used as directed by a physician. In case of doubt, consult your doctor or pharmacist.
This medicine is intended for topical application to the skin.
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 prevents contaminants from the skin entering the solution.
The duration of treatment must not exceed 12 weeks.
Use of more Aknemycin Plus than recommended
No data available.
If more medicine is used than recommended or if the medicine is accidentally ingested, contact a doctor immediately.
Missed dose of Aknemycin Plus
Do not use a double dose to make up for a missed dose.
Stopping the use of the medicine
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 a severe skin reaction occurs—such as red, scaly rash with subcutaneous nodules and blisters (erythema multiforme)—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 reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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

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

5. How to store Aknemycin Plus

Store below 25°C.
The medicine is flammable. 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 will help protect the environment.

6. Contents of the pack and other information

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

What Aknemycin Plus looks like and contents of the pack
Aknemycin Plus is a clear, slightly yellowish topical solution with the smell of ethanol.
The medicine is available in a pack containing a 25 ml amber glass bottle with an applicator, secured with a white cap, placed in a cardboard carton.
For further information, please contact the responsible party 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
21465 Reinbek
Schleswig-Holstein
Germany

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Marketing Authorisation number in the Czech Republic, country of export: 46/268/02-C
Parallel Import Authorisation number: 328/20