Aknemicin Plus

Leaflet attached to the packaging: patient information

WARNING! Keep the leaflet, information on the immediate packaging in a foreign language.

Aknemycin Plus

(40 mg + 0.25 mg)/g, liquid for the skin
Erythromycin+ Tretinoin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Aknemycin Plus and what is it used for
• 2. Important information before using Aknemycin Plus
• 3. How to use Aknemycin Plus
• 4. Possible side effects
• 5. How to store Aknemycin Plus
• 6. Contents of the packaging and other information

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

Aknemycin Plus is a liquid, a topical anti-acne medicine for use on the skin. The active substances of the medicine are erythromycin and tretinoin.
Erythromycin is a macrolide antibiotic that acts on Gram-positive and some Gram-negative bacteria, including Propionibacterium acnes, which plays a significant role in the development of acne.
Tretinoin belongs to the group of retinoids, which promotes skin peeling, inhibits keratinization of the epidermis, and causes the removal of blackheads.

Indications

All forms of acne, including non-inflammatory forms with blackheads and inflammatory forms with pustules, especially in patients with high 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 any of the other ingredients of this medicine (listed in section 6),
• in acute eczema,
• in rosacea,
• in acute inflammatory skin conditions, especially in the area around the mouth (perioral dermatitis),
• in pregnant women,
• in women planning to become pregnant.

Warnings and precautions

Before starting to use Aknemycin Plus, you should discuss it with your doctor or pharmacist.
You should be careful not to get Aknemycin Plus in your eyes or under your eyelids.
1 of 4
If the medicine comes into contact with your eyes, you should rinse them thoroughly with plenty of water.
Aknemycin Plus should not be applied to the area around the mouth and nose.
In the initial treatment period, there may be an exacerbation of acne lesions with an increase in inflammatory reaction - this is a sign that the medicine has started to work, and these symptoms are usually transient. This is not a reason to stop treatment, but your doctor may reduce the frequency of application of the medicine.
The medicine should always be applied using the enclosed applicator. If, despite using the applicator, the medicine comes into contact with your fingers, you should wash your hands thoroughly.
During therapy with Aknemycin Plus, the skin may become more sensitive (photosensitive) to ultraviolet radiation (UV) (sunlight, quartz lamps, or sunbeds).
Skin irritation that occurs during the use of the medicine (see section 4) may be exacerbated by UV radiation, X-ray radiation, or bathing in saltwater or chlorinated water. This applies especially to people who are exposed to sunlight for a long time and to patients who are particularly sensitive to sunlight. During therapy with Aknemycin Plus, you should avoid direct exposure to sunlight or UV radiation from other sources (i.e., from sunlamps and sunbeds).
Before using Aknemycin Plus, any sunburn should be healed.

Aknemycin Plus and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
You should avoid using other skin medicines at the same time, due to the risk of exacerbating skin irritation.
Skin irritation that occurs during the use of the medicine may be exacerbated by UV radiation (sunlight, quartz lamps, sunbeds), X-ray radiation, or bathing in saltwater or chlorinated water.

Effects on fertility, pregnancy, and lactation:

Before using any medicine, you should consult your doctor.
Aknemycin Plus should NOT be used during pregnancy or when planning to become pregnant. More information can be obtained from your doctor.
Special caution should be exercised when the doctor recommends using the medicine during breastfeeding.
To avoid direct contact between the medicine and the skin of the newborn, Aknemycin Plus should not be applied to the breast during breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Aknemycin Plus contains ethanol.

This medicine contains 754 mg of alcohol (ethanol) in each ml of liquid, which may cause a burning sensation on damaged skin.
Due to the alcohol content (ethanol), the medicine is flammable. It should be kept away from fire and not used near an open flame, lit cigarette, or certain devices (e.g., hair dryers).

3. How to use Aknemycin Plus

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
2 of 4
The medicine is intended for topical use on the skin.

Adults

The medicine should be applied to the affected skin once or twice a day, after prior skin cleansing.
Aknemycin Plus should be applied directly to the skin using the enclosed applicator.
The applicator prevents contamination of the liquid with skin impurities.
The treatment period should not exceed 12 weeks.

Using a higher dose of Aknemycin Plus than recommended

No data available.
In case of using a higher dose of the medicine than recommended or accidental ingestion, you should contact your doctor.

Missing a dose of Aknemycin Plus

You should not use a double dose to make up for a missed dose.

Stopping the use of Aknemycin Plus

In case of any further doubts regarding the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aknemycin Plus can cause side effects, although not everybody gets them.
Rarely (less often than in 1 in 1000 treated patients), the medicine may cause skin discoloration, skin irritation in the form of redness, burning, dryness, and peeling.
Very rarely (less often than in 1 in 10,000 treated patients), the above side effects may be a sign of an allergic reaction (allergic contact dermatitis).
In the initial treatment period, there may be an exacerbation of acne lesions with an increase in inflammatory reaction.
If the patient experiences a severe skin reaction: red, peeling rash with nodules under the skin and blisters (pustular psoriasis), they should contact their doctor immediately. The frequency of these side effects is unknown (cannot be determined based on available data).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store Aknemycin Plus

3 of 4
Store in a temperature below 25°C.
The medicine should be stored in a place that is 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 specified month. The shelf life after first opening the bottle

• 6 months.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The medicine is flammable. Additional information - see section 2.

6. Contents of the packaging and other information

What Aknemycin Plus contains

The active substances of the medicine are erythromycin and tretinoin.
One gram of liquid for the skin contains: 40 mg of erythromycin and 0.25 mg of tretinoin.
The other ingredients (excipients) of the medicine are: ethanol 95%, glycerol 85%, copolyvidone.

What Aknemycin Plus looks like and what the packaging contains

Aknemycin Plus is a liquid for the skin.
The available packaging of the medicine is a brown glass bottle with an applicator, sealed with a white cap, containing 25 ml of liquid for the skin, placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

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
Authorization number in the Czech Republic, the country of export: 46/268/02-C
Parallel import authorization number:467/12
Date of leaflet approval: 26.05.2022
4 of 4