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, skin solution
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 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 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 solution for topical 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 exfoliation, 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 consult a doctor or pharmacist.
Be careful not to get Aknemycin Plus in your eyes or under your eyelids.
If the medicine comes into contact with your eyes, rinse them thoroughly with plenty of water.
Aknemycin Plus should not be applied to the area around the mouth and nose.
In the initial period of treatment, there may be an exacerbation of acne lesions with an increase in inflammatory reactions - this is a sign that the medicine has started to work, and these symptoms are usually transient. This is not a reason to discontinue treatment, but your doctor may reduce the frequency of application.
The medicine should always be applied using the applicator provided. If, despite using the applicator, the medicine comes into contact with your fingers, 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 treatment (see section 4) may worsen due to 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 treatment 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

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Avoid using other skin medicines at the same time, due to the risk of exacerbating skin irritation.
Skin irritation that occurs during treatment may worsen due to 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, consult your doctor.
Aknemycin Plus should not be used during pregnancy or when planning to become pregnant. For more information, consult 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 baby's skin, Aknemycin Plus should not be applied to the breast during breastfeeding.

Driving and using machines

The medicine has no effect on the ability to drive or use machines.

Aknemycin Plus contains ethanol

This medicine contains 752 mg of alcohol (ethanol) per ml of solution, which may cause a burning sensation on damaged skin.
Due to the alcohol content, the medicine is flammable. Keep it away from fire and do not use it 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 as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The medicine is intended for topical use on the skin.

Adults

Apply the medicine to the affected skin once or twice a day, after first cleaning the skin.
Aknemycin Plus should be applied directly to the skin using the applicator provided.
The applicator prevents contamination of the solution from the skin.
Treatment should not exceed 12 weeks.

Using more than the recommended dose of Aknemycin Plus

No data available.
If you use more of the medicine than recommended or accidentally swallow it, contact your doctor.

Missing a dose of Aknemycin Plus

Do not use a double dose to make up for a missed dose.

Stopping treatment with Aknemycin Plus

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aknemycin Plus can cause side effects, although not everybody gets them.
Rarely (less than 1 in 1000 treated patients), the medicine may cause skin discoloration, skin irritation in the form of redness, burning, dryness, and flaking.
Very rarely (less than 1 in 10,000 treated patients), the above side effects may be symptoms of an allergic reaction (allergic contact dermatitis).
In the initial period of treatment, there may be an exacerbation of acne lesions with an increase in inflammatory reactions.
If the patient experiences a severe skin reaction: red, flaking 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 you experience any side effects, including any side effects not listed in this leaflet, you should inform 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aknemycin Plus

Store at a temperature below 25°C.
The medicine is flammable. For more information, see section 2.
Shelf life after first opening the bottle: 6 months.
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 month stated.
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.

6. Contents of the packaging and other information

What Aknemycin Plus contains

The active substances of the medicine are erythromycin and tretinoin.
1 g of solution 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 contents of the packaging

Aknemycin Plus is a solution for the skin.
The medicine is available in a 25 ml solution for the skin in a brown glass bottle with an applicator, sealed with a white cap, and packaged in a cardboard box.
For more detailed information, consult 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:46/268/02-C
Parallel import authorization number:893/12
Date of approval of the leaflet: 20.09.2022
[Information about the trademark]