AKNEMYCIN 40 mg /0.25 Mg Liquid

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Aknemycin Plus and what is it used for
   1. Indications
3. Important information before using Aknemycin Plus
   1. When not to use Aknemycin Plus
   2. Warnings and precautions
   3. Aknemycin Plus and other medicines
   4. Effects on fertility, pregnancy, and lactation:
   5. Driving and using machines
   6. Aknemycin Plus contains ethanol.
4. How to use Aknemycin Plus
   1. Adults
   2. Using a higher dose of Aknemycin Plus than recommended
   3. Missing a dose of Aknemycin Plus
   4. Stopping the use of Aknemycin Plus
5. Possible side effects
   1. Reporting side effects
6. How to store Aknemycin Plus
7. Package contents and other information
   1. What Aknemycin Plus contains
   2. What Aknemycin Plus looks like and what the package contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

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

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please 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. Package contents and other information

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

Aknemycin Plus is a liquid, anti-acne medicine 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 bacteria and some Gram-negative bacteria, including Propionibacterium acnesbacteria, which play 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 severe seborrhoea.

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, the patient should discuss it with their doctor or pharmacist.
Caution should be exercised to avoid getting Aknemycin Plus in the eyes or under the eyelids.
In case of contact with the eyes, they should be rinsed carefully with a large amount 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 the doctor may reduce the frequency of application.
The medicine should always be applied using the enclosed applicator. If, despite using the applicator, the medicine comes into contact with the fingers, the hands should be washed thoroughly.
During therapy with Aknemycin Plus, the skin may become more sensitive (photosensitive) to ultraviolet radiation (UV) (sunlight, quartz lamps, or sunbeds).
Irritation of the skin 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, direct exposure to sunlight or UV radiation from other sources (i.e., tanning lamps and sunbeds) should be avoided.
Before using Aknemycin Plus, any sunburn should be healed.

Aknemycin Plus and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
The patient should avoid using other skin medicines at the same time, due to the risk of exacerbating skin irritation.
Irritation of the skin 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, the patient should consult their doctor.
Aknemycin Plus should NOT be used during pregnancy or when planning to become pregnant. More information can be obtained from the 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 has no effect on the ability to drive or operate machines.

Aknemycin Plus contains ethanol.

This medicine contains 754 mg of alcohol (ethanol) per ml of liquid, which may cause a burning sensation on damaged skin.
Due to the alcohol content, 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 as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
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 cleaning the skin.
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 duration 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 accidentally ingesting the medicine, the patient should contact their doctor.

Missing a dose of Aknemycin Plus

A double dose should not be used to make up for a missed dose.

Stopping the use of Aknemycin Plus

In case of any further doubts about the use of this medicine, the patient should consult their 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 peeling.
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, peeling 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 estimated from the available data).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Aknemycin Plus

Store at a temperature below 25°C.
The medicine is flammable. Additional information - see section 2.
Shelf life after first opening the bottle - 6 months.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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: anhydrous ethanol, glycerol 85%, copolyvidone.

What Aknemycin Plus looks like and what the package contains

Aknemycin Plus is a liquid for the skin.
The available package of the medicine is a bottle made of colorless or brown, or opaque glass, with an applicator, sealed with a white urea-formaldehyde resin or white polypropylene cap, containing 25 ml of liquid for the skin, and placed in a cardboard box.

Marketing authorization holder and manufacturer

Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
(logo)
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Almirall Sp. z o.o.
ul. Pileckiego 63
02-781 Warsaw
tel. 22 330 02 57
fax 22 313 01 57
Date of the last update of the leaflet: