Zineryt

Package leaflet: Information for the patient

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Zineryt
40 mg/ml + 12 mg/ml, powder and solvent for solution for cutaneous application
Erythromycinum cum zinco
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience 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

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

1. What Zineryt is and what it is used for

Zineryt is an anti-acne medicine for topical use on the skin.
Zineryt contains erythromycin in the form of a complex with zinc acetate. Bacteria sensitive to erythromycin include Staphylococcus epidermidis and Propionibacterium acnes, which are commonly involved in acne. Zinc enhances the local effect of erythromycin in the treatment of acne.
After drying, Zineryt is invisible on the skin and therefore is cosmetically acceptable.
Indications
Zineryt is indicated for topical treatment of moderate to severe acne when local treatment without antibiotics has been insufficient or not tolerated.

2. Important information before using Zineryt

When not to use Zineryt:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if there is hypersensitivity to other antibiotics of the macrolide group.

Warnings and precautions
Before starting treatment with Zineryt, discuss this with your doctor or pharmacist.
Avoid contact of Zineryt with the eyes or the mucous membranes of the nose and mouth. The medicine may cause burning and irritation in these areas. If Zineryt comes into contact with the eyes or mucous membranes of the nose or mouth, rinse thoroughly with water and inform your doctor.
Cross-resistance may occur with other antibiotics of the macrolide group, as well as with lincomycin and clindamycin. Cross-hypersensitivity between macrolides may also occur.
Zineryt and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Interactions between Zineryt and other medicines are not known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Zineryt should not be used during pregnancy unless the doctor considers it absolutely necessary.
Driving and operating machinery
There are no data available on the effect of Zineryt on the ability to drive or operate machinery.
However, such an effect seems unlikely.

3. How to use Zineryt

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
Dosage:
Before applying the medicine, thoroughly clean and dry the area of skin to which the medicine will
be applied.
Unless otherwise directed by a physician, Zineryt should be applied to the affected areas of skin
twice daily, usually for a period of 10 to 12 weeks. A significant therapeutic effect is usually
achieved within 12 weeks. If there is no improvement or if the condition worsens, consult a
physician. If the physician determines bacterial resistance to the medicine, treatment should be
discontinued for a period of two months.
Method of application
Zineryt should be applied to the entire face or other affected areas (not only the individual lesion),
covering the entire treatment area completely, using approximately 0.5 ml of solution each time.
To prepare the solution for use, follow the steps described in the Instructions for Use included
later in this leaflet.
After preparing the solution, invert the bottle with the applicator and apply the medicine to the
affected area of skin by moving the applicator across it. The amount of solution dispensed from
the bottle is controlled by increasing or decreasing the pressure of the applicator on the skin.

Instructions for Use
Preparing the solution
The package contains the following (see figure):

(A). Bottle with powder for solution
(B). Bottle with solvent for solution
(C). Applicator

1. After removing the caps, pour the contents of the solvent bottle (B) into the bottle containing the powder (A).
2. Close the bottle containing the powder and solvent, and mix thoroughly by shaking the bottle for about one minute.
3. Remove the cap from the bottle containing the prepared solution.
4. Insert the applicator (C) into the neck of the solution bottle, pressing firmly until fully seated.
5. Close the bottle with the applicator.
6. After preparation, the solution may be used for up to 5 weeks. The expiry date should be marked on the bottle.

Use of more than the recommended dose of Zineryt
The risk of accidental overdose is negligible when the medicine is used as directed.
Accidental ingestion of the entire contents of a Zineryt package will primarily cause symptoms of acute ethanol poisoning due to the ethanol content of the medicine.

Missed dose of Zineryt
If a single dose is missed, continue treatment as usual. There is no need to apply an additional amount of the medicine to the skin.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions occurring not very often (occur in 1 to 10 people per 1,000):
itching, redness, skin irritation, burning sensation, stinging, dry skin, peeling of the outer layer of skin.
Adverse reactions occurring very rarely (occur less frequently than in 1 person per 10,000):
hypersensitivity.
If the patient develops a severe skin reaction: red, peeling rash with lumps under the skin and blisters (erythema multiforme), contact a doctor immediately. The frequency of these adverse effects is unknown (cannot be estimated based on available data).
In some individuals, other adverse reactions may occur during treatment with Zineryt.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 enables continued monitoring of the safety of the medicine.

5. How to store Zineryt

Keep the medicine out of the sight and reach of children.
Store below 25°C, in the original packaging.
The shelf life of the solution after preparation is 5 weeks.
Do not use Zineryt 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. Package contents and other information

What Zineryt contains
1 ml of the ready-to-use solution contains:

• active substances: 40 mg of erythromycin and 12 mg of zinc acetate, in the form of an erythromycin-zinc acetate complex;
• excipients: diisopropyl sebacate, anhydrous ethanol.

What Zineryt looks like and contents of the pack
Zineryt is a powder and solvent for solution for topical use.
Packaging:
1 HDPE bottle containing the powder and 1 HDPE bottle containing the solvent for the preparation of 30 ml of solution,
together with a PP applicator, in a cardboard box.
The bottle containing the powder includes the active substances: erythromycin and zinc acetate dihydrate.
The bottle containing the solvent includes the excipients: diisopropyl sebacate and anhydrous ethanol.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Cheplapharm Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Manufacturer:
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in Romania, country of export: 7452/2015/01
Parallel import licence number: 77/26