ZINERYT 40 mg /Ml + 12 Mg/Ml Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Zineryt
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Zineryt and what is it used for
   1. Indications
5. Important information before using Zineryt
   1. When not to use Zineryt:
   2. Warnings and precautions
   3. Zineryt and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
6. How to use Zineryt
   1. Using more than the recommended dose of Zineryt
   2. Missing a dose of Zineryt
7. Possible side effects
   1. Reporting side effects
8. How to store Zineryt
9. Contents of the packaging and other information
   1. What Zineryt contains
   2. What Zineryt looks like and what the packaging contains
   3. Marketing authorization holder in Portugal, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 146/23
   8. Date of approval of the leaflet: 19.07.2023

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zineryt

40 mg/ml + 12 mg/ml
powder and solvent for solution for the skin
Erythromycinum cum zinco

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 to a specific person. It should not be given 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zineryt and what is it 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 packaging and other information

1. What is Zineryt and what is it used for

Zineryt is an anti-acne medicine for use on the skin.
Zineryt contains erythromycin in the form of a complex with zinc acetate. Bacteria sensitive to erythromycin include bacteria such as Staphylococcus epidermidisand Propionibacterium acnes, which often occur in acne. Zinc enhances the effect of erythromycin in local acne treatment.
After drying, Zineryt is invisible on the skin and is therefore cosmetically acceptable.

Indications

Zineryt is indicated for the local treatment of moderate to severe acne, in cases where 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 any of the other ingredients of this medicine (listed in section 6);
• if there is hypersensitivity to other macrolide antibiotics.

Warnings and precautions

Before starting to use Zineryt, you should discuss it with your doctor or pharmacist.
You should avoid contact between Zineryt and the eyes or the mucous membrane of the nose and mouth. The medicine may cause burning and irritation of these areas. If Zineryt comes into contact with the eyes or the mucous membrane of the nose and mouth, they should be thoroughly rinsed with water and the doctor should be informed.
Cross-resistance may occur with other macrolide antibiotics and with lincomycin and clindamycin. Cross-sensitivity may also occur between macrolides.

Zineryt and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Interactions between Zineryt and other medicines are not known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Zineryt should not be used during pregnancy, unless your doctor considers it absolutely necessary.

Driving and using machines

There are no data on the effect of Zineryt on the ability to drive and use machines.
However, such an effect is unlikely.

3. How to use Zineryt

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Dosage:
Before using the medicine, the skin surface to be treated should be thoroughly cleaned and dried.
Unless the doctor recommends otherwise, Zineryt should be applied to the affected areas of the skin twice a day, 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, you should consult a doctor. If the doctor finds that the bacteria are resistant to the medicine, you should stop using it for a period of two months.
Method of administration
Zineryt should be applied to the entire face or other affected areas (not just the individual lesion), until the treated area is completely covered, using about 0.5 ml of solution each time.
To obtain a ready-to-use solution, you should follow the instructions in the Instructions for usesection, which appears later in the leaflet.
After preparing the solution, you should turn the bottle with the applicator upside down and apply the medicine to the affected area of the skin, moving the applicator over it.
The amount of solution flowing out of the bottle is regulated by increasing or decreasing the pressure of the applicator on the skin.
Instructions for use
Preparing the solution
The packaging contains (see picture):

• (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 powder bottle (A).
• 2. Close the bottle containing the powder and solvent, and mix its contents by shaking the bottle for about one minute.
• 3. Remove the cap from the bottle with the resulting solution.
• 4. Place the applicator (C) in the neck of the solution bottle, pushing it firmly until it stops.
• 5. Close the bottle with the applicator.
• 6. After preparation, the solution can be used for 8 weeks. The expiry date should be written on the bottle.

Using more than the recommended dose of Zineryt

The risk of accidental overdose is minimal if the medicine is used as recommended.
Accidental ingestion of the entire contents of the Zineryt packaging may cause symptoms of acute ethanol poisoning contained in the medicine.

Missing a dose of Zineryt

If a single dose is missed, treatment can be continued without changes.
There is no need to apply an additional amount of medicine to the skin.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Zineryt can cause side effects, although not everybody gets them.
Uncommon side effects (occurring in 1 to 10 people per 1000):
itching, redness, skin irritation, burning sensation, pricking, dryness of the skin, peeling of the skin.
Rare side effects (occurring in less than 1 person per 10,000):
hypersensitivity.
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 from available data).
Some people may experience other side effects while using Zineryt.

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, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zineryt

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Store in the original packaging.
The shelf life of the solution after preparation is 8 weeks.
Zineryt should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
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.

6. Contents of the packaging 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 a complex of erythromycin with zinc acetate dihydrate;
• excipients: diisopropyl sebacate, ethanol.

What Zineryt looks like and what the packaging contains

Zineryt is a powder and solvent for solution for the skin.
The packaging of the medicine:
1 bottle with powder and 1 bottle with solvent for preparing 30 ml of solution, and an applicator, in a cardboard box.
The bottle with powder contains the active substances: erythromycin and zinc acetate.
The bottle with solvent contains the excipients: diisopropyl sebacate and ethanol.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Cheplapharm Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

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
Authorization number in Portugal, the country of export:8699207

Parallel import authorization number: 146/23

Date of approval of the leaflet: 19.07.2023

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