Zinerit

Leaflet attached to the packaging: patient information

Zineryt

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

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

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• 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 cutaneous use.
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 action of erythromycin in local acne treatment.
After drying, Zineryt is invisible on the skin and is therefore cosmetically acceptable.

Indications

Zineryt is indicated for local 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 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, the patient should discuss it with their doctor or pharmacist.
The patient should avoid contact between Zineryt and the eyes or the mucous membranes 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 membranes of the nose and mouth, they should be thoroughly rinsed with water and the doctor should be informed.
Cross-resistance with other macrolide antibiotics and with lincomycin and clindamycin may occur. Mutual cross-hypersensitivity between macrolides may also occur.

Zineryt and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Interactions between Zineryt and other medicines are not known.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Zineryt should not be used during pregnancy, unless the 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 as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Dosage:
Before using the medicine, the skin surface to be treated should be thoroughly cleaned and dried.
Unless the doctor has prescribed 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, the patient should consult their doctor. If the doctor finds that the bacteria are resistant to the medicine, the patient 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 the ready-to-use solution, the patient should follow the instructions in the Instructions for usesection, which appears later in the leaflet.
After preparing the solution, the patient 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 released from 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 diagram):
ZINERYT
ZINERYT
B

SOLVENT

CONTAINER

A

POWDER

A
C
B

• (A).Bottle with powder for solution preparation
• (B).Bottle with solvent for solution preparation
• (C).Applicator
• 1. After removing the caps, the patient should pour the contents of the solvent bottle (B) into the powder bottle (A).
• 2. The patient should close the bottle containing the powder and solvent and shake it for about one minute to mix the contents.
• 3. The patient should remove the cap from the bottle with the resulting solution.

• 4. The patient should place the applicator (C) in the neck of the solution bottle, pushing it firmly until it stops.
• 5. The patient should close the bottle with the applicator.
• 6. After preparation, the solution can be used for 5 weeks. The expiry date should be written on the bottle.

Using more Zineryt than recommended

The risk of accidental overdose is minimal if the medicine is used as directed.
If the entire contents of the Zineryt packaging are accidentally ingested, it will mainly cause symptoms of acute ethanol poisoning, which is contained in the medicine.

Missing a dose of Zineryt

If a single dose is missed, the patient can continue treatment without changes. There is no need to apply an additional amount of medicine to the skin.
In case of any further doubts about using this medicine, the patient should consult their 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 1,000):
itching, redness, skin irritation, burning sensation, pricking, dryness of the skin, peeling of the skin.
Very 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 eruption), 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 any side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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, PL-02-222 Warsaw
Phone: +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 Zineryt

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
The shelf life of the solution after preparation is 5 weeks.
Zineryt should not be used after the expiry date stated on the packaging after: 'Expiry date (EXP):'. The expiry date refers to the last day of the month stated.
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. 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, micronized;
• excipients: diisopropyl sebacate, anhydrous ethanol.

What Zineryt looks like and contents of the packaging

Zineryt is a powder and solvent for solution for cutaneous use.
Packaging of the medicine:
1 bottle with powder and 1 bottle with solvent for preparation of 30 ml 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.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
Date of last revision of the leaflet: