Zineryt
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Zineryt
40 mg/ml + 12 mg/ml
powder and solvent for solution for cutaneous use
Erythromycinum cum zinco
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
- Keep this leaflet so that you can read it again if necessary.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Zineryt is and what it is used for
- Important information before using Zineryt
- How to use Zineryt
- Possible side effects
- How to store Zineryt
- 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.
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 found in acne. Zinc enhances the action of erythromycin in the topical treatment of acne.
After drying, Zineryt is invisible on the skin and is therefore cosmetically acceptable.
Indications
Zineryt is indicated for topical treatment of moderate to severe acne when topical treatment without antibiotics has been insufficient or not tolerated.
2. 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, consult your doctor or pharmacist.
Avoid contact of Zineryt with the eyes or the mucous membranes of the nose and mouth. The medicine may cause stinging and irritation in these areas. In case of contact with Zineryt, rinse the eyes or mucous membranes of the nose and mouth 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. Mutual cross-hypersensitivity between macrolides may also occur.
Zineryt and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
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 clearly necessary, as determined by the doctor.
Driving and operating machinery
There are no data regarding 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 exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Dosage:
Before applying the medicine, thoroughly clean and dry the skin area to be treated.
Unless otherwise directed by your doctor, Zineryt should be applied to the affected skin areas 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 your doctor. If your doctor determines bacterial resistance to the medicine, treatment should be discontinued for a period of two months.
Method of application:
Apply Zineryt to the entire face or other affected areas (not only the individual lesions), covering the entire treatment area completely. Use approximately 0.5 mL of solution each time.
To obtain the ready-to-use solution, follow the instructions described in the Instructions for Use section provided later in this leaflet.
After preparing the solution, invert the bottle with the applicator and apply the medicine to the affected skin area by moving the applicator over it.
The amount of solution dispensed from the bottle is regulated by increasing or decreasing the pressure applied with the applicator on the skin.
Instructions for Use
Preparation of the solution
The package contains the following (see figure):
(A) Bottle with powder for solution
(B) Bottle with solvent for solution
(C) Applicator
- After removing the caps, pour the contents of the solvent bottle (B) into the bottle containing the powder (A).
- Close the bottle containing the powder and solvent, and mix thoroughly by shaking for about one minute.
- Remove the cap from the bottle containing the prepared solution.
- Insert the applicator (C) into the neck of the solution bottle, pressing firmly until it stops.
- Close the bottle with the applicator attached.
- The prepared solution may be used for up to 8 weeks. Write the expiry date 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 may 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 doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicinal product can cause adverse reactions, although not everyone experiences them.
Adverse reactions occurring not very frequently (occur in 1 to 10 people out of 1000):
itching, redness, skin irritation, burning sensation, stinging, dry skin, skin peeling.
Adverse reactions occurring very rarely (occur less frequently than in 1 person out of 10,000):
hypersensitivity.
If a patient develops a severe skin reaction: red, peeling rash with nodules under the skin and blisters (erythema multiforme), contact a doctor immediately. The frequency of these adverse effects is unknown (cannot be estimated from available data).
Other adverse reactions may occur in some individuals during treatment with Zineryt.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of the medicine's safety.
5. How to store Zineryt medicine
Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging.
The shelf life of the solution after preparation is 8 weeks.
Do not use Zineryt medicine 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 in use. This will help protect the environment.
6. Contents of the pack and other information
What Zineryt contains
1 ml of the prepared solution contains:
- active substances: 40 mg of erythromycin and 12 mg of zinc acetate, in the form of a complex of erythromycin with dihydrate zinc acetate;
- excipients: diisopropyl sebacate, ethanol.
What Zineryt looks like and contents of the pack
Zineryt is a powder and solvent for solution for the skin.
Pack contents:
1 vial of powder and 1 vial of solvent for the preparation of 30 ml of solution, together with an applicator,
in a cardboard carton.
The vial of powder contains the active substances: erythromycin and zinc acetate.
The vial of solvent contains the excipients: diisopropyl sebacate and ethanol.
For more detailed information, please contact the responsible entity or the parallel importer.
Responsible entity in Portugal, 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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in Portugal, country of export: 8699207
Parallel import authorisation number: 146/23