Zineryt
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet! Foreign language text on the immediate packaging.
Zineryt
40 mg/ml + 12 mg/ml, powder and solvent for solution for skin application
Erythromycinum cum zinco
Please read the entire 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 any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- 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 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 found in acne. Zinc enhances the action of erythromycin in the local treatment of acne.
After drying, Zineryt is invisible on the skin and therefore is cosmetically acceptable.
Indications
Zineryt is indicated for the topical treatment of moderate to severe acne, when topical 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 product may cause stinging and irritation in these areas. If Zineryt comes into contact with the eyes or the 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. Mutual cross-hypersensitivity between macrolides may also occur.
Zineryt and other medicines
Tell your doctor or pharmacist about all 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 child, she should consult her doctor or pharmacist before using this medicine.
Zineryt should not be used during pregnancy unless clearly necessary and prescribed by a 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
Always use this medicine exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Dosage
Before applying the medicine, thoroughly clean and dry the area of skin to which the medicine will be applied.
Unless otherwise advised by your doctor, apply Zineryt twice daily to the affected areas of skin, 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, discontinue treatment for a period of two months.
Instructions for use
Apply Zineryt to the entire face or other affected areas (not only to the individual lesions), covering the entire treatment area completely, using approximately 0.5 ml of solution each time.
To prepare the solution for use, 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 area by moving the applicator across the skin.
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
Preparing the solution
The package contains the following (see figure):
(A) Bottle with powder for solution preparation
(B) Bottle with solvent for solution preparation
(C) Applicator
- After removing the caps, transfer 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 solution.
- Insert the applicator (C) into the neck of the solution bottle, pressing firmly until fully seated.
- Replace and tighten the cap on the bottle with the applicator.
- The prepared solution may be used for up to 5 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 before. There is no need to apply an additional amount of 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 any medicine, this product may cause adverse reactions, although not everyone experiences them.
Adverse reactions occurring not frequently (occur in 1 to 10 out of 1000 people):
itching, redness, skin irritation, burning sensation, stinging, dry skin, skin peeling.
Adverse reactions occurring very rarely (occur in fewer than 1 out of 10,000 people):
hypersensitivity.
If the patient develops a severe skin reaction: red, scaly rash with subcutaneous nodules and blisters (erythema multiforme), medical advice must be sought immediately.
The frequency of occurrence of these adverse effects is unknown (cannot be estimated from the 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 of Adverse Drug Reactions at 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 the collection of further information on 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. 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 hydrated zinc acetate;
- excipients: diisopropyl sebacate, anhydrous ethanol.
What Zineryt looks like and contents of the pack
Zineryt is a powder and solvent for solution for the skin.
Pack contents:
1 HDPE bottle with powder and 1 HDPE bottle with solvent for preparing 30 ml of solution,
and a PP applicator, in a cardboard box.
The bottle with powder contains the active substances: erythromycin and dihydrated zinc acetate.
The bottle with solvent contains the excipients: diisopropyl sebacate and anhydrous ethanol.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Romania, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24, 17489 Greifswald, Germany
Manufacturer:
Astellas Pharma Europe B.V.
Hogemaat 2, 7942 JG Meppel, The Netherlands
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 Romania, country of export: 7452/2015/01
Parallel import authorisation number: 125/23