Zineryt
Poland
Table of Contents
Patient Information Leaflet
Warning! 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 topical use
Erythromycinum cum zinco
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
- Keep this leaflet, so that you may 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 give it to others. This medicine may harm another person, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
Table of contents
- What Zineryt is and what it is used for
- What you need to know 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 involved 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. 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 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 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 available regarding the effects 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. If in doubt, consult a 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 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 no improvement occurs or if the condition worsens, consult a doctor. If the doctor determines bacterial resistance to the medicine, treatment should be discontinued for a period of two months.
Method of administration:
Apply Zineryt 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 obtain the ready-to-use solution, 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 by moving the applicator across the skin. The amount of solution dispensed from the bottle is regulated by increasing or decreasing the pressure of the applicator on the skin.
Instructions for Use
Preparing the solution
The package contains (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.
- Close the bottle with the applicator.
- The prepared solution may be used for 8 weeks. The expiry date should be marked on the bottle.
Overdose of Zineryt
The risk of accidental overdose is negligible when the medicine is used as directed.
Accidental ingestion of the entire contents of the Zineryt package would primarily result in symptoms of acute ethanol intoxication due to the ethanol contained in 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 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 medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions occurring not frequently (occur in 1 to 10 out of 1,000 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 lumps under the skin and blisters (erythema multiforme), contact a doctor immediately. The frequency 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 reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
5. How to store Zineryt
Keep the medicine out of the sight and reach of children.
Store below 25°C.
Store in the original packaging.
The solution's shelf life after preparation is 8 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 in use. This will help protect the environment.
6. Contents of the pack and other information
What Zineryt contains
1 ml of the ready 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 contents of the pack
Zineryt is a powder and solvent for solution for the skin.
Pack:
1 vial with powder and 1 vial with solvent for preparing 30 ml of solution, and an applicator, in a cardboard box.
The vial with powder contains the active substances: erythromycin and zinc acetate.
The vial with solvent contains the excipients: diisopropyl sebacate and ethanol.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Portugal, 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 Portugal, country of export: 8699207
Parallel import authorisation number: 192/24