Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Erythromycin; Zinc acetate dihydrate

Available from:

IMED Healthcare Ltd.

ATC code:

D10AF52

INN (International Name):

Erythromycin; Zinc acetate dihydrate

Dosage:

40 + 12 milligram(s)

Pharmaceutical form:

Powder and solvent for cutaneous solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

erythromycin, combinations

Authorization status:

Authorised

Authorization date:

2012-11-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINERYT
®
40 MG + 12 MG
POWDER AND SOLVENT FOR CUTANEOUS SOLUTION
erythromycin/zinc acetate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their symptoms are the
same as yours.
•
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
IN THIS LEAFLET:
1.
What Zineryt
®
is and what is it used for
2.
What you need to know before you use Zineryt
®
3.
How to use Zineryt
®
4.
Possible side effects
5.
How to store Zineryt
®
6.
Contents of the pack and other information
7.
Information for healthcare professionals
1.
WHAT ZINERYT
® IS AND WHAT IT IS USED FOR
The active substance of Zineryt belongs to the group of
antibiotics for treatment of acne, often referred to as pimples or
spots. These medicines are used to reduce the growth of bacteria
which cause acne.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZINERYT
®
DO NOT USE ZINERYT
•
if you are allergic (hypersensitive) to erythromycin, or zinc or
to any of the other ingredients of Zineryt (see list in section 6
‘Contents of the pack and other information’). Your doctor
may decide to give you another medicine instead.
•
if you are allergic to antibiotics of the macrolide group. Ask
your doctor or pharmacist if you are unsure.
WARNINGS AND PRECAUTIONS
•
Avoid contact with the eyes and mucous membranes of the
nose and mouth. However, if this occurs, then rinse the
affected area immediately with cold or lukewarm water for
several minutes. Contact your doctor for further advice.
OTHER MEDICINES AND ZINERYT
Please tell your doctor or pharmacist if you are taking or have
recently taken, used or might use any other medicin

Summary of Product characteristics

Health Products Regulatory Authority
09 March 2022
CRN00CSYY
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin 40 mg per ml and zinc acetate dihydrate 12 mg per ml on
constitution.
Excipient(s) with known effect: ethanol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for cutaneous solution.
_Product imported from Romania and Czech Republic_:
Powder: White crystalline powder
Solvent: Clear colourless liquid
4 CLINICAL PARTICULARS
As per PA2239/018/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2239/018/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Di-isopropyl sebacate
Anhydrous ethanol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product as
marketed in the country of origin
Upon reconstitution: Use within 5 weeks.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled outer carton containing screw-capped HDPE bottles; a
dabbing applicator cap is fitted when dispensed.
When constituted packs are of 30 ml.
Health Products Regulatory Authority
09 March 2022
CRN00CSYY
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
The powder is reconstituted with the solvent (ethanol 68% w/w) prior
to dispensing as follows:-
(i) Remove the caps from the powder bottle and the solution bottle;
retain the cap of the powder bottle.
(ii) Pour the contents of the solution bottle into the powder bottle
and recap the latter.
(iii) Immediately, shake well for one minute. Remove and retain cap.
(iv) Open the plastic holder containing the applicator assembly and
use the holder to position the applicator assembly over
the neck of th