Zineryt, powder and solvent for cutaneous solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
06-01-2018
Summary of Product characteristics
(SPC)
06-01-2018
Active ingredient:
Erythromycin; Zinc acetate
Available from:
PCO Manufacturing Ltd.
ATC code:
D10AF; D10AF52
INN (International Name):
Erythromycin; Zinc acetate
Dosage:
40/12 milligram(s)/millilitre
Pharmaceutical form:
Pdr+Solv for Cut Soln
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Antiinfectives for treatment of acne; erythromycin, combinations
Authorization status:
Authorised
Authorization date:
2007-10-19
Patient Information leaflet
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINERYT
®
, POWDER AND SOLVENT FOR
CUTANEOUS SOLUTION
erythromycin / zinc acetate
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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Zineryt is and what it is 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
medicines, including medicines
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zineryt, powder and solvent for cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin 40 mg per ml and zinc acetate 12 mg per ml on
constitution.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for cutaneous solution
_Product imported from Hungary and Romania:_
Powder: White crystalline powder
Solvent: Clear colourless liquid
4 CLINICAL PARTICULARS
As per PA0046/065/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0046/065/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Di-isopropyl sebacate
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 on
the market 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 original container.
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6.5 NATURE AND CONTENTS OF CONTAINER
Screw-capped bottles; a dabbing applicator cap is fitted when
dispensed. When constituted packs are of 30 ml.
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 so
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