ZINERYT

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ERYTHROMYCIN ; ZINC ACETATE

Available from:

LTT Pharma Limited

ATC code:

D10AF52

INN (International Name):

ERYTHROMYCIN ; ZINC ACETATE

Dosage:

40/12 Mg/Ml

Pharmaceutical form:

Pdr+Solv for Cut Soln

Prescription type:

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

Therapeutic area:

erythromycin, combinations

Authorization status:

Authorised

Authorization date:

2016-09-02

Patient Information leaflet

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:
What Zineryt is and what it is used for
What you need to know before you
use Zineryt
How to use Zineryt
Possible side effects
How to store Zineryt
Contents of the pack and other
information
Information for healthcare professionals
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.
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 obtained
without a prescription.
PREGNANCY, BREAST-FEEDING AND FERTILITY
Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant or breastfeeding, think you may
be p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zineryt Powder and Solvent for Cutaneous Solution, 30 ml
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 Portugal_
Powder : White crystalline powder
Solvent : Clear colourless liquid.
4 CLINICAL PARTICULARS
As per PA1025/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1025/007/001
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 for this product is 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.
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6.5 NATURE AND CONTENTS OF CONTAINER
Screw-capped HDPE 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 solvent (ethanol 68% w/w) prior
to