Zineryt 40mg/12mg per ml powder and solvent for cutaneous solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zinc acetate; Erythromycin

Available from:

Imbat Limited

ATC code:

D10AF; D10AF52

INN (International Name):

Zinc acetate; Erythromycin

Dosage:

40mg/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:

2011-05-06

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINERYT
® 40MG/12MG PER ML
POWDER AND SOLVENT FOR CUTANEOUS SOLUTION
(erythromycin/zinc acetate dihydrate)
Your medicine is available using the name Zineryt
40mg/12mg per ml powder and solvent for cutaneous
solution but will be referred to as Zineryt throughout this
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:
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
f

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zineryt 40mg/12mg per ml powder and solvent for cutaneous solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin 40mg per ml and zinc acetate dihydrate 12mg 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 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
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
Store at temperatures below 25°C in original packaging
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled outer carton containing a screw-capped HDPE bottle; a
dabbing applicator cap is fitted when dispensed.
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When constituted packs are of 30ml.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER