Zyloric 300 mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-02-2018
Summary of Product characteristics
(SPC)
03-02-2017
Active ingredient:
Allopurinol
Available from:
PCO Manufacturing Ltd.
ATC code:
M04AA; M04AA01
INN (International Name):
Allopurinol
Dosage:
300 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Preparations inhibiting uric acid production; allopurinol
Authorization status:
Authorised
Authorization date:
1989-02-01
Patient Information leaflet
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZYLORIC
® 300 MG TABLETS
allopurinol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, nurse or
pharmacist.
–
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours
–
If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zyloric is and what it is used for
2.
What you need to know before you take Zyloric
3.
How to take Zyloric
4.
Possible side effects
5.
How to store Zyloric
6.
Contents of the pack and other information
1.
WHAT ZYLORIC IS AND WHAT IT IS USED FOR
Zyloric contains the active substance allopurinol. This medicine
belongs to a group of medicines called enzyme inhibitors, which
control the speed at which certain chemical changes occur in
your body.
Zyloric Tablets are used to treat conditions where too much uric
acid is produced by your body, such as: gout; certain types of
kidney disease and kidney stones; cancer and some enzyme
disorders which lead to the build-up of too much uric acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYLORIC
DO NOT TAKE ZYLORIC IF:
you ever had an allergy (rash, itching, shortness of breath)
to Zyloric, allopurinol or any of the other tablet ingredients
listed in section 6 of this leaflet
If you are not sure, check with your doctor first before taking the
medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Zyloric about/ if:
you are suffering, or have you suffered, from liver or kidney
disease
you are taking medicines (diuretics and/or a medicine called
ACE inhibitors) for heart disease or high blood pressure
you are experiencing an acute attack of gout
you are of Han Chinese, African
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zyloric 300 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg of allopurinol.
Each tablet also contains the excipient lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Italy:_
Circular, white tablet, imprinted with ‘C9 B’ and a breakline on
one side, plain on the other side.
4 CLINICAL PARTICULARS
As per PA1691/002/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1691/002/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize Starch
Povidone
Magnesium stearate (E572)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
°
C.
Store in original container.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 30 tablets contained in an outer cardboard carton.
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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
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit
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