Purinol 300mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Allopurinol

Available from:

Pinewood Laboratories 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:

Not marketed

Authorization date:

1982-11-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Purinol 100 mg and 300 mg Tablets
Allopurinol
24LF
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 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 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.
What is in this leaflet
1.
What Purinol Tablets are and what they are used for
2.
What you need to know before you take Purinol Tablets
3.
How to take Purinol Tablets
4.
Possible side effects
5.
How to store Purinol Tablets
6.
Contents of the pack and other information
1.
What Purinol Tablets are and what they are used for
Purinol Tablets contain the active ingredient allopurinol, this
belongs to a group of medicines called xanthine oxidase inhibitors,
which act to control the
speed at which certain chemical changes occur in the body.
Purinol tablets are used to treat conditions in which there is too
much uric acid in the body such as:
•
gout
•
certain types of kidney disease and kidney stones
•
cancer and some enzyme disorders which lead to the build up of uric
acid (symptoms may include swelling and inflammation of the joints).
2.
What you need to know before you take Purinol Tablets
Do NOT take Purinol Tablets if you:
•
have had an allergic reaction to Purinol, allopurinol or any of the
other ingredients (see section 6 and end of section 2)
Warnings and precautions
Talk to your doctor or pharmacist before taking Purinol Tablets if:
•
you are suffering, or suffered from liver or kidney disease
•
you are taking medicines for heart disease or high blood pressure,
e.g. diuretics (water tablets) or ACE inhibitors
•
you are experiencing an acute attack of gout
•
you are of Han Chin

Summary of Product characteristics

HealthProductsRegulatoryAuthority
27February2019
CRN008WVT
Page1of12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Purinol300mgTablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachtabletcontains300mgAllopurinol
Excipients:Eachtabletcontains180mglactosemonohydrate.
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Tablet
White,biconvextablet,engraved2K1,plainonthereverse.
Thescorelineisonlytofacilitatebreakingforeaseofswallowing
andnottodivideintoequaldoses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allopurinolisindicatedforreducingurate/uricacidformationinconditionswhereurate/uricaciddepositionhasalready
occurred(e.g.goutyarthritis,skintophi,nephrolithiasis)orisapredictableclinicalrisk(e.g.treatmentofmalignancypotentially
leadingtoacuteuricacidnephropathy).
Themainclinicalconditionswhereurate/uricaciddepositionmayoccurare:

idiopathicgout;

uricacidlithiasis;

acuteuricacidnephropathy;

neoplasticdiseaseandmyeloproliferativediseasewithhighcellturnoverrates,inwhichhighuratelevelsoccur
eitherspontaneously,oraftercytotoxictherapy;

certainenzymedisorderswhichleadtooverproductionofurate,forexample:
-
hypoxanthine-guaninephosphoribosyltransferase,includingLesch-Nyhansyndrome;
-
glucose-6-phosphataseincludingglycogenstoragedisease;
- phosphoribosylpyrophosphatesynthetase;
- phosphoribosylpyrophosphateamidotransferase;
- adeninephosphoribosyltransferase;
Allopurinolisindicatedforthemanagementof2,8-dihydroxyadenine(2,8-DHA)renalstonesrelatedtodefic