Zyloric 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Allopurinol

Available from:

Lexon (UK) Ltd

ATC code:

M04AA01

INN (International Name):

Allopurinol

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010400

Patient Information leaflet

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 only. Do not
pass it onto 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.
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 tablets contain a medicine called allopurinol. It works by
slowing down the speed of certain chemical reactions in your
body to lower the level of uric acid in the blood and urine.
Zyloric is used:
•
to reduce or prevent the formation of urate/uric acid
deposition in conditions where your body produces too
much of a substance called uric acid. These may include
gout or some types of kidney stones or certain other types
of kidney problems or when you are having treatment
for cancer or some other conditions. In gout the uric acid
builds up in your joints and tendons as crystals. These
crystals cause an inflammatory reaction. The inflammation
causes the skin around certain joints to become swollen,
tender and sore when only slightly touched. You can also
find you get severe pain when the joint is moved.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYLORIC
DO NOT TAKE ZYLORIC IF:
•
you are allergic (hypersensitive) to allopurinol or any of
the other ingredients of Zyloric (listed in Section 6).
If you are not sure, talk to your doctor or pharmacist before
taking Zyloric.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking your
medicine if:
•
you are of Han Chinese, African or Indian origin
•
yo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zyloric 300 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Allopurinol 300 mg (Zyloric-300 Tablets)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Each 300 mg tablet is round, white to off-white, biconvex, bisected
tablet, debossed with Z3
on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide the
tablet into equal
doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zyloric 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.
Zyloric is indicated for the management of 2,8-dihydroxyadenine
(2,8-DHA) renal stones
related to deficient activity of adenine phosphoribosyltransferase.
Zyloric is indicated for the management of recurrent mixed calcium
oxalate renal stones in the
presence of hyperuricosuria, when fluid, dietary and similar measures
have failed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_Adults _
_ _
Zyloric should be introduced at low dosage e.g. 100 mg/day to reduce
the risk of adverse
reactions and increased only if the serum urate response is
unsatisfactory. Extra caution