ALLOPURINOL SANDOZ allopurinol 100 mg tablet bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

allopurinol, Quantity: 100 mg

Dostupné z:

Sandoz Pty Ltd

Forma lieku:

Tablet, uncoated

Zloženie:

Excipient Ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose

Spôsob podávania:

Oral

Počet v balení:

200 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Main clinical manifestations of urate/uric acid deposition. These are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. Such clinical manifestations may occur in: 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 and involve hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. Management of 2,8-dihydroxyadenine (2,8-DHA) renal stones relate to deficient activity of adenine phosphoribosyl transferase. Management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Prehľad produktov:

Visual Identification: White, round, biconvex tablets with single sided score notch; Diameter: 8.0 + 0.1mm; Height 2.8 - 3.25mm.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

1998-08-31

Príbalový leták

ALLOPURINOL SANDOZ
®
1
ALLOPURINOL SANDOZ
®
_allopurinol tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Allopurinol Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALLOPURINOL
SANDOZ IS USED
FOR
This medicine is used to treat or
prevent medical problems that may
occur if too much uric acid is present
in the body.
These include gout, gouty arthritis,
certain kidney problems or enzyme
disorders where the body produces
too much uric acid.
It contains the active ingredient
allopurinol.
Allopurinol belongs to a group of
medicines called xanthine oxidase
inhibitors.
It works by reducing the production
of uric acid in the body, therefore
helping to prevent the formation of
deposits of uric acid crystals.
Deposits of uric acid crystals in the
body can cause a variety of medical
problems.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ALLOPURINOL
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
allopurinol, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under Product Description.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
hay fever
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU OR
A MEMBER OF YOUR IMMEDIAT

Súhrn charakteristických

180313-allopurinol-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
ALLOPURINOL SANDOZ
® (ALLOPURINOL)
1
NAME OF THE MEDICINE
Allopurinol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Allopurinol Sandoz 100 mg tablet contains 100 mg allopurinol.
Each Allopurinol Sandoz 300 mg tablet contains 300 mg allopurinol.
Allopurinol is a white or off-white, almost odourless powder. It is
very slightly soluble in water
and in alcohol, and is practically insoluble in chloroform and in
ether. It dissolves in dilute
solutions of alkali hydroxides.
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Allopurinol Sandoz allopurinol 100 mg tablet – round, white, scored
tablet.
Allopurinol Sandoz allopurinol 300 mg tablet – oblong, white, scored
tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Main clinical manifestations of urate/uric acid deposition. These are
gouty arthritis, skin tophi
and/or
renal
involvement
through
crystal
deposition
or
stone
formation.
Such
clinical
manifestations may occur in: 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 and involve:
•
hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan
syndrome
•
glucose-6-phosphatase including glycogen storage disease
•
phosphoribosylpyrophosphate synthetase
•
phosphoribosylpyrophosphate amidotransferase
Management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to
deficient activity of
adenine phosphoribosyl transferase.
Management
of
recurrent
mixed
calcium
oxalate
renal
stones
in
the
presence
of
hyperuricosuria, when fluid, dietary and similar measures have failed.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage should be adjusted by monitoring serum urate concentrations
and urinary urate/uric
acid levels at appropriate intervals.
180313-all