PROGOUT 100 Allopurinol 100mg tablet bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

allopurinol, Quantity: 100 mg

Tilgjengelig fra:

Alphapharm Pty Ltd

Legemiddelform:

Tablet, uncoated

Sammensetning:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; povidone; macrogol 8000; purified talc; sodium lauryl sulfate

Administreringsrute:

Oral

Enheter i pakken:

200

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

INDICATIONS AS AT 11 May 2001: 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. Progout is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltransferase. Progout is indicated for the management of recurrent mixed calcium oxalate renal stones in the p

Produkt oppsummering:

Visual Identification: 9.5mm white normal convex tablet marked AL/100 on one side, G on the reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1991-10-21

Informasjon til brukeren

PROGOUT
_allopurinol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Progout.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Progout against
the benefits expected for you.or your
child.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PROGOUT IS USED
FOR
Progout is used in the treatment of:
•
gouty arthritis or gout, a
condition of painful swollen
joints caused by uric acid crystals
•
kidney stones
•
other rare conditions where high
levels of uric acid occur in the
blood, for example Lesch-Nyhan
syndrome.
Progout helps to treat the symptoms
of these conditions but will not cure
them. It will not help treat the pain
that occurs in an acute attack of gout.
Progout belongs to a group of
medicines called anti-uricaemic
agents. These medicines reduce the
amount of uric acid in the body. Most
commonly, high levels of uric acid in
the body are related to gout. Excess
amounts of uric acid in the blood
may lead to the development of
crystals which deposit in the joints,
causing pain, swelling and
tenderness.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PROGOUT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Progout for another reason.
Progout is available only with a
doctor's prescription.
There is no evidence that Progout is
addictive.
BEFORE YOU TAKE
PROGOUT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PROGOUT IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
ALLOPURINOL (E.G. ZYLOPRIM) OR ANY
OF THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET, INCLUDING LACTOSE
MONOHYDRATE.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
PROGOUT
_Allopurinol _
1
NAME OF THE MEDICINE
Allopurinol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PROGOUT tablet contains 100 mg or 300 mg of allopurinol as the
active ingredient.
Excipients with known effect:
PROGOUT 100: galactose, sulfites and sugars as lactose.
PROGOUT 300: sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PROGOUT 100:
100 mg tablet: white, scored, marked AL/100 on one side, G on reverse
PROGOUT 300:
300 mg tablet: white, scored, marked AL/300 on one side, G on reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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.
PROGOUT is indicated for the management of 2,8-dihydroxyadenine
(2,8-DHA) renal stones related to
deficient activity of adenine phosphoribosyltransferase.
PROGOUT 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
DOSE AND METHOD OF ADMINISTRATION
The dosage should be adjusted by monitoring serum urate concentrations
and urinary urate/uric acid levels at
appropriate intervals.
PROGOUT – PRODUCT INFORMATION
2
DOSE FREQUENCY
PROGOUT may be taken orally after a meal and may be taken once a day.
It is well tolerated, especially