Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
allopurinol, Quantity: 100 mg
Arrotex Pharmaceuticals Pty Ltd
Allopurinol
Tablet, uncoated
Excipient Ingredients: povidone; maize starch; lactose monohydrate; stearic acid
Oral
200 tablets
(S4) Prescription Only Medicine
INDICATIONS AS AT 6 February 2003: 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 phosphoriboslytransferase including Lesch-Nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. ALLOPURINOL-ARX is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase. ALLOPURINOL-ARX is indicated for the management of recurred mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.
Visual Identification: White, biconvex round tablets, one side embossed with 'AP' and '100' separated by a break line and plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2017-05-03
ZYLOPRIM- Consumer Medicine Information Page 1 of 4 ZYLOPRIM™ TABLETS _allopurinol _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ZYLOPRIM (Allopurinol tablets). It does not contain all of the available information about ZYLOPRIM tablets. It does not replace talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking ZYLOPRIM against the benefits he or she expects it will have. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS ZYLOPRIM The name of your medicine is ZYLOPRIM and is available in tablets of two different strengths. The active ingredient is called allopurinol. _ _ Allopurinol_ _belongs to a group of medicines called anti-uricaemic agents and is used to reduce the amount of uric acid in the body. Most commonly, high levels of uric acid in the body are related to gout. ZYLOPRIM is available as a 100 mg and 300 mg tablet. WHAT ZYLOPRIM IS USED FOR ZYLOPRIM is used to treat high levels of uric acid in the blood (hyperuricaemia) associated with gout or some other conditions. Your doctor will identify these other conditions if necessary, as they are very uncommon (e.g. Lesch-Nyhan Syndrome). Your doctor however, may have prescribed ZYLOPRIM for another purpose not listed above. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZYLOPRIM HAS BEEN PRESCRIBED FOR YOU. If you have any concerns, you should discuss this with your doctor. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ Do not take ZYLOPRIM if you are allergic to: • Allopurinol or any of the ingredients listed at the end of this leaflet including lactose. Some of the symptoms of an allergic reaction to ZYLOPRIM may include urticaria and other skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness. D Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION – ALLOPURINOL-ARX (ALLOPURINOL) TABLETS 1 NAME OF THE MEDICINE Allopurinol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ALLOPURINOL-ARX tablets contain 100 mg or 300 mg allopurinol. Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ALLOPURINOL-ARX 100 mg tablets are white, biconvex round tablets, one side embossed with ‘AP’ and ‘100’ separated by a break line and plain on the other side. ALLOPURINOL-ARX 300 mg tablets are white, biconvex round tablets, one side embossed with ‘AP’ and ‘300’ separated by a break line and plain on the other side. 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. 2 ALLOPURINOL-ARX is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase. ALLOPURINOL-ARX 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 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. DOSE FREQUENCY ALLOPURI Прочитајте комплетан документ