Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
allopurinol, Quantity: 300 mg
Sandoz Pty Ltd
Tablet, uncoated
Excipient Ingredients: powdered cellulose; povidone; macrogol 4000; crospovidone; purified talc; magnesium stearate; microcrystalline cellulose
Oral
60 tablets
(S4) Prescription Only Medicine
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.
Visual Identification: White to off-white, biconvex oblong tablets with both-sided breaking notch and intact surface. Length: 16.9 - 17.3mm; Width: 6.9 - 7.3mm; Height: 4.0 - 4.4mm; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
1998-08-31
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 Perskaitykite visą dokumentą
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 Perskaitykite visą dokumentą