Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Febuxostat 120mg;
A. Menarini New Zealand Pty Ltd
Febuxostat 120 mg
120 mg
Film coated tablet
Active: Febuxostat 120mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 85F42129
Blister pack, PVC/Aclar/Aluminium, 28 tablets
Prescription
Prescription
Esteve Quimica SA
Treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults.
Package - Contents - Shelf Life: Blister pack, PVC/Aclar/Aluminium - 28 tablets - 36 months from date of manufacture stored at or below 30°C
2012-11-13
ADENURIC ® T ABLETS _febuxostat 80 mg and 120 mg _ _tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ADENURIC ® Tablets. 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 ADENURIC ® Tablets 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 ADENURIC ® TABLETS ARE USED FOR ADENURIC ® Tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble. When this happens, urate crystals may form in and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi may form in and around joints. These tophi may cause joint and bone damage. ADENURIC ® Tablets work by reducing uric acid levels. Keeping uric acid levels low by taking ADENURIC ® tablets once every day stops crystals building up, and over time it reduces symptoms. Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi. ADENURIC 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers. When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented. BEFORE YOU TAKE ADENURIC ® TABLETS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ADENURIC ® TABLETS IF: • you have ever had an allergy to febuxostat or any of the ingredients listed at the en Read the complete document
NEW ZEALAND DATASHEET 1 PRODUCT NAME ADENURIC ® 80 mg, 120 mg film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains either 80 mg or 120 mg of febuxostat. Excipient(s) with known effects: Each 80 mg tablet contains 76.50 mg of lactose (as monohydrate). Each 120 mg tablet contains 114.75 mg of lactose (as monohydrate). For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM ADENURIC ® 80 mg and 120 mg tablets are pale yellow to yellow, film-coated, capsule shaped tablets, with “80” or “120” on one side. They are immediate release tablets containing 80 mg or 120 mg of febuxostat as the active substance. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications ADENURIC ® 80 mg ADENURIC ® is indicated for the treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). ADENURIC ® is indicated in adults. ADENURIC ® 120 mg ADENURIC ® is indicated for the treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). ADENURIC ® is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). ADENURIC ® is indicated in adults. 4.2 Dose and method of administration _Gout _ The recommended oral dose of ADENURIC ® is 80 mg once daily with or without food. If serum uric acid is > 6 mg/dL (357 micromole/L) after 2-4 weeks, ADENURIC ® 120 mg once daily may be considered. ADENURIC ® works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357micromole/L). Gout flare prophylaxis of at least 6 months is recommended (see section 4.4). _Tumor Lysis Syndrome _ The recommended oral dose of ADENURIC ® is 120 mg once daily with or without food. ADENURIC ® should be started two days before the beginning of cytot Read the complete document