Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
irbesartan, Quantity: 75 mg
Sandoz Pty Ltd
Irbesartan
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; purified talc; hyprolose; hypromellose; magnesium stearate; macrogol 6000; croscarmellose sodium; titanium dioxide
Oral
30
(S4) Prescription Only Medicine
Indicated for the treatment of hypertension. Indicated for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (greater than or equal to 30mg per 24 hours) or urinary protein in excess of 900mg per 24 hours.
Visual Identification: White, oval biconvex film-coated tablets, marked 75 on one side and scored on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-10-28
Irbesartan Sandoz® Tablets 1 IRBESARTAN SANDOZ® TABLETS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING IRBESARTAN SANDOZ? Irbesartan Sandoz contains the active ingredient irbesartan. Irbesartan Sandoz is used to treat high blood pressure and is also used in the treatment of kidney disease in patients with high blood pressure and type 2 diabetes. For more information, see Section 1. Why am I taking Irbesartan Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE IRBESARTAN SANDOZ? Do not use if you have ever had an allergic reaction to Irbesartan Sandoz or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take Irbesartan Sandoz? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Irbesartan Sandoz and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE IRBESARTAN SANDOZ? • Your doctor will tell you how many tablets to take each day. The standard dose is one 150 mg tablet per day. This dose may be increased to a 300 mg once per day. • Swallow the tablet whole with a glass of water and take Irbesartan Sandoz at about the same time each day. More instructions can be found in Section 4. How do I take Irbesartan Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING IRBESARTAN SANDOZ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Irbesartan Sandoz. • If you become pregnant or plan to breastfeed while taking Irbesartan Sandoz tell your doctor immediately. • If you are about to be started on any new medicine, tell your doctor and pharmacist you are taking Irbesartan Sando Aqra d-dokument sħiħ
210226-Irbesartan Sandoz-pi Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION IRBESARTAN SANDOZ ® (IRBESARTAN) TABLETS 1 NAME OF THE MEDICINE Irbesartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Irbesartan Sandoz 75 mg tablets contain 75 mg irbesartan. Irbesartan Sandoz 150 mg tablets contain 150 mg irbesartan. Irbesartan Sandoz 300 mg tablets contain 300 mg irbesartan. _Excipients with known effect:_ lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Irbesartan Sandoz 75 mg - white, oval biconvex film-coated tablets, marked “75” on one side and scored on the other side. Irbesartan Sandoz 150 mg - white, oval biconvex film-coated tablets, marked “150” on one side and scored on the other side. Irbesartan Sandoz 300 mg - white, oval biconvex film-coated tablets, marked “300” on one side and scored on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Irbesartan Sandoz is indicated for the treatment of hypertension. Irbesartan Sandoz is indicated for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (≥ 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Irbesartan may be used either alone or in combination with other antihypertensive agents (e.g., thiazide diuretic, beta-adrenergic blocking agent, long-acting calcium-channel blocking agent). The usual initial and maintenance dose of Irbesartan Sandoz is 150 mg once daily. Therapy should be adjusted according to blood pressure response. Patients requiring further reduction in blood pressure should have the dose increased to 300 mg once daily. In patients with hypertension and type II diabetic renal disease, 300 mg of Irbesartan Sandoz once daily is the preferred maintenance dose. Although irbesartan slowed the progression of renal disease in hypertensive patients separately to its effect on blood pressure, this does not remove the clinical requirement for Aqra d-dokument sħiħ