Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
irbesartan, Quantity: 300 mg
Arrotex Pharmaceuticals Pty Ltd
Irbesartan
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; lactose monohydrate; magnesium stearate; povidone; titanium dioxide; hypromellose; macrogol 4000
Oral
30s
(S4) Prescription Only Medicine
Irbesartan is indicated for the following: For the treatment of hypertension. For delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (equal to or greater than 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.
Visual Identification: White to off-white, oval shaped, biconvex, film coated tablet, debossed with "L174" on one side and "300" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-10-02
APO-IRBESARTAN 1 APO-IRBESARTAN _Irbesartan _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about irbesartan. 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 using 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Irbesartan is used to treat high blood pressure and kidney disease in type 2 diabetic patients with high blood pressure. It belongs to a group of medicines known as angiotensin-II receptor antagonists. _HOW IT WORKS _ Irbesartan relaxes your blood vessels, helping to lower your blood pressure. It also slows the decrease of kidney function in type 2 diabetic patients with high blood pressure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • irbesartan • any other angiotensin-II receptor antagonists or ‘sartans’ • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD THE FOLLOWING MEDICAL CONDITIONS: • diabetes or moderate to severe kidney impairment, and you are tak Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION APO-IRBESARTAN (IRBESARTAN) TABLETS 1 NAME OF THE MEDICINE Irbesartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg, 150 mg or 300 mg irbesartan, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Sugars as lactose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 75 MG TABLETS: White to off-white, oval shaped, biconvex, film-coated tablet debossed with “L172” on one side and “75” on the other side. 150 MG TABLETS: White to off-white, oval shaped, biconvex, film-coated tablet debossed with “L173” on one side and “150” on the other side. 300 MG TABLETS: White to off-white, oval shaped, biconvex, film-coated tablet debossed with “L174” on one side and “300” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irbesartan is indicated for: • Treatment of hypertension. • 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. 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Irbesartan tablets are intended for oral 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 is 150 mg once daily. Irbesartan may be administered with or without food. 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 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 a patient’s blood pressu Przeczytaj cały dokument