Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
indapamide hemihydrate, Quantity: 1.5 mg
Arrotex Pharmaceuticals Pty Ltd
indapamide hemihydrate
Tablet, modified release
Excipient Ingredients: lactose monohydrate; magnesium stearate; povidone; colloidal anhydrous silica; hypromellose; macrogol 3350; titanium dioxide; purified talc; polyvinyl alcohol
Oral
10 tablets, 90 tablets, 30 tablets
(S4) Prescription Only Medicine
Treatment of hypertension. It may be tried as a sole therapeutic agent in the treatment of hypertension. Normally, indapamide is used as the initial agent in multiple drug regimes.
Visual Identification: White to off-white, round, biconvex, film coated tablets.; Container Type: Blister Pack; Container Material: PVC/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
2014-05-07
APO-INDAPAMIDE SR TABLETS 1 APO-INDAPAMIDE SR TABLETS _Indapamide hemihydrate _ 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 indapamide slow- release (SR) 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 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 Indapamide SR is used to treat mild to moderate high blood pressure (also known as hypertension). These tablets release the active ingredient, indapamide, progressively over 24 hours. Indapamide belongs to a group of medicines called diuretics (a type of ‘fluid’ or ‘water’ tablet). Indapamide is thought to lower blood pressure by relaxing some of the blood vessels in the body. The blood vessels can then carry the same volume of blood more easily. Everyone has blood pressure. This pressure helps to move your blood all around the body. Your blood pressure may be different at different times of the day, depending on how busy or stressed you are. You have high blood pressure when your blood pressure stays higher than is needed, even when you are calm and relaxed. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually it can cause stroke, heart disease and kidney failure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT 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 T Lue koko asiakirja
1 AUSTRALIAN PRODUCT INFORMATION – APO- INDAPAMIDE SR MODIFIED RELEASE TABLETS (INDAPAMIDE HEMIHYDRATE) 1 NAME OF THE MEDICINE Indapamide hemihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release tablet contains 1.5 mg of indapamide hemihydrate 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 The tablets are white to off-white, round, biconvex, film coated. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. It may be tried as a sole therapeutic agent in the treatment of hypertension. Normally, indapamide is used as the initial agent in multiple drug regimes. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS One modified release coated tablet (1.5 mg indapamide hemihydrate) daily to be taken, by oral route, in the morning. The tablet should be swallowed whole and must not be chewed or crushed. The action of indapamide modified release tablets is progressive and whilst the optimum reduction in blood pressure is usually seen after four weeks, a further small but useful reduction in blood pressure may be observed over the following four to six weeks. A larger dose than one tablet of indapamide modified release daily is not recommended as there is little additional antihypertensive effect, whilst the diuretic effect becomes more pronounced. A single daily tablet of indapamide modified release may effectively be combined with the following antihypertensive medicines: beta-blockers, methyldopa sesquihydrate, clonidine, prazosin and ACE inhibitors. Combination with a diuretic is not recommended as significant electrolyte disturbances may occur. Indapamide has a slight but significant carry-over hypotensive effect lasting up to 1 or 2 weeks after treatment is stopped. 4.3 CONTRAINDICATIONS • Severe renal failure, anuria, progressive and severe oliguria. • Hepatic coma, hepatic encephalopathy or severe impairment of liver function. • Known hypersensitivity to Lue koko asiakirja