Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
indapamide hemihydrate, Quantity: 2.5 mg
Servier Laboratories (Aust) Pty Ltd
Tablet, film coated
Excipient Ingredients: maize starch; povidone; sodium lauryl sulfate; macrogol 6000; magnesium stearate; white beeswax; glycerol; titanium dioxide; lactose monohydrate; purified talc; hypromellose
Oral
10 tablets sample pack, 90 tablets, 30 tablets
(S4) Prescription Only Medicine
Natrilix is indicated in the management of essential hypertension. It may be tried as the sole therapeutic agent in the treatment of mild to moderate hypertension. Normally Natrilix is used as the initial agent in multiple drug regimens.
Visual Identification: White, unscored bi-convex film-coated tablet approximately 3.5mm thick and 6mm in diameter.; Container Type: Blister Pack; Container Material: Al laminated with PVC/paper; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1993-07-13
NATRILIX _indapamide (pronounced ind-ap-a-mide)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NATRILIX. It does not contain all the available information about this medicine. Reading this leaflet 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 NATRILIX against the expected benefits 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 NATRILIX IS The name of your medicine is NATRILIX. NATRILIX contains the active ingredient indapamide which belongs to a group of medicines called chlorosulfamoyl diuretics (a type of "fluid" or "water" tablet). WHAT NATRILIX IS USED FOR YOU HAVE BEEN PRESCRIBED NATRILIX SR FOR HIGH BLOOD PRESSURE. NATRILIX is available only with a doctor's prescription. There is no evidence that NATRILIX is addictive. _WHY NATRILIX IS USED FOR_ _HIGH BLOOD PRESSURE_ Everyone has blood pressure. This pressure helps to circulate 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 (also known as hypertension) which is 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. NATRILIX helps to lower your blood pressure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NATRILIX HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE NATRILIX There are some people who should not take NATRILIX. Please read the lists below. If you think any of these situations apply to you, or you have any questions, please consult your doctor or pharmacist. _WHEN YOU MUST NOT TAKE_ _NATRILIX:_ DO NOT TAKE NATRILIX IF: • YOU ARE AL Aqra d-dokument sħiħ
AUSTRALIAN PRODUCT INFORMATION – NATRILIX ® (INDAPAMIDE HEMIHYDRATE) Version 13 1/13 AUSTRALIAN PRODUCT INFORMATION NATRILIX (INDAPAMIDE HEMIHYDRATE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Indapamide hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each NATRILIX tablet contains 2.5mg of indapamide hemihydrate. Excipient with known effect: lactose monohydrate. For the full list of excipients, _see section 6.1 - List of _ _excipients_. 3 PHARMACEUTICAL FORM Each NATRILIX 2.5 tablet is a white, film-coated biconvex tablet containing indapamide hemihydrate 2.5 mg. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of hypertension. It may be tried as a sole therapeutic agent in the treatment of hypertension. Normally NATRILIX is used as the initial agent in multiple drug regimes. 4.2 D OSE AND METHOD OF ADMINISTRATION ADULTS: One NATRILIX 2.5 mg tablet to be taken daily, by oral route, in the morning. The action of NATRILIX 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 (2.5 mg) of NATRILIX daily is not recommended as there is little additional antihypertensive effect, whilst the diuretic effect becomes more pronounced. A single daily tablet of NATRILIX 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 one or two weeks after the treatment is stopped. 4.3 C ONTRAINDICATIONS NATRILIX is contraindicated in: • Severe renal failure, anuria, progressive and severe oliguria. • Hepatic coma, hepatic encephalopathy or severe impairment of liver function. • Known hypersensitivity to indapamide, other sulfonamide derivatives, o Aqra d-dokument sħiħ