Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
fosinopril sodium, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Fosinopril sodium
Tablet, uncoated
Excipient Ingredients: zinc stearate; crospovidone; lactose
Oral
30 tablets
(S4) Prescription Only Medicine
HYPERTENSION - Treatment of mild to moderate hypertension. FOSINOPRIL is effective alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of FOSINOPRIL and diuretics used concomitantly are approximately additive. Data have not been provided to support the use of FOSINOPRIL in severe or renovascular hypertension. HEART FAILURE - Management of heart failure when added to conventional therapy, including diuretics.
Visual Identification: White, capsule shaped biconvex tablet with indents, engraved "APO" on one side and "FOS-10" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2006-08-31
APO-FOSINOPRIL _Contains the active ingredient fosinopril sodium_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about fosinopril. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. 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. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Fosinopril. It contains the active ingredient fosinopril. It is used to treat: • high blood pressure (hypertension) • heart failure. Both of these are long term (chronic) diseases so it is important that you continue to take your medicine every day. High blood pressure (hypertension): Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. If you have hypertension (high blood pressure), this means that your blood pressure stays higher than is needed, even when you are relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious hea Baca dokumen lengkapnya
1 AUSTRALIAN PRODUCT INFORMATION – APO-FOSINOPRIL TABLETS (FOSINOPRIL SODIUM) 1 NAME OF THE MEDICINE Fosinopril Sodium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg or 20 mg of fosinopril sodium, as the active ingredient. For the full list of excipients see section 6.1 List of excipients 3 PHARMACEUTICAL FORM 10 MG TABLETS: White, capsule shaped biconvex tablets with indents, engraved “APO” on one side and “FOS-10” on the other side. 20 MG TABLETS: White, oval, biconvex tablets engraved “APO” on one side and “FOS-20” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION Treatment of mild to moderate hypertension. Fosinopril is effective alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of fosinopril and diuretics used concomitantly are approximately additive. Data have not been provided to support the use of fosinopril in severe or renovascular hypertension. HEART FAILURE Fosinopril is indicated for management of heart failure when added to conventional therapy, including diuretics. 4.2 DOSE AND METHOD OF ADMINISTRATION HYPERTENSION Patients Not Being Treated with Diuretics The recommended initial dose of fosinopril is 10 mg once a day. The usual dose range required to maintain blood pressure control is 10 to 40 mg/day administered as a single dose. Fosinopril should be taken at the same time each day. Dosage should then be adjusted according to blood pressure response. If blood pressure is not adequately controlled with fosinopril alone, a diuretic may be added. Patients Currently Being Treated with Diuretics (or who may be volume depleted) The diuretic should preferably be discontinued for several days prior to beginning therapy with fosinopril in order to reduce the risk of an excessive hypotensive response (see 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). If blood pressure is inadequately controlled after an observation period of approximately four weeks, diuretic therapy may be Baca dokumen lengkapnya