Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
fosinopril sodium, Quantity: 10 mg
Alphapharm Pty Ltd
Fosinopril sodium
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; hyprolose; crospovidone; glyceryl behenate
Oral
14, 100, 56, 28, 30
(S4) Prescription Only Medicine
MONACE is indicated for the treatment of mild to moderate hypertension. MONACE is effective alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of MONACE and diuretics used concomitantly are approximately additive. Data have not been provided to support the use of MONACE in severe or renovascular hypertension. Heart failure: MONACE is indicated for the management of heart failure when added to conventional therapy, including diuretics.
Visual Identification: White to off-white, arc-rectangular shaped tablet, with 'G' scoreline 'G' on one side and 'FS' scoreline '10' on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-11-08
MONACE _fosinopril sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Monace tablets. This leaflet answers some common questions about Monace 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 benefits and risks. Your doctor has weighed the risks of you taking Monace tablets against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT MONACE IS USED FOR Monace is used for treating high blood pressure (hypertension) or heart failure. Both of these are long term (chronic) diseases so it is important that you continue to take your Monace tablets 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. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and 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 health problems, including stroke, heart disease and kidney failure. HEART FAILURE Heart failure means that the heart muscle is weak and cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not mean that the heart stops. Heart failure may start off with no symptoms, but as the condition progresses, patients may feel short of breath or may get tired easily after light physical activity such as walking. Some patients may wake up short of breath at night. Fluid may collect in different parts of the body, ofte Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION MONACE _fosinopril sodium tablets _ 1 NAME OF THE MEDICINE Fosinopril sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Monace tablet contains 10 mg or 20mg of fosinopril sodium as the active ingredient. List of excipients with known effect: Monace tablets also contain traces of benzoates and sulfites. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM MONACE 10: Fosinopril sodium 10 mg tablets; white to off-white, arc-rectangular shaped, with “G G” on one side and “FS 10” on the other side. MONACE 20: Fosinopril sodium 20 mg tablets; white to off-white, capsule shaped, with “G G” on one side and “FS 20” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: Monace is indicated in the treatment of mild to moderate hypertension. Monace is effective alone as initial therapy or in combination with other antihypertensive agents. The antihypertensive effects of Monace and diuretics used concomitantly are approximately additive. Data have not been provided to support the use of Monace in severe or renovascular hypertension. HEART FAILURE Monace is indicated for the management of heart failure when added to conventional therapy, including diuretics. 4.2 DOSE AND METHOD OF ADMINISTRATION HYPERTENSION _FOR HYPERTENSIVE PATIENTS NOT BEING TREATED WITH DIURETICS: _ The recommended initial dose of Monace is 10 mg once a day. The usual dose range required to maintain blood pressure control is 10 to 40 mg per day administered as a single dose. Monace 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 Monace alone, a diuretic may be added. _FOR HYPERTENSIVE 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 Monace in order to reduce the risk of an excessive Pročitajte cijeli dokument