País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
lisinopril dihydrate, Quantity: 5.44 mg
Sandoz Pty Ltd
Lisinopril dihydrate
Tablet
Excipient Ingredients: calcium hydrogen phosphate dihydrate; mannitol; maize starch; magnesium stearate; croscarmellose sodium; iron oxide red
Oral
30
(S4) Prescription Only Medicine
1.Hypertension: Lisinopril is indicated for the treatment of hypertension. It may be used alone or concomitantly with other classes of antihypertensive agents. Sufficient data have not been provided to support the use of lisinopril in severe hypertension or renovascular hypertension. 2. Congestive heart failure: Lisinopril is also indicated for the treatment of heart failure. In such patients, it is recommended that lisinopril be administered together with a diuretic. 3. Acute myocardial infarction: Lisinopril is indicated for the treatment of acute myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100mmHg. Lisinopril may be initiated within 24 hours of an acute myocardial infarction.
Visual Identification: Round, biconvex and a score notch on one side. The tablets are uniformly red, mottled, the surface must be smooth.; 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
2010-03-31
LISINOPRIL SANDOZ ® 1 LISINOPRIL SANDOZ _lisinopril dihydrate tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Lisinopril Sandoz. 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 taking 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 need to read it again. WHAT LISINOPRIL SANDOZ IS USED FOR This medicine is used to treat: • high blood pressure (hypertension) • heart failure • patients who have just had a heart attack. It contains the active ingredient lisinopril dihydrate. Lisinopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. It works by widening your blood vessels, which reduces pressure in the vessels. This makes it easier for your heart to pump blood around your body. This also helps to increase the supply of oxygen to your heart, so that when you place extra demands on your heart, such as exercise, your heart may cope better and you may not get short of breath as easily. By making it easier for your heart to pump blood around your body and by increasing the supply of oxygen to your heart, Lisinopril Sandoz may reduce the risk of further damage to your heart after you have had a heart attack. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE LISINOPRIL SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD AN ALLERGY TO: • lisinopril dihydrate, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product description • Llegiu el document complet
190605-lisinopril-sandoz-pi Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION LISINOPRIL SANDOZ ® (LISINOPRIL DIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Lisinopril dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lisinopril Sandoz 5 mg tablet contains 5.44 mg lisinopril dihydrate equivalent to 5 mg lisinopril. Each Lisinopril Sandoz 10 mg tablet contains 10.89 mg lisinopril dihydrate equivalent to 10 mg lisinopril. Each Lisinopril Sandoz 20 mg tablet contains 21.78 mg lisinopril dihydrate equivalent to 20 mg lisinopril. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Lisinopril Sandoz 5 mg tablets are round, biconvex and a score notch on one side. The tablets are uniformly red, mottled, the surface must be smooth. Lisinopril Sandoz 10 mg tablets are round, biconvex and a score notch on one side. The tablets are uniformly red, mottled, the surface must be smooth. Lisinopril Sandoz 20 mg tablets are round, biconvex and a score notch on one side. The tablets are uniformly red, mottled, the surface must be smooth 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS _HYPERTENSION _ Lisinopril Sandoz is indicated for the treatment of hypertension. It may be used alone or concomitantly with other classes of antihypertensive agents. Sufficient data have not been provided to support the use of lisinopril in severe hypertension or renovascular hypertension. _CONGESTIVE HEART FAILURE _ Lisinopril Sandoz is also indicated for the treatment of heart failure. In such patients, it is recommended that lisinopril be administered together with a diuretic. _ACUTE MYOCARDIAL INFARCTION _ Lisinopril Sandoz is indicated for the treatment of acute myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg. Lisinopril may be initiated within 24 hours of an acute myocardial infarction. 190605-lisinopril-sandoz-pi Page 2 of 24 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Lisinopril Llegiu el document complet