Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
enalapril maleate, Quantity: 5 mg
Arrotex Pharmaceuticals Pty Ltd
enalapril maleate
Tablet
Excipient Ingredients: croscarmellose sodium; hypromellose; sodium stearylfumarate; maleic acid; lactose monohydrate
Oral
30
(S4) Prescription Only Medicine
HYPERTENSION ,Enalapril is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. ,CONGESTIVE HEART FAILURE ,Enalapril is indicated for the treatment of all degrees of symptomatic heart failure. In such patients, it is recommended that Enalapril be administered together with a diuretic. ,LEFT VENTRICULAR DYSFUNCTION ,All degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35 percent, irrespective of the presence or severity of obvious symptoms of heart failure.
Visual Identification: White to off white, round, flat faced, beveled edge tablets with breakline on one side and "5" debossed on the other side.; Container Type: Carton; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-05-28
APO-Enalapril Tablets 1 APO-ENALAPRIL _Contains the active ingredient enalapril (as enalapril maleate) _ 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 this medicine. 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 THIS MEDICINE IS USED FOR Enalapril is used to treat: • heart failure • high blood pressure (also known as hypertension) Enalapril belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. One of the ways enalapril helps lower blood pressure and treat heart failure is that it widens blood vessels. This means that blood is able to pass through them more easily and the heart doesn't have to pump as hard to move blood around the body. This also means that when you place extra demands on your heart, such as during exercise, the heart may cope better so you may not get short of breath as easily. 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. You may feel fine and have no symptoms, but eventually hypertension can cause stroke, heart disease and kidney failure. HEART F Baca dokumen lengkapnya
1 AUSTRALIAN PI - APO-ENALAPRIL (ENALAPRIL MALEATE) 1 NAME OF THE MEDICINE Enalapril maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet (5 mg, 10 mg and 20mg) contains enalapril maleate 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 5 MG TABLETS White to off white, round, flat-face beveled edge tablets with breakline on one side and “5” debossed on the other side. 10 MG TABLETS White to off white, round, flat-face beveled edge tablets with breakline on one side and “10” debossed on the other side. 20 MG TABLETS White to off white, round, flat-face beveled edge tablets with breakline on one side and “20” debossed on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enalapril is indicated in the treatment of: • HYPERTENSION o All grades of essential hypertension o Renovascular hypertension • CONGESTIVE HEART FAILURE All degrees of symptomatic heart failure. In such patients, it is recommended that APO- Enalapril be administered together with a diuretic. • LEFT VENTRICULAR DYSFUNCTION All degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure. 2 4.2 DOSE AND METHOD OF ADMINISTRATION ESSENTIAL HYPERTENSION In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of APO-Enalapril. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with APO-Enalapril to reduce the likelihood of hypotension (see section 4.4-Special warnings and precautions for use). If the patient's blood pressure is not controlled with APO-Enalapril alone, diuretic therapy may be resumed. If the diuretic cannot be discontinued an initial dose of 2.5mg (break the 5mg tablet) should be used under medical supervision for at least one hour to determin Baca dokumen lengkapnya