País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
enalapril maleate
Sandoz Pty Ltd
enalapril maleate
Registered
ENALAPRIL AN 1 ENALAPRIL AN _enalapril maleate tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Enalapril AN. 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 it is expected to 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 ENALAPRIL AN IS USED FOR The name of your medicine is Enalapril AN. It contains the active ingredient enalapril maleate. Enalapril AN is used to lower high blood pressure (hypertension). It is also used to treat heart failure. HYPERTENSION Everyone has blood pressure. This pressure helps to circulate the 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. Enalapril AN helps to lower your blood pressure. HEART FAILURE Heart failure means that the heart muscle 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 working. 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 Llegiu el document complet
180511-Enalapril AN-pi Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION ENALAPRIL AN TABLETS (ENALAPRIL MALEATE) 1 NAME OF THE MEDICINE Enalapril maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Enalapril is the ethyl ester of the parent diacid, enalaprilat. Enalapril maleate is a white to off- white crystalline powder. Melting point: approximately 144 ° C Solubility: sparingly soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Enalapril AN 5 mg (AUST R 188552) – oval, convex, white tablets, with one side scored and marked EN 5. Enalapril AN 10 mg (AUST R 188553) – oval, convex, red-brown tablets, with one side scored and marked EN 10. Enalapril AN 20 mg (AUST R 188554) – oval, convex, orange tablets, with one side scored and marked EN 20. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS _Hypertension _ Enalapril AN is indicated in the treatment of: • All grades of essential hypertension • Renovascular hypertension. _Congestive heart failure _ Enalapril AN is indicated for the treatment of all degrees of symptomatic heart failure. In such patients it is recommended that Enalapril AN 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. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _ESSENTIAL HYPERTENSION _ In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of Enalapril-PS. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with Enalapril AN to 180511-Enalapril AN-pi Page 2 of 18 reduce the likelihood of hypotension. (See Section 4.4 Special warnings and precautions for use.) If the patient' Llegiu el document complet