Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
enalapril maleate, Quantity: 20 mg; hydrochlorothiazide, Quantity: 6 mg
Sandoz Pty Ltd
enalapril maleate,Hydrochlorothiazide
Tablet, uncoated
Excipient Ingredients: magnesium stearate; sodium bicarbonate; maize starch; lactose monohydrate; purified talc
Oral
30 tablets
(S4) Prescription Only Medicine
Mild to moderate hypertension. Treatment should not be initiated with this fixed dose combination.
Visual Identification: White, oval, biconvex tablets with snap tab on one side, scored and marked "EN20" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-07-11
ENALAPRIL/HCT SANDOZ ® 1 ENALAPRIL/HCT SANDOZ ® _20 MG/6 MG TABLETS _ _enalapril maleate and hydrochlorothiazide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Enalapril/HCT Sandoz 20 mg/6 mg. 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 Enalapril/HCT Sandoz 20 mg/6 mg 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/HCT SANDOZ 20 MG/6 MG IS USED FOR Enalapril/HCT Sandoz 20 mg/6 mg lowers high blood pressure, which doctors call 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/HCT Sandoz 20 mg/6 mg helps to lower your blood pressure. _HOW ENALAPRIL/HCT SANDOZ _ _20 MG/6 MG WORKS _ Enalapril/HCT Sandoz 20 mg/6 mg contains two active ingredients. One of these is enalapril maleate. It belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. It works by widening your 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. The other active ingredient is hy Lesen Sie das vollständige Dokument
210826-enalapril/hct-sandoz-pi Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION ENALAPRIL/HCT SANDOZ ® (ENALAPRIL MALEATE/ HYDROCHLOROTHIAZIDE) TABLETS 1 NAME OF THE MEDICINE Enalapril maleate/ hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Enalapril/HCT Sandoz 20 mg/6 mg tablet contains enalapril maleate 20 mg and hydrochlorothiazide 6 mg. _Excipient with known effect: _ Sugars as lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Enalapril/HCT Sandoz 20 mg/6 mg are white, oval, biconvex tablets with snap tab on one side, scored and marked “EN20” on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Mild to moderate hypertension. Treatment should not be initiated with this fixed dose combination. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Treatment with Enalapril/HCT 20 mg/6 mg should only be commenced after titration of the enalapril component has been shown not to be effective in achieving the required lowering of blood pressure. _HYPERTENSION _ In hypertension, the usual dosage of Enalapril/HCT 20 mg/6 mg is one tablet, administered once daily. _PRIOR DIURETIC THERAPY _ Symptomatic hypotension may occur following the initial dose of Enalapril/HCT 20 mg/6 mg; this is more likely in patients who are volume or salt depleted as a result of prior diuretic therapy. The diuretic therapy should be discontinued for two to three days prior to initiation of therapy with Enalapril/HCT 20 mg/6 mg. Patients receiving concomitant diuretic and ACE inhibitor therapy in doses greater than or equal to those contained in Enalapril/HCT 20 mg/6 mg may be transferred to Enalapril/HCT 20 mg/6 mg without discontinuation of the diuretic. METHOD OF ADMINISTRATION Enalapril/HCT 20 mg/6 mg is supplied as tablets for oral administration. 210826-enalapril/hct-sandoz-pi Page 2 of 22 DOSAGE ADJUSTMENT IN: renal impairment Thiazides may not be appropriate diuretics for use in patients with renal impairment and are ineffective at creatinin Lesen Sie das vollständige Dokument