Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
nebivolol hydrochloride, Quantity: 1.363 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet
Excipient Ingredients: copovidone; magnesium stearate; pregelatinised maize starch; lactose monohydrate; crospovidone
Oral
28 tablets
(S4) Prescription Only Medicine
Nebivolol is indicated: ? to treat essential hypertension; ? to treat stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older.
Visual Identification: White to off white, round biconvex tablets debossed 'APO over 1.25 on one side and single score on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2018-02-21
APO-Nebivolol Tablet 1 APO-NEBIVOLOL _Contains the active ingredient nebivolol hydrochloride _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about nebivolol hydrochloride. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- NEBIVOLOL Tablet. It contains the active ingredient Nebivolol hydrochloride. It is used to treat: • high blood pressure (essential hypertension) or, • chronic heart failure. It is usually used in combination with other medicines. _HOW IT WORKS _ This medicine belongs to a group of medicines called beta-blockers. High Blood Pressure (Hypertension): Nebivolol can be used to treat high blood pressure. It works by blocking the transmission of messages to the beta receptors in the heart which slows down the activity of the heart. It also relaxes the blood vessels and reduces the resistance that the heart has to pump against. The blood pressure lowering effects occur after 1 to 2 weeks, although it may take up to 4 weeks for the full effect to occur. Chronic Heart Failure: Nebivolol can also be Baca dokumen lengkapnya
1 AUSTRALIAN PRODUCT INFORMATION – APO-NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Nebivolol hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.25 mg, 5 mg or 10 mg nebivolol (as hydrochloride salt). EXCIPIENTS WITH KNOWN EFFECT Contains sugars as lactose monohydrate. For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 1.25 MG TABLETS: White to off-white, round, biconvex tablets debossed “APO” over “1.25” on one side and single score on the other side; the score line on the 1.25 mg tablets is for identification purposes only and is not intended for dividing doses. 5 MG TABLETS: White to off-white, round, biconvex tablets debossed “APO” over “N5” on one side and cross scored on the other side. 10 MG TABLETS: White to off-white, round, biconvex tablets debossed “APO” on one side and “N10” on one the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-Nebivolol is indicated: • To treat essential hypertension. • To treat stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older. 4.2 DOSE AND METHOD OF ADMINISTRATION Nebivolol tablets are intended for oral administration. The dose of nebivolol should always be adjusted to the individual requirements of the patient (see SECTION 5 PHARMACOLOGICAL PROPERTIES, 5.2 PHARMACOKINETIC PROPERTIES). 2 Hypertension The dose is one 5 mg tablet daily, preferably at the same time of the day. Tablets may be taken with or without meals. The blood pressure lowering effect becomes evident after 2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks. Combination with other antihypertensive agents: Nebivolol may be used as monotherapy or in combination with hydrochlorothiazide (12.5 mg - 25 mg). Patients with renal insufficiency In patients with renal insufficiency, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. Patients with hepatic insu Baca dokumen lengkapnya