País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
nebivolol hydrochloride, Quantity: 10.9 mg (Equivalent: nebivolol, Qty 10 mg)
A Menarini Australia Pty Ltd
Nebivolol hydrochloride
Tablet
Excipient Ingredients: polysorbate 80; colloidal anhydrous silica; hypromellose; lactose monohydrate; magnesium stearate; croscarmellose sodium; maize starch; microcrystalline cellulose
Oral
28 tablets of 10mg strength, 7 Tablets (sample pack), 4 tablets (sample pack)
(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: Almost white, round, slightly biconvex, unscored tablet with "10" embossed on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2009-06-26
NEBILET ® _nebivolol hydrochloride_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NEBILET. 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 NEBILET 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 NEBILET IS USED FOR NEBILET is used to treat : • high blood pressure (essential hypertension) or, • chronic heart failure. It is usually used in combination with other medicines. This medicine belongs to a group of medicines called beta-blockers. HIGH BLOOD PRESSURE (HYPERTENSION): NEBILET 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: NEBILET can also be used to treat chronic heart failure. It slows down the heart rate and makes it beat more regularly. It also reduces the pressure the heart has to pump against and therefore reduces the amount of work that the heart has to do. This improves the symptoms of chronic heart failure, and reduces the likelihood of you being hospitalised and/or dying from your heart condition. 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. It is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for children under the age of 18 years. BEFORE YOU TAKE NEB Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION – NEBILET ® NEBIVOLOL (AS HYDROCHLORIDE) NEBILET PI vA09-0 Page 1 of 18 1 NAME OF THE MEDICINE Nebivolol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NEBILET tablets contain 1.25 mg, 5 mg or 10 mg of nebivolol present as the hydrochloride salt. Excipient with known effect: lactose. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM NEBILET 1.25 mg tablets: almost white, round, slightly biconvex tablets 3.1 mm high with a diameter of 9 mm and a single score on one side; the score line on the 1.25 mg tablet is for identification purposes only and is not intended for dividing doses. NEBILET 5 mg tablets: almost white, round, cross-scored tablets. NEBILET 10 mg tablets: almost white, round, slightly biconvex with embossment “10” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEBILET 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 The dose of NEBILET should always be adjusted to the individual requirements of the patient (see section 5.2 PHARMACOKINETIC PROPERTIES)._ _ 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: NEBILET may be used as monotherapy or in combination with hydrochlorothiazide (12.5 - 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. NEBILET PI vA09-0 Page 2 of 18 Patients with hepatic insufficiency: Data in patients with hepatic insufficiency or impaired liver function are limited. Therefore the use of NEBILET in these patients is contra-indicated. Eld Llegiu el document complet