Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
nebivolol hydrochloride, Quantity: 5.45 mg (Equivalent: nebivolol, Qty 5 mg)
Southern Cross Pharma Pty Ltd
Tablet
Excipient Ingredients: lactose monohydrate; maize starch; croscarmellose sodium; hypromellose; polysorbate 80; microcrystalline cellulose; silicon dioxide; magnesium stearate
Oral
28
(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, circular, biconvex uncoated tablets debossed with T 56 on one side and cross score line on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 32 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-04-03
NEBIVOLOL SANDOZ 1 NEBIVOLOL SANDOZ _nebivolol hydrochloride _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NEBIVOLOL SANDOZ. 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 NEBIVOLOL SANDOZ 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 NEBIVOLOL SANDOZ IS USED FOR NEBIVOLOL SANDOZ is used to treat : • high blood pressure (essential hypertension) or, • chronic heart failure. It is usually used in combination 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 SANDOZ 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 hospitalized 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/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. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE NEBIVOLOL SANDOZ IF YOU: • have liver problems • have acute heart failure or cardiogenic shock, a Lestu allt skjalið
1 20200318-Nebivolol SANDOZ PI-V1.3 AUSTRALIAN PRODUCT INFORMATION – NEBIVOLOL SANDOZ (NEBIVOLOL HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Nebivolol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nebivolol tablets contain 1.25 mg, 5 mg or 10 mg of nebivolol present as the hydrochloride salt. Excipients with known effect: sugars as lactose. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Nebivolol Tablets 1.25mg White to off white, circular flat face bevelled edge uncoated tablets debossed with ‘U 53’ on one side and plain on the other side. Nebivolol Tablets 5mg White to off white, circular, biconvex uncoated tablets debossed with “T 56” on one side and cross score line on the other side. Nebivolol Tablets 10 mg: White to off white, circular, biconvex uncoated tablets debossed with “T 57” on one side and score line on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Nebivolol SANDOZ is indicated: • to treat essential hypertension; • to treat stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older. 2 20200318-Nebivolol SANDOZ PI-V1.3 4.2 D OSE AND METHOD OF ADMINISTRATION The dose of nebivolol 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: Nebivolol 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. Patients with hepatic insufficiency: Data in patients with hepatic insufficiency or impaired liver Lestu allt skjalið