Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
nebivolol hydrochloride, Quantity: 1.363 mg (Equivalent: nebivolol, Qty 1.25 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 flat face bevelled edge uncoated tablets debossed with U 53 on one side and plain 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 Lupin v1 1 NEBIVOLOL LUPIN CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING NEBIVOLOL LUPIN? Nebivolol Lupin contains the active ingredient Nebivolol hydrochloride. Nebivolol Lupin is used to treat high blood pressure (essential hypertension) or chronic heart failure. It is usually used in combination with other medicines. For more information, see Section 1. Why am I using Nebivolol Lupin? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NEBIVOLOL LUPIN? Do not take Nebivolol Lupin if you have ever had an allergic reaction to Nebivolol Lupin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Nebivolol Lupin? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Nebivolol Lupin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE NEBIVOLOL LUPIN? • Follow all directions given to you by your doctor. They will determine your dose. Take your medicine at about the same time each day. Swallow the tablets whole with a full glass of water. Do not crush or chew the tablets. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well. More instructions can be found in Section 4. How do I use Nebivolol Lupin? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NEBIVOLOL LUPIN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking Nebivolol Lupin • Keep all of your doctor's appointments so that your progress can be checked • Tell your doctor if you believe that Nebivolol Lupin is not helping your condition Lestu allt skjalið
Nebivolol Lupin v2 Page 1 of 21 (nebivolol hydrochloride) tablets AUSTRALIAN PRODUCT INFORMATION – NEBIVOLOL LUPIN (NEBIVOLOL HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Nebivolol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nebivolol tablets contain 1.25 mg, 2.5 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 2.5 mg: White to off white, capsule shape, biconvex uncoated tablets debossed with “T 55” on one side and score line 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 Lupin is indicated: • to treat essential hypertension; • to treat stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older. Nebivolol Lupin v2 Page 2 of 21 (nebivolol hydrochloride) tablets 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 Lestu allt skjalið