Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
nebivolol hydrochloride, Quantity: 5.45 mg (Equivalent: nebivolol, Qty 5 mg)
A Menarini Australia Pty Ltd
Nebivolol hydrochloride
Tablet
Excipient Ingredients: microcrystalline cellulose; polysorbate 80; maize starch; croscarmellose sodium; hypromellose; magnesium stearate; colloidal anhydrous silica; lactose monohydrate
Oral
42 tablets of 1.25mg and 14 tablets of 5mg
(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: Off-white, circular, biconvex tablet cross-scored on one side and blank on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2009-06-26
NEBILET ® N E B I L E T ® 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 TAKING NEBILET? NEBILET contains the active ingredient nebivolol hydrochloride. NEBILET 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 taking NEBILET? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE NEBILET? Do not take NEBILET if you have ever had an allergic reaction to NEBILET 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 take NEBILET? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NEBILET 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 TAKE NEBILET? • 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 take NEBILET? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING NEBILET? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking NEBILET • Keep all of your doctor's appointments so that your progress can be checked • Tell your doctor if you believe that NEBILET is not helping your condition • If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly THINGS YOU SHOUL Izlasiet visu dokumentu
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 Izlasiet visu dokumentu