Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
bisoprolol fumarate, Quantity: 10 mg
Medreich Australia Pty Ltd
Bisoprolol fumarate
Tablet, film coated
Excipient Ingredients: magnesium stearate; crospovidone; iron oxide red; maize starch; microcrystalline cellulose; iron oxide yellow; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 400
Oral
28
(S4) Prescription Only Medicine
Treatment of stable chronic moderate to severe heart failure in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides
Visual Identification: Pale orange - light orange coloured, heart shaped, film coated tablets, scored on both sides; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-08-26
Page 1 of 8 BISOPROLOL DR.REDDY’S 2.5 MG, 5 MG AND 10 MG TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BISOPROLOL DR.REDDY’S. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking BISOPROLOL DR.REDDY’S against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT BISOPROLOL DR.REDDY’S IS USED FOR BISOPROLOL DR.REDDY’S is used to treat heart failure. It is usually used in combination with other medicines. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body's needs. Heart failure may start off with no symptoms, but as the condition progresses patients may feel short of breath and notice swelling of the feet and ankles due to fluid build up. BISOPROLOL DR.REDDY’S belongs to a group of medicines called beta-blockers. These medicines work by affecting the body's response to some nerve impulses, especially in the heart. As a result, it decreases the heart's need for blood and oxygen and therefore reduces the amount of work the heart has to do. BISOPROLOL DR.REDDY’S also slows your heart rate, which in turn increases the efficiency of your heart. BISOPROLOL DR.REDDY’S can help to reduce the number of heart failure episodes needing hospital admission and also the risk of sudden death. Your doctor may have prescribed BISOPROLOL DR.REDDY’S for another reason. Ask your doctor if you have any questions about why BISOPROLOL DR.REDDY’S has been prescribed for you. BISOPROLOL DR.REDDY’S is not reccomended for use in children, as the safety and efficacy in children have not been established. BISOPROLOL DR.REDDY’S is available only with a doctor's prescription. There is no evidence that BI Прочетете целия документ
1 AUSTRALIAN PRODUCT INFORMATION – BISOPROLOL DR.REDDY’S (BISOPROLOL FUMARATE) TABLETS 1 NAME OF THE MEDICINE Bisoprolol fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each BISOPROLOL DR.REDDY’S 2.5 mg, 5 mg and 10 mg tablet contains 2.5 mg, 5 mg and 10 mg of bisoprolol fumarate respectively. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM • BISOPROLOL DR.REDDY’S 2.5 mg – white coloured, heart-shaped, film-coated tablets, scored on both sides • BISOPROLOL DR.REDDY’S 5 mg – White-yellow, heart-shaped, film-coated tablets, scored on both sides • BISOPROLOL DR.REDDY’S 10 mg - pale orange – light orange coloured, heart-shaped, film- coated tablets, scored on both sides 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of stable chronic moderate to severe heart failure in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. 4.2 D OSE AND METHOD OF ADMINISTRATION Treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a β-blocker, diuretics, and when appropriate cardiac glycosides. Patients should be stable (without acute failure) when bisoprolol treatment is initiated. It is recommended that the treating physician should be experienced in the management of chronic heart failure. TITRATION PHASE The treatment of stable chronic heart failure with bisoprolol requires a titration phase. The treatment with bisoprolol is to be started with a gradual uptitration according to the following steps: • 1.25 mg once daily for 1 week, if well tolerated increase to • 2.5 mg once daily for a further week, if well tolerated increase to 2 • 3.75 mg once daily for a further week, if well tolerated increase to • 5 mg once daily for the 4 following weeks, if well tolerated increase to • 7.5 mg once daily for the 4 following weeks, if well tolerated increase to • 10 mg once daily for the maintenance therapy. The maximum recommended dose is 10 mg once d Прочетете целия документ