Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
bisoprolol fumarate, Quantity: 5 mg
Sandoz Pty Ltd
Bisoprolol fumarate
Tablet, film coated
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; iron oxide yellow; calcium hydrogen phosphate; colloidal anhydrous silica; pregelatinised maize starch; hypromellose; lactose monohydrate; macrogol 4000; titanium dioxide
Oral
28 tablets
(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: Scored yellow round tablets. Embossed on one side with "BIS 5".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2009-03-04
BISOPROLOL SANDOZ ® 1 BISOPROLOL SANDOZ ® _bisoprolol fumarate film-coated tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bisoprolol 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 this medicine 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 BISOPROLOL SANDOZ IS USED FOR This medicine is used to treat heart failure. It is usually used in combination with other medicines. It contains the active ingredient bisoprolol fumarate. Bisoprolol fumarate belongs to a group of medicines called beta-blockers. It works 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 Sandoz also slows your heart rate, which in turn increases the efficiency of your heart. Bisoprolol Sandoz can help to reduce the number of heart failure episodes needing hospital admission and also the risk of sudden death. 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. 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 recommended for use in children. This medicine is not addictive. BEFORE YOU TAKE BISOPROLOL SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • bisoprolol fumarate, the active ingredient, or t Read the complete document
210317-bisoprolol sandoz-pi Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION BISOPROLOL SANDOZ ® (BISOPROLOL FUMARATE) FILM COATED TABLETS 1. NAME OF THE MEDICINE Bisoprolol fumarate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Bisoprolol Sandoz 2.5 mg film-coated tablet contains 2.5 mg bisoprolol fumarate. Each Bisoprolol Sandoz 5 mg film-coated tablet contains 5 mg bisoprolol fumarate. Each Bisoprolol Sandoz 10 mg film-coated tablet contains 10 mg bisoprolol fumarate. _Excipient with known effect: _ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Bisoprolol Sandoz 2.5 mg film coated tablets: White, round film-coated tablets, marked with a breakline and embossed on one side with ‘BIS 2.5’. Bisoprolol Sandoz 5 mg film coated tablets: Yellow, round film-coated tablets, marked with a breakline and embossed on one side with ‘BIS 5’. Bisoprolol Sandoz 10 mg film coated tablets: Light orange, round film-coated tablets, marked with a breakline and embossed on one side with ‘BIS 10’. 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 chronic heart failure 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 Read the complete document