Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
bisoprolol fumarate
Sandoz Pty Ltd
Bisoprolol fumarate
Registered
Bisoprolol GH 1 BISOPROLOL GH BISOPROLOL FUMARATE FILM‐COATED TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bisoprolol GH. 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 GH 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 GH also slows your heart rate, which in turn increases the efficiency of your heart. Bisoprolol GH 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. Bisoprolol GH 2 This medicine is not recommended for use in children. This medicine is not addictive. BEFORE YOU TAKE BISOPROLOL GH _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: bisoprolol fumarate, the active ingredient, or to any of the othe Read the complete document
- 1 - PRODUCT INFORMATION Bisoprolol GH _Bisoprolol fumarate _ NAME OF THE MEDICINE _Generic name:_ Bisoprolol fumarate _ _ _Chemical name: _(±)‐1‐[[ ‐(2‐Isopropoxyethoxy)‐_p_‐tolyl]oxy]‐3‐isopropylamino‐2‐ propanol hemifumarate _ _ _Chemical structure: _ _ _ _CAS : _ [104344‐23‐2] _Empirical formula:_ C18H31NO4.1/2C4H4O4 _MW: _ 383.49 DESCRIPTION Bisoprolol fumarate is a white crystalline substance with a melting range of 100‐ 104°C. It is very soluble in water and methanol, freely soluble in ethanol, glacial acetic acid and chloroform. As the substance is present in the form of a racemate, the aqueous solution does not show optical activity. _Excipients _ _‐ _ Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, Opadry II OY‐L‐28900, iron oxide yellow CI77492 (5 & 10 mg tablets only) and iron oxide red CI77491 (10 mg tablet only). _ _ _ _ BISOPROLOL GH – Product Information Generic Health Pty Ltd _ _ _- 2 - _ PHARMACOLOGY Pharmacodynamics Bisoprolol is a β 1 ‐selective‐adrenoceptor blocking agent, lacking intrinsic stimulating and relevant membrane stabilising activity. It only shows very low affinity to the β 2 ‐ receptor of the smooth muscles of bronchi and vessels as well as to the β 2 ‐receptors concerned with metabolic regulation. Therefore, bisoprolol is generally not to be expected to influence the airway resistance and β 2 ‐mediated metabolic effects. Its β 1 ‐selectivity extends beyond the therapeutic dose range. However, its β 1 ‐selectivity is not absolute and at doses greater than the maximum recommended of 10mg, bisoprolol may also inhibit β 2 ‐adrenoreceptors. The haemodynamic effects of bisoprolol are those that can be expected from β‐ adrenoceptor blockade. Besides the negative chronotropic effect resulting in a reduction in resting and exercise heart rate there is, as shown in acute studies with intravenous administrat Read the complete document