Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bisoprolol fumarate
Medreich Plc
C07AB07
Bisoprolol fumarate
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 05060292740874
PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOL FUMARATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If any of the side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bisoprolol is and what it is used for 2. What you need to know before you take Bisoprolol 3. How to take Bisoprolol 4. Possible side effects. 5. How to store Bisoprolol 6. Contents of the pack and other information The name of this medicine is Bisoprolol 5mg Tablets or Bisoprolol 10mg Tablets referred to as Bisoprolol throughout this leaflet. Bisoprolol belongs to a group of medicines commonly called ‘beta-blockers’ which work by blocking the transmission of certain nerve impulses. Bisoprolol is used to help treat: angina pectoris (chest pain) hypertension (high blood pressure). DO NOT TAKE BISOPROLOL IF YOU: are allergic (hypersensitive) to bisoprolol or any of the other ingredients in this medicine (listed in Section 6) are in acute heart failure or if you require injection of inotropic drugs (drugs which increase the force of contraction of the heart) have had cardiogenic shock (a condition in which your heart is unable to pump enough blood to your body) suffer from heart block suffer from low heart rate or your heart rate is abnormal because of a condition known as sick sinus syndrome have very poor circulation or Raynaud’s Syndrome have unusually low blood pressure have a tumour of the adrenal gland (phaeochromocytoma) suffer from severe asthma or have severe breathing difficulties suffer from metabolic acidosis (a d Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol Fumarate 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Bisoprolol fumarate 5 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Round, white, film-coated convex tablets with ”R5” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. The management of hypertension. 2. The management of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults_ The usual adult dose is 10mg once daily with a maximum recommended dose of 20mg per day. In some patients, 5mg per day may be adequate. Renal or hepatic impairment: In patients with final stage impairment of renal function (creatinine clearance less than 20ml/min) or in patients with severe hepatic dysfunction, the dosage should not exceed 10mg bisoprolol once daily. Experience of use of bisoprolol in renal dialysis patients is limited, however. It is thought that bisoprolol fumarate cannot be dialysed. _Special populations_ _ _ Elderly No dosage adjustment is normally required but 5mg per day may be adequate in some elderly patients; as for other adults, the dosage may have to be reduced in cases of severe renal or hepatic dysfunction. Paediatric population There is no paediatric experience with bisoprolol, therefore its use cannot be recommended for children. METHOD OF ADMINISTRATION Bisoprolol tablet should be taken in morning and can be taken with food. They should be swallowed in liquid and should not be chewed. 4.3 CONTRAINDICATIONS Bisoprolol is contraindicated in patients with: • acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy • cardiogenic shock. • sinoatrial block. • second or third degree AV block (without pacemaker). • bradycardia (heart rate less than 60 beats/min prior to start of therapy). • severe bronchial asthma or severe chronic obstructive pulmonary disease. • sick sinus syndrome. • hypoten Prečítajte si celý dokument