Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bisoprolol fumarate
Kent Pharma (UK) Ltd
C07AB07
Bisoprolol fumarate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000
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 Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol 10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Bisoprolol 10 mg tablet contains 8.49 mg bisoprolol equivalent to 10 mg bisoprolol fumarate. Excipient with known effect_ _ Each tablet contains 130.20 mg of lactose monohydrate per tablet For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Bisoprolol 10 mg tablets, are mottled beige, round and convex with the following identification markings: BI centrally above a break-line with 10 below. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Hypertension Chronic stable angina pectoris 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be individually adjusted. It is recommended to start with the lowest possible dose. In some patients, 5 mg per day may be adequate. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. _Special Populations _ _Renal or liver impairment _ Adjustment of dose in patients with mild to moderate liver- or kidney impairment is usually not necessary. In patients with severe renal impairment (creatinine clearance < 20 ml/min) or severe liver impairment, the dose should not exceed 10 mg once daily. This dosage may eventually be divided into halves. _Elderly _ No dosage adjustment is normally required. It is recommended to start with the lowest possible dose. _Paediatric population _ Bisoprolol tablets are not recommended for use in children due to a lack of data (see section 5.3). _Discontinuation of treatment _ Treatment should not be stopped abruptly (see section 4.4). The dosage should be diminished slowly by a weekly halving of the dose. Method of administration Bisoprolol 10 mg tablets are for oral administration. The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food. 4.3 CONTRAINDICATIONS Bisoprolol is contraindicated in patients with: - hypersensitiv Lestu allt skjalið