দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bisoprolol fumarate
Lexon (UK) Ltd
C07AB07
Bisoprolol fumarate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000
BISOPROLOL 5 MG AND 10 MG TABLETS PATIENTS INFORMATION LEAFLET This leaflet gives you some important information about your medicine. Please read it carefully before you start taking your medicine. ABOUT YOUR MEDICINE Bisoprolol Tablets are coated tablets containing either 5 mg or 10 mg of the active ingredient Bisoprolol fumarate. WHAT IS YOUR MEDICINE USED FOR? Bisoprolol Tablets are used: • to reduce high blood pressure (hypertension). • to relieve chest pain (angina) BEFORE YOU TAKE BISOPROLOL TABLETS DO NOT USE BISOPROLOL TABLETS IF YOU: • have you ever had an allergic (hypersensitive) reaction to bisoprolol fumarate or any of the ingredients in the tablet with symptoms of a rash, itching or difficulty breathing. • have suffered from sudden heart failure, irregular heart beats or a slow heart rate • suffer from extremely low blood pressure • suffer from lung disease, asthma, have a family history of asthma. • suffer from diseases which affect blood flow to your fingers and toes e.g Raynaud’s syndrome • have untreated adrenal gland tumour called phaeochromocytoma • have metabolic acidosis which would be measured by a blood test by your doctor TAKE SPECIAL CARE WITH BISOPROLOL TABLETS Tell your doctor or pharmacist before you start using these tablets if you: • suffer from any heart disease, including heart failure and angina • suffer from bronchospasm associated with bronchial asthma and other lung diseases • suffer from severe kidney or liver disease • suffer from uncontrolled diabetes • are fasting • having desensitisation treatment for allergies • suffer from psoriasis or have a history of psoriasis • have thyroid problems • are due to go into hospital for an operation then tell your doctor. Treatment with Bisoprolol should not be stopped suddenly especially in patients already with heart disease. POM 1 4 XXXXXXX PC NO. 3014 Very rare (affects less than 1 person in 10,000): • irritation and redness of the eye (conjunctivitis) • hair loss • appearance or worsening সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vivacor 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains bisoprolol as 10mg of bisoprolol fumarate. Refer to Section 6.1 for excipients. 3 PHARMACEUTICAL FORM Film-coated tablet. Description: Round, biconvex, light brown coloured, film-coated tablets with a scoreline on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of hypertension. Management of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION Oral POSOLOGY _Adults: _The usual dose is 10mg once daily with a maximum recommended dose of 20mg per day. In some patients 5mg per day may be adequate. Experience of the use of bisoprolol fumarate in renal dialysis patients is limited; however, there is no evidence that the dosage regimen needs to be altered. _Elderly: _No dosage adjustment is normally required but 5mg per day may be adequate in some patients; as for other adults, dosage may have to be reduced in cases of severe renal or hepatic dysfunction. _Children: _There is no paediatric experience with bisoprolol, therefore its use cannot be recommended for children. _Renal impairment:_ In patients with final stage impairment of renal (creatinine clearance <20ml/min), use a maximum 10mg daily in severe renal impairment _Severe liver impairment:_ Maximum 10mg daily in severe liver impairment 4.3 CONTRAINDICATIONS As with other beta-adrenoceptor antagonists bisoprolol fumarate should not be used in cases of: • Hypersensitivity to bisoprolol fumarate or any other ingredients in the tablet. • Acute heart failure or during episodes of heart failure decompensation requiring iv inotropic therapy. • Cardiogenic shock. • Marked bradycardia (heart rate less than 60 beats per minute prior to start of therapy). • Sinoatrial block • Second or third degree AV block (without a pacemaker) • Sick sinus syndrome. • Extreme hypotension (systolic blood pressure < 100mmHg) • Severe bronchial asthma or severe chronic o সম্পূর্ণ নথি পড়ুন