Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bezafibrate
Teva UK Ltd
C10AB02
Bezafibrate
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5012617017499
pharmacode 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, pharmacist or nurse. • 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET WHAT BEZALIP IS AND WHAT IT IS USED FOR WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEZALIP HOW TO TAKE BEZALIP POSSIBLE SIDE EFFECTS HOW TO STORE BEZALIP CONTENTS OF THE PACK AND OTHER INFORMATION WHAT BEZALIP IS AND WHAT IT IS USED FOR Bezalip belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides. Bezalip is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEZALIP DO NOT TAKE Bezalip: • if you are ALLERGIC (hypersensitive) to bezafibrate or any of the other ingredients in the tablets (see section 6). • if you are ALLERGIC (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines. • if you are taking STATINS (e.g. atorvastatin) AND have any of the following which may increase the risk of you DEVELOPING MUSCLE DISEASE (weakness, wasting and pain): - impaired KIDNEY function - an underactive THYROID (hypothyroidism) - severe INFECTION - TRAUMA - SURGERY - a change in the levels of HORMONES or CHEMICALS in your body (seen in a blood test) - a high ALCOHOL intake. • if you are having DIALYSIS. • if you have LIVER disease. • if you have GALL BLADDER disease. • if you have NEPHROTIC SYNDROME (a kid Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bezalip Bezafibrate 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of bezafibrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet for oral use. Bezalip is a round film-coated tablet with a white core and is imprinted G6. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bezalip is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS The recommended dosage for Bezalip tablets is one tablet three times a day, equivalent to 600mg bezafibrate. Each tablet should be swallowed whole with sufficient fluid after a meal. Occasionally gastro-intestinal symptoms may occur. In susceptible patients a slowly increasing dosage over 5 to 7 days may help to avoid such symptoms. ELDERLY In elderly patients there is a physiological reduction of the renal function with age. Bezafibrate dosage should be adjusted based on serum creatinine clearance values (see _Renal impairment _below). PAEDIATRIC POPULATION At present there is inadequate information regarding an appropriate dosage in children. RENAL IMPAIRMENT In dialysis patients the use of bezafibrates is contraindicated. In patients with renal insufficiency the dose should be adjusted according to serum creatinine levels or creatinine clearance as shown in the following table; _Serum _ _creatinine_ _(_ μ _mol/l)_ _Creatinin_ _e _ _clearance_ _(ml/min)_ _Dosage _ _(tablets/d_ _ay) _ Up to 135 Over 60 3 136 – 225 60 – 40 2 226 – 530 40 – 15 1 every 1 or 2 days Over 530 Less than 15 Contra- indicated The response to therapy is normally rapid, although a progressive improvement may occur over a number of weeks. Treatment should be withdrawn if an adequate respon Read the complete document