Fibre - Capsule Fenofibrate - 200mg 10 Capsule(s) / Strip The White Horse Pharmaceuticals Ltd Introduction: Fibre is a medicine used to treat high cholesterol. This medicine helps by lowering triglycerides and "bad" cholesterol (LDL), while at the same time raising the levels of "good" cholesterol (HDL). Lowering cholesterol levels reduces the risk of heart attack and stroke. Fibre should be taken in the dose and duration as advised by the doctor. You can take it at any time of day with food but try to take it at the same time each day. Most people with high cholesterol do not feel ill, but if you stop taking this medicine, your condition could get worse. This... Uses of Fibre: High triglyceridesHigh cholesterol Side effects of Fibre: Increased liver enzymesNauseaVomitingFlatulenceAbdominal painDiarrhea How to use Fibre: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Fibre is to be taken empty stomach. How Fibre works: Fibre is a lipid lowering medication. It works by lowering the levels of triglycerides and "bad" cholesterol (LDL), while raising the levels of "good" cholesterol (HDL). What if you forget to take Fibre?: If you miss a dose of Fibre, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Hyperlipidemia, Hypercholesterolaemia, Hypertriglyceridaemia Administration: Should be taken with food. Adult Dose: Oral Hypercholesterolemia, Mixed dyslipidemia, Hypertriglyceridemia Tablet: 40-160mg once daily. Capsule: 200mg once daily. Hepatic impairment: Contraindicated. Child Dose: Safety and efficacy not established Renal Dose: Renal impairment Mild-Moderate: Initial: lower dose Severe: contraindicated Contraindication: Hypersensitivity; severe hepatic and renal impairment. Unexplained persistent liver function abnormality and primary biliary cirrhosis; preexisting gall bladder disease. Pregnancy, lactation. Mode of Action: Fenofibrate, a fibric acid derivative, lowers plasma triglyceride by activating lipoprotein lipase thus increasing catabolism of VLDL w/ consequent increase in HDL levels. Precaution: Renal or hepatic impairment. Monitor LFTs and blood counts regularly. Increased risk of cholelithiasis, pancreatitis, skeletal muscle effects. Withdraw treatment if no adequate response after 2 mth of treatment at max recommended dose. Lactation: Unknown if excreted in breast milk; not recommended Side Effect: 1-10% Abdominal pain (4.6%),Back pain (3.4%),Increased AST (3.4%),Headache (3.2%),Increased ALT (3%),Increased CPK (3%),Nausea (2.3%),Constipation (2.1%) Potentially Fatal: Hepatitis, cholecystitis. Pregnancy Category Note: Pregnancy Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes Animal data In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical dose of 120 mg daily, based on body surface area (mg/m2) Adverse reproductive outcomes occurred at higher doses in presence of maternal toxicity; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus Lactation... Interaction: Decreased absorption w/ bile acid sequestrants (e.g. colestyramine). May increase risk of ciclosporin-induced nephrotoxicity. Increased risk of muscle toxicity w/ HMG-CoA reductase inhibitors (e.g. simvastatin). May increase risk of bleeding w/ oral anticoagulants.