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BEZAFIBRATE NOUMED is a brand name for Bezafibrate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bezafibrate Noumed 400mg prolonged-release tablets are 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults The recommended dosage for Bezafibrate Noumed 400mg prolonged-release tablets is one tablet, equivalent to 400mg bezafibrate and should be swallowed whole with sufficient fluid after a meal either in the morning or at night.
Elderly In elderly patients there is a physiological reduction of the renal function with age. Bezafibrate Noumed 400mg prolonged-release tablets should not be prescribed/administered to older people whose creatinine clearance is below 60ml/min (see Renal impairment below).
Paediatric population At present there is inadequate information regarding an appropriate dose recommendation in children. Renal impairment Bezafibrate Noumed 400mg prolonged-release tablets are contraindicated in dialysis patients.
Bezafibrate should not be given to patients with renal impairment with serum creatinine > 135 micromol/l or creatinine clearance < 60 ml/min. Such patients may be treated with conventional tablets (200mg Bezafibrate) using an appropriately reduced daily dosage.
For patients with a history of gastric sensitivity, the dosage may be gradually increased over 5-7 days to the maintenance level. 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Treatment should be withdrawn if an adequate response has not been achieved within 3 to 4 months.
). - Since oestrogens may lead to a rise in lipid levels, the prescribing of bezafibrate in patients taking oestrogens or oestrogen-containing contraceptives must be critically considered on an individual basis. g. colestyramine), the two drugs should be taken at least 2 hours apart.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 5 Interaction with other medicinal products and other forms of interactions: Care is required in administering Bezafibrate Noumed 400mg prolonged- release Tablets to patients taking coumarin-type anticoagulants, the action of which may be potentiated.
The dosage of anticoagulant should be reduced by up to 50% and readjusted by monitoring blood coagulation. As bezafibrate improves glucose utilisation the action of antidiabetic medication, including insulin, may be potentiated. Hypoglycaemia has not been observed although increased monitoring of the glycaemic status may be warranted for a brief period after introduction of Bezafibrate Noumed 400mg prolonged-release tablets.
Should combined therapy with an ion-exchange resin be considered necessary, there should be an interval of 2 hours between the intake of the resin and Bezafibrate Noumed 400mg prolonged-release Tablets as the absorption of bezafibrate otherwise may be impaired.
In isolated cases, a pronounced though reversible impairment of renal function (accompanied by a corresponding increase in serum creatinine level) has been reported in organ transplant patients receiving immuno-suppressant therapy and concomitant bezafibrate.
Accordingly, renal function should be closely monitored in these patients and, in the event of relevant significant changes in laboratory parameters, bezafibrate should if necessary, be discontinued. MAO-inhibitors (with hepatotoxic potential) should not be administered together with bezafibrate.
g. diabetes, gout). - Secondary causes of dyslipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism should be adequately treated before Bezafibrate therapy is initiated.
- Bezafibrate and other fibrates may cause myopathy, manifested as muscle weakness or pain, often accompanied by a considerable increase in creatine kinase (CPK). In isolated cases severe muscle damage (rhabdomyolysis) has been observed.
The risk of rhabdomyolysis may be increased when higher than recommended doses of bezafibrate are used, most frequently in the presence of impaired renal function and in patients with predisposing factors for myopathy, (including renal impairment, elderly (aged >65 years), personal of familial history of hereditary muscular disorders and previous history of muscular toxicity with a fibrate or other lipid lowering drugs, hypothyroidism, severe infection, trauma, surgery, disturbances of hormone or electrolyte imbalance and a high alcohol intake).
- Bezafibrate should be used with caution in combination with HMG CoA reductase inhibitors as the combination of HMG CoA inhibitors and fibrates has been shown to increase the incidence and severity of myopathy. Patients should be informed of symptoms and monitored for signs of myopathy and increased CPK activity and combination therapy discontinued if signs of myopathy develop.
5). - Bezafibrate alters the composition of bile. There have been isolated reports of the development of gallstones. 8 Undesirable effects). - Since oestrogens may lead to a rise in lipid levels, the prescribing of bezafibrate in patients taking oestrogens or oestrogen-containing contraceptives must be critically considered on an individual basis.
g. colestyramine), the two drugs should be taken at least 2 hours apart. - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
1. - Significant hepatic disease (other than fatty infiltration of the liver associated with raised triglyceride values). - Gall-bladder diseases with or without cholelithiasis. 2). 4. 5) - Known photoallergic or phototoxic reactions to fibrates.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Interaction between HMG CoA reductase inhibitors and fibrates may vary in nature and intensity depending on the combination of the administered drugs. 4) for specific dose recommendations of statins refer also to the SPC of the relevant product.
6 Fertility, pregnancy and lactation Fertility There is insufficient information available on the effects of Bezafibrate tablets on human fertility. Animal fertility studies with bezafibrate has shown no indication of reduced fertility.
Pregnancy There are limited data from the use of bezafibrate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Bezafibrate Noumed 400mg prolonged-release tablets is not recommended during pregnancy and in women of childbearing potential not using contraception.
Lactation There is insufficient information on the excretion of bezafibrate or its metabolites in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bezafibrate Noumed 400mg prolonged-release tablets therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
7 Effects on ability to drive and use machine: Bezafibrate Noumed 400mg prolonged-release tablets have been shown to cause dizziness and can have a minor to moderate effect on the ability to drive or use machines. Patients should not drive or use machines if they are affected.
8 Undesirable effects The overall safety profile of bezafibrate is based on a combination of clinical study data and post-marketing experience. The frequency of adverse drug reactions (ADRs) according to MedDRA System Organ Class is displayed in the table below.
Frequency of reporting:
Very common (≥1/10), Common (≥ 1/100 to <1/10), Uncommon (≥ 1/1,000 to <1/100), Rare (≥ 1/10,000 to <1/1000), Very rare (<1/10,000).
Blood and lymphatic system disorders:
Very rare: Pancytopenia, thrombocytopenic purpura.
Immune system disorders:
Uncommon: Hypersensitivity reactions including anaphylactic reactions.
Metabolism and nutrition disorders:
Common: Decreased appetite.
Nervous system disorders:
Uncommon: Dizziness, headache.
Rare:
Peripheral neuropathy, paraesthesia.
Psychiatric disorders:
Rare: Depression, insomnia.
Gastrointestinal disorders:
Common: Gastrointestinal disorders.
Uncommon:
Abdominal pain, constipation, dyspepsia, abdominal distension, diarrhoea, nausea.
Rare:
Pancreatitis Hepatobiliary disorders: Uncommon: Cholestasis.
Very rare:
Cholelithiasis.
Skin and subcutaneous tissue disorders:
Uncommon: Pruritus, urticaria, photosensitivity reaction, alopecia, rash.
Very rare:
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders:
Uncommon: Muscular weakness, myalgia, muscle cramp.
Very rare:
Rhabdomyolysis.
Renal and urinary disorders:
Uncommon: Acute renal failure.
Reproductive system and breast disorders:
Uncommon: Erectile dysfunction NOS.
Respiratory, thoracic and mediastinal disorders:
Very rare: Interstitial lung disease.
Investigations:
Uncommon: Increased blood creatinine phosphokinase, blood creatinine increased, decreased gamma-glutamyl transferase and in parallel alkaline phosphatase Very rare: Haemoglobin decreased, platelet increased, white blood cell count decreased, gamma-glutamyl transferase increased, transaminase increased.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.