8 Undesirableeffects). - 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 interaction Care is required in administering Bezafibrate Crescent 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 Crescent 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 Crescent 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.
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 Crescent 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 Crescent 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 machines Bezafibrate Crescent 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: […]