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Cholib is a brand name for Fenofibrate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
Verbatim from this product's EMA label. Tap a section to expand.
Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment (like oral oestrogens), alcoholism should be adequately treated, before Cholib therapy is considered and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment.
Posology The recommended dose is one tablet per day. 5). Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)). Elderly patients (≥ 65 years old) No dose adjustment is necessary.
3). 3). 4). 3). Paediatric population Cholib is contraindicated in children and adolescents up to 18 years old. 3). Concomitant therapy In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day.
) Method of administration Each tablet should be swallowed whole with a glass of water. The tablets should not be crushed or chewed. 2).
Summary of the safety profile The most commonly reported adverse drug reactions (ADRs) during Cholib therapy are increased blood creatinine, upper respiratory tract infection, increased platelet count, gastroenteritis and increased alanine- aminotransferase.
Tabulated list of adverse reactions During four double blind clinical trials of 24-week duration 1,237 patients have received treatment with co-administered fenofibrate and simvastatin. 8% (4 subjects on 225) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/40 mg per day.
Treatment emergent adverse reactions reported in patients receiving co-administration of fenofibrate and simvastatin occurring are listed below by system organ class and frequency. The adverse reactions of Cholib are in line with what is known from its two active substances: fenofibrate and simvastatin.
The frequencies of adverse reactions are ranked according to the following: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
4% with statin monotherapy. 3% of patients receiving co-administration had clinically relevant increases in creatinine to values >200 μmol/l. Additional information on the individual active substances of the fixed dose combination Additional adverse reactions associated with the use of medicinal products containing simvastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Cholib are listed below.
Frequency categories are based on information available from simvastatin and fenofibrate Summary of Product Characteristics available in the EU. g. g. g. 031). 0% [48/4900 patients] versus […]
Muscle Skeletal muscle toxicity, including rare cases of rhabdomyolysis with or without renal failure, has been reported with administration of lipid-lowering substances like fibrates and statins. The risk of myopathy with statins and fibrates is known to be related to the dose of each component and to the nature of the fibrate.
4 Reduced function of transport proteins Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis. 521T>C genotype. 521T>C) coding for a less active OATP1B1 protein have an increased systemic exposure of simvastatin and increased risk of myopathy.
The risk of high dose (80 mg) simvastatin related myopathy is about 1 % in general, without genetic testing. 5%. 2). Immune-mediated necrotizing myopathy (IMNM) There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.
IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti- HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents.
Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Consider risk of IMNM carefully prior to initiation of another statin. If therapy is initiated with another statin, monitor for signs and symptoms of IMNM.
5). Physicians contemplating combined therapy with Cholib and lipid-modifying doses (≥ 1 g/day) of niacin (nicotinic acid) or medicinal products containing niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
g. g. 4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fenofibrate in European Union.
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5). Simvastatin is a substrate of the Breast Cancer Resistant Protein (BCRP) efflux transporter. , elbasvir and grazoprevir) may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy; therefore, a dose adjustment of simvastatin should be considered depending on the prescribed dose.
5). 5). Cholib must not be co-administered with fusidic acid. 5). In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
5 Statin therapy may be re-introduced seven days after the last dose of fusidic acid. g. for the treatment of severe infections, the need for co-administration of Cholib and fusidic acid should only be considered on a case by case basis and under close medical supervision.
Creatine kinase measurement Creatine Kinase should not be measured following strenuous exercise or in the presence of any plausible alternative cause of Creatine Kinase increase as this makes value interpretation difficult. If Creatine Kinase levels are significantly elevated at baseline (> 5 x ULN), levels should be re-measured within 5 to 7 days later to confirm the results.
Before the treatment All patients starting therapy, or whose dose of simvastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness. Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis.
In order to establish a reference baseline value, a Creatine Kinase level should be measured before starting a treatment in the following situations: • Elderly ≥ 65 years • Female gender • Renal impairment • Uncontrolled hypothyroidism • Hypoalbuminaemia • Personal or familial history of hereditary muscular disorders • Previous history of muscular toxicity with a statin or a fibrate • Alcohol abuse In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
In order to establish a reference baseline […]