CHOLIB FILM-COATED TABLET 145MG/20MG

4.1 Therapeutic Indications

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.

A beneficial effect of Cholib® on cardiovascular morbidity and mortality has not yet been demonstrated.

4.3 Contraindications

• Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1 (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
• Active liver disease or unexplained persistent elevations of serum transaminases
• Known gallbladder disease
• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
• Moderate to severe renal insufficiency (estimated glomerular filtration rate < 60 mL/min/1.73 m2)
• Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• Concomitant administration of gemfibrozil, ciclosporine, or danazol (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• Paediatric population (age below 18 years)
• Pregnancy and breast-feeding (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

4.2 Posology and Method of Administration

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. Grapefruit juice should be avoided (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m2 where Cholib® is contraindicated (see section 4.3).

Patients with renal impairment

Cholib® is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m2 (see section 4.3).

Cholib® should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m2 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment

Cholib® has not been studied in patients with hepatic impairment and is therefore contraindicated in this population (see section 4.3).

Paediatric population

Cholib® is contraindicated in children and adolescents up to 18 years old. (see section 4.3).

Method of administration

Each tablet should be swallowed whole with a glass of water. The tablets should not be crushed or chewed. They may be taken with or without food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).