Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
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.
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.
The recommended dose is one tablet per day. Grapefruit juice should be avoided (see section 4.5).
Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)).
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).
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).
Cholib has not been studied in patients with hepatic impairment and is therefore contraindicated in this population (see section 4.3).
Cholib is contraindicated in children and adolescents up to 18 years old. (see section 4.3).
In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day (See sections 4.4 and 4.5).
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).
2 years.
Store below 30°C.
Alu/Alu blisters.
Pack sizes: 10, 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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