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Posology: The recommended dose of Nilemdo is one film-coated tablet of 180 mg taken once daily.
Concomitant simvastatin therapy: When Nilemdo is coadministered with simvastatin, simvastatin dose should be limited to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks) (see Precautions and Interactions).
Special populations: Elderly patients: No dose adjustment is necessary in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment. There are limited data available in patients with severe renal impairment (defined as estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2), and patients with end-stage renal disease (ESRD) on dialysis have not been studied. Additional monitoring for adverse reactions may be warranted in these patients when Nilemdo is administered (see Precautions).
Patients with hepatic impairment: No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B). No data are available in patients with severe hepatic impairment (Child-Pugh C). Periodic liver function tests should be considered for patients with severe hepatic impairment (see Precautions).
Paediatric population: The safety and efficacy of Nilemdo in children aged less than 18 years have not yet been established. No data are available.
Method of administration: Each film-coated tablet should be taken orally with or without food. Tablet should be swallowed whole.
