RANEXA PROLONGED-RELEASE TABLET 750 MG

A. MENARINI SINGAPORE PTE. LTD.

A. MENARINI SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED, EXTENDED RELEASE

**4.2 Posology and method of administration** Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets. Adults: The recommended initial dose of Ranexa is 375 mg twice daily. After 2–4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient’s response, further titrated to a recommended maximum dose of 750 mg twice daily (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If a patient experiences treatment-related adverse events (e.g. dizziness, nausea, or vomiting), down-titration of Ranexa to 500 mg or 375 mg twice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued. Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (e.g. diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin) (see sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Renal impairment: Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30–80 ml/min) (see sections 4.4, 4.8, and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Elderly: Dose titration in elderly patients should be exercised with caution (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Elderly may have increased ranolazine exposure due to age-related decrease in renal function (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The incidence of adverse events was higher in the elderly (see section 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Low weight: The incidence of adverse events was higher in patients with low weight (≤ 60 kg). Dose titration in patients with low weight should be exercised with caution (see sections 4.4, 4.8, and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Congestive heart failure (CHF): Dose titration in patients with moderate to severe CHF (NYHA Class III–IV) should be exercised with caution (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Ranexa in children below the age of 18 years have not been established. No data are available Method of administration Ranexa tablets should be swallowed whole and not crushed, broken, or chewed. They may be taken with or without food.