RANEXA PROLONGED-RELEASE TABLET 500 MG [SIN14862P]

Product Info

RANEXA PROLONGED-RELEASE TABLET 500 MG

[SIN14862P]

4.1 Therapeutic indications

Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Moderate or severe hepatic impairment (see sections 4.2 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.