RANEXA Prolonged-release tablet Ref.[7346] Active ingredients: Ranolazine

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).

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).

Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5).

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). Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.3 and 5.2).

Hepatic impairment

Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2). Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2).

Elderly

Dose titration in elderly patients should be exercised with caution (see section 4.4). Elderly may have increased ranolazine exposure due to age-related decrease in renal function (see section 5.2). The incidence of adverse events was higher in the elderly (see section 4.8).

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).

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).

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.

In an oral high-dose tolerability study in angina patients, the incidence of dizziness, nausea, and vomiting increased in a dose-dependent manner. In addition to these adverse events, diplopia, lethargy, and syncope were observed in an intravenous overdose study in healthy volunteers. In the event of overdose, the patient should be closely monitored and the treatment should be symptomatic and supportive.

Approximately 62% of ranolazine is bound to plasma proteins, and therefore, complete clearance by haemodialysis is unlikely.

Shelf life

Blister pack: 5 years.

Bottle pack: 4 years.

This medicinal product does not require any special storage conditions.

PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets.

Not all pack-sizes may be marketed.

No special requirements.