Download Procoralan Ivabradine Prescribing Information Refer to

▼Procoralan  Ivabradine
Prescribing Information
Refer to Summary of Product Characteristics (SPC) before prescribing.
Presentation: Film-coated tablets, 5mg, 7.5mg. Indications: Symptomatic treatment of
Chronic stable angina pectoris: in coronary artery disease adults with normal sinus rhythm
and heart rate ≥ 70 bpm. Indicated in patients unable to tolerate or with a contra-indication to
the use of beta-blockers, or in combination with beta-blockers in patients inadequately
controlled with an optimal beta-blocker dose. Chronic heart failure: NYHA class II to IV
with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in
combination with standard therapy including beta-blocker therapy or when beta-blocker
therapy is contraindicated or not tolerated. Dosage and Administration: Chronic stable
angina pectoris: the decision to initiate or titrate treatment should be based upon serial heart
rate measurements, ECG or ambulatory 24-hour monitoring. The starting dose should not
exceed 5 mg twice daily in patients aged below 75 years. After 3 or 4 weeks of treatment, if
the patient is still symptomatic, see SPC for details of upward dose titration. The maintenance
dose should not exceed 7.5 mg twice daily. Discontinue treatment if there is no improvement
in angina symptoms within 3 months of treatment initiation. Consider discontinuation of
treatment if symptomatic response is limited with no clinically relevant reduction in resting
heart rate within 3 months. See SPC for details of when downward dose titration is
recommended. Monitor the heart rate after dose reduction. Discontinue treatment if heart rate
remains below 50 bpm or symptoms of bradycardia persist despite dose reduction. Chronic
heart failure: Initiate only in patients with stable heart failure. Recommended starting dose is
5 mg twice daily increased after two weeks to 7.5 mg twice daily, if resting heart rate is
persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice
daily) if resting heart rate is persistently below 50 bpm or if symptoms related to bradycardia
occur. Discontinue if heart rate remains below 50 bpm or symptoms of bradycardia persist.
(See SPC for details of when dose titration is recommended). Usual dose is one tablet in the
morning and one tablet in the evening during meals. Older people (≥ 75 years): Consider a
lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily). Renal
insufficiency: Use with caution in patients with creatinine clearance below 15 ml/min.
Hepatic impairment: Use with caution in patients with moderate hepatic impairment; contraindicated in severe hepatic impairment. Children and adolescents: Not recommended.
Contraindications: History of hypersensitivity to Procoralan® or any of the excipients;
resting heart rate below 70 bpm before treatment; cardiogenic shock; acute myocardial
infarction; severe hypotension (< 90/50 mmHg); severe hepatic insufficiency; sick sinus
syndrome; sino-atrial block; unstable or acute heart failure; pacemaker dependent (heart rate
imposed exclusively by the pacemaker); unstable angina; 3rd degree AV block; combination
with strong cytochrome P450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics,
HIV protease inhibitors); combination with verapamil or diltiazem (moderate CYP3A4
inhibitors with heart rate reducing properties); Pregnancy, lactation and women of childbearing potential not using appropriate contraceptive measures. Warnings: Ivabradine has no
benefits on cardiovascular outcomes in patients with symptomatic chronic stable angina
pectoris (e.g. myocardial infarction or cardiovascular death). As heart rate may fluctuate
considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour
monitoring should be considered before treatment initiation or dose titration. Cardiac
arrhythmias: Not recommended in patients with atrial fibrillation or other cardiac arrhythmias
that interfere with sinus node function. Regular clinical monitoring for the occurrence of
sustained or paroxysmal atrial fibrillation (ECG included) is recommended especially in
patients receiving concomitant amiodarone or potent class I anti-arrhythmics (atrial
fibrillation is more common in these patients). Inform patients of signs and symptoms of atrial
fibrillation and advise them to contact their physician if these occur. Reconsider the balance
of benefits and risk of continued treatment if atrial fibrillation occurs. Chronic heart failure
patients with intraventricular conduction defects (bundle branch block) and ventricular
dyssynchrony should be monitored closely. 2nd degree AV block: Not recommended. Low
heart rate: Do not use in patients with pre-treatment resting heart rate below 70 bpm.
Chronic heart failure: Caution in heart failure patients with NYHA functional classification
IV due to limited data. Stroke: Not recommended immediately after stroke. Visual function:
Discontinuation should be considered if deterioration in visual function occurs unexpectedly.
Use with caution in patients with retinitis pigmentosa. Excipients: Contains lactose, should
not be used in patients with galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption. Precautions: Mild to moderate hypotension: Use with caution.
Atrial fibrillation/ Cardiac arrhythmias: If non urgent DC-cardioversion is required, leave 24
hours between the last dose of ivabradine and the procedure. Patients with congenital QT
syndrome or treated with QT prolonging medicinal products: Avoid. Hypertensive patients
requiring changes to antihypertensive treatment: Monitor blood pressure at an appropriate
interval after modifications. Moderate hepatic insufficiency: Use with caution. Severe renal
insufficiency: Use with caution. Interactions: QT prolonging medicinal products: not
recommended; Potassium-depleting diuretics: use with caution as hypokalaemia and
bradycardia may predispose to severe arrhythmias especially in association with long QT
syndrome; Grapefruit juice should be avoided; for other pharmacokinetic interactions see
SPC. Side Effects: Very common: Visual symptoms (Luminous phenomena [phosphenes,
described as a halo, stroboscopic/kaleidoscopic effects, coloured bright lights or multiple
images]). Common: Blurred vision; bradycardia; 1st degree AV block; ventricular
extrasystoles; atrial fibrillation; headaches; dizziness, uncontrolled blood pressure.
Uncommon: Palpitations; dyspnoea; hyperuricaemia; elevated blood creatinine; angioedema;
ECG prolonged QT interval. Very rare: 2nd and 3rd degree AV block, sick-sinus syndrome.
Consult SPC for full list of side effects. NHS Price: Procoralan 5mg 56 pack: £40.17,
Procoralan 7.5mg 56 pack: £40.17. Legal Category: POM. Product Licence Numbers:
EU/1/05/316/003 and EU/1/05/316/010. Further Information: Servier Laboratories Ltd.,
Rowley, Wexham Springs, Slough SL3 6PJ, Tel (01753) 666409. Date of Revision: January
2015.
Adverse events should be reported. Reporting forms and information can be
found at www.mhra.gov.uk/yellowcard. Adverse events should also be
reported to Servier Laboratories Ltd. Tel (01753) 666409