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Coralan

 

1. NAME OF THE MEDICINAL PRODUCT

Coralan 5 mg film-coated tablets
Coralan 7.5 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Coralan 5 mg
One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Excipient with known effect: 63.91 mg lactose monohydrate
Coralan 7.5 mg
One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine hydrochloride).
Excipient with known effect: 61.215 mg lactose monohydrate
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Film-coated tablet.
Coralan 5 mg: Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with "5" on one face and on the other face.
The tablet can be divided into equal doses.
Coralan 7.5 mg: Salmon-coloured, triangular, film-coated tablet engraved with "7.5" on one face and on the other face.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic treatment of chronic stable angina pectoris
Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥70 bpm. Ivabradine is indicated:
in adults unable to tolerate or with a contra-indication to the use of beta-blockers
or in combination with beta-blockers in patents inadequately controlled with an optimal beta-blocker dose.


Treatment of chronic heart failure
Ivabradine is indicated in chronic heart failure NYHA II to IV class 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. (see section 5.1)

4.2 Posology and method of administration
Posology
For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.

Symptomatic treatment of chronic stable angina pectoris
It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring.

The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years. After three to four weeks of treatment, if the patient is still symptomatic, if the initial dose is well tolerated and if resting heart rate remains above 60 bpm, the dose may be increased to the next higher dose in patients receiving 2.5 mg twice daily or 5 mg twice daily. The maintenance dose should not exceed 7.5 mg twice daily.

If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.

In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months.

If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily). After dose reduction, heart rate should be monitored (see section 4.4). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.

Treatment of chronic heart failure
The treatment has to be initiated only in patient with stable heart failure. It is recommended that the treating physician should be experienced in the management of chronic heart failure.

The usual recommended starting dose of ivabradine is 5 mg twice daily. After two weeks of treatment, the dose can be increased 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 in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension. If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.

If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily. If heart rate increases persistently above 60 beats per minute at rest, the dose can be up titrated to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.

Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist (see section 4.4).

Special population
Older people
In patients aged 75 years or more, a lower starting dose should be considered (2.5 mg twice daily i.e. one half 5 mg tablet twice daily) before up-titration if necessary.

Patients with renal impairment
No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min (see section 5.2).

No data are available in patients with creatinine clearance below 15 ml/min. Ivabradine should therefore be used with precaution in this population.

Patients with hepatic impairment
No dose adjustment is required in patients with mild hepatic impairment. Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see sections 4.3 and 5.2).

Paediatric population
The safety and efficacy of ivabradine in children aged below 18 years have not yet been established. No data are available.

Method of administration
Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals (see section 5.2).

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Resting heart rate below 70 beats per minute prior to 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
AV-block of 3rd degree
Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2)
Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5)
Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)

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