CARIVALAN FILM-COATED TABLET 12.5 MG/5 MG [SIN15626P]

Product Info

CARIVALAN FILM-COATED TABLET 12.5 MG/5 MG

[SIN15626P]

4.1 Therapeutic indications

Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for:

• the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients

• the treatment of chronic heart failure (II–IV NYHA-class) with systolic dysfunction

4.2 Posology and method of administration

Posology

The recommended dose of Carivalan is one tablet twice daily, once in the morning and once in the evening.

Carivalan should only be used in patients controlled on stable doses of the individual components given concurrently when carvedilol and ivabradine are at the optimal dose.

The fixed dose combination is not suitable for initiation therapy.

If a change of posology is required, titration should be done with the individual components carvedilol and ivabradine, ensuring the patient is maintained at an optimal dose of carvedilol and ivabradine. It is recommended that the decision to titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring.

If during treatment, heart rate decreases below 50 beats per minute at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, down titration should be done with the individual components carvedilol and ivabradine, ensuring the patient is maintained at an optimal dose of carvedilol and ivabradine. After dose reduction, heart rate should be monitored (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.

Renal impairment
No dosage adjustment is required in patients with renal insufficiency and creatinine clearance above 15 mL/min (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and SBP >100 mmHg.

No data are available in patients with creatinine clearance below 15 mL/min. Carivalan should be used with precaution in patients with creatinine clearance below 15 mL/min.

Monitoring of renal function is recommended in chronic heart failure patients with SBP <100 mmHg.

Hepatic impairment
It may be necessary to adjust the dose in patients with mild to moderate hepatic impairment.
Caution should be exercised in patients with moderate 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).
Carivalan is contraindicated in patients with 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
Carivalan can be administered in elderly patients with caution (see section 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 Carivalan in children and adolescents have not been established. No data are available with Carivalan.

Method of administration
Oral use.
Carivalan tablet should be taken twice daily during a meal (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Hypersensitivity to the active substances or to any other beta-blockers or to any of the excipients of this medicinal product listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;

• Severe hepatic impairment;

• Acute or unstable/decompensated heart failure;

• Unstable angina;

• Prinzmetal’s angina;

• AV-block of 2^nd and 3^rd degree;

• Sick sinus syndrome (including sino-atrial block);

• Symptomatic or severe bradycardia (<50 bpm);

• Acute myocardial infarction;

• Cardiogenic shock;

• Pacemaker dependent (heart rate imposed exclusively by the pacemaker);

• Severe peripheral vascular disease (e.g. Raynaud’s phenomenon);

• Severe hypotension (systolic arterial blood pressure <90 mmHg, diastolic arterial blood pressure <50 mmHg);

• Chronic obstructive pulmonary disease associated with bronchial obstruction;

• History of bronchospasm or asthma;

• Metabolic acidosis;

• Untreated phaeochromocytoma;

• Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).