MULTAQ® FILM-COATED TABLET 400MG [SIN13849P]

Product Info

MULTAQ® FILM-COATED TABLET 400MG

[SIN13849P]

4.1 Therapeutic indications

MULTAQ is indicated in adult clinically stable patients with history of paroxysmal or persistent atrial fibrillation (AF) when sinus rhythm has been restored, for the maintenance of sinus rhythm. MULTAQ has been shown to decrease the risk of AF-related hospitalisations in these patients (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Due to its safety profile, Multaq should be prescribed after alternative treatment options have been considered.

4.2 Posology and method of administration

The recommended dose is 400 mg twice daily in adults. It should be taken as

• one tablet with the morning meal and

• one tablet with the evening meal.

If a dose is missed, patients should take the next dose at the regular scheduled time and should not double the dose.

Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting MULTAQ (see sections 4.3 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is limited information on the optimal timing to switch from amiodarone to MULTAQ. It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life. If a switch is envisaged, this should be done under the supervision of a specialist (see sections 4.3 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment with MULTAQ can be initiated in an outpatient setting.

Paediatric Population
There is no experience in children and adolescents below 18 years of age. Therefore, MULTAQ is not recommended in this population.

Elderly
Efficacy and safety were comparable in both elderly who did not suffer from other cardiovascular diseases and younger patients. Caution is needed in elderly patients ≥ 75 years when co-morbidities are present (see section 4.3, 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Although plasma exposure in elderly females was increased in a pharmacokinetic study conducted in healthy subjects, dose adjustments are not considered necessary (see sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
MULTAQ is contraindicated in patients with severe hepatic impairment because of the absence of data (see section 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
MULTAQ is contraindicated in patients with severe renal impairment (creatinine clearance (CrCl) <30 ml/min (see section 4.3). No dose adjustment is required in patients with renal 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).

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

• Second- or third- degree atrio-ventricular block, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)

• Bradycardia < 50 beats per minute (bpm)

• Permanent AF with an AF duration ≥ 6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician

• Patients in unstable hemodynamic conditions

• History of, or current heart failure or left ventricular systolic dysfunction

• Patients with liver and lung toxicity related to the previous use of amiodarone

• Co-administration with potent cytochrome P 450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), Class I and III antiarrhythmics) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• QTc Bazett interval ≥500 milliseconds

• Severe hepatic impairment

• Severe renal impairment (CrCl < 30ml/min)

• Co-administration with dabigatran