MULTAQ Film-coated tablet Ref.[6810] Active ingredients: Dronedarone

Treatment should be initiated and monitored only under specialist supervision (see section 4.4). Treatment with MULTAQ can be initiated in an outpatient setting.

Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting MULTAQ.

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).

Posology

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.

Grapefruit juice should not be taken together with MULTAQ (see section 4.5). If a dose is missed, patients should take the next dose at the regular scheduled time and should not double the dose.

Paediatric population

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

Elderly

Efficacy and safety were comparable in elderly patients who did not suffer from other cardiovascular diseases and younger patients. Caution is needed in patients ≥75 years old when co-morbidities are present (see sections 4.3, 4.4 and 5.1). 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).

Hepatic impairment

MULTAQ is contraindicated in patients with severe hepatic impairment because of the absence of data (see section 4.3 and 4.4). No dose adjustment is required in patients with mild or moderate hepatic impairment (see section 5.2).

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 other patients with renal impairment (see sections 4.4 and 5.2).

Method of administration

Oral use.

It is recommended to swallow the tablet whole with a drink of water during a meal. The tablet cannot be divided into equal doses.

It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).

There is no specific antidote available. In the event of overdose, treatment should be supportive and directed toward alleviating symptoms.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

• Opaque PVC/Aluminium blister in packs of 20, 50 and 60 film-coated tablets.
• Opaque PVC/Aluminium perforated unit dose blister in packs of 100x1 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.