Multaq

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dronedarone

Available from:

Sanofi Winthrop Industrie

ATC code:

C01BD07

INN (International Name):

dronedarone

Therapeutic group:

Cardiac therapy

Therapeutic area:

Atrial Fibrillation

Therapeutic indications:

Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, Multaq should only be prescribed after alternative treatment options have been considered.Multaq should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2009-11-25

Patient Information leaflet

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MULTAQ 400 MG FILM-COATED TABLETS
dronedarone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MULTAQ is and what it is used for
2.
What you need to know before you take MULTAQ
3.
How to take MULTAQ
4.
Possible side effects
5
How to store MULTAQ
6.
Contents of the pack and other information
1.
WHAT MULTAQ IS AND WHAT IT IS USED FOR
MULTAQ contains an active substance named dronedarone. It belongs to a
group of medicines called
anti-arrhythmics that help regulate your heart beat.
MULTAQ is used if you have a problem with your heart rhythm (your
heart beats out of time - atrial
fibrillation) and spontaneously, or through a treatment called
cardioversion has changed your heartbeat
back to normal rhythm.
MULTAQ prevents repetition of your problem of irregular heart rhythm.
MULTAQ is used only in
adults.
Your doctor will consider all available treatment options before
prescribing MULTAQ to you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MULTAQ
DO NOT TAKE MULTAQ:
-
if you are allergic to dronedarone or to any of the other ingredients
of this medicine (listed in
section 6),
-
if you have a problem with the nerves in your heart (heart block).
Your heart might beat very
slowly or you may feel dizzy. If you have had a pacemaker fitted for
this problem, you can use
MULTAQ,
-
if you have a very slow heart beat (less than 50 beats a minute),
-
if your ECG (electrocardiogram) shows a heart problem called
“prolonged QT corrected
interval”

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
MULTAQ 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains 400 mg of dronedarone (as hydrochloride).
Excipient with known effect:
Each tablet also contains 41.65 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White, oblong shaped tablets, engraved with a double wave marking on
one side and “4142”code on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MULTAQ is indicated for the maintenance of sinus rhythm after
successful cardioversion in adult
clinically stable patients with paroxysmal or persistent atrial
fibrillation (AF). Due to its safety profile
(see sections 4.3 and 4.4), MULTAQ should only be prescribed after
alternative treatment options
have been considered.
MULTAQ must not be given to patients with left ventricular systolic
dysfunction or to patients with
current or previous episodes of heart failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and monitored only under specialist
supervision (see section 4.4).
Treatment with dronedarone 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 dronedarone.
There is limited information on the optimal timing to switch from
amiodarone to dronedarone. 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 to dronedarone (see
section 4.5).
3
If a dose is mis