Cordarone 200mg scored Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

C01BD01

INN (International Name):

AMIODARONE HYDROCHLORIDE 200 mg

Pharmaceutical form:

TABLET

Composition:

AMIODARONE HYDROCHLORIDE 200 mg

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Withdrawn

Authorization date:

2005-11-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CORDARONE 200 MG SCORED TABLETS
AMIODARONE HYDROCHLORIDE
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 Cordarone 200 mg scored tablets are and what they are used for
2.
What you need to know before you take Cordarone 200 mg scored tablets
3.
How to take Cordarone 200 mg scored tablets
4.
Possible side effects
5.
How to store Cordarone 200 mg scored tablets
6.
Contents of the pack and other information
1.
WHAT CORDARONE 200 MG SCORED TABLETS ARE AND WHAT THEY ARE USED FOR
Pharmacotherapeutic group: CLASS III ANTIARRHYTHMICS, ATC code:
C01BD01.
This medicine is used to prevent and treat certain serious heartbeat
problems.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CORDARONE 200 MG SCORED TABLETS
IF YOU HAVE BEEN TOLD BY YOUR DOCTOR THAT YOU HAVE AN INTOLERANCE TO
SOME SUGARS, CONTACT YOUR DOCTOR
BEFORE TAKING THIS
MEDICINAL PRODUCT DO NOT TAKE CORDARONE 200 MG SCORED TABLETS:
•
If you are allergic (hypersensitive) to amiodarone or any of the other
ingredients of this medicine
(listed in section 6).
•
If you are allergic to iodine,
•
If you have hyperthyroidism (disease of the thyroid gland),
•
If you have certain problems with your heartbeat or problems with the
system that sends the signals
that cause your heart to contract,
•
If your heartbeat is too slow,
•
If you are more than 3 months pregnant,
•
If you are breast-feeding.
•
If you are taking other medicines, make sure that combined use with
Cordarone 200 mg is not
contraindica

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CORDARONE 200 MG SCORED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amiodarone hydrochloride
....................................................................................................................
200 mg
For one scored tablet.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Scored tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
PREVENTION OF RECURRENCE OF:
•
life-threatening ventricular tachycardia; treatment should be
instituted in a hospital
setting
under monitoring,
•
documented, symptomatic and incapacitating ventricular tachycardia,
•
documented, supraventricular tachycardia in patients refractory to
therapy or in whom other treatments
are contraindicated,
•
ventricular fibrillation.
TREATMENT OF SUPRAVENTRICULAR TACHYCARDIA:
Slowing or reduction in atrial fibrillation or atrial flutter.
Amiodarone can be used in patients with coronary artery disease and/or
impaired left ventricular
function (see section 5.1).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Loading dose _
The usual dosage regimen is 3 tablets per day, for 8 to 10 days.
In some cases, patients may require
higher loading doses (4 to 5 tablets per day), always for short
periods and with ECG monitoring.
_Maintenance dose _
The minimum effective dose (which varies between patients) of between
1/2 tablet per day (1 tablet every
2 days) to 2 tablets per day must be used.
_Paediatric population _
The safety and efficacy of amiodarone in children have not been
established. Currently available data are
described in section 5.1 and 5.2.
METHOD OF ADMINISTRATION
Oral use.
4.3.
CONTRAINDICATIONS
This medicinal product is contraindicated in the following situations:
•
sinus bradycardia and sinoatrial block, unless a pacemaker is fitted,
•
sick sinus syndrome (risk of sinus arrest), unless a pacemaker is
fitted,
•
severe atrioventricular conduction disorders, unless a pacemak