Cordarone Tablets 200mg

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

AMIODARONE HYDROCHLORIDE

Tersedia dari:

Sanofi Malta Limited

Kode ATC:

C01BD01

INN (Nama Internasional):

AMIODARONE HYDROCHLORIDE

Bentuk farmasi:

TABLET

Komposisi:

AMIODARONE HYDROCHLORIDE 200 milligram(s)

Jenis Resep:

POM

Area terapi:

CARDIAC THERAPY

Status otorisasi:

Authorised

Tanggal Otorisasi:

2005-11-30

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
CORDARONE 200 MG SCORED TABLETS
AMIODARONE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE. IT
CONTAINS IMPORTANT INFORMATION
REGARDING YOUR TREATMENT.
•
Keep this leaflet as 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. 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.
IN THIS LEAFLET:
1.
What Cordarone 200mg 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 200mg scored tablets
4.
Possible side effects
5.
How to store Cordarone 200mg scored tablets
6.
Contents of the pack and other information
1. WHAT CORDARONE 200MG SCORED TABLETS ARE AND WHAT THEY ARE USED FOR.
Pharmacotherapeutic group: CLASS III ANTIARRHYTHMIC, ATC code:
C01BD01.
This medicine is used to prevent and treat certain serious heartbeat
problems
2. TABLETSWHAT YOU NEED TO KNOW BEFORE YOU TAKE CORDARONE 200 MG
SCORED TABLETS
If your doctor has told you that you have an intolerance to certain
sugars, contact him/her before
taking this medicine.
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
contraindicated (see “Other medicines and Co

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CORDARONE 200 mg, scored tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amiodarone hydrochloride
................................................................
200 mg
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 RECURRENCES OF
-
life-threatening ventricular tachycardia: the treatment should be
instituted in a hospital environment
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 the presence of 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, the patient may require higher loading doses (4 to 5
tablets per day), always for short periods
and under electrocardiographic monitoring.
_Maintenance treatment_
Use the minimum effective dose, which will depend on the patient, and
ranges from 1/2 tablet per day (1 tablet
every 2 days) to 2 tablets every day.
_Paediatric population_
The safety and efficacy of amiodarone in children has not been
established. Sections 5.1. and 5.2. for currently
available data.
METHOD OF ADMINISTRATION
Oral route.
4.3 CONTRAINDICATIONS
This medicinal product is contraindicated in the following situations:
• sinus bradycardia and sinoatrial heart block in unpaced patients;
• sinus node disease in unpaced patients (risk of sinus arrest);
• high-degree atrioventricular conduction disorders in unpaced
patients;
• hyperthyroidism because of possible exacerbation by amiodar