Flecainide 100mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Flecainide acetate

Tilgængelig fra:

Waymade Healthcare Plc

ATC-kode:

C01BC04

INN (International Name):

Flecainide acetate

Dosering:

100mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 02030200

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
FLECAINIDE ACETATE 50 MG
TABLETS
FLECAINIDE ACETATE 100 MG
TABLETS
flecainide acetate
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 Flecainide is and what it is used for
2. What you need to know before you take
Flecainide
3. How to take Flecainide
4. Possible side effects
5. How to store Flecainide
6. Contents of the pack and other
information
1. WHAT FLECAINIDE IS AND WHAT IT IS
USED FOR
Flecainide belongs to a group of medicines
called antiarrhythmic agents. Flecainide is
used to treat an irregularity in the heartbeat
(known as an arrhythmia). It works by
correcting irregular heartbeats to a normal
rhythm.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FLECAINIDE
DO NOT TAKE FLECAINIDE:
•
if you are allergic to flecainide acetate
or any of the other ingredients of this
medicine (listed in section 6).
•
if you suffer from heart failure or some
types of heart rhythm disorders
•
if you suffer from heart valve disease
•
if you have a history of heart attacks
•
if you have low blood pressure or a slow
beating heart
•
if you have a serious heart condition
called cardiogenic shock which causes
rapid breathing, weakness, looking
pale, confusion and can lead to a loss of
consciousness
•
if you have a heart condition called
Brugada Syndrome, which causes you to
have a potentially life-threatening heart
rhythm disorder
•
if you are already taking Disopyramide to
regulate your heartbeat
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharma

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flecainide Acetate Tablets 100mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg Flecainide Acetate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White, circular, biconvex, uncoated tablets one side embossed with a
breakline
and the identifying letters “C” above the line and “FJ” below,
the reverse side
embossed with a breakline.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of AV nodal reciprocating tachycardia; arrhythmias
associated with
Wolff-Parkinson-White Syndrome and similar conditions with accessory
pathways, when other treatment has been ineffective.
Treatment of severe symptomatic and life-threatening paroxysmal
ventricular
arrhythmia which has failed to respond to other forms of therapy or
where
other treatments have not been tolerated.
Treatment of paroxysmal atrial arrhythmias (atrial fibrillation,
atrial flutter and
atrial tachycardia) in patients with disabling symptoms after
conversion
provided that there is definite need for treatment on the basis of
severity of
clinical symptoms, when other treatment has been ineffective.
Structural heart
disease and/or impaired left ventricular function should be excluded
because
of the increased risk for pro-arrhythmic effects.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Adults:
Supraventricular arrhythmias: The recommended starting dose is 50mg
twice daily
and most patients will be controlled at this dose. If required the
dose may be
increased to a maximum of 300mg daily.
Ventricular arrhythmias: The recommended starting dose is 100mg twice
daily. The
maximum daily dose is 400mg and this is normally reserved for patients
of large
build or where rapid control of the arrhythmia is required. After 3-5
days it is
recommended that the dosage be progressively adjusted to the lowest
level which
maintains cont