Flecainide 50mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Flecainide acetate

Tilgjengelig fra:

DE Pharmaceuticals

ATC-kode:

C01BC04

INN (International Name):

Flecainide acetate

Dosering :

50mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02030200

Informasjon til brukeren

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Flecainide Tablets
50 & 100mg x 60’s (UK)
148x210 (Reel Fed)
50965038
Leaflet for Blisters
5959
R.Wrey
18/02/19
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FMD info
NA (not a carton)

No

Yes
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Details
FLECAINIDE ACETATE 50MG & 100MG TABLETS PIL - UK
Black
Profile
BBBA4689
S.Anson
29.04.19
14.11.19
S.Anson
148 x 210
7pt
Accord UK
n/a
n/a
6
Version 2
01.11.2017
FLECAINIDE ACETATE 50MG
AND 100MG TABLETS
_Continued over page_
_Continued top of next column_
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,
pharmacist or nurse.
• 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT FLECAINIDE ACETATE TABLETS ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FLECAINIDE ACETATE TABLETS
3
HOW TO TAKE FLECAINIDE ACETATE TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE FLECAINIDE ACETATE TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT FLECAINIDE ACETATE TABLETS ARE AND WHAT THEY
ARE USED FOR
Flecainide Acetate tablets belong to a group of medicines called
anti

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Flecainide Acetate 50 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains flecainide acetate 50 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
_ _
White to off-white, round [diameter 6.5 mm], biconvex tablets embossed
with
‘CC’ on one side and ‘11’ on the other side.
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
Initiation of flecainide acetate therapy and dose changes should be
made under
medical supervision and monitoring of ECG and plasma level.
Hospitalization could
be necessary during such procedures for certain patients, especially
for patients with
life threatening ventricular arrhythmias.These decisions should be
made under
supervision of specialist.
In patients with an underlying organic cardiopathy and especially
those with a history
of myocardial infarction, flecainide treatment should only be started
when other
arrhythmic agents, other than class IC (especially amiodarone), are
ineffective or not
tolerated and when non-pharmacological treatment (surgery, ablation,
implanted
defibrillator