Flecainide 100mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Flecainide acetate

Tilgængelig fra:

Milpharm Ltd

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; GTIN: 8901175013708

Indlægsseddel

FLECAINIDE ACETATE 50 MG TABLETS
FLECAINIDE ACETATE 100 MG TABLETS
Flecainide acetate
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Acetate is and what it is used for
2.
What you need to know before you take Flecainide Acetate
3.
How to take Flecainide Acetate
4.
Possible side effects
5.
How to store Flecainide Acetate
6.
Contents of the pack and other information
Flecainide belongs to the group of medicines that work against
cardiac arrhythmia (known as anti-arrhythmics). It inhibits stimulus
conduction in the heart and extends the time during which the heart
is at rest, causing the heart to pump normally again.
Flecainide Acetate is used
-
for certain serious cardiac arrhythmias, which are often
expressed as serious palpitations of the heart or tachycardia.
-
for serious cardiac arrhythmias that did not respond well to
treatment with other medicines, or when other treatments
cannot be tolerated.
DO NOT TAKE FLECAINIDE ACETATE
•
if you are allergic to flecainide or any of the other ingredients of
this medicine (listed in section 6).
•
If you suffer from another heart condition, different from the
heart condition for which you are taking this medicine. If you are
unsure, or if you would like additional information, consult your
doctor or pharmacist.
•
you are taking certain other antiarrhythmics (sodium channel
blockers) as well;
•
If you know that you have a genetic disease [Brugada
syndrome] characterized by abnormal electrocardiog

Produktets egenskaber

OBJECT 1
FLECAINIDE ACETATE 100 MG TABLETS
Summary of Product Characteristics Updated 27-Jul-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Flecainide Acetate 100 mg tablets
2. Qualitative and quantitative composition
Each tablet contains flecainide acetate 100 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White to off-white, round [diameter 8.5 mm], biconvex, scored tablets
debossed with '1' and '2' separated
by deep score line on one side and 'CC' on the other side. The tablet
can be divided 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
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 othe