Flec-EM flecainide acetate 100 mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

flecainide acetate, Quantity: 100 mg

Dostupno od:

Emcure Pharmaceuticals Pty Ltd

Farmaceutski oblik:

Tablet, uncoated

Sastav:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate

Administracija rute:

Oral

Jedinice u paketu:

Carton pack consist of 60 Tablets (6 blisters of 10s in a carton)

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Flec-EM is indicated for:,1. Supraventricular arrhythmias: a) Due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes b) Due to dual AV nodal pathways in patients with debilitating symptoms c) Paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms,Although Flec-EM may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, Flec-EM should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,Use of Flec-EM in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. Life threatening ventricular arrhythmias not controlled by other drugs. Flec-EM tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.

Proizvod sažetak:

Visual Identification: White to off white, round, biconvex tablets debossed with break line separating H and P on one side and 184 on other side of tablet.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2020-05-27

Uputa o lijeku

Flec-EM 1
FLEC-EM
_Flecainide acetate (fleck-ain-ide-ass-e-tate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This
leaflet
answers
some
common
questions about Flec-EM tablets. It does
not
contain
all
the
available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Flec-EM against the benefits
they expect it can have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
FLEC-EM
IS
USED
FOR?
Flec-EM is used to treat a heart
condition
called
arrhythmia.
Arrhythmia
is
an
irregular
or
abnormal
heart
beat.
The
active
ingredient
in
Flec-EM,
flecainide
acetate,
belongs
to
a
group
of
drugs
called
antiarrhythmic
medicines
which
slow
down
the
impulses that cause the heart to
beat in an irregular or abnormal
way.
Your
doctor may
have
prescribed
Flec-EM for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Flec-EM
is
available
only
with
a
doctor's prescription.
BEFORE
USING
OR
BEING
GIVEN FLEC-EM
_WHEN YOU MUST NOT USE OR HAVE _
_FLEC-EM _
DO NOT USE OR HAVE FLEC-EM IF YOU
HAVE AN ALLERGY TO:

flecainide acetate

any of the ingredients listed at
the end of this leaflet.
Some
of
the
symptoms
of
an
allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue
or other parts of the body

rash, itching or hives on the skin
DO NOT GIVE FLEC-EM TO CHILDREN.
DO NOT TAKE OR HAVE THIS MEDICINE:

if you have severe heart, liver or
kidney
disease
unless
your
doctor says it is suitable for you

after the USE BY date. The USE
BY date can be found on the
box and tablet blister.

if the packaging is torn or shows
signs of tampering
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING OR BE GIVEN THIS
MEDICINE, TALK TO YOUR DOCTOR.
_BEFORE YOU START TO TAKE OR

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – FLEC-EM
(FLECAINIDE ACETATE) TABLETS
1
NAME OF THE MEDICINE
Flecainide Acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flec-EM 50 mg tablets contain 50 mg of the active ingredient
flecainide acetate.
Flec-EM 100 mg tablets contain 100 mg of the active ingredient
flecainide acetate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
100 MG TABLETS: White to off white, round, biconvex tablets debossed
with break line separating ‘H’
and ‘P’ on one side and “184” on other side of tablet.
50 MG TABLETS: White to off white, round, biconvex tablets, debossed
with “HP” on one side and
“183” on other side of tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Flec-EM is indicated for:
1.
Supraventricular arrhythmias:
a)
Due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and
Lown-Ganong-Levine
syndromes
b)
Due to dual AV nodal pathways in patients with debilitating symptoms
c)
Paroxysmal atrial fibrillation/flutter (PAF) associated with disabling
symptoms
Although Flec-EM may be effective in supraventricular arrhythmias in
patients with structural
heart disease, its use has been associated with life-threatening and
occasionally fatal ventricular
arrhythmias. In these patients, particularly in the presence of
impaired left ventricular function,
Flec-EM should be used with extreme caution, preferably after other
antiarrhythmic drugs have
been tried or considered inappropriate.
Use
of
Flec-EM
in
chronic
atrial
fibrillation
has
not
been
adequately
studied and
is
not
recommended.
2.
Life threatening ventricular arrhythmias not controlled by other
drugs.
Flec-EM tablets are used for continuous maintenance of normal rhythm
following initial oral or
intravenous (available in other brands) therapy or conversion by other
means.
PRESCRIBERS SHOULD ALSO CONSULT THE SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE OF THIS
PRODUCT INFORMATION.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
The dosage of Flec-EM must