TAMBOCOR flecainide acetate 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flecainide acetate, Quantity: 100 mg

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; hydrogenated vegetable oil; magnesium stearate; croscarmellose sodium; pregelatinised maize starch

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Supraventricular arrhythmias: (a) due to pre-excitation syndromes, eg 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 TAMBOCOR 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, TAMBOCOR should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate. Use of TAMBOCOR in chronic atrial fibrillation has not been adequately studied and is not recommended. 2. Life threatening ventricular arrhythmias not controlled by other drugs. Intravenous TAMBOCOR is indicated when rapid control or short-term prophylaxis of the above arrhythmias is the main clinical requir

Product summary:

Visual Identification: A white, biconvex round tablet being approximately 8.5mm in diameter, marked 'TR' breakline '100' on one side and plain on the other.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-08-27

Patient Information leaflet

TAMBOCOR
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING TAMBOCOR?
Tambocor contains the active ingredient flecainide acetate. Tambocor
tablets and injection are used to treat a heart condition called
arrhythmia. Arrhythmia is an irregular or abnormal heartbeat.
For more information, see Section 1. Why am I taking Tambocor? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TAMBOCOR?
Do not use if you have ever had an allergic reaction to Tambocor or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Tambocor? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Tambocor and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TAMBOCOR?
•
The usual starting dose of Tambocor tablets is 50 mg to 100 mg every
12 hours. The usual maximum dose is 300 mg a day.
However, some patients may need up to 400 mg a day. Follow your
doctor's instructions exactly.
•
The dose for Tambocor IV injection is usually around 2 mg/kg body
weight and is given in a hospital. Your doctor may vary the
dose to suit your condition.
More instructions can be found in Section 4. How do I use Tambocor? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING TAMBOCOR?
THINGS YOU
SHOULD DO
•
If you are about to start on any new medicines, remind your doctor and
pharmacist that you are taking
Tambocor tablets or are being given Tambocor injection
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking Tambocor.
THINGS YOU
SHOULD NOT DO
•
Follow your doctor's instructions exactly. Do not stop taking Tambocor
or

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
TAMBOCOR

® (FLECAINIDE ACETATE) 50 MG TABLETS,
TAMBOCOR
® (FLECAINIDE ACETATE) 100 MG TABLETS &
TAMBOCOR
® (FLECAINIDE ACETATE) 150 MG/15 ML INJECTION
1
NAME OF THE MEDICINE
Flecainide acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flecainide acetate belongs to the benzamide class of antiarrhythmic
drugs and is structurally related
to lidocaine and procainamide. It is chemically distinguished from
these agents by the presence of
trifluoroethoxy- substituents in the aromatic portion of the molecule
and a piperidine ring in the
amide side chain instead of the diethylaminoethyl group of the
procainamide side chain. The
compound is a racemic mixture. It is soluble in water, dilute acetic
acid, methanol and ethanol and
practically insoluble in dilute hydrochloric acid.
EXCIPIENTS
Tablets:
Pregelatinised Maize Starch; Croscarmellose Sodium; Microcrystalline
Cellulose;
Hydrogenated Vegetable Oil; Magnesium Stearate.
Injection:
Sodium Acetate; Glacial Acetic Acid, water for injections.
3
PHARMACEUTICAL FORM
TAMBOCOR flecainide acetate 50mg tablet blister pack: A white,
biconvex round tablet approximately
6.35mm in diameter, marked 'TR' over '50' on one side and plain on the
other.
TAMBOCOR flecainide acetate 100mg tablet blister pack: A white,
biconvex round tablet being
approximately 8.5mm in diameter, marked 'TR' breakline '100' on one
side and plain on the other.
TAMBOCOR flecainide acetate 150mg/15mL injection ampoule: Clear
solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TAMBOCOR 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 TAMBOCOR may be effective in supraventricular arrhythmias in
patients with structural
heart disease, its use has been associated with life-threatening and
occasionally fata