Tambocor

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Flecainide acetate 10 mg/mL;  

Available from:

iNova Pharmaceuticals (New Zealand) Limited

INN (International Name):

Flecainide acetate 10 mg/mL

Dosage:

10 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Flecainide acetate 10 mg/mL   Excipient: Glacial acetic acid Sodium acetate trihydrate Water for injection

Units in package:

Ampoule, 5x15mL, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Orgapharm SAS

Therapeutic indications:

TAMBOCOR injection is indicated in patients without structural heart disease when rapid control or short-term prophylaxis of the arrhythmias below is the main clinical requirement, including: · ventricular tachyarrhythmias where these are resistant to other treatment; · AV nodal reciprocating tachycardia, arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways; · paroxysmal atrial fibrillation in patients with disabling symptoms. Arrhythmias of recent onset will respond more readily.

Product summary:

Package - Contents - Shelf Life: Ampoule, 15mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C

Authorization date:

1984-09-20

Patient Information leaflet

TAMBOCOR™
1
TAMBOCOR™
_(TAM-BO-CORE) _
_Flecainide acetate (fleck-ain-ide-ass-e-tate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tambocor tablets,
CR capsules and injection. 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 Tambocor
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 TAMBOCOR IS
USED FOR
Tambocor is used to treat a heart
condition called arrhythmia.
Arrhythmia is an irregular or
abnormal heart beat. The active
ingredient in Tambocor, 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
Tambocor for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Tambocor is available only with a
doctor's prescription.
BEFORE USING OR BEING
GIVEN TAMBOCOR
_WHEN YOU MUST NOT USE OR _
_HAVE TAMBOCOR _
DO NOT USE OR HAVE TAMBOCOR 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 TAMBOCOR 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 blister foil of the tablets and
CR capsules. For the injection
this can be found on the box and
vial label
•
if the packaging is torn or s

Summary of Product characteristics

NEW ZEALAND DATA SHEET
TAMBOCOR
TM
Tablets
TAMBOCOR
TM
CR Capsules
TAMBOCOR
Page 1 of 18
1 PRODUCT NAME
TAMBOCOR 50 mg tablets
TAMBOCOR 100 mg tablets*
TAMBOCOR CR 100 mg capsules
TAMBOCOR CR 200 mg capsules
TAMBOCOR CR 300 mg capsules*
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TAMBOCOR 50 mg tablet contains flecainide acetate 50 mg.
Each TAMBOCOR 100 mg tablet contains flecainide acetate 100 mg.
Each TAMBOCOR CR 100 mg capsule contains flecainide acetate 100 mg.
Each TAMBOCOR CR 200 mg capsule contains flecainide acetate 200 mg.
Each TAMBOCOR CR 300 mg capsule contains flecainide acetate 300 mg.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
TAMBOCOR 50 mg tablet: White, circular, biconvex tablets 6.5 mm in
diameter marked TR50 on one face
and plain on the other face.
TAMBOCOR 100 mg tablets: White, circular, biconvex tablets 8.5 mm in
diameter marked TR100 on one
face over a break line and plain on the other face.
Modified release capsule
TAMBOCOR CR 100 mg capsule: Grey and white hard gelatin capsules with
the captions 3M and 100 printed
in black ink in the axial direction on the respective capsule halves.
TAMBOCOR CR 200 mg capsule: Grey and pink hard gelatin capsules with
the captions 3M and 200 printed
in black ink in the axial direction on the respective capsule halves.
TAMBOR CR 300 mg capsule: Grey and light blue with the captions 3M and
300 printed in black ink in the
axial direction on the respective capsule halves.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
In patients without structural heart disease and without myocardial
infarction tablets and capsules are
indicated for the prevention of:
NEW ZEALAND DATA SHEET
TAMBOCOR
TM
Tablets
TAMBOCOR
TM
CR Capsules
TAMBOCOR
Page 2 of 18
Supraventricular arrhythmias
•
paroxysmal supraventricular tachycardias (PSVT) including
atrioventricular nodal re-entrant
tachycardia, atrioventricular re-entrant tachycardia and other
supraventricular tachycardias of
unspecified mechanism associated with disabling symptoms;
•