Tegretol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Carbamazepine 400mg;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Carbamazepine 400 mg

Dosage:

400 mg

Pharmaceutical form:

Tablet

Composition:

Active: Carbamazepine 400mg   Excipient: Carmellose sodium Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, PVC/PE/PVdC/Al, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Zhejiang Raybow Pharmaceutical Co Ltd

Therapeutic indications:

· Epilepsy - Complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. - Generalized tonic-clonic seizures. Mixed forms of seizures. Tegretol® is suitable for both monotherapy and combination therapy. Tegretol is usually not effective in absences (petit mal) and myoclonic seizures

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

1969-12-31

Patient Information leaflet

_____________________________________________________________________________________________________
Tegretol

1
TEGRETOL

_200mg and 400mg tablets _
_200mg and 400mg CR tablets _
_100mg/5mL syrup _
_Carbamazepine_
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
____________________
WHAT IS IN THIS LEAFLET
__________________________________
This leaflet answers some common
questions about
Tegretol.
It does not contain all the available
information
.
It does not take the place
of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
this medicine against the benefits
they expect it will have.
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 TEGRETOL
IS USED FOR
______________________
Tegretol has several uses:
•
to control epilepsy, a condition
in which there are repeated
seizures (fits). There are many
different types of seizures,
ranging from mild to severe.
•
to control sudden, repeated
attacks of facial pain, known as
trigeminal neuralgia.
•
to control mania, a mental
condition with episodes of
overactivity, elation or
irritability.
•
to control bipolar mood disorder
where periods of mania alternate
with periods of depression.
•
to control the pain associated
with painful diabetic neuropathy.
•
to control diabetes insipidus, a
condition where there is
excessive thirst

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1
1.
PRODUCT NAME
TEGRETOL
®
200 mg Tablets
TEGRETOL
®
400 mg Tablets
TEGRETOL
®
200 mg CR Tablets
TEGRETOL
®
400 mg CR Tablets
TEGRETOL
®
100 mg / 5 mL Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Tablets
•
200 mg: Each tablet contains 200 mg carbamazepine
•
400 mg: Each tablet contains 400 mg carbamazepine
CR tablets
•
200
mg:
Each
modified-release
film-coated,
divisible
tablet
contains
200
mg
carbamazepine
•
400 mg: Each modified-release film-coated, divisible tablet contains
400 mg
carbamazepine
Syrup
•
5 mL: Each 5 mL of syrup contains 100 mg carbamazepine
For a full list of excipients, see section 6.1. The syrup contains
propylene glycol (refer to section
4.4, subsection
_Excipients of known effect_
).
3.
PHARMACEUTICAL FORM
•
Tablet containing 200mg carbamazepine. Round, white, flat tablet, 9mm
in diameter,
with bevelled edges. Imprinted CG on one side, and G/K on the scored
side. The tablet
can be divided into equal doses.
•
Tablet containing 400mg carbamazepine. White, flat, rod-shaped tablet
with bevelled
edges. 17mm in length and 5.5mm in width. Imprinted CG/CG on one side
and LR/LR
on the second side; both sides of the tablet are scored. The tablet
can be divided into
equal doses.
•
Controlled Release Tablet containing 200mg carbamazepine.
Beige-orange, ovaloid-
shaped, film-coated divisible tablet with slightly convex faces.
Approximate length is
12.2mm, and approximate width is 5.6mm. Both sides are scored; one
side is imprinted
C/G, and the other side H/C.
•
Controlled Release Tablet containing 400mg carbamazepine.
Brown-orange, ovaloid-
shaped, film-coated
divisible tablet, with slightly
convex faces.
Approximately
16.7mm in length, and approximately 6.6mm in width. Imprinted CG/CG on
one side,
and ENE/ENE on the other side; both sides are scored.
•
Syrup containing 100mg/5mL carbamazepine. A viscous white suspension
with a
caramel odour and taste. It contains sorbitol (875mg/5mL), which is
converted slowly
into glucose, making