TEGRETOL 100 carbamazepine 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carbamazepine, Quantity: 100 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; carmellose sodium

Administration route:

Oral

Units in package:

200 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. Epilepsy: Complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalisation; Generalised tonic-clonic seizures; Mixed seizure patterns incorporating the above. Tegretol is suitable for monotherapy and combination therapy. Tegretol is usually not effective in absence seizures, atonic seizures and myoclonic seizures and should not be used for status epilepticus (see "PRECAUTIONS"). 2. Trigeminal neuralgia: For relief of pain in idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis; and in idiopathic glossopharyngeal neuralgia. (Tegretol is not a simple analgesic and is not intended for trivial facial pain or headache). 3. Mania and bipolar affective disorders: Treatment of mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence.

Product summary:

Visual Identification: White, round flat tablets with bevelled edges. One side bears the imprint "Geigy", the other "B/W" and a score; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-09-09

Patient Information leaflet

TEGRETOL
®
_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.NOVARTIS.COM.AU.
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.
Tegretol belongs to a group of
medicines called anticonvulsants.
These medicines are thought to work
by regulating the way messages in
the brain are passed on by nerves so
that seizures do not happen. Tegretol
also regulates other nerve functions
in the body.
Tegretol may be used alone or in
combination with other medicines to
treat your condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Tegretol is only availabl

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - TEGRETOL
®
(CARBAMAZEPINE)
1.
NAME OF THE MEDICINE
Australian Approved Name: carbamazepine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tegretol tablets containing 100 mg or 200 mg of carbamazepine.
Tegretol controlled release (CR) tablets containing 200 mg or 400 mg
of carbamazepine
Tegretol liquid containing 100 mg of carbamazepine per 5 mL
Carbamazepine is a white or yellowish-white almost odourless
crystalline powder, tasteless
or with a slightly bitter taste; melting point: 189 to 193

C. The powder is slightly soluble in
water and ether; soluble 1 in 10 of alcohol and 1 in 10 of chloroform;
soluble in acetone.
Tegretol
liquid
contains
hydroxybenzoates,
saccharin,
sorbates,
sorbitol
and
traces
of
benzoates. For the full list of excipients, see Section 6.1 List of
excipients.
3.
PHARMACEUTICAL FORM
Tablets
_100 mg_
: white, scored, marked BW, GEIGY on reverse
_200 mg_
: white, scored, marked GK, CG on reverse
_200 mg CR_
: beige-orange, ovaloid, scored, marked H/C and C/G
_400 mg CR_
: brown-orange, ovaloid, scored, marked ENE/ENE and CG/CG
Liquid
White, viscous, caramel-flavoured suspension.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPILEPSY
•
Complex or simple partial seizures (with or without loss of
consciousness) with or
without secondary generalisation
•
Generalised tonic-clonic seizures
•
Mixed seizure patterns incorporating the above.
Tegretol is suitable for monotherapy and combination therapy. Tegretol
is usually not
effective in absence seizures, atonic seizures and myoclonic seizures
and should not be used
for status epilepticus (see section 4.4 "SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE").
2
TRIGEMINAL NEURALGIA
For relief of pain in idiopathic trigeminal neuralgia and trigeminal
neuralgia due to multiple
sclerosis; and in idiopathic glossopharyngeal neuralgia. (Tegretol is
not a simple analgesic
and is not intended for trivial facial pain or headache).
MANIA AND BIPOLAR AFFECTIVE DISORDERS
Treatment of mania and maintenance treatment of bipola