CARBAMAZEPINE SANDOZ carbamazepine 100mg 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; carmellose sodium; magnesium stearate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

200 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Epilepsy 1. Complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalisation. 2. Generalised tonic-clonic seizures 3. Mixed seizure patterns incorporating the above. Carbamazepine Sandoz is suitable for monotherapy and combination therapy. Carbamazepine Sandoz is usually not effective in absence seizures, atonic seizures and myoclonic seizures and should not be used for status epilepticus (see precautions). Trigeminal neuralgia For relief of pain in idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis; and in idiopathic glossopharyngeal neuralgia. ( Carbamazepine Sandoz 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 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; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2001-04-20

Patient Information leaflet

CARBAMAZEPINE
SANDOZ
®
_Carbamazepine tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Carbamazepine
Sandoz.
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 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 CARBAMAZEPINE
SANDOZ IS USED FOR
Carbamazepine Sandoz 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.
Carbamazepine Sandoz 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. This medicine also regulates
other nerve functions in the body.
Carbamazepine Sandoz 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

Summary of Product characteristics

Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
CARBAMAZEPINE SANDOZ
®
(CARBAMAZEPINE) TABLETS
1
NAME OF THE MEDICINE
Carbamazepine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carbamazepine Sandoz tablets contain 100 mg or 200 mg of
carbamazepine.
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.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Carbamazepine tablets 100 mg: White round flat tablets with bevelled
edges. One side bears
the imprint “GEIGY”, the other “B/W” and a score
Carbamazepine tablets 200 mg: White round flat tablets with bevelled
edges. One side bears
the imprint “CG”, the other “G/K” and a score
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
Carbamazepine Sandoz is suitable for monotherapy and combination
therapy. Carbamazepine
Sandoz 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)
TRIGEMINAL NEURALGIA
For relief of pain in idiopathic trigeminal neuralgia and trigeminal
neuralgia due to multiple
sclerosis; and in idiopathic glossopharyngeal neuralgia.
(Carbamazepine Sandoz 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 bipolar affective
disorders to prevent or
attenuate recurrence.
Page 2 of 24
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_EPILEPSY _
Wherever possible, Carbamazepine Sandoz should be prescribed as
monotherapy. Treat