TEGRETOL 200 carbamazepine 200mg tablet bottle

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

carbamazepine, Quantity: 200 mg

Saatavilla:

Novartis Pharmaceuticals Australia Pty Ltd

Lääkemuoto:

Tablet, uncoated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

1000

luokka:

Medicine Registered

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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.

Tuoteyhteenveto:

Visual Identification: White, round flat tablets with bevelled edges. One side bears the imprint "CG", the other "G/K" and a score; Container Type: Bottle; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-08-02

Valmisteyhteenveto

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