LEVEFINTAIC levetiracetam 1000 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 1000 mg

Available from:

AdiraMedica Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; pregelatinised maize starch; copovidone; magnesium stearate; purified talc; titanium dioxide; polyvinyl alcohol; macrogol 3350; polysorbate 80; macrogol 4000

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Levetiracetam is indicated for: ? use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation; ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy; ? add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME); and ? add-on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).

Product summary:

Visual Identification: White coloured, oval shaped, film coated tablets, embossed with OL bisect 1000 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-12-07

Summary of Product characteristics

Levefintaic Tablets version: 2.0
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION –LEVEFINTAIC
(LEVETIRACETAM)
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levefintaic film-coated tablets are available in strengths of 250 mg,
500 mg, 750 mg and 1000
mg levetiracetam.
Levetiracetam is a white to off-white powder with a faint odor and a
bitter taste. It is very
soluble in water (104 g/100 mL). It is freely soluble in chloroform
(65.3 g/100 mL) and in
methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/ 100mL),
sparingly soluble in acetonitrile
(5.7 g/100 mL) and practically insoluble in n-hexane.
It does not contain any excipient with known affect. For the full list
of excipients, see Section
6.1 List of excipients.
3
PHARMACEUTICAL FORM
Levetiracetam film coated tablets are available in four different
strengths with the following
descriptions:
250 mg: Blue Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect “250”
on one side and plain on other side.
500 mg:
Yellow Coloured, ‘Oval’ shaped, film coated tablets, embossed with
“OL” bisect “500”
on one side and plain on other side.
*750 mg: Orange Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect
“750” on one side and plain on other side.
1000 mg: White Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect
“1000” on one side and plain on other side.
*This strength is currently not distributed in Australia
Levefintaic Tablets version: 2.0
Page 2 of 32
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Levetiracetam is indicated for:
•
use in epileptic patients aged 4 years and older, initially as add-on
therapy, in the
treatment of partial onset seizures with or without secondary
generalisation;
•
monotherapy in the treatment of partial onset seizures, with or
without secondary
generalisation, in patients from 16 years of age with newly diagnosed
epilepsy;
•
add-on therapy in the treatment of myoclonic seizures in adults and