LEVECETAM 1000 levetiracetam 1000mg tablet blister pack

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

levetiracetam, Quantity: 1000 mg

Доступно од:

Dr Reddys Laboratories Australia Pty Ltd

INN (Међународно име):

Levetiracetam

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: povidone; titanium dioxide; purified talc; magnesium stearate; hypromellose; silicon dioxide; macrogol 400; sodium starch glycollate type A; maize starch

Пут администрације:

Oral

Јединице у пакету:

60 tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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). Add-on therapy in the treatment of Primary Generalized Tonic Clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).

Резиме производа:

Visual Identification: White to off-white, oval shaped, film coated tablets debossed with breakline separating '1000' and 'MG' on one side and '1017' on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

2010-05-27

Информативни летак

Levecetam
1
LEVECETAM (LEVETIRACETAM) TABLETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LEVECETAM?
Levecetam contains the active ingredient Levetiracetam. Levecetam is
used to 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
For more information, see Section 1. Why am I using Levecetam? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEVECETAM?
Do not use if you have ever had an allergic reaction to levecetam or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Levecetam? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Levecetam and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE LEVECETAM?
•
The film coated tablets must be taken orally, swallowed with liquid
and may be taken with or without food.
•
The daily dose is administered in two equally divided doses.
More instructions can be found in Section 4. How do I use Levecetam?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEVECETAM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly (if relevant).
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how this
medicine affects you. Children
should be careful doing things like riding bicycles or climbing trees.
DRINKING
ALCO

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION
LEVECETAM (LEVETIRACETAM) TABLETS
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Levecetam 250, 500, 1000/ tablets is
levetiracetam 250 mg, 500 mg or
1000 mg.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Levecetam
250
levetiracetam
250
mg
are
blue
coloured,
oval
shaped,
film-coated
tablets
debossed with breakline separating ‘250’ and ‘MG’ on one side
and ‘1014’ on other side.
Levecetam 500 levetiracetam 500 mg are yellow coloured, oval shaped,
film-coated tablets
debossed with breakline separating ‘500’ and ‘MG’ on one side
and ‘1015’ on other side.
Levecetam 1000 levetiracetam 1000 mg are white to off white, oval
shaped, film-coated tablets
debossed with breakline separating ‘1000’ and ‘MG’ on one side
and ‘1017’ on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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).
Add-on therapy in the treatment of Primary Generalized Tonic Clonic
(PGTC) seizures in adults
and children from 4 years of age with idiopathic generalised epilepsy
(IGE).
4.2
D
OSE AND METHOD OF ADMINISTRATION
The film coated tablets must be taken orally, swallowed with liquid
and may be taken with or
without food. The daily dose is administered in two equally divided
doses.
MONOTHERAPY. The recommended starting dose is 250 mg twice daily which
should be increased
to an initial therapeutic dose of 500 mg twice daily after two weeks.
The dose can be further
increased by 250 mg twice daily every two weeks depend