Levetiracetam (Pharmacare)

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Levetiracetam 750mg

Mevcut itibaren:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Adı):

Levetiracetam 750 mg

Doz:

750 mg

Farmasötik formu:

Film coated tablet

Kompozisyon:

Active: Levetiracetam 750mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Maize starch Opadry orange 85F23452 Povidone Purified talc

Reçete türü:

Prescription

Tarafından üretildi:

Hetero Labs Limited

Terapötik endikasyonlar:

Use in epileptic patients aged 6 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 seizures in adults and children from 6 years of age with idiopathic generalized epilepsy (IGE).

Ürün özeti:

Package - Contents - Shelf Life: Blister pack, Alu foil with 250 microns PVC/60 GSM PVdC film or Alu foil with 250 microns PVC film - 60 dose units - 36 months from date of manufacture stored at or below 25°C

Yetkilendirme tarihi:

2016-04-19

Bilgilendirme broşürü

NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI)
Page 1 of 7
LEVETIRACETAM 250MG, 500MG, 750MG & 1000MG FILM-COATED TABLETS
(PHARMACARE®)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Levetiracetam 250mg, 500mg, 750mg and
1000mg film-coated tablets (Pharmacare®).
This leaflet answers some common questions about Levetiracetam. It
does not contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Levetiracetam against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT LEVETIRACETAM IS USED FOR
Levetiracetam is used to control epilepsy.
Epilepsy is a condition where you have repeated seizures (fits). There
are many different types of
seizures, ranging from mild to severe.
Levetiracetam belongs to a group of medicines called antiepileptics.
These medicines are thought
to work by controlling brain chemicals which send signals to nerves so
that seizures do not
happen.
Levetiracetam may be used alone, or in combination with other
medicines, to treat your condition.
Your doctor may prescribe Levetiracetam in addition to your current
therapy.
Ask your doctor if you have any questions about why Levetiracetam has
been prescribed for you.
There is no evidence that Levetiracetam is addictive.
This medicine is available only with a doctor's prescription.
The safety and effectiveness of Levetiracetam has not been established
in patients less than
4 years of age.
BEFORE YOU TAKE LEVETIRACETAM
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LEVETIRACETAM IF YOU HAVE AN ALLERGY TO:
•
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Levetiracetam may include:
o
shortness of breath, wheezing or difficulty breathing
o
swelling of the face, lips, tongue or other parts of the bo

Ürün özellikleri

NEW ZEALAND DATA SHEET
Page 1 of 14
NAME OF MEDICINE
LEVETIRACETAM 250MG, 500MG, 750MG & 1000MG FILM-COATED TABLETS
(PHARMACARE®)
PRESENTATION
LEVETIRACETAM 250MG FILM-COATED TABLETS (PHARMACARE®) contain 250mg
of levetiracetam
(form-I). Dimensions 14.20 x 6.20mm. Blue coloured, oblong shaped,
scored, film coated tablets
debossed with 'H' on one side and '87' on other side.
LEVETIRACETAM 500MG FILM-COATED TABLETS (PHARMACARE®) contain 500mg
of levetiracetam
(form-I). Dimensions 18.50 x 7.50mm. Yellow coloured, oblong shaped,
scored, film coated tablets
debossed with 'H' on one side and '88' on other side.
LEVETIRACETAM 750MG FILM-COATED TABLETS (PHARMACARE®) contain 750mg
of levetiracetam
(form-I). Dimensions 18.90 x 9.60mm. Orange coloured, oblong shaped,
scored, film coated tablets
debossed with 'H' on one side and '90' on other side.
LEVETIRACETAM 1000MG FILM-COATED TABLETS (PHARMACARE®) contain 1000mg
of levetiracetam
(form I). Dimensions 21.40 x 10.20mm. White coloured, oblong shaped,
scored, film coated tablets
debossed with 'H' on one side and '91' on other side.
The 250mg & 750mg strength tablets can’t be halved. Refer to 'Dosage
and Administration' section.
USES
MECHANISM OF ACTION
The precise mechanism of action by which Levetiracetam induces seizure
protection still remains to
be fully elucidated, but appears to be unrelated to the mechanisms of
current anti-epileptic drugs.
_In vitro _and _in vivo _experiments suggest that Levetiracetam does
not alter basic cell characteristics
and normal neurotransmission.
_In vitro _studies show that Levetiracetam affects intraneuronal Ca
2+
levels by partial inhibition of
N-type Ca
2+
currents and by reducing the release of Ca
2+
from intraneuronal stores. In addition, it
partially reverses the reductions in GABA- and glycine-gated currents
induced by zinc and β-
carbolines. Furthermore, Levetiracetam has been shown in _in vitro
_studies to bind to a specific site
in rodent brain tissue.
This binding site is the synaptic vesicle protein 2A, believed to be
i