Sabril

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Vigabatrin

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

SABRIL
®

_vigabatrin_
CONSUMER MEDICINES INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sabril.
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 taking Sabril against the benefits
this medicine is expected to 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 SABRIL IS USED
FOR
Sabril is a medicine used to help
control epilepsy, a condition where
you have repeated fits or
convulsions. Sabril is used in
addition to other medicines to treat
epilepsy.
Sabril is an anticonvulsant. It works
by stopping the breakdown of an
important chemical transmitter
("messenger") in the brain and this
helps reduce seizure activity.
Your doctor, however, may have
prescribed Sabril for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SABRIL IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT TAKE IT IF YOU ARE PREGNANT
OR INTEND TO BECOME PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT TAKE IT IF YOU ARE BREAST-
FEEDING OR PLANNING TO BREAST-FEED.
Sabril passes into breast milk and
there is a possibility your baby may
be affected.
DO NOT TAKE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you take this medicine after the
expiry date has passed, it may not
work as well.
DO NOT TAKE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERING.
_BEFORE YOU START TO TAKE IT_
TELL YOUR

Summary of Product characteristics

Sabril PI 
CCDSv11 PIv9 1 Oct 13 
Page 1  

PRODUCT INFORMATION 
SABRIL
®
 TABLETS 500 MG / SABRIL
®
 SACHETS 500 MG 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Vigabatrin 
CHEMICAL STRUCTURE 
H
2
C = 
CH ─ CH ─ CH
2

─ CH
2

─ COOH 

| 

NH
2

CAS NUMBER 
60643-86-9 
DESCRIPTION 
Sabril sachets contain the inactive ingredient povidone EP. 
Sabril tablets contain the following inactive
ingredients: povidone BP, cellulose microcrystalline EP, 
sodium  starch  glycollate  USNF,  magnesium  stearate  EP,  hydroxypropyl  methylcellulose  EP, 
titanium dioxide BP and polyethylene glycol 8000. 
PHARMACOLOGY 
CLASS 
Actions: Anticonvulsant 
PHARMACODYNAMICS 
The  mechanism  of  action  is  attributed  to  dose-dependent  enzyme  inhibition  of  GABA-
transaminase  (GABA-T)  and  consequent  increased  levels  of  the  inhibitory  neurotransmitter, 
GABA.  In  mice,  decreased  GABA-T  levels  in  the  brain  persisted  for  5  days  following  a  single 
intraperitoneal  dose  (1500  mg/kg)  and  was  accompanied  by  a  marked  rise  in  brain  GABA 
concentration. 
Animal  safety  studies  carried  out  in  rat,  mouse,  dog  and  monkey  have  indicated  that  vigabatrin 
has  no  significant  adverse  effects  on  the  liver,  kidney,  lung,  heart or  gastrointestinal tract. In the 
brain, microvacuolation has been observed in white matter tracts of rat, mouse and dog at doses 
of  30-50  mg/kg/day.  This  effect  is  caused  by  a  separation  of  the  outer  lamellar  sheath  of 
myelinated fibres, a change
characteristic of intramyelinic oedema. 
In  both  rat  and  dog  (mouse,  not  tested),  the  intramyelinic  oedema  was  reversible  on  stopping 
vigabatrin  tre