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SABRIL TABLETS 500MG

Active substance(s): VIGABATRIN

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CODE ARTICLE
7062010
RECTO

LAIZE
157,5 mm

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057658)
NOTICE PLIÉE
(L19)
SABRIL 500 mg / comprimés / Angleterre
V7_21 JUL 2014

DIMENSIONS : 210 x 157,5 mm
DÉPLIÉE : 420 x 157,5 mm

VERSO

RECTO / VERSO
À PLAT / P. 1

Responsable: Mr FRANC Pascal
Patheon France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93 88 37 fax.: 04 74 93 87 81

Package leaflet:
Information for the user

Sabril 500 mg
film-coated tablets
vigabatrin

I s this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Sabril is and what it is used for
2. What you need to know before you take Sabril
3. How to take Sabril
4. Possible side effects
5. How to store Sabril
6. Contents of the pack and other information
1. What Sabril is and what it is used for
Sabril is used to help control various forms of epilepsy.
It is used together with your current medication to treat
“difficult to control” epilepsy. It will initially be prescribed
by a specialist. Your response to the treatment will be
monitored.
It is also used to control infantile spasms (West’s syndrome).
2. Before you take Sabril
Do not take Sabril
× if you are allergic to vigabatrin or any of the other
ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor before taking Sabril if:
 You are breast-feeding
 You are pregnant or plan to become pregnant
 You have or have had depression or any other
psychiatric illness in the past
 You have had any kidney problems
 You have had any problems with your eyes

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Visual field loss (loss of sight from the edges of your
field of vision) may occur during treatment with Sabril.
You should discuss this possibility with your doctor
before you begin treatment with this medicine. This
visual field loss may be severe and irreversible, so
it must be found early. A deterioration of this visual
field loss after treatment is discontinued cannot be
excluded. It is important that you inform your doctor
promptly if you become aware of any change to your
vision. Your doctor should perform a Visual field
examination before you start taking Sabril and at
regular intervals during the treatment.
If you develop symptoms like sleepiness, reduced
consciousness and movements (stupor) or confusion
consult your doctor who will decide upon a dose
reduction or withdrawal.
A small number of people being treated with
antiepileptics such as vigabatrin have had thoughts of
harming or killing themselves. If at any time you have
had these thoughts, immediately contact your doctor.
Children
Movement disorders have been seen in young infants
treated for infantile spasms (West’s syndrome).If you
observe unusual movement disorders in the child, consult
your doctor who will decide if it is necessary to consider
changing the treatment.
Other medicines and Sabril
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.
Sabril should not be used in combination with other
medicines that may have side effects related to the eye.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before
taking this medicine.
Do not take Sabril during pregnancy unless your doctor
tells you to. Sabril may cause problems to unborn
children. However, do not stop taking the medicine
suddenly because this may risk the mother’s health as
well as the baby’s health.
Sabril passes into breast milk. If you are breast-feeding,
ask your doctor for advice before taking this medicine.
Breast-feeding should not be done during treatment.
Driving and using machines
Do not drive or operate machinery if your epilepsy is
uncontrolled.
Sabril sometimes causes symptoms like drowsiness or
dizziness and your ability to concentrate and react may
be reduced. If such symptoms occur whilst taking Sabril,
you should not do any hazardous tasks such as driving or
operating machinery.
Visual disorders, which can affect your ability to drive and
use machines, have been found in some patients taking
this medicine. If you wish to continue driving you must
be tested regularly (every six months) for the presence of
visual disorders even if you do not notice any changes to
your vision.

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3. How to take Sabril
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
It is important to follow your doctor’s instructions exactly.
Never change the dose yourself. The doctor prescribes the
dose and adjusts it individually for the patients.
The usual starting dose for adults is 1 g (2 tablets) daily.
However, your doctor may wish to increase or decrease
the dose depending on your response; the usual
adult daily dose is 2 to 3 g (4 to 6 tablets). The highest
recommended dose is 3 g/day.
If you are older people and/or have kidney problems, your
doctor may wish to give you a smaller dose.
Use in children
Resistant partial epilepsy
For children, the dose is based on age and weight. The
usual starting dose for children is 40 milligrams per
kilogram bodyweight daily. The following table gives the
number of tablets to give to a child according to his/her
bodyweight. Remember that this is just a guideline. The
child’s doctor may wish to have slightly different doses.
Bodyweight 10 - 15 kg

15 - 30 kg

30 - 50 kg

greater than 50 kg

0.5-1 g (1-2 tablets)/day
1-1.5 g (2-3 tablets)/day
1.5-3 g (3-6 tablets)/day
2-3 g (4-6 tablets)/day
(adult dose).

Children with infantile spasms (West’s Syndrome)
The recommended starting dose for infants with West’s
Syndrome (infantile spasms) is 50 milligrams per kilogram
bodyweight per day although higher doses may be used
sometimes.
Method of administration
The route of administration is oral use (by mouth).
Always swallow the tablet with at least a half of a drinking
glass of water.
You can take Sabril before or after meals.
The daily dose can be taken as a single dose or divided in
two doses.
If you take more Sabril than you should
If you or your child accidentally take too many Sabril
tablets, tell your doctor immediately or go to your nearest
hospital or Poison Information Centre.
Possible signs of overdose include drowsiness or loss/
depressed level of consciousness.
If you forget to take Sabril
If you forget to take a dose, take it as soon as you do
remember. If it is almost time for your next dose, just take
one dose. Do not take a double dose to make up for the
missed dose.
If you stop taking Sabril
Do not stop taking this medicine without talking to your
doctor. If your doctor decides to stop your treatment you
will be advised to gradually reduce the dose. Do not stop
suddenly as this may cause your seizures to occur again.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
As with other antiepileptic medicines, some patients may
experience an increase in the number of seizures (fits)
whilst taking this medicine. If this happens to you, or to
your child, contact your doctor immediately.
Talk to your doctor immediately if you experience:
Very common side effects (may affect more than 1 in 10
people)
• Visual field changes – About ⅓ or 33 out of 100 patients
treated with Sabril may have changes in the visual field
(narrow visual field). This “visual field defect” can range
from mild to severe. It is usually detected after months
or years of treatment with Sabril. The changes in the
visual field may be irreversible, so it must be found early.
If you or your child experience(s) visual disturbances,
contact your doctor or hospital immediately.
Other side effects include:
Very common side effects (may affect more than 1 in 10
people)
• Tiredness and pronounced sleepiness
• Joint pain
Common side effects (may affect up to 1 in 10 people)
• Headache
• Weight gain
• Shaking (tremor)
• Swelling (oedema)
• Dizziness
• Sensation of numbness or tingling (pins and needles)
• Disturbance of concentration and memory
• Psychological disturbances including agitation,
aggression, nervousness, irritability, depression,
thought disturbance and feeling suspicious without
reason (paranoia). These side effects are usually
reversible when the dose is reduced or gradually
discontinued. However, do not decrease your dose
without first talking to your doctor. Contact your
doctor if you experience these side effects.
• Nausea, Vomiting and abdominal pain
• Blurred vision, double vision, and uncontrolled
movement of the eye, which may cause dizziness
• Speech disorder
• Decrease in the number of red blood cell count
(anaemia)
Uncommon side effects (may affect up to 1 in 100 people)
• Lack of coordination in movements or fumbling
• More severe psychological disturbances such as
feeling elated or over-excited which causes unusual
behaviour, and feeling detached from reality
• Skin rash

sens lecture
code laetus

PLIAGE

Reflex Blue

Country version
Logo version

Recto

DÉFILEMENT

couleur(s) pantone
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CODE ARTICLE
7062010
LAIZE
157,5 mm

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057658)
NOTICE PLIÉE
(L19)
SABRIL 500 mg / comprimés / Angleterre
V7_21 JUL 2014

DIMENSIONS : 210 x 157,5 mm
DÉPLIÉE : 420 x 157,5 mm

RECTO / VERSO
À PLAT / P. 2

Responsable: Mr FRANC Pascal
Patheon France
40, boulevard de Champaret
CS 11006 – 38307 Bourgoin-Jallieu Cedex
tél.: 04 74 93 88 37 fax.: 04 74 93 87 81

couleur(s) pantone
trames:
dans l’ordre prévu linéature: 150 lpi
inclinaison :
d’impression :

Reflex Blue

DU NOIR

CODE LAETUS : 599

Verso

Rare side effects (may affect up to 1 in 1.000 people)
• Serious allergic reaction, which causes swelling of the
face or throat: If you experience these symptoms, you
should tell your doctor immediately.
• Hives or nettle rash
• Marked sedation, stupor and confusion. These side
effects are usually reversible when the dose is reduced
or gradually discontinued. However, do not decrease
your dose without first talking to your doctor. Contact
your doctor if you experience these side effects.
• Suicide attempt
• Other eye problems such as retinal disorder, for
example poor vision at night and difficulty adjusting
from bright to dim areas, sudden or unexplained loss
of vision, loss of sight from the edges of your field of
vision, sensitivity to light.
Very rare side effects (may affect up to 1 in 10,000 people)
• Other eye problems such as pain in your eyes (optic
neuritis) and loss of vision, including colour vision
(optic atrophy)
• Hallucinations (feeling, seeing or hearing things that
are not there)
• Liver problems
Additional side effects in children
Very common side effects (may affect more than 1 in 10
people)
• Excitation or restless
Not known frequency (frequency cannot be estimated
from the available data)
Movement disorders in young infants treated for infantile
spasm.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly (see
details below).
United Kingdom
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D’Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Sabril
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the outer cardboard box and blisters. The expiry
date refers to the last day of that month.
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This medicine does not require any special storage
conditions.
Do not throw away any medicines via waste or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the
enviornment.
6. Contents of the pack and other information
What Sabril contains
- The active substance is vigabatrin. One film-coated
tablet contains 500 mg vigabatrin.
- The other ingredients are:

Tablet Core:
Povidone K30 (E1201), Microcrystalline cellulose
(E460), Sodium starch glycollate (type A)
Magnesium stearate

Tablet Coating:
Hypromellose 15 mPa s (E464), Titanium dioxide
(E171), Macrogol 8000
What Sabril looks like and contents of the pack
Sabril appears as white to off-white, oval, biconvex filmcoated tablets with a break-line on one side and “SABRIL”
engraved on the other side.
It is available in clear blisters or opaque blisters of 10 tablets.
Each package contains 30, 50, 60, 100 or 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
MA Holder:
Sanofi,
One Onslow Street,
Guildford, Surrey,
GU1 4YS, UK.
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufactured by:
Patheon France SA,
Boulevard de Champaret,
38300 Bourgoin-Jallieu, France
For any information about this medicine, please contact
the Marketing Authorisation Holder.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria: Sabril 500 mg Filmtabletten
Belgium: Sabril 500 mg filmomhulde tabletten
Denmark: Sabrilex
Finland: Sabrilex 500 mg tabletti, kalvopäällysteinen
France: Sabril 500 mg comprimé pelliculé
Germany: Sabril 500 mg Filmtabletten
Greece: Sabril 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
Ireland: Sabril 500 mg film-coated tablets
Italy: Sabril 500 mg compresse rivestite con film
Luxembourg: Sabril 500 mg comprimés pelliculés
Netherlands: Sabril 500 mg filmomhulde tablet
Portugal: Sabril 500 mg comprimidos revestidos por
pelicula
Spain: Sabrilex 500 mg comprimidos recubiertos con
pelicula
Sweden: Sabrilex 500 mg filmdragerade tabletter
United Kingdom: Sabril 500 mg film-coated tablets
This leaflet was last approved in July 2014

7062010

DÉFILEMENT

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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