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SABRIL SACHET 0.5G

Active substance(s): VIGABATRIN

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Package leaflet:
Information for the user

1

Is this leaflet hard to see or read?
Country Version
CRGB V1-05/2012

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.

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.

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

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.

1. What Sabril is and what it is used for

RECTO / VERSO
EN ROULEAU / P. 1

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).

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.

2. What you need to know before you take
Sabril

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.

Do not take Sabril
× if you are allergic to vigabatrin or any of the
other ingredients of this medicine (listed in
Section 6).

Recto

VERSO

DIMENSIONS
210 x 140 mm

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.

vigabatrin

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

CODE LAETUS : 600

Taille mini du texte : 8 pt

DU NOIR

Reflex Blue

LAIZE
140 mm
RECTO

CODE ARTICLE
7062004

 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

Sabril 500 mg granules
for oral solution

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057598)
NOTICE DOUBLE
(L14)
SABRIL 500 mg / sachets / Angleterre
V6_21 JUL 2014

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

3

Warnings and precautions
Talk to your doctor before taking Sabril if:
 You are breast-feeding
 You are pregnant or plan to become pregnant

Sabril passes into breast milk. If you are breastfeeding, ask your doctor for advice before

1

DÉFILEMENT

taking this medicine. Breast-feeding should not be
done during treatment.

If you have any further questions on
the use of this medicine, ask your doctor or
pharmacist.

If you are older people and/or have kidney
problems, your doctor may wish to give you a
smaller dose.

4. Possible side effects

DÉFILEMENT

DU NOIR

2

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

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.

Verso

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,

Bodyweight 10-15 kg 0.5-1 g (1-2 sachets)/day

15-30 kg 1-1.5 g (2-3 sachets)/day

30-50 kg 1.5-3 g (3-6 sachets)/day

greater than 50 kg
2-3 g (4-6 sachets)/day
(adult dose).

CODE LAETUS : 600

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.

Reflex Blue

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 sachets 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.

CODE ARTICLE
7062004

The usual starting dose for adults is 1 g (2 sachets)
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 sachets).
The highest recommended dose is 3 g/day.

PLI / COLLE

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.

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

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.

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057598)
NOTICE DOUBLE
(L14)
SABRIL 500 mg / sachets / Angleterre
V6_21 JUL 2014

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
patients.

LAIZE
140 mm

If you take more Sabril than you should
If you or your child accidentally take too many
Sabril sachets, 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.

DIMENSIONS
210 x 140 mm

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.

RECTO / VERSO
EN ROULEAU / P. 2

Method of administration
The route of administration is oral use (by mouth).
Do not open the sachets until it is time for you
to take your medicine. To take a dose you should
dissolve all the powder from the recommended
number of sachets in half a drinking glass full
of cold water or soft drink, like juice or milk.
When all the powder has dissolved, drink all of
the solution straight away and do not leave it
standing.
You can take Sabril before or after meals.
The daily dose can be taken as a single dose or
divided in two doses.

PLI / COLLE

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

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

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
(anaemia)

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 via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Sabril
Keep this medicine 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
sachets. The expiry date refers to the last day of
that month.

Uncommon side effects (may affects 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

Recto

RECTO / VERSO
EN ROULEAU / P. 3

DIMENSIONS
210 x 140 mm

• O
 ther 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.

Other side effects include:
Very common side effects (may affect more than
1 in 10 people)
• Tiredness and pronounced sleepiness.
• Joint pain

CODE LAETUS : 600

DU NOIR

Reflex Blue

LAIZE
140 mm

CODE ARTICLE
7062004

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057598)
NOTICE DOUBLE
(L14)
SABRIL 500 mg / sachets / Angleterre
V6_21 JUL 2014

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

so it must be found early. If you or your child
experience(s) visual disturbances, contact your
doctor or hospital immediately.

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

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

6. Contents of the pack and other information
What Sabril contains
- The active substance is vigabatrin. One sachet
contains 500 mg vigabatrin.
- The other ingredient is: Povidone K30 (E1201)
What Sabril looks like and contents of the pack
Sabril appears as white to off-white granular powder.
It is available in packs of 50, 60 or 100 sachets.
Not all pack sizes may be marketed.

3

DÉFILEMENT

This leaflet was last approved in July 2014

DU NOIR

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

Reflex Blue

CODE LAETUS : 600

DÉFILEMENT

Verso

7062004

4

DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057598)
NOTICE DOUBLE
(L14)
SABRIL 500 mg / sachets / Angleterre
V6_21 JUL 2014

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

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria: Sabril 500 mg lösliches Pulver
Denmark: Sabrilex
Finland: Sabrilex 500 mg rakeet oraaliliuosta varten
France: Sabril 500 mg granulés pour solution
buvable en sachet-dose
Germany: Sabril Beutel
Ireland: Sabril 500 mg granules for oral solution
Italy: Sabril 500 mg granulato per soluzione orale
Netherlands: Sabril 500 mg granulaat voor
drank
Portugal: Sabril 500 mg granulado para soluçào
oral
Spain: Sabrilex 500 mg granulado para solución
oral
Sweden: Sabrilex 500 mg granulat till oral
lösning
United Kingdom: Sabril 500 mg granules for oral
solution

CODE ARTICLE
7062004

For any information about this medicine, please
contact the Marketing Authorisation Holder.

LAIZE
140 mm

Manufactured by:
Patheon France SA,
Boulevard de Champaret,
38300 Bourgoin-Jallieu, France

DIMENSIONS
210 x 140 mm

RECTO / VERSO
EN ROULEAU / P. 4

sens lecture
code laetus

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

Expand view ⇕

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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