Sabril 500mg granules for oral solution sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:

Vigabatrin

Available from:

Sanofi

ATC code:

N03AG04

INN (International Name):

Vigabatrin

Dosage:

500mg

Pharmaceutical form:

Granules for oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5015265300234

Patient Information leaflet

                                TEXTE
TEXTE
1
3
VERSO
RECTO
DÉFILEMENT
Recto
COULEUR(S) PANTONE
DANS L’ORDRE PRÉVU
D’IMPRESSION:
CODE ARTICLE
7062004
DESCRIPTIF TECHNIQUE DE L’ARTICLE
(Remplace 7057598)
NOTICE DOUBLE
(L14)
SABRIL 500 MG / SACHETS / ANGLETERRE
V6_21 JUL 2014
LAIZE
140 MM
REFLEX BLUE
DU NOIR
TRAMES:
LINÉATURE: 150 LPI
INCLINAISON :
Taille mini du texte : 8 PT
CODE LAETUS : 600
DIMENSIONS
210 X 140 MM
Responsable: M
r
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
RECTO / VERSO
EN ROULEAU / P. 1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
SABRIL 500 MG GRANULES
FOR ORAL SOLUTION
vigabatrin
Is 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SABRIL
DO NOT TAKE SABRIL
×
if you are allergic to vigabatrin or any of the
other ingredients of this medicine (listed 
                                
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Summary of Product characteristics

                                OBJECT 1
SABRIL 500 MG GRANULES FOR ORAL SOLUTION
Summary of Product Characteristics Updated 14-Jul-2014 | SANOFI
1. Name of the medicinal product
Sabril 500 mg granules for oral solution
2. Qualitative and quantitative composition
Each sachet contains 500 mg vigabatrin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Granules for oral solution
White to off-white granular powder.
4. Clinical particulars
4.1 Therapeutic indications
Treatment in combination with other antiepileptic medicinal products
for patients with resistant partial
epilepsy with or without secondary generalisation, that is where all
other appropriate medicinal product
combinations have proved inadequate or have not been tolerated.
Monotherapy in the treatment of infantile spasms (West's syndrome).
4.2 Posology and method of administration
Sabril treatment may only be initiated by a specialist in
epileptology, neurology or paediatric neurology.
Follow-up should be arranged under supervision of a specialist in
epileptology, neurology or paediatric
neurology.
Posology
Sabril is for oral administration once or twice daily and may be taken
before or after meals. Sachet
contents may be placed in beverage (e.g. water, fruit juice or milk)
immediately before oral
administration.
If the control of epilepsy is not clinically significantly improved
after an adequate trial, vigabatrin
treatment should not be continued. Vigabatrin should be gradually
withdrawn under close medical
supervision.
Adults
Maximal efficacy is usually seen in the 2- 3g/day range. A starting
dose of 1 g daily should be added to
the patient's current antiepileptic medicinal product regimen. The
daily dose should then be titrated in
0.5g increments at weekly intervals depending on clinical response and
tolerability. The highest
recommended dose is 3 g/day.
No direct correlation exists between the plasma concentration and the
efficacy. The duration of the effect
of the medicinal product is dependent on the rate of GABA transaminase
resynthesis rather than the
c
                                
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