Sabril 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Vigabatrin

Available from:

Dowelhurst Ltd

ATC code:

N03AG04

INN (International Name):

Vigabatrin

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100

Patient Information leaflet

1. WHAT SABRIL IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE SABRIL
3. HOW TO TAKE SABRIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
SABRIL
® 500MG TABLETS
(vigabatrin)
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.
The name of your medicine is Sabril 500mg tablets but it will
be referred to as Sabril throughout this leaflet.
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
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). DO NOT TAKE SABRIL
x
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
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
s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sabril 500 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg vigabatrin
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval, biconvex, tablets with a break-line on one
side and “Sabril”
engraved on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
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.
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 1g 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 3g/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 concentration of the drug i