Sabril 500 mg Film Coated Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Vigabatrin

Beschikbaar vanaf:

PCO Manufacturing Ltd.

ATC-code:

N03AG; N03AG04

INN (Algemene Internationale Benaming):

Vigabatrin

Dosering:

500 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Fatty acid derivatives; vigabatrin

Autorisatie-status:

Authorised

Autorisatie datum:

2008-02-01

Bijsluiter

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
SABRIL
® 500 MG FILM-COATED 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.
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 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
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, up to tunnel vision or loss of vision, and irreversible, so it
must be found

Productkenmerken

Health Products Regulatory Authority
18 May 2021
CRN00CCP6
Page 1 of 2
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
_Product as imported from The Czech Republic:_
White, oval biconvex film-coated tablets with a breakline on one side
and 'SABRIL' on the other.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA0540/023/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/023/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
TABLET CORE
Povidone (E1201)
Microcrystalline cellulose (E460)
Sodium starch glycollate (type A)
Magnesium Stearate
FILM COAT
Hypromellose 15 mPa.s (E464)
Titanium dioxide (E171)
Macrogol 8000
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Health Products Regulatory Authority
18 May 2021
CRN00CCP6
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Container(s) : PVC/Aluminium foil blister packed in cardboard cartons.
Pack size : 100 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/203/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of First Authorisation: 1st February 2008
Last updated: August 2014.
10 DATE OF REVISION OF THE TEXT
May 2021