Gabitril 10 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Tiagabine

Boleh didapati daripada:

Teva Pharma B.V.

Kod ATC:

N03AG; N03AG06

INN (Nama Antarabangsa):

Tiagabine

Dos:

10 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Fatty acid derivatives; tiagabine

Status kebenaran:

Marketed

Tarikh kebenaran:

1997-03-07

Risalah maklumat

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
GABITRIL 5 MG FILM-COATED TABLETS
GABITRIL 10 MG FILM-COATED TABLETS
GABITRIL 15 MG FILM-COATED TABLETS
Tiagabine (as hydrochloride monohydrate)
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 Gabitril is and what it is used for
2.
What you need to know before you take Gabitril
3.
How to take Gabitril
4.
Possible side effects
5.
How to store Gabitril
6.
Contents of the pack and other information
1.
WHAT GABITRIL IS AND WHAT IT IS USED FOR
Gabitril is an anti-epileptic medicine. Tiagabine, the active
substance in Gabitril, increases the level of
gamma-aminobutyric acid (GABA) in the brain, which prevents or reduces
the number of seizures
(epileptic events).
Gabitril is used to help control epilepsy in adults and adolescents
over 12 years old with partial
seizures.
It is taken in combination with other medicines when these are not
effective enough alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABITRIL
DO NOT TAKE GABITRIL:
-
if you are allergic to tiagabine or any of the other ingredients of
this medicine (listed in section
6).
-
if you suffer from severe liver disease.
-
in combination with a herbal preparations containing St. John’s Wort
(Hypericum perforatum).
See ‘Other medicines and Gabitril’.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Gabitril
-
if you are under the age of 12 years.
-
if you suffer from generalised epilepsy, as you may experience
worsening of absences (short
periods of cloudin

Ciri produk

Health Products Regulatory Authority
06 July 2022
CRN00CZ32
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabitril 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Gabitril 10 mg tablet contains:
Tiagabine 10 mg (as hydrochloride monohydrate)
Excipient(s) with know effect:
Each Gabitril 10 mg film-coated tablet contains 117 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gabitril 10 mg film-coated tablet is a white, oval biconvex
film-coated tablet embossed on one side with "252".
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Add-on treatment of partial seizures with or without secondary
generalisation which are not satisfactorily controlled with other
anti-epileptic medicinal products.
The medicinal product should only be used in adults and adolescents
over 12 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rapid titration and/or large dose increments of tiagabine may not be
well-tolerated and should be avoided (see section 4.4)
_Paediatric population below 12 years_
Tiagabine is not recommended for use in children below 12 years due to
a lack of data on safety and efficacy (see section 4.4).
_Adults and adolescents over 12 years:_
Dosing schemes may need to be individualised based upon a patient's
particular characteristics such as age, liver function and
concomitant medicinal products (see section 4.5).
The initial daily dose should be taken as a single dose or divided
into two doses. The daily maintenance dose should be divided
into two or three single doses.
_In association with enzyme-inducing medicinal products:_
The initial dose is 5-10 mg/day tiagabine, followed by dose titration
in weekly increments of 5-10 mg/day to reach the
maintenance dose.
The usual maintenance dose in patients taking enzyme-inducing
medicinal products is 30-50 mg/day. Doses up to 70 mg/day
are well tolerated.
_In association with non enzyme-inducing medicinal products:_
The initial dose is 5-10 mg/day tiagabine, followed