Gabitril 10mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Tiagabine hydrochloride monohydrate

Dostopno od:

Teva UK Ltd

Koda artikla:

N03AG06

INN (mednarodno ime):

Tiagabine hydrochloride monohydrate

Odmerek:

10mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04080100; GTIN: 5035546000264

Navodilo za uporabo

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_Title: _
_Format: 135 x 600 mm_
_Folding to format: 135 x 37,125 mm 135 x 300 mm_
_Scale: 1:1_
_Designed: Priit Lille_
_Date: 18.11.2019_
_Signature: _
_Paper: OP MEDICAL PRINT 45 g_
_Sheet: 1/2_
_Approved: _
_Date: _
_Signature: _
_Revision: v01_
_LEAFLET 135 X 600 MM_
CENTERLINE
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.
-
if you are taking St John’s Wort
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before taking GABITRIL.
TAKE SPECIAL CARE WITH GABITRIL IF
YOU:
-
Stop taking GABITRIL

Lastnosti izdelka

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 anhydrous, INN 10 mg (as hydrochloride monohydrate)
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
10 mg: Tablet. White, oval biconvex film-coated tablet embossed on one
side with ‘252’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gabitril is an anti-epileptic drug indicated as add-on therapy for
partial seizures with or without
secondary generalisation where control is not achieved by optimal
doses of at least one other
anti-epileptic drug.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gabitril should be taken orally with meals.
Dosing schemes may need to be individualised based upon a patient’s
particular characteristics
such as age and concomitant medications_. _
_ _
_Concomitant use with drugs involving CYP 3A4/5 metabolism: _As
CYP3A4/5 is involved in the
metabolism of tiagabine, it is recommended that the dose of tiagabine
is adjusted when it is taken
in combination with CYP3A4/5 inducers (see section 4.5 Interactions
with other medicinal
products and other forms of interactions).
Following a given dose of tiagabine, the estimated plasma
concentration in non-induced
patients is more than twice that in patients receiving enzyme-inducing
agents. To achieve
similar systemic exposures of tiagabine, non-induced patients require
lower and less frequent
doses of tiagabine than induced patients. These patients may also
require a slower titration of
tiagabine compared to that of induced patients.
Dosage adjustment of tiagabine should be
considered whenever a change in patient’s metabolic enzyme-inducing
status occurs as a
result of the addition, discontinuation, or dose change of the
enzyme-inducing agent.
_Adults and children over 12 years_: The initial daily dose is 5-10 mg
tiagabine, followed by
weekly increments of 5-10 mg/day. The usual maintenance dose