Gabitril 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tiagabine hydrochloride monohydrate

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N03AG06

INN (International Name):

Tiagabine hydrochloride monohydrate

Dosage:

10mg

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

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 because it may
cause a recurrence of seizures. Do not
stop taking GABITRIL without consulting
your doctor.
-
Feel anxious or depressed, or have done
so in the past then these symptoms may
get worse or appear again during
treatment with GABITRIL. You must tell
your doctor if you feel absent, depressed
or anxious.
-
Notice an increase in the number of
seizures or new types of seizures you
shoul

Summary of Product characteristics

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