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GABITRIL 10MG TABLETS

Active substance(s): TIAGABINE HYDROCHLORIDE MONOHYDRATE

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6816
Package leaÁet: Information for the user

GABITRIL® 5 mg,
Film-coated Tablets
(Tiagabine hydrochloride)

Digitally signed by

james.croo james.crooks@tevaph
arm.com
ks@tevaph DN:
cn=james.crooks@tev
arm.com apharm.com
Date: 2016.07.07

GABITRIL® 10 mg,
Film-coated Tablets
(Tiagabine hydrochloride)
GABITRIL® 15 mg,
Film-coated Tablets
(Tiagabine hydrochloride)

16:00:18 +01'00'

Read all of this leaÁet carefully before
you start taking this medicine because it
contains important information for you.
– Keep this leaÁet. 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
leaÁet. See section 4.

• Rifampicin (medicine for treatment of
tuberculosis), because it may weaken and
shorten the effects of GABITRIL.
• St John’s Wort.

What is in this leaÁet:
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.

Inform your doctor if you become pregnant
or are planning to have a baby.

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 gammaaminobutyric acid (GABA) in the brain,
which prevents or reduces the number of
seizures (epileptic events).

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

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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
should contact your doctor. He will advise
you on any changes that may need to be
made to your treatment.
– Notice a serious rash, including Áuid
Àlled pimples or blisters, or if you notice
spontaneous bruising or blackening of the
skin, contact your doctor immediately.
– Notice any visual disorders, you should
contact your doctor.
– Have been told by your doctor that you
have an intolerance to some sugars, you
should not take GABITRIL because it
contains lactose.
– Have mild or moderate liver disorders,
your doctor will have to adapt the dose
of GABITRIL prescribed.
A small number of people being treated with
anti-epileptics such as GABITRIL have had
thoughts of harming or killing themselves.
If at any time you have these thoughts,
immediately contact your doctor.
If you experience (or have experienced) any
of these symptoms, please tell your doctor.
Children
Do not give Gabitril to children below 12 years.

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500 x 150mm

LEAFLET

43088

Gabitril 15mg/10mg/5mg FC Tabs All
CeUK (Submission)

Other medicines and GABITRIL
Tell you doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines, including:
• Other anti-epileptic medicines like
phenytoin, carbamazepine, phenobarbital
and primidone, because they may weaken
and shorten the effects of GABITRIL.
Version 3.12

GABITRIL with food and drink
You should take GABITRIL tablets during a
meal or snack.
Pregnancy and breast-feeding
As a precautionary measure, it is preferable
not to take GABITRIL during pregnancy or
breast-feeding.

Driving and using machines
You should discuss with your doctor
whether it is safe for you to drive or operate
machinery. GABITRIL may cause dizziness,
sleepiness or tiredness, especially at the
beginning of the treatment. Do not drive
a vehicle or operate machinery if you are
feeling dizzy, sleepy or tired.
GABITRIL contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

GABITRIL is used to help control epilepsy
in adults and adolescents over 12 years old
with partial seizures.

REG0073251

In case of combination with one or several of
these drugs, your doctor may adapt the dose
of GABITRIL.

3. How to take GABITRIL
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
GABITRIL tablets should be swallowed with
a glass of water, during a meal or snack.
When you Àrst start using GABITRIL, your
doctor will work with you to Ànd the dose that
will control your epilepsy. You will begin by
taking GABITRIL tablets once or twice a day.
The dose will then be gradually increased until
it is sufÀcient to control your epilepsy.
Once your dose has been established, you may
need to take GABITRIL tablets two or three
times a day. The dosage on starting treatment
with GABITRIL is 5 to 10 mg daily and it is
increased weekly by 5 to 10 mg daily.
The average maintenance dose can range
between 15 and 45 mg per day but higher
doses may sometimes be prescribed.
If you have mild or moderate liver disorders,
your doctor will have to adjust the dose of
GABITRIL.
GABITRIL tablets may be used with caution
for treatment in the elderly. Your doctor will
decide if it is the best treatment for you.
If you take more GABITRIL than you should
The symptoms of overdosage with GABITRIL
are headache, becoming mute (silent) and
withdrawn, vomiting (being sick), increased
salivary Áow, inability to stop passing
urine, difÀculty controlling movements,
sleepiness, dizziness, confusion, feeling
agitated, aggressive behaviour, uncontrolled
movements of the eye, impaired speech,
impaired memory, hallucinations (seeing
or hearing things that are not there), odd
beliefs, slower or faster heart beat, low or
high blood pressure, shaking, twitching,
seizures (Àts), loss of consciousness,
difÀculty in breathing or stopping breathing
and coma.
If you have taken too many tablets or if a
child has taken any, immediately contact
your doctor or the nearest hospital
If you forget to take GABITRIL
If you have forgotten to take a dose, continue
with the treatment as prescribed by your
doctor.
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking GABITRIL
You should continue to take GABITRIL for as
long as indicated by your doctor.
Do not stop treatment with GABITRIL
without having Àrst informed your doctor,
because there is a risk of recurrence of
seizures. Your doctor will explain to you
how to gradually reduce the dose (over
2-3 weeks).

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If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

The other ingredients are:

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
The side effects are generally mild to
moderate. Most occur during the Àrst few
months of the treatment and are often
short-lived. These may include:
Very common side effects (occurring in more
than 1 in 10 people):
• Dizziness
• Tremor
• Feeling nervous
• Tiredness
• Feeling sick (nausea)
Common side effects (occurring in less than
1 in 10 people, but more than 1 in 100):
• Diarrhoea, being sick (vomiting),
abdominal pain
• DifÀculty in sleeping, feeling overemotional
• Acting in a hostile or aggressive way
• DifÀculty in controlling movements;
walking, stepping or running oddly;
difÀculty speaking
• Muscle twitching
• Blurred vision
• DifÀculty in concentrating
• Feeling depressed
• Slowness of speech
• Confusion
• Accidental injury
Uncommon side effects (occurring in less
than 1 in 100, but more than 1 in 1,000):
• Loss of reality
• Drowsiness
• Bruising
• Severe blistering rash. If you notice
any skin complaints, contact your doctor
immediately.

Tablet core:
Cellulose, microcrystalline (E 460), Ascorbic
acid (E 300), Lactose anhydrous, Starch,
pregelatinised (maize), Crospovidone, Silica,
colloidal anhydrous (E 551), Hydrogenated
vegetable oil (Type 1), Stearic acid,
Magnesium stearate,
Film-coating:
Hypromellose, Hydroxypropylcellulose
(E 463), Titanium dioxide (E 171)
What GABITRIL looks like and contents
of the pack
GABITRIL are white, round or oval and
slightly curved Àlm-coated tablets.
GABITRIL tablets are supplied in a plastic
bottle with a screw-top.
The plastic bottle of GABITRIL contains
a drying agent container which looks like
a cylindrical canister. Be careful not to
swallow it.
GABITRIL 5 mg tablets are marked “251”.
GABITRIL 10 mg tablets are marked “252”.
GABITRIL 15 mg tablets are marked “253”.
GABITRIL tablets are supplied in bottles of
50 or 100 tablets. However not all pack
sizes may be available in your country.
Marketing Authorisation Holder
Cephalon UK Limited, Ridings Point,
Whistler Drive, Castleford, West Yorkshire,
WF10 5HX, UK
Manufacturers
Almac Pharma Services,
Seagoe Industrial Estate, Craigavon,
County Armagh,
BT63 5AU, UK
This leaÁet was last revised in 06/2016.

Rare side effects (occurring in less than 1 in
1,000 people, but more than 1 in 10,000):
• A state of epilepsy that continues without
any Àtting
• Visual defects
• Hallucinations
• False beliefs
Unknown (exact frequency cannot be
estimated from the available data)
• Encephalopathy (lethargy, confusion, with
or without seizures)
• Serious rash, including Áuid Àlled pimples
or blisters; or a severe rash with reddening
and peeling of skin
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaÁet. You can
also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store GABITRIL
Keep out of the sight and reach of children.
Do not use this medicine after the expiry
date which is stated on the box and bottle.
The expiry date refers to the last day of
that month.
Do not refrigerate (2-8°C) or freeze.
Store in the original package.
Take this medicine out of its packaging only
when you are ready to use it.
Do not remove the drying agent container
(small cylindrical looking canister) from
the bottle.
Do not use this medicine if you notice the
tablets have changed in appearance
(e.g. if their colour changes: they are
normally white).
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
to protect the environment.
6. Contents of the pack and other
information
What GABITRIL contains
The active substance is tiagabine anhydrous,
present in the medicine as hydrochloride
monohydrate.
Each GABITRIL 5 mg tablet contains 5 mg of
tiagabine anhydrous.
Each GABITRIL 10 mg tablet contains 10 mg
of tiagabine anhydrous.
Each GABITRIL 15 mg tablet contains
15 mg of tiagabine anhydrous.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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