TRAVEL DIRECTION

PACKAGE LEAFLET: INFORMATION FOR THE USER

GABITRIL® 5 mg,

Film-coated Tablets

(Tiagabine hydrochloride)

GABITRIL® 10 mg,

Film-coated Tablets

(Tiagabine hydrochloride)

GABITRIL® 15 mg,

Film-coated Tablets

(Tiagabine hydrochloride)

Read all of this leaflet carefully before you

start using this medicine.

-    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. Do not pass it on to others. It may

Any other medicines (this includes any

over-the-counter medicines or any medicines another doctor may have prescribed for you).

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

the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What GABITRIL is and what it is used for.

2.    Before you take GABITRIL.

3.    How to take GABITRIL.

4.    Possible side effects.

5.    How to store GABITRIL.

6.    Further information.

Taking 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.

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

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

Driving and operating machinery

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.

Important information about some of the ingredients of GABITRIL

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

2. BEFORE YOU TAKE GABITRIL Do not take GABITRIL if you:

- Are allergic (hypersensitive) to tiagabine

or any of the other ingredients of GABITRIL.

Are under the age of 12 years. Suffer from severe liver disease

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE GABITRIL

Always take GABITRIL exactly as your doctor has told you. You should 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.

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When you first start using GABIIRIL, your doctor will work with you to find the dose

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 r doctor.

-    Feel anxious or depressed, or have done so in the past then these symptoms may get worse or appear again during Tea^ent with GABITRIL. You must tell your doctor if you feel absent, depressed or anxious.

-    Notice an increase in the number of

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 sufficient 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

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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 fluid filled pimples or blisters, or if you notice

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

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

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 flow, inability to stop passing urine, difficulty controlling movements, sleepiness,

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. Taking other medicines If you are taking or have recently taken any of

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 (fits), loss of consciousness, difficulty 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

the following, talk to your doctor or pharmacist before starting GABITRIL:

• Other anti-epileptic medicines like phenytoin, carbamazepine, phenobarbital and primidone, because they may weaken and shorten the effects of GABITRIL.

with the treatment as prescribed by your

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

Rifampicin (medicine for treatment of tuberculosis), because it may weaken and shorten the effects of GABITRIL.

by your d

(Continued overleaf)

Dimensions 1 50 mm / 5.90 inches

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Do not stop treatment with GABITRIL without The other ingredients are: having first informed your doctor, because Tablet core:

^^{ere is a risk of recurrence of seizures}. Y^our Cellulose, microcrystalline (E 460), Ascorbic ^{doctor w|11 e}xp^{lain to} y^{ou how to} g^radually acid (E 300), Lactose anhydrous, Starch, ^{reduce h dose (over} 2-^{3 weeks)}.    pregelatinised (maize), Crospovidone, Silica,

If you have any further questions on the use c°^{llo|dal anhydrous (E} 551^), H^ydrogenated

of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, GABITRIL can cause side effects, although not everybody gets them. The side effects are generally mild to moderate. Most occur during the first 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):

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 film-coated tablets.

GABITRIL tablets are supplied in a plastic bottle with a screw-top.

The plastic bottle of GABITRIL contains a dry

•    Tremor

•    Feeling nervous

•    Tiredness

•    Feeling sick (nausea)

Common side effects (occurring in less than 1 in 10 people, but more than 1 in 100):

ns ^{a dr}y.ng ■lindrical

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

Diarrhoea, being sick (vomiting), abdominal pain Difficulty in sleeping, feeling over-emotional

Acting in a hostile or aggressive way Difficulty in controlling movements; walking, stepping or running oddly;

sizes may be available in your country. Marketing Authorisation Holder

Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, UK

Muscle twitching Blurred vision Difficulty in concentrating Feeling depressed Slowness of speech Confusion Accidental injury

Almac Pharma Services, Seagoe Industrial Estate, Craigavon, County Armagh,

BT63 5AU, UK

This leaflet was last revised in March 2013.

Uncommon side effects (occurring in less han 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.

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 fitting

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Hallucinations ^ralse beliefs

Unknown (exact frequency cannot be estimated from the available data)

• Encephalopathy (lethargy, confusion, with or without seizures)

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pimples or blisters; or a severe rash with reddening and peeling of skin If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

'~5. HOW TO STORE GABITRIL

Keep out of the reach and sight of children.

Do not use GABITRIL after the expiry date which is stated on the box and bottle after "Do not use after" or "EXP" (Expiry date). 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 GABITRIL if you notice the tablets have changed in appearance (e.g. if their colour changes: they are normally white). Medicines should not be disposed of via wastewater or household waste. Ask your

pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER 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.

of tiagabine anhydrous.

1190/6 PX681/5

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Dimensions 150 mm / 5.90 inches