GABITRIL 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Gabitril 10 mg Film-Coated Tablets

Tiagabine (as monohydrate hydrochloride)

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.

Contents of the pack:

1. What is Gabitril and what is it used for
2. What you need to know before you take Gabitril
3. How to take Gabitril
4. Possible side effects
5. Storage of Gabitril
6. Contents of the pack and other information

1. What is Gabitril and what is it used for

Gabitril is an antiepileptic medicine. Tiagabine, the active substance of Gabitril, increases the brain levels of gamma-aminobutyric acid (GABA), thus preventing or reducing the number of seizures (epileptic episodes).

Gabitril is used to help control epilepsy in adults and adolescents over 12 years of age with partial seizures.

It is given in combination with other medicines when these are not effective enough on their own.

2. Before taking Gabitril

Do not take Gabitril:

• If you are allergic (hypersensitive) to tiagabine or any of the other ingredients of this medicine listed in section 6.
• If you have severe liver disease.
• In combination with herbal preparations containing St. John's Wort (Hypericum perforatum). See “Using other medicines”.

Be cautious when taking Gabitril:

• If you are under 12 years of age.
• If you have generalized epilepsy, as you may experience worsening of absences (short periods of clouding of consciousness).
• If you stop treatment with Gabitril because it may cause a recurrence of seizures. Do not stop taking Gabitril without consulting your doctor.
• If you have anxiety or depression, or have had them in the past, these symptoms may worsen or recur during treatment with Gabitril. You should inform your doctor if you feel absent, anxious, or depressed.
• A small number of people treated with antiepileptics such as tiagabine have had thoughts of self-harm or suicide. If at any time you experience these thoughts, contact your doctor immediately.
• If you notice an increase in the number of seizures or new types of seizures, you should inform your doctor. He will indicate whether it is necessary to modify your treatment.
• If you notice the appearance of a skin rash, including blisters or if you notice the spontaneous appearance of bruises on the skin or darkening of the skin, contact your doctor immediately.
• If you notice any vision problems, you should contact your doctor as Gabitril may occasionally cause visual field defects.
• If your doctor has told you that you have an intolerance to some sugars, do not take Gabitril, as it contains lactose.
• If you have mild or moderate liver problems, your doctor should adjust the dose of Gabitril.

If you experience (or have experienced) any of these symptoms, please inform your doctor.

Using other medicines:

If you are taking, have recently taken, or might take any of the following medicines, please consult your doctor or pharmacist before starting to take Gabitril:

• Other antiepileptic medicines such as phenytoin, carbamazepine, phenobarbital, and primidone, as they may reduce and shorten the effects of Gabitril.
• Rifampicin (a medicine for the treatment of tuberculosis), as it may reduce and shorten the effects of Gabitril.
• Herbal preparations containing St. John's Wort (Hypericum perforatum), as they should not be taken with Gabitril (see “Do not take Gabitril”).

In case you need to combine it with one or more of these medicines, your doctor may need to adjust the dose of Gabitril.

Taking Gabitril with food and drinks:

You should take Gabitril tablets with food or a snack.

Pregnancy and breastfeeding:

As a precautionary measure, it is preferable not to take Gabitril during pregnancy or breastfeeding.

Inform your doctor if you discover that you are pregnant or plan to have a child.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

This medicine may cause symptoms such as drowsiness, dizziness, or changes in vision and reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Important information about some of the ingredients of Gabitril:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Gabitril

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

Gabitril tablets should always be taken with water, during a meal or snack.

When you start taking Gabitril, your doctor will work with you to determine the appropriate dose to control your epilepsy. You will start taking Gabitril tablets once or twice a day. Then, the dose will be gradually increased until the sufficient dose to control your epilepsy is reached.

Once the dose is established, you may need to take Gabitril tablets two or three times a day.

The starting dose of Gabitril is 5 to 10 mg daily, with the dose increased weekly by 5 to 10 mg daily.

Depending on the other medicines you are taking, the average maintenance dose of Gabitril may range from 15 to 50 mg daily, although sometimes higher doses are indicated.

If you have mild or moderate liver problems, your doctor will need to adjust the dose of Gabitril.

Gabitril tablets can be used with caution for the treatment of elderly patients. Your doctor will decide what the most appropriate treatment is for you.

If you take more Gabitril than you should

In cases of overdose or accidental ingestion, consult your doctor, nurse, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

The most common symptoms of Gabitril overdose are seizures, mutism (silence), and withdrawal, loss of consciousness, loss of memory, coma, difficulty in coordinating movements, drowsiness, abnormal involuntary movements (dyskinesia), dizziness, confusion, speech alteration, agitation, tremors, muscle contraction, vomiting, and hostility.

If you forget to take Gabitril

If you forget your daily dose, take the next dose normally. Do not take a double dose to make up for the forgotten dose.

If you stop taking Gabitril

You should continue taking Gabitril for as long as your doctor considers it necessary.

Do not stop taking Gabitril without consulting your doctor first, as there is a risk of recurrence of seizures. Your doctor will explain how to gradually reduce the dose (over 2-3 weeks).

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

4. Possible side effects

Like all medicines, Gabitril can cause side effects, although not everybody gets them.

Side effects are usually mild to moderate. Most occur during the first few months of treatment and are often brief. These may include:

Very common side effects (may affect more than 1 in 10 people):

• Dizziness
• Tremors
• Drowsiness
• Depression
• Nervousness
• Difficulty concentrating
• Fatigue
• Nausea

Common side effects (may affect up to 1 in 10 people):

• Diarrhea
• Appearance of bruises (darkening of the skin). If you notice the appearance of bruises, contact your doctor immediately.

Uncommon side effects (may affect up to 1 in 100 people)

Rare side effects (may affect up to 1 in 10,000 people):

• Epileptic state that remains without seizure, a decrease in brain activity as determined by electroencephalogram, due to either rapid dose adjustment or dose increase of the medicine.
• Visual defects
• Confusion
• Hallucination
• Agitation
• False beliefs

Frequency not known (cannot be estimated from the available data):

• Encephalopathy (lethargy, confusion, with or without convulsions)
• Severe blistering rash. If you notice skin changes, contact your doctor immediately.
• Severe rash, including blisters or a severe rash with redness and skin peeling.
• Vomiting, abdominal pain
• Difficulty controlling movements; walking, stopping, or running in an unusual way, difficulty speaking
• Muscle twitches
• Blurred vision
• Temporary memory loss

Reporting of side effects:

Ifyou experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabitril

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C. Store in the original package.

Do not remove the tablets from their packaging until you are ready to take them.

Do not use Gabitril if you notice that the appearance of the tablets has changed (e.g., if you notice that the color changes: they are usually white).

Medicines should not be disposed of via wastewater or household waste. Return any unused tablets to your pharmacist. This will help to protect the environment.

6. Further information

Composition of Gabitril

• The active substance is tiagabine, present in the medicine as monohydrate hydrochloride.
• Each Gabitril 5 mg film-coated tablet contains 5 mg of tiagabine.

• The other ingredients are:

Core of the tablet:

Microcrystalline cellulose (E 460)

Ascorbic acid (E300)

Lactose

Pregelatinized starch (maize)

Crospovidone

Colloidal anhydrous silica (E 551)

Hydrogenated vegetable oil (Type 1)

Stearic acid

Magnesium stearate

Coating:

Hypromellose

Hydroxypropylcellulose (E 463)

Titanium dioxide (E 171)

Appearance of the product and pack contents:

Gabitril is a white, film-coated tablet.

The Gabitril 5 mg tablets are round and have “251” engraved on them.

Gabitril tablets are presented in a plastic bottle with a screw cap and an integrated desiccant.

Gabitril tablets are available in bottles of 20, 30, 50, 100, and 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Manufacturer:

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa, 2600

Bulgaria

Local Representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid), Spain

This leaflet was approved in August 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/