Gabitril 15 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabitril 15 mg film-coated tablets

Tiagabine (as monohydrochloride monohydrate)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Gabitril is and what it is used for
2. What you need to know before taking Gabitril
3. How to take Gabitril
4. Possible adverse 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 antiepileptic medicine. Tiagabine, the active substance in Gabitril, increases brain levels of gamma-aminobutyric acid (GABA), thereby 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 sufficiently effective on their own.

2. Before taking Gabitril

Do not take Gabitril:

• If you are allergic (hypersensitive) to tiagabine or to 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 "Use with other medicines".

Take special care with Gabitril:

• If you are under 12 years of age.
• If you have generalized epilepsy, as your absence seizures (brief periods of impaired consciousness) may worsen.
• If you stop treatment with Gabitril, as this may cause seizures to return. Do not stop taking Gabitril without consulting your doctor.
• If you have or have previously had anxiety or depression, these symptoms may worsen or reappear during treatment with Gabitril. You should inform your doctor if you feel absent-minded, anxious, or depressed.
• A small number of patients treated with antiepileptic medicines such as tiagabine have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately.
• If you notice an increase in the number of seizures or new types of seizures, you must inform your doctor. Your doctor will decide whether your treatment needs to be adjusted.
• If you develop a skin rash, including fluid-filled spots and blisters, or notice unexplained bruising or darkening of the skin, contact your doctor immediately.
• If you experience any vision problems, you should contact your doctor, as Gabitril may occasionally cause visual field defects.
• If your doctor has informed you that you have an intolerance to certain sugars, you should not take Gabitril, as it contains lactose.
• If you have mild or moderate liver problems, your doctor will need to adjust the prescribed dose of Gabitril.

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

Use with other medicines:

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

• Other antiepileptic medicines such as phenytoin, carbamazepine, phenobarbital, and primidone, as they may reduce and shorten the effects of Gabitril.
• Rifampicin (a medicine used to treat tuberculosis), as it may reduce and shorten the effects of Gabitril.
• Herbal preparations containing St. John's wort (Hypericum perforatum), as they must not be taken together with Gabitril (see "Do not take Gabitril").

If you need to take Gabitril together with one or more of these medicines, your doctor may need to adjust the dose of Gabitril.

Taking Gabitril with food and drink:

You should take Gabitril tablets with meals or a snack.

Pregnancy and breast-feeding:

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

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines:

This medicine may cause symptoms such as drowsiness, dizziness, or vision disturbances and may reduce your reaction time. These effects, as well as your underlying condition, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special alertness until your doctor has assessed your response to this medicine.

Important information about some of the ingredients of Gabitril:

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gabitril

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

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

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

The initial dose of Gabitril is 5 to 10 mg daily, increasing the dose by 5 to 10 mg weekly.

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

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

Gabitril tablets can be used with caution for treatment in elderly patients. Your doctor will decide which treatment is most suitable for you.

If you take more Gabitril than you should

In cases of overdose or accidental ingestion, contact your doctor, nurse, or call the Toxicology Information Service immediately at telephone number 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, memory loss, coma, difficulty in coordinating movements, somnolence, involuntary abnormal movements (dyskinesia), dizziness, confusion, speech disturbance, agitation, tremors, involuntary muscle contractions, vomiting, and hostility.

If you forget to take Gabitril

If you miss your daily dose, take the next dose as usual. Do not take a double dose to make up for the missed dose.

If you stop taking Gabitril

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

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

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

4. Possible adverse effects

Like all medicines, Gabitril can produce adverse effects, although not everyone experiences 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 adverse effects (may affect more than 1 in 10 people):

• Dizziness
• Tremors
• Somnolence (drowsiness)
• Depression
• Nervousness
• Difficulty concentrating
• Fatigue
• Nausea

Common adverse effects (may affect between 1 and 10 in 100 people):

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

Uncommon adverse effects (affect fewer than 1 in 100 people but more than 1 in 1,000):

Rare adverse effects (may affect between 1 and 10 in 10,000 people):

• Epileptic state without seizures, with decreased brain activity as determined by electroencephalogram, due either to rapid dose adjustment or to an increase in the dose of the medicine.
• Visual disturbances
• Confusion
• Hallucination
• Agitation
• Delusions

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

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging and bottle following EXP. The expiry date refers to the last day of the month indicated.

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

Do not remove the tablets from their container until it is time to take the medicine.

Do not use Gabitril if you notice any changes in the appearance of the tablets (e.g. if you observe a change in colour: they are normally white).

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional 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 components are:

Tablet core:

Microcrystalline cellulose (E 460)

Ascorbic acid (E300)

Lactose

Pregelatinized starch (corn)

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 contents of the package:

Gabitril are white, film-coated tablets.

Gabitril 5 mg tablets are round and marked with "251".

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Teva B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

Manufacturer responsible:

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa, 2600

Bulgaria

Local representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid), Spain

This patient information leaflet was approved in August 2016

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