Package Leaflet: Information for the User

Gabitril 5 mg Film-Coated Tablets

Tiagabina (as hydrochloride monohydrate)

Gabitril is an antiepileptic medication. Tiagabina, the active ingredient of 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 old with partial seizures.

It is administered in combination with other medications when these alone are not sufficiently effective

Do not take Gabitril:

• If you are allergic (hypersensitive) to tiagabina or to any of the other components of this medication included in section 6.
• If you have a severe liver disease.
• In combination with herbal preparations containing St. John's Wort (Hypericum perforatum).See “Use of other medications”.

Be especially careful with Gabitril:

• If you are under 12 years old.
• If you have generalized epilepsy, as you may experience a worsening of absence seizures (short periods of clouding of consciousness).
• If you interrupt treatment with Gabitril as 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. Inform your doctor if you feel absent, anxious, or depressed.
• A small number of people treated with antiepileptic drugs like tiagabina have had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor immediately.
• If you notice an increase in the number of seizures or new types of seizures, inform your doctor. He will indicate if it is necessary to modify your treatment.
• If you observe the appearance of a skin rash, including pustules with fluid and blisters or if you observe the spontaneous appearance of petechiae on the skin or darkening of the same, contact your doctor immediately.
• If you notice any type of vision problem, contact your doctor as Gabitril may occasionally cause visual field defects.
• If your doctor has informed you that you have 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 indicated dose of Gabitril.

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

Use of other medications:

If you are using, have used recently, or may need to use any of the following medications, please consult your doctor or pharmacist before starting to take Gabitril:

• Other antiepileptic medications such as phenytoin, carbamazepine, phenobarbital, and primidone, as they may reduce and shorten the effects of Gabitril.
• Rifampicin (medication 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 medications, your doctor may need to adjust the dose of Gabitril.

Taking Gabitril with food and beverages:

You should take Gabitril tablets with meals or with a snack.

Pregnancy and breastfeeding:

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

Inform your doctor if you discover that you are pregnant or plan to become pregnant.

If you are pregnant or breastfeeding, believe you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication

Driving and operating machinery:

This medication may cause symptoms such as drowsiness, dizziness, or visual disturbances and may decrease your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor evaluates your response to this medication.

Important information about some of the components of Gabitril:

This medication contains lactose. If your doctor has indicated that you have intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as 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 starting to take 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 a day. Subsequently, the dose will be gradually increased to reach the sufficient dose to control your epilepsy.

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

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

Depending on the other medications you are taking, the average maintenance dose of Gabitril may range from 15 to 50 mg per day, although higher doses may be indicated in some cases.

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 the treatment of elderly patients. Your doctor will decide on the most suitable treatment 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 or indicate the medication and the amount ingested.

The most common symptoms of Gabitril overdose are seizures, mutism, and withdrawal, memory loss, coma, difficulty in coordinating movements, drowsiness, dizziness, confusion, speech alteration, agitation, tremors, involuntary abnormal movements (dyskinesia), involuntary 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 compensate for the missed dose.

If you interrupt treatment with Gabitril

You should continue taking Gabitril for the time your doctor deems necessary.

Do not interrupt treatment with Gabitril without having informed your doctor in advance, as there is a risk of seizure recurrence. Your doctor will explain how to gradually reduce the dose (over 2-3 weeks).

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

Like all medications, Gabitril may cause side effects, although not everyone will experience them.

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

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

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

Common side 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.

Rare side effects (affect fewer than 1 in 100 people but more than 1 in 1,000):

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

• Seizure disorder that remains without seizures, a decrease in brain activity as determined by electroencephalogram, due to either a rapid dose adjustment or an increase in the medication dose.
• Visual defects
• Confusion
• Hallucination
• Agitation
• False beliefs

Unknown frequency (cannot be estimated from available data):

• Encephalopathy (drowsiness, confusion, with or without seizures)
• Severe skin rash with blisters. If you observe skin alterations, contact your doctor immediately.
• Severe rash, including fluid-filled 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 spasms
• Blurred vision
• Temporary memory loss

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the bottle after CAD. The expiration date is the last day of the month indicated.

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

Do not remove the tablets from their packaging until the time to take the medication.

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 through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Gabitril

• The active ingredient is tiagabine, present in the medication as monohydrochloride monohydrate.
• Cada comprimido recubierto con película de Gabitril 5 mg contiene 5 mg de Tiagabina. is translated to: Each Gabitril 5 mg film-coated tablet contains 5 mg of Tiagabina.

• Other components are:

Core of the tablet:

Cellulose, microcrystalline (E 460)

Ascorbic acid (E300)

Lactose

Pre-gelatinized cornstarch

Crospovidone

Colloidal anhydrous silica (E 551)

Hydrogenated vegetable oil (Type 1)

Stearic acid

Magnesium stearate

Coating:

Hydroxypropylmethylcellulose (E 463)

Di titanium dioxide (E 171)

Appearance of the product and contents of the package:

Gabitril are film-coated tablets, white.

Gabitril 5 mg tablets are round and have the imprint “251”.

Gabitril tablets are presented in a plastic bottle with a screw cap containing a desiccant.

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

Only some package sizes may be marketed.

Marketing Authorization Holder:

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Holland

Responsible for Manufacturing:

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 leaflet was approved in August 2016

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