Gabitril

Package Leaflet: Information for the Patient

Gabitril

5 mg, coated tablets
10 mg, coated tablets
15 mg, coated tablets
Tiagabine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Gabitril and what is it used for
• 2.Important information before taking Gabitril
• 3. How to take Gabitril
• 4. Possible side effects
• 5. How to store 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 concentration of gamma-aminobutyric acid (GABA) in the brain, which prevents seizures (epileptic events) or reduces their frequency.
Gabitril helps control epilepsy in adults, children, and adolescents over 12 years old with partial seizures.
It is used in combination with other medicines that are not effective enough when taken alone.

2. Important information before taking Gabitril

When not to take Gabitril

• if you are allergic to tiagabine or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver impairment
• if you are taking St. John's Wort

When to be cautious when taking Gabitril

• in children under 12 years of age;
• in patients with generalized seizures, who may experience absence seizures (a brief state of limited consciousness);
• after stopping treatment, as sudden withdrawal may cause a recurrence of seizures. Do not stop taking the medicine without consulting your doctor;
• in patients with serious behavioral disorders, including depression and anxiety in the past, as there is a risk of worsening or recurrence of symptoms during treatment with Gabitril. Inform your doctor about any disturbances of consciousness, depression, and anxiety.
• a small number of patients taking antiepileptic medicines, such as tiagabine, have had thoughts of self-harm or suicide. If you have ever had such thoughts,

contact your doctor immediately.

• if the frequency of seizures increases or new types of seizures occur during treatment with Gabitril, inform your doctor. The doctor may recommend necessary changes in the treatment.
• if a severe rash occurs, including blisters or fluid-filled blisters, or spontaneous bruising, inform your doctor immediately.
• if you experience any vision disturbances, consult your doctor, as Gabitril may rarely cause vision disturbances.
• due to the presence of lactose in the medicine, patients with known intolerance to some sugars should not take Gabitril.
• in patients with mild to moderate liver function disorders, the doctor will adjust the dose of Gabitril.

If you experience any of the above symptoms, inform your doctor.

Gabitril and other medicines

If you are taking or have recently taken any of the following medicines, inform your doctor before starting Gabitril:

• Other antiepileptic medicines, such as phenytoin, carbamazepine, phenobarbital, and primidone, as they may weaken the effect of Gabitril and shorten its duration of action.
• Rifampicin (a medicine used to treat tuberculosis), as it may weaken the effect of Gabitril and shorten its duration of action. Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

If you are taking any of the above medicines, your doctor may adjust the dose of Gabitril.
Taking St. John's Wort (Hypericum perforatum) at the same time may increase the metabolism of tiagabine.
Therefore, taking St. John's Wort and tiagabine at the same time is contraindicated.

Gabitril with food and drink

Take the medicine with food.

Pregnancy and breastfeeding

Do not take Gabitril during pregnancy and breastfeeding.
Women taking antiepileptic medicines should avoid unplanned pregnancy. Patients should use effective contraception and consult their doctor before planned pregnancy.
It is very important to inform the treating doctor about planned pregnancy and pregnancy as soon as possible.
In case of pregnancy during treatment with Gabitril, contact the treating doctor immediately.
If you are breastfeeding, consult your doctor before taking the medicine.

Driving and using machines

Gabitril may cause dizziness and other central nervous system symptoms, such as drowsiness or fatigue, especially in the initial treatment phase, which may affect the ability to drive and operate machinery.

Important information about some ingredients of Gabitril

Gabitril contains lactose.
Due to the presence of lactose, Gabitril should not be taken by patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

3. How to take Gabitril

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine orally, with a glass of water, during meals.
When starting treatment with Gabitril, your doctor will determine the dose that will allow control of epilepsy. You will start taking Gabitril once or twice a day. Then, the dose will be gradually increased until the dose that controls epilepsy is reached.
After determining the dose, you will take Gabitril twice or three times a day.
Usually, the initial dose is 5 to 10 mg/day, increased by 5 to 10 mg/day every week.
Depending on other medicines you are taking, the average maintenance dose of Gabitril is 15 to 50 mg/day, but your doctor may prescribe a higher dose of the medicine.
If you have mild or moderate liver function disorders, your doctor will adjust the dose of Gabitril.
Gabitril should be used with caution in elderly patients. Your doctor will decide if such treatment is best for you.

Taking a higher dose of Gabitril than recommended

The most common symptoms of Gabitril overdose are seizures, depression, withdrawal, memory loss, coma, coordination disorders, drowsiness, dizziness, confusion (disorientation), speech disorders, agitation, tremors, involuntary movements (dyskinesia), involuntary muscle contraction, vomiting, and hostility.
In case of overdose or accidental ingestion by a child, contact your doctor or the nearest hospital immediately.

Missing a dose of Gabitril

If you miss a dose, continue treatment as recommended by your doctor.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Gabitril

Take Gabitril for as long as your doctor has prescribed.
Do not stop taking Gabitril without consulting your doctor, as there is a risk of seizure recurrence. Your doctor will explain how to gradually reduce the dose of the medicine (over 2-3 weeks).
If you have any further questions about taking 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 side effects occur within the first few months of treatment and are usually transient.
After taking Gabitril, the following side effects have occurred:
Very common (in more than 1 in 10 patients):
dizziness, tremors, drowsiness, depressed mood, nervousness, concentration disorders, feeling of fatigue, nausea
Common (in less than 1 in 10 patients):
emotional instability, diarrhea, abdominal pain, bruising
Rare (in less than 1 in 1000 patients):
non-convulsive status epilepticus, slowed EEG (when rapidly increasing the dose of the medicine), vision disturbances, confusion (disorientation), paranoid reactions (hallucinations, agitation, delusions).
With unknown frequency (frequency cannot be estimated from available data):
encephalopathy (lethargy, confusion, with or without seizures), hostility, insomnia, ataxia, gait disturbances, speech disorders, blurred vision, temporary memory loss, vomiting, muscle tremors, vesicular rash, exfoliative dermatitis.
If you notice a rash, contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax +48 22 49 21 309;
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gabitril

Do not store above 25°C. Store in the original package.
Keep out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the package.

6. Contents of the pack and other information

What Gabitril contains:

• Each coated tablet contains the active substance: 5 mg, 10 mg, or 15 mg of tiagabine (as a monohydrate hydrochloride).
• Other ingredients of the medicine are: tablet core: microcrystalline cellulose, ascorbic acid, lactose, pregelatinized corn starch, crospovidone, anhydrous colloidal silica, hydrogenated vegetable oil (Type I), stearic acid, magnesium stearate; tablet coating: hypromellose, hydroxypropylcellulose, titanium dioxide (E171).

What Gabitril looks like and what the pack contains

Gabitril 5 mg: white, round, biconvex coated tablets with the number "251" embossed on one side; the tablet is not divisible.
Gabitril 10 mg: white, oval, biconvex coated tablets with the number "252" embossed on one side; the tablet is not divisible.
Gabitril 15 mg: white, oval, biconvex coated tablets with the number "253" embossed on one side; the tablet is not divisible.
Gabitril coated tablets are placed in an HDPE bottle with a child-resistant PP cap, containing a built-in desiccant, in a cardboard box.
The pack contains 50 tablets of 5 mg, 10 mg, or 15 mg of tiagabine.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer/importer:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa, 2600
Bulgaria

Date of last revision of the leaflet: April 2023