Gabitril

Leaflet attached to the packaging: patient information

Gabitril

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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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. Package contents 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

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 the treatment, as sudden withdrawal may cause a recurrence of seizures. The medicine should not be stopped without consulting a 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. The patient should inform their 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 the patient has ever had such thoughts,

they should contact their doctor immediately.

• 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 any of the above symptoms occur, the patient should inform their doctor.

Gabitril and other medicines

If the patient is taking or has recently taken any of the following medicines, they should inform their 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. The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

If the patient is taking any of the above medicines, the doctor may adjust the dose of Gabitril.
Concomitant use of St. John's Wort (Hypericum perforatum) may increase the metabolism of tiagabine.
Therefore, concomitant use of St. John's Wort and tiagabine is contraindicated.

Gabitril with food and drink

The medicine should be taken with food.

Pregnancy and breastfeeding

Gabitril should not be taken during pregnancy and breastfeeding.
Women taking antiepileptic medicines should prevent unplanned pregnancy. Patients should use effective contraception and consult their doctor before planning a 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, the patient should contact their doctor immediately.
If a woman is breastfeeding, she should consult her 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 phase of treatment, 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

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine should be taken orally, with a glass of water, during meals.
When starting Gabitril for the first time, the doctor will determine the dose that will allow control of epilepsy. The patient will start taking Gabitril once or twice a day. Then, the dose will be gradually increased until the dose that controls epilepsy is reached.
Once the dose is established, the patient will take Gabitril two 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 the patient is taking, the average maintenance dose of Gabitril is 15 to 50 mg/day, but the doctor may prescribe a higher dose of the medicine.
If the patient has mild or moderate liver function disorders, the doctor will adjust the dose of Gabitril.
Gabitril should be used with caution in elderly patients. The doctor will decide if such treatment is best for the patient.

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), muscle spasms, vomiting, and hostility.
In case of overdose or accidental ingestion by a child, the patient should immediately contact their doctor or the nearest hospital.

Missing a dose of Gabitril

If a dose of Gabitril is missed, the patient should continue treatment as directed by the doctor.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Gabitril

Gabitril should be taken for as long as the doctor recommends.
The patient should not stop taking Gabitril without consulting their doctor, as there is a risk of recurrence of seizures. The doctor will explain how to gradually reduce the dose of the medicine (over 2-3 weeks).
If the patient has any further doubts about taking this medicine, they should consult their 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.
The following side effects have occurred after taking Gabitril:
Very common (in more than 1 in 10 patients):
dizziness, tremors, drowsiness, low mood, nervousness, concentration disorders, feeling of fatigue, nausea
Common (in no more than 1 in 10 patients):
emotional instability, diarrhea, abdominal pain, bruising
Rare (in no more than 1 in 1000 patients):
non-convulsive status epilepticus, slowed EEG (when the dose of the medicine was rapidly increased), vision disturbances, confusion (disorientation), paranoid reactions (hallucinations, agitation, delusions).
With unknown frequency (frequency cannot be estimated from the available data):
encephalopathy (lethargy, confusion, with or without seizures), hostility, insomnia, ataxia, gait disturbances, speech disorders, blurred vision, temporary memory loss, vomiting, muscle tremors, blistering skin rash, exfoliative dermatitis.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, more information can be collected on the safety of the medicine.

5. How to store Gabitril

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

6. Package contents 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, maize starch paste, 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 package 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 package 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