Sabril

PATIENT INFORMATION LEAFLET: USER INFORMATION

Sabril, 500 mg, coated tablets

Vigabatrin

Please read carefully the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Sabril and what is it used for
• 2. Important information before taking Sabril
• 3. How to take Sabril
• 4. Possible side effects
• 5. How to store Sabril
• 6. Contents of the pack and other information

1. What is Sabril and what is it used for

Sabril contains vigabatrin, which is a selective, irreversible inhibitor of GABA aminotransferase (an enzyme responsible for the breakdown of GABA). Vigabatrin increases the concentration of gamma-aminobutyric acid (GABA) in brain tissue, one of the main inhibitory neurotransmitters in the brain.
Sabril is indicated for the treatment, in combination with other anti-epileptic medicines, of patients with partial seizures that are resistant to treatment, which are or are not secondarily generalized, when all other anti-epileptic medicines used in combination are insufficient or poorly tolerated.
Additionally, it is used as monotherapy (as the only medicine) for infantile spasms (West syndrome).
(Sabril, 500 mg, granules for oral solution are also available).

2. Important information before taking Sabril

When not to take Sabril

• If the patient has been found to be hypersensitive to vigabatrin or any of the other ingredients of the medicine listed in section 6.

Warnings and precautions

Before starting treatment with Sabril, the patient should discuss it with their doctor if:

• the patient has or has had psychotic, depressive, and/or behavioral disorders (see section 4),
• the patient has kidney problems and is elderly; these patients should be monitored for side effects such as sedation and confusion (see section 3),
• the patient is also taking clonazepam (a medicine used to treat epilepsy). Concomitant use of these medicines may enhance the sedative effect of clonazepam or lead to coma (see section 2 "Warnings and precautions").
• the patient has vision problems.

Patients starting treatment with vigabatrin should undergo systematic visual field examinations and visual acuity tests at the beginning of treatment and at regular intervals (every 6 months) throughout the treatment period.
About 1/3 of patients receiving vigabatrin have been observed to have visual field defects.
These visual field defects can be severe, up to tunnel vision or loss of vision, and irreversible. It cannot be excluded that after discontinuation of vigabatrin, visual field defects may increase.
The patient should immediately inform their doctor if they experience vision disturbances. In such cases, the doctor will refer the patient to an ophthalmologist and may decide to discontinue the medicine.
Vigabatrin should not be used concomitantly with other medicines that are toxic to the retina.
It is not recommended to use vigabatrin in patients with existing visual field defects of clinical significance.
Sabril may impair vision, causing eye disorders such as retinal disorders, blurred vision, optic atrophy, or optic neuritis (see section 4 "Side effects"). If the patient notices a decrease in vision, they should contact an ophthalmologist.
Sabril should not be used as monotherapy except for the treatment of infantile spasms.
As with other anti-epileptic medicines, sudden discontinuation of Sabril may lead to an increased frequency of seizures. If it is necessary to stop treatment, the doctor will advise gradual reduction of the dose over 2-4 weeks.
The patient treated with Sabril should be under close medical supervision due to the risk of side effects from the nervous system.
A small number of people taking anti-epileptic medicines containing vigabatrin have thought about harming or killing themselves. If such thoughts ever occur to the patient, they should contact their doctor immediately.

Children

Motor disorders and abnormalities in magnetic resonance imaging of the brain have been observed in young infants treated for infantile spasms (West syndrome). If unusual motor disorders are observed in a child, the parents should contact the doctor, who will decide whether to consider changing the treatment.

Sabril and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Vigabatrin is not metabolized, nor does it bind to proteins, and it does not induce liver enzymes of the cytochrome P450 system involved in drug metabolism, so interactions with other medicines are unlikely.
Vigabatrin may increase the amount of amino acids in the urine, which can lead to false-positive test results for certain rare genetic metabolic disorders.
Clonazepam
Concomitant use of vigabatrin and clonazepam may enhance the sedative effect of clonazepam or lead to coma (see section 2 "Warnings and precautions").

Taking Sabril with food and drink

The medicine can be taken before or after a meal.

Pregnancy and breastfeeding

Pregnancy
If the patient becomes pregnant or plans to become pregnant, the doctor should reassess the need for treatment. Sudden discontinuation of effective anti-epileptic treatment may lead to worsening of the disease in the mother, which may harm the fetus.
Vigabatrin may be used during pregnancy only if it is absolutely necessary.
Breastfeeding
Vigabatrin passes into breast milk. Therefore, breastfeeding is not recommended during treatment with vigabatrin.

Driving and using machines

Patients with uncontrolled epilepsy should not drive vehicles or operate potentially hazardous machinery. In clinical trials, drowsiness has been observed in patients after administration of vigabatrin.
Visual field defects, which can significantly affect the ability to drive vehicles and operate mechanical equipment, have been commonly associated with the use of Sabril. Patients should be examined for visual field defects (see also section 2 "Warnings and precautions").

Sabril contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Sabril

The medicine should be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.
Sabril should be taken orally once or twice a day, before or after a meal.
Sabril should be used in combination with other anti-epileptic medicines taken by the patient.

Adults

The greatest efficacy is usually observed at a dose of 2 to 3 g per day. Vigabatrin at an initial dose of 1 g per day should be added to the anti-epileptic medicines currently taken by the patient. The daily dose should then be gradually increased by 0.5 g per week, depending on the clinical response and the patient's tolerance to the medicine. The recommended maximum dose is 3 g per day.

Children

Partial seizures resistant to treatment
The recommended initial dose for infants, children, and adolescents is 40 mg/kg body weight per day.
Dosage should be determined based on body weight:
Do not exceed the maximum recommended dose in each group.
Monotherapy for infantile spasms (West syndrome):
The recommended initial dose is 50 mg/kg body weight per day. If necessary, it can be gradually increased within one week.
Doses up to 150 mg/kg body weight per day are used.
Elderly patients and patients with renal impairment:
The medicine should be used with caution in elderly patients and in patients with a creatinine clearance of less than 60 ml/min. In such cases, the doctor will consider adjusting the dose and frequency of administration. In these patients, a lower maintenance dose may be effective.
These patients should be closely monitored for side effects such as sedation or confusion (see section 2 and section 4).
Method of administration
For oral use.
Tablets should be swallowed with a small amount of water.
Sabril can be taken before or after meals.
If the patient feels that the effect of Sabril is too strong or too weak, they should consult their doctor.

Overdose of Sabril

In case of overdose, the patient should immediately contact their doctor.
In the event of an overdose, the doctor will provide symptomatic treatment, as there is no specific antidote for vigabatrin.
The most common observed symptoms of overdose included drowsiness or coma. Other less common symptoms included: dizziness, headaches, psychosis, respiratory depression or apnea, bradycardia (bradyarrhythmia), hypotension, agitation, irritability, confusion, or speech disorders.

Missing a dose of Sabril

If a dose of the medicine is missed, the patient should take it as soon as possible, unless it is close to the time of the next dose. The patient should not take a double dose to make up for the missed dose.
In case of doubts about taking the medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Sabril can cause side effects, although not everybody gets them.
The following side effects have been observed in patients treated with vigabatrin:
Very common side effects (affecting at least 1 in 10 people) include visual field defects (mild to severe), which can interfere with daily activities. The onset of symptoms usually occurs after several months or years of treatment with vigabatrin. According to studies, about 1/3 of patients treated with vigabatrin develop visual field defects (see also section 2).
In about 50% of patients in controlled clinical trials, side effects were observed during treatment with vigabatrin. In adults, these were mainly effects on the central nervous system, such as sedation, drowsiness, fatigue, and impaired concentration. In children, however, common side effects include hyperactivity or psychomotor agitation. The frequency of these side effects is generally higher at the beginning of treatment and decreases over time.
As with other anti-epileptic medicines, the use of vigabatrin may lead to an increased frequency of seizures, including status epilepticus. This applies especially to patients with myoclonic seizures. In rare cases, new or worsening myoclonic seizures may occur.
Side effects are presented below according to the following frequency classification:
very common (affecting at least 1 in 10 people), common (affecting less than 1 in 10 people), uncommon (affecting less than 1 in 100 people), rare (affecting less than 1 in 1,000 people), very rare (affecting less than 1 in 10,000 people), frequency not known (cannot be estimated from the available data).
Very common side effects include:

• drowsiness
• visual field defects
• fatigue
• joint pain Common side effects include:
• weight gain
• speech disorders, headaches, tremors, dizziness, paresthesia (tingling sensation), concentration and memory disorders, thinking disorders
• blurred vision, double vision, nystagmus
• nausea, vomiting, abdominal pain
• edema, irritability
• psychomotor agitation, aggression, nervousness, depression, paranoid reaction (delusions, hallucinations), insomnia
• anemia
• alopecia

Uncommon side effects include:

• ataxia (lack of coordination), movement disorders
• rash
• hypomania, mania (mood disorders associated with hyperactivity, agitation), psychosis

Rare side effects include:

• encephalopathic symptoms (significant sedation, stupor, and confusion)
• retinal disorders (mainly peripheral)
• angioedema, urticaria
• suicidal attempt Very rare side effects include:
• optic neuritis
• optic atrophy
• hepatitis
• hallucinations

Side effects with frequency not known:

• cases of abnormalities in magnetic resonance imaging of the brain, which may be a sign of cytotoxic edema
• decreased visual acuity
• edema in the protective layer of nerve cells in the brain, observed in magnetic resonance imaging

Additional side effects in children:

Very common side effects include:

• hyperactivity, psychomotor agitation Side effects with frequency not known:
• motor disorders in young infants treated for infantile spasms (West syndrome)
• cases of abnormalities in magnetic resonance imaging of the brain, especially in infants
• edema in the protective layer of nerve cells in the brain, observed in magnetic resonance imaging, especially in infants

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell 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 or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sabril

Before taking the medicine, the patient should check the expiry date on the packaging.
The medicine should be stored out of sight and reach of children.
Do not use Sabril after the expiry date stated on the packaging.
Storage - no special requirements.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sabril contains

1 coated tablet contains as active substance:
500 mg of vigabatrin
and as excipients:
povidone K30, microcrystalline cellulose, sodium carboxymethylcellulose (type A), and magnesium stearate.
Coating: hypromellose, titanium dioxide, macrogol 8000.

What Sabril looks like and contents of the pack

Sabril 500 mg coated tablets are packaged in blisters and a cardboard box.
The pack contains 10 blisters of 10 coated tablets each.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France
Manufacturer
Patheon France S.A.
40, Boulevard de Champaret
38300 Bourgoin-Jallieu
France
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder in Poland:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00

Date of last revision of the leaflet: