Sabril

PATIENT INFORMATION LEAFLET: USER INFORMATION

Sabril, 500 mg, granules for oral solution

Vigabatrin

Read the 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 only. 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 any not listed in this leaflet, tell your 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 (the enzyme responsible for GABA breakdown). Vigabatrin increases the concentration of gamma-aminobutyric acid (GABA) in the brain tissue, one of the main inhibitory neurotransmitters in the brain.
Sabril is indicated for the treatment, in combination with other anti-epileptic drugs, of patients with partial seizures that are resistant to treatment, which are or are not secondarily generalized, when all other anti-epileptic drugs used in combination are insufficient or poorly tolerated.
Additionally, it is used as monotherapy (as the only drug) for infantile spasms (West syndrome).

2. Important information before taking Sabril

When not to take Sabril

• If the patient has been diagnosed with hypersensitivity to vigabatrin or any of the other ingredients of the medicine listed in section 6.

Warnings and precautions

Before starting treatment with Sabril, discuss with your doctor if:

• the patient has or has had psychotic, depressive, and/or behavioral disorders (see section 4),
• the patient has kidney problems and if the patient is elderly; in these patients, attention should be paid to the occurrence of side effects such as sedation and confusion (see section 3),
• the patient is taking clonazepam (a medicine used to treat epilepsy) at the same time. Taking these medicines together may increase 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 examinations for visual field defects and visual acuity at the beginning of treatment and at regular intervals (every 6 months) throughout the treatment period.
Visual field defects have been observed in about 1/3 of patients receiving vigabatrin.
These visual field defects can be severe, up to tunnel vision or loss of vision, and irreversible. It cannot be excluded that after stopping vigabatrin treatment, visual field defects may increase.
The patient should immediately inform the doctor about any vision disturbances. In such a case, the doctor will refer the patient to an ophthalmologist and may decide to discontinue the medicine.
Vigabatrin should not be used at the same time as other medicines that are toxic to the retina of the eye.
It is not recommended to use vigabatrin in patients with existing visual field defects of significant clinical importance.
Sabril may impair vision, causing eye disorders such as retinal disorders, blurred vision, optic nerve 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.

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 doctor should be consulted, who will decide whether to consider changing the treatment.

Sabril and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Vigabatrin is not metabolized, does not bind to proteins, or 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
Taking vigabatrin and clonazepam at the same time may increase 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.
The contents of the sachet can be poured into a drink (e.g., water, fruit juice, or milk) just before consumption.

Pregnancy and breastfeeding

Pregnancy
If the patient becomes pregnant or plans to become pregnant, the doctor should reconsider the need for treatment. Suddenly stopping 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 when it is absolutely necessary.
Breastfeeding
Vigabatrin passes into human milk. Therefore, breastfeeding is not recommended during vigabatrin treatment.

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 taking vigabatrin.
Visual field defects, which can significantly affect the ability to drive vehicles and operate mechanical equipment, have been commonly associated with Sabril use. Patients should be examined for visual field defects (see also section 2 "Warnings and precautions").

3. How to take Sabril

Take the medicine as directed by your doctor. If you are unsure, consult your doctor.
Sabril should be taken orally once or twice a day, before or after a meal.
Sabril should be taken with other anti-epileptic medicines that the patient is currently taking.

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 every 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.
Dosing should be determined based on body weight:
Do not exceed the maximum recommended dose for 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 creatinine clearance 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

Oral administration.
The granules in the sachets should be dissolved in cold water, fruit juice, or milk just before consumption.
Sabril can be taken before or after meals.
If you feel that the effect of Sabril is too strong or too weak, consult your doctor.

Overdose

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

Missing a dose

If you miss a dose, take it as soon as possible, unless it is close to the time of the next dose. Do not take a double dose to make up for a missed dose.
If you are unsure about taking the medicine, consult your 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:
Visual field defects (mild to severe) are common in patients receiving vigabatrin, which can affect functioning. The onset of symptoms usually occurs after several months or years of vigabatrin treatment. According to studies, visual field defects develop in about 1/3 of patients treated with vigabatrin (see also section 2).

About 50% of patients in controlled clinical trials experienced side effects during vigabatrin treatment. In adults, these were mainly effects related to the central nervous system, such as sedation, drowsiness, fatigue, and concentration disorders.
In children, however, excitement or psychomotor restlessness is common. The frequency of these side effects is usually higher at the beginning of treatment and decreases over time.
As with other anti-epileptic medicines, vigabatrin may cause an increase in seizure frequency in some patients, 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 (at least 1 in 10 people):

• drowsiness
• visual field defects
• fatigue
• joint pain Common (less than 1 in 10 people):
• weight gain
• speech disorders, headache, tremor, dizziness, paresthesia (tingling sensation), concentration and memory disorders, thinking disorders
• blurred vision, double vision, nystagmus
• nausea, vomiting, abdominal pain
• edema, irritability
• psychomotor restlessness, aggression, nervousness, depression, paranoid reaction (delusions, hallucinations), insomnia
• anemia
• alopecia

Uncommon (less than 1 in 100 people):

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

Rare (less than 1 in 1000 people):

• encephalopathic symptoms (significant sedation, stupor, and confusion)
• retinal disorders (mainly peripheral)
• angioedema, urticaria
• suicidal attempt Very rare (less than 1 in 10,000 people):
• optic neuritis
• optic nerve atrophy
• hepatitis
• hallucinations Frequency not known (cannot be estimated from the available data):
• 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:

• excitement, psychomotor restlessness 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 you experience any side effects, including any not listed in this leaflet, tell 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 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, check the expiry date on the packaging.
Store the medicine 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. Ask your 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 sachet of granules for oral solution contains as the active substance:
500 mg vigabatrin
and the excipient: povidone K30

What Sabril looks like and contents of the pack

Sabril 500 mg granules for oral solution are packaged in sachets and cardboard boxes.
White or off-white powder in the form of granules.
The pack contains 50 sachets.

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, contact the representative of the marketing authorization holder in Poland:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00

Date of last revision of the leaflet: