500 mg film-coated tablets
vigabatrin
What Sabrilex is and what it is used for
Sabrilex helps control various forms of epilepsy.
It is used in combination with your regular medicines to treat epilepsy, which is difficult to control. It will be printed by a specialist for the first time. You will follow how you respond to the treatment.
It can also be used to control a particular type of seizure in children (West syndrome).
What you need to know before you take Sabrilex
Do not take Sabrilex
- if you are allergic to vigabatrin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before taking Sabrilex if:
- you breastfeed
- you are pregnant or planning to become pregnant
- you have or have previously had depression or other mental illness
- you have had kidney problems
- you have had eye problems
| Visual field loss (loss of vision at the edges of the visual field ) may occur during treatment with Sabrilex. You should discuss this possibility with your doctor before starting treatment with this medicine. This visual field loss can be severe, in severe cases cause tunnel vision and vision loss, and irreversible (not transient), so it must be detected early. Deterioration of visual field loss after treatment can not be ruled out. You must contact a doctor immediately if you notice any vision change. Your doctor should perform a visual field examination and visual acuity test before starting treatment with Sabrilex and regularly throughout treatment. Sabrilex may cause impaired vision due to eye problems such as retinal problems, blurred vision, optic nerve loss, or optic nerve inflammation ( see section 4). If your vision changes, consult an ophthalmologist. |
If you experience symptoms such as drowsiness, decreased alertness and mobility (so-called dizziness ), or confusion, consult a doctor who decides whether to reduce the dose or stop treatment.
A small number of people treated with antiepileptic drugs such as vigabatrin have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
Children
Disorders affecting the movement pattern and abnormal magnetic resonance imaging (MRI) of the brain have been reported in young children treated for infantile spasm (West syndrome). If you notice an abnormal movement pattern in your child, consult a doctor who will decide if it is necessary to consider changing the treatment.
Other medicines and Sabrilex
Tell your doctor if you are taking clonazepam as concomitant use of Sabrilex may increase the risk of drowsiness.
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Sabrilex should not be taken in combination with other medicines that may cause eye side effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Do not use Sabrilex during pregnancy unless your doctor tells you to. Sabrilex can cause problems in the fetus. Do not stop taking this medicine abruptly, as this may risk both the mother’s and the baby’s health.
Sabrilex passes into breast milk. If you are breastfeeding, talk to your doctor before taking this medicine. Do not breastfeed during treatment.
Driving and using machines
Do not drive or use any tools or machines if your epilepsy is not under control.
Sabrilex can sometimes cause symptoms such as drowsiness or dizziness and your ability to concentrate and react may be impaired. If such symptoms occur while taking Sabrilex, you should not perform any risky tasks such as driving or using machines.
Visual field disturbances, which may affect your ability to drive or use machines, have occurred in some patients taking this medicine. If you want to continue driving, you must regularly (every six months) test your vision for any visual disturbances, even if you do not notice any vision changes.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sabrilex contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take Sabrilex
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
You must always follow your doctor’s instructions exactly. Never change the dosage yourself. The doctor prescribes a dose and adjusts it individually for the patient.
The usual starting dose for adults is 1 g (2 tablets daily). Your doctor may want to increase or decrease the dose depending on how you react. The usual maintenance dose for adults is 2-3 g (4-6 tablets). The highest recommended dose is 3 g / day.
If you are elderly and/or have kidney problems, your doctor may want to give you a lower dose.
Use in children
Therapy-resistant partial epilepsy
For children, dose one is based on age and body weight. The usual starting dose for children is 40 mg/kg body weight and day. The following table shows how many tablets can be given to a child depending on body weight. Remember that this is a guide only. The child’s doctor may prescribe another dose .
| Body weight | 10-15 kg | 0.5-1 g (1-2 tablets) / day |
| 15-30 kg | 1-1.5 g (2-3 tablets) / day | |
| 30-50 kg | 1.5-3 g (3-6 tablets) / day | |
| more than 50 kg | 2-3 g (4-6 tablets) / day (adult dose) |
Children with infantile spasm (West syndrome)
The recommended starting dose for children with West syndrome (seizures in children) is 50 mg/kg body weight, but one may then need to be increased.
Method of administration
Oral use (taken by mouth).
Always swallow the tablet with at least half a glass of water.
You can take Sabrilex before or after a meal.
The daily dose can be taken at a single time or divided into two doses.
If you take more Sabrilex than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Any signs of overdose include drowsiness or lost/decreased alertness.
If you forget to take Sabrilex
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, take only one dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sabrilex
Do not stop taking this medicine without talking to your doctor. If the doctor decides to stop treatment, the dose will be reduced gradually. Do not stop taking the medication abruptly as it may cause new seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other antiepileptic medicines, some patients treated with this medicine may experience an increased number of seizures (seizures). Contact a doctor immediately if this happens to you or your child.
Contact a doctor immediately if you get:
Widespread side effects (may affect more than 1 in 10 people)
- Visual field defects – Approximately 1/3 of all those treated with Sabrilex may experience visual field disorders (reduced visual field ). These visual disturbances can be mild to severe. They usually occur after months to years of treatment with Sabrilex. Visual field disorders can be irreversible (not transient), so they must be detected early. Contact a doctor or hospital immediately if you or your child experience visual disturbances.
Other side effects include:
Widespread side effects (may affect more than 1 in 10 people)
- Fatigue and pronounced drowsiness
- Joint pain
Common side effects (may affect up to 1 in 10 people)
- Headache
- Weight gain
- Tremors ( tremor )
- Swelling ( edema )
- Dizziness
- Numbness and tingling (and crawling)
- Concentration difficulties and memory disorders
- Psychological disorders such as anxiety, aggression, nervousness, irritability, depression, thought disorders and paranoia (persecution mania), insomnia. These reactions are usually transient when the dose is reduced or when treatment is stopped gradually. Do not reduce dose one without first consulting a doctor. Contact a doctor if you get any of these side effects.
- Nausea, vomiting, and abdominal pain
- Blurred vision, double vision, and rapid involuntary eye movements
- Speech disorders
- Reduction of red blood cell count ( anemia )
- Spotty hair loss ( alopecia )
Uncommon side effects (may affect up to 1 in 100 people)
- Lack of coordination of movements or clumsiness
- More serious psychological disorders such as mania, hypomania (a milder form of mania), and psychosis
- Rash
Rare side effects (may affect up to 1 in 1,000 people)
- The severe allergic reaction that causes swelling of the face or throat: Contact a doctor immediately if you experience these symptoms.
- Hives
- Decreased alertness, stiffness, and confusion. These side effects are usually transient when the dose is reduced or gradually stopped. Do not reduce dose one without first consulting a doctor. Contact a doctor if you experience these side effects.
- Suicide attempt
- Other eye problems such as damage to the retina of the eye
Very rare side effects (may affect up to 1 in 10,000 people).
- Other eye problems such as optic nerve inflammation and optic nerve loss
- Hallucinations
- Liver problems
Has been reported (occurs in an unknown number of users)
- Impaired visual acuity
- Abnormal changes were seen in images of the brain taken with MRI
- Swelling in the layer that protects nerve cells in a part of the brain has been observed on MRI images
Other side effects in children
Widespread side effects (may affect more than 1 in 10 people)
- Overactive state or restlessness
No known frequency (frequency can not be calculated from available data)
- Disorders that affect the movement pattern of young children being treated for infantile spasm
- Abnormal changes are seen on images of the brain taken with MRI, especially in infants
- Swelling in the layer that protects nerve cells in a part of the brain observed in MRI images, especially in infants
How to store Sabrilex
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and blister after “EXP”.
The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is vigabatrin. One film-coated tablet contains 500 mg of vigabatrin.
- Other ingredients are: Tablet core: Povidone K30 (E1201), Microcrystalline cellulose (E460), Sodium starch glycolate (type A), Magnesium stearate
Tablet coating:Hypromellos 15 mPa.s (E464), Titanium dioxide (E171), Macrogol 8000
What the medicine looks like and the contents of the pack
Sabrilex is a white to off-white, oval, biconvex film-coated tablet with a score line on one side and embossed “SABRILEX” on the other side.
It occurs in clear or opaque blisters of 10 tablets. Each pack contains 30, 50, 60, 100 or 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of marketing authorization in Sweden:
Sanofi AB
Box 30052
104 25 Stockholm
Manufacturer
Patheon France SA
40, Boulevard de Champaret
38317 Bourgoin-Jallieu, Cedex
France
This medicinal product is authorized under the European Economic Area under the names:
Sabril: Belgium, France, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, the United Kingdom, Germany, and Austria
Sabrilex: Denmark, Finland, Spain, and Sweden