SABRIL <500 MG Film-coated tablets

Зміст інструкції

1. Sabril 500 mg film-coated tablets
   1. What is Sabril and what is it used for
   2. What you need to know before you take Sabril
   3. How to take Sabril
   4. Possible side effects
   5. How to store Sabril
   6. Contents of the pack and other information
2. Sabril 500 mg granules for oral solution
   1. What is Sabril and what is it used for
   2. What you need to know before you take Sabril
   3. Possible side effects
   4. How to store Sabril
   5. Contents of the pack and other information

Sabril 500 mg film-coated tablets

vigabatrin

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sabril is and what it is used for
• 2. What you need to know before you take 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 is used to help control various forms of epilepsy.
It is used in addition to ongoing therapy to treat “difficult to control” epilepsy. Initially the
medicine will be prescribed by a specialist. Your response to treatment will be monitored.
It is also used for the control of infantile spasms (West Syndrome).

2. What you need to know before you take Sabril

Do not take Sabril

• if you are allergic to vigabatrin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Sabril:

• if you are breastfeeding
• if you are pregnant or planning a pregnancy
• if you suffer from or have previously suffered from depression or other psychiatric illness
• if you have had kidney problems
• if you have had eye problems

During treatment with Sabril, loss of visual field (loss of vision at the edges of the
visual field) may occur. Before starting therapy with this medicine, discuss this possibility with your
doctor. Loss of visual field may be severe, up to tunnel vision or loss of vision, and
irreversible, therefore it must be identified promptly. Worsening of visual field defects after discontinuation of treatment cannot be ruled out.
It is important that you immediately inform your doctor if you experience any changes in your vision. The
doctor will need to perform a visual field test and an assessment of visual acuity, before starting the
administration of Sabril and at regular intervals during therapy.
Sabril can cause a reduction in vision due to eye problems, such as retinal disturbance,
blurred vision, optic atrophy or optic neuritis (see section 4). If your vision changes, consult your
eye doctor.
If you experience symptoms such as drowsiness, reduced levels of consciousness and movements (stupor) or confusion,
consult your doctor who will decide about a dose reduction or discontinuation.
A small number of patients treated with antiepileptic drugs have developed self-harmful or
suicidal thoughts. If thoughts of this kind emerge at any time, contact your doctor immediately.

Children
In young children treated for infantile spasms (West syndrome), movement disorders and abnormalities in brain magnetic resonance imaging (MRI) have been reported. If you observe unusual
movement disorders in the child, consult your doctor who will decide whether it is necessary to change the therapy.

Other medicines and Sabril
Tell your doctor if you are taking clonazepam as concomitant use with Sabril may increase the
risk of sedation.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Sabril must not be used in combination with other medicines that could have undesirable effects
related to the eyes.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before
taking this medicine.
Do not take Sabril during pregnancy unless your doctor tells you to. Sabril can cause
problems for the fetus. However, avoid suddenly stopping taking the medicine, as this may
pose a risk to the health of both the mother and the fetus.
Sabril passes into breast milk. If you are breastfeeding, ask your doctor for advice before taking this
medicine. You should not breastfeed during treatment.

Driving and operating machinery
Do not drive or operate machinery if your epilepsy is not controlled.
Sometimes Sabril can cause symptoms such as drowsiness or dizziness and your ability to concentrate and
react may be reduced. If these symptoms occur during treatment with Sabril, you should not perform
dangerous work such as driving and operating machinery.
Visual disturbances have been reported in some patients taking this medicine, which may
affect the ability to drive and operate machinery. If you want to continue driving, you should have
regular checks (every six months) to check for the onset of visual disturbances, even if you do not notice any changes in your vision.

Sabril contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Sabril

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. It is important to follow exactly the doctor's instructions. Never change the
dose on your own initiative. The doctor prescribes the dose and adjusts it individually for each patient.
Initially, the usual daily dose for adults is 1 g (2 tablets). However, the doctor may
decide to increase or decrease the dose based on your response; the usual daily dose for adults
is 2-3 g (4 to 6 tablets). The maximum recommended dose is 3 g/day.
Furthermore, if you are an elderly person and/or have kidney problems, the doctor may decide to administer a
lower dose.

Use in children
Resistant partial epilepsy
For children, the dose is based on age and weight. Initially, the usual daily dose for children is
40 milligrams per kg of body weight. The table below indicates the number of tablets to
administer to a child based on body weight. It is important to emphasize that this is simply
a guideline. The pediatrician may deem slightly different doses appropriate.
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 spasms (West Syndrome)
The recommended initial daily dose for children with West syndrome (infantile spasms) is 50
milligrams per kg of body weight, although higher doses may sometimes be used.

Method of administration
The route of administration is oral (by mouth).
Always swallow the tablet with at least half a glass of water.
You can take Sabril before or after meals.
The daily dose can be taken as a single dose or divided into two doses.

If you take more Sabril than you should
If you or your child accidentally take too many Sabril tablets, inform your doctor immediately or go to the nearest
hospital or Poison Control Center.
Possible signs of overdose include drowsiness or loss / decreased level of consciousness.

If you forget to take Sabril
If you forget a dose, take it as soon as you remember. If it is already time to take the next dose,
take one dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Sabril
Do not stop taking this medicine without consulting your doctor. If the doctor decides to
stop treatment, he/she will inform you of the need to reduce the dose gradually. Do not stop
treatment suddenly, as this could cause a recurrence of seizures.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Similar to other antiepileptics, during treatment with this medicine, some patients may
experience an increase in the frequency of seizures. If this happens to you or your child, contact
your doctor immediately.

Immediately inform your doctor if you experience:
Very common side effects (may affect more than 1 in 10 people)

• Changes in visual field - Approximately 1/3 or 33 patients out of 100 treated with Sabril may experience changes in visual field (narrowing of the visual field). The degree of this “visual field defect” can range from mild to severe. It is usually detected after months or years of treatment with Sabril. Changes in the visual field may be irreversible and, therefore, must be

identified early. If you or your child experience vision problems, contact your doctor or hospital immediately.

Other side effects include:
Very common 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
• Tremor (shaking)
• Swelling (edema)
• Dizziness
• Feeling of numbness or tingling
• Changes in concentration and memory
• Psychological disturbances including agitation, aggression, nervousness, irritability, depression, altered thinking and paranoia, insomnia. These side effects are usually reversible when the dose is reduced or gradually discontinued. However, do not reduce the dose without first consulting your doctor. Contact your doctor if you experience these side effects.
• Nausea, vomiting and abdominal pain
• Blurred vision, diplopia (double vision) and rapid involuntary eye movement
• Speech disorders
• Decreased number of red blood cells (anemia)
• Unusual hair loss or thinning (alopecia).

Uncommon side effects (may affect up to 1 in 100 people)

• Lack of coordination of movements or clumsy physical movements.
• More serious psychological disturbances such as hypomania, mania and psychosis.
• Skin rash.

Rare side effects (may affect up to 1 in 1,000 people)

• Severe allergic reactions, causing swelling of the face or throat: if these symptoms occur, consult your doctor immediately.
• Hives.
• Marked sedation, stupor and confusion. These side effects are usually reversible when the dose is reduced or gradually discontinued. However, do not reduce the dose without first consulting your doctor. Contact your doctor if you experience these side effects.
• Suicidal attempts.
• Other eye problems such as retinal disorders.

Very rare side effects (may affect up to 1 in 10,000 people)

• Other eye problems such as optic neuritis and optic nerve atrophy.
• Hallucinations.
• Liver disorders.

Frequency not known (the frequency cannot be estimated from the available data)

• Decreased visual acuity.
• Abnormal changes in brain images obtained with magnetic resonance imaging.
• Swelling of the protective layer of nerve cells in part of the brain, as observed in magnetic resonance images.

Additional side effects in children
Very common side effects (may affect more than 1 in 10 people)

• Excitement or agitation

Frequency not known (the frequency cannot be estimated from the available data)

• Movement disorders in young children treated for infantile spasms.
• Abnormal changes in brain images obtained with magnetic resonance imaging, especially in infants.
• Swelling of the protective layer of nerve cells in part of the brain, as observed in magnetic resonance images, especially in infants.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Sabril

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the outside of the cardboard box and on the
blisters. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sabril contains

• The active ingredient is vigabatrin. One film-coated tablet contains 500 mg of vigabatrin.
• The other ingredients are: Tablet core: Povidone K30 (E1201), microcrystalline cellulose (E460), sodium starch glycolate (type A), magnesium stearate.

Tablet coating:
Hypromellose 15 mPa.s (E464), titanium dioxide (E171), Macrogol 8000

Description of Sabril and contents of the pack
Sabril is presented as film-coated tablets, biconvex, oval, from white to almost white
with a fracture line on one side and “Sabril” imprinted on the other side.
It is available in transparent or opaque blisters of 10 tablets.
Each pack contains 30, 50, 60, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi S.r.l.
viale L. Bodio, 37/B
20158 Milano

Manufacturer
PATHEON FRANCE S.A.S.
40, Boulevard de Champaret - 38317 Bourgoin-Jallieu (France)
For further information on Sabril, contact the local representative of the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria:Sabril 500 mg Filmtabletten

Belgium:Sabril 500 mg film-coated tablets

Denmark: Sabrilex

Finland:Sabrilex 500 mg tablet, film-coated

France: Sabril 500 mg comprimé pelliculé

Germany:Sabril 500 mg Filmtabletten

Greece: Sabril 500 mg επικαλυμμένα με λεπτό υμένιο δισκία

Ireland:Sabril 500 mg film-coated tablets

Italy:Sabril 500 mg compresse rivestite con film

Luxembourg: Sabril 500 mg comprimés pelliculés

Netherlands:Sabril 500 mg film-coated tablet

Portugal: Sabril 500 mg comprimidos revestidos por pelicula

Spain:Sabrilex 500 mg comprimidos recubiertos con pelicula

Sweden: Sabrilex 500 mg filmdragerade tabletter

United Kingdom:Sabril 500 mg film-coated tablets

This leaflet was last approved:

Sabril 500 mg granules for oral solution

vigabatrin

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sabril is and what it is used for
• 2. What you need to know before you take 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 is used to help control various forms of epilepsy.
It is used in addition to ongoing therapy to treat “difficult to control” epilepsy. Initially the
medicine will be prescribed by a specialist. Your response to treatment will be monitored.
It is also used for the control of infantile spasms (West Syndrome).

2. What you need to know before you take Sabril

Do not take Sabril

• if you are allergic to vigabatrin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Sabril:

• if you are breastfeeding
• if you are pregnant or planning a pregnancy
• if you suffer from or have previously suffered from depression or other psychiatric illness
• if you have had kidney problems
• if you have had eye problems

During treatment with Sabril, loss of visual field (loss of vision at the edges of the
visual field) may occur. Before starting therapy with this medicine, discuss this possibility with your
doctor. Loss of visual field may be severe, up to tunnel vision or loss of vision, and
irreversible, therefore it must be identified promptly. Worsening of visual field defects after discontinuation of treatment cannot be ruled out.
It is important that you immediately inform your doctor if you experience any changes in your vision. The
doctor will need to perform a visual field test and an assessment of visual acuity, before starting the
administration of Sabril and at regular intervals during therapy.
Sabril can cause a reduction in vision due to eye problems, such as retinal disturbance,
blurred vision, optic atrophy or optic neuritis (see section 4). If your vision changes, consult your
eye doctor.
If you experience symptoms such as drowsiness, reduced consciousness and movements (stupor) or confusion, consult your
doctor who will decide on a dose reduction or discontinuation.
A small number of patients treated with antiepileptic drugs have developed self-harm or
suicidal thoughts. If thoughts of this kind emerge at any time, contact your doctor immediately.

Children
In young children treated for infantile spasms (West syndrome), movement disorders and abnormalities in brain magnetic resonance imaging (MRI) have been reported. If you observe unusual
movement disorders in the child, consult your doctor who will decide whether it is necessary to change the therapy.

Other medicines and Sabril
Tell your doctor if you are taking clonazepam as concomitant use with Sabril may increase the
risk of sedation.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Sabril must not be used in combination with other medicines that could have undesirable effects
related to the eyes.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before
taking this medicine. Do not take Sabril during pregnancy unless your doctor tells you to.
Sabril can cause problems for the fetus. However, avoid suddenly stopping
taking the medicine, as this may pose a risk to the health of the mother and also the fetus.
Sabril passes into breast milk. If you are breastfeeding, ask your doctor for advice before taking this
medicine. You should not breastfeed during treatment.

Driving and operating machinery
Do not drive or operate machinery if your epilepsy is not controlled.
Sometimes Sabril can cause symptoms such as drowsiness or dizziness and your ability to concentrate and
react may be reduced. If these symptoms occur during treatment with Sabril, you should not perform
dangerous work such as driving and operating machinery.
Visual disturbances have been reported in some patients taking this medicine, which can
affect the ability to drive and operate machinery. If you want to continue driving, you should have
regular checks (at six-month intervals) to check for the onset of visual disturbances,
even if you do not notice any changes in your vision.

• 3. How to take Sabril

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your
doctor or pharmacist. It is important to follow your doctor's instructions exactly. Do not change the dose
on your own initiative. The doctor prescribes the dose and adjusts it individually for each patient.
Initially the usual daily dose for adults is 1 g (2 sachets). However, the doctor may decide to
increase or decrease the dose based on the individual patient's response; the usual daily dose for
adults is 2-3 g (4 to 6 sachets). The maximum recommended dose is 3 g/day.
In addition, if you are an elderly person and/or have kidney problems, the doctor may decide to administer a
lower dose.

Use in children
Resistant partial epilepsy
For children, the dose is based on age and weight. Initially the usual daily dose for children is
40 milligrams per kg of body weight. The table below indicates the number of sachets to
administer to a child based on body weight. It is important to emphasize that this is simply
an indication. The pediatrician may deem slightly different doses appropriate.
Body weight 10-15 kg 0.5-1 g (1-2 sachets)/day
15-30 kg 1-1.5 g (2-3 sachets)/day
30-50 kg 1.5-3 g (3-6 sachets)/day
more than 50 kg 2-3 g (4-6 sachets)/day (adult dose).

Children with infantile spasms (West Syndrome)
The recommended initial daily dose for children with West syndrome (infantile spasms) is 50
milligrams per kg of body weight, although higher doses may sometimes be used.

How to administer
The route of administration is oral (by mouth).
Do not open the sachets until it is time to take the medicine. To take a dose, dissolve
all the powder from the recommended number of sachets in half a glass of cold water or
an alcohol-free beverage, such as fruit juice or milk. As soon as all the powder is dissolved, drink the whole
solution immediately without letting it sit.
You can take Sabril before or after meals.
The daily dose can be taken as a single dose or divided into two doses.

If you take more Sabril than you should
If you or your child accidentally take too many Sabril sachets, inform your doctor immediately or
go to the nearest hospital or Poison Control Center.
Possible signs of overdose include drowsiness or loss / decreased level of consciousness.

If you forget to take Sabril
If you forget a dose, take it as soon as you remember. If it is already time to take the next dose,
take one dose. Do not take a double dose to make up for a missed dose.

If you stop taking Sabril
Do not stop taking this medicine without consulting your doctor. If the doctor decides to
stop treatment, they will inform you of the need to reduce the dose gradually. Do not stop
treatment suddenly, as this may cause a recurrence of seizures.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Similar to other antiepileptics, during treatment with this medicine, some patients may
experience an increase in the frequency of seizures. If this happens to you or your child, contact
your doctor immediately.

Immediately inform your doctor if you experience:
Very common side effects (may affect more than 1 in 10 people)

• Changes in the visual field - Approximately 1/3 or 33 patients out of 100 treated with Sabril may experience changes in the visual field (narrowing of the visual field). The degree of this “visual field defect” can vary from mild to severe. It is usually detected after months or years of treatment with Sabril. Changes in the visual field may be irreversible and, therefore, must be identified early. If you or your child experience vision problems ,contact your doctor or hospital immediately.

Other side effects include:
Very common 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
• Tremor (shaking)
• Swelling (edema)
• Dizziness
• Sensation of numbness or tingling
• Changes in concentration and memory.
• Psychological disorders including agitation, aggression, nervousness, irritability, depression, changes in thinking and paranoia, insomnia. These side effects are usually reversible when the dose is gradually reduced or stopped. However, do not reduce the dose without first consulting your doctor. Contact your doctor if you experience these side effects.
• Nausea, vomiting and abdominal pain.
• Blurred vision, diplopia (double vision) and rapid involuntary eye movement.
• Speech disorders.
• Decreased number of red blood cells (anemia)
• Unusual hair loss or thinning (alopecia).

Uncommon side effects (may affect up to 1 in 100 people)

• Lack of coordination of movements or disjointed physical movements.
• More serious psychological disorders such as hypomania, mania and psychosis.
• Skin rash.

Rare side effects (may affect up to 1 in 1,000 people)

• Severe allergic reactions, causing swelling of the face or throat: if these symptoms occur, consult your doctor immediately.
• Hives.
• Marked sedation, stupor and confusion. These side effects are usually reversible when the dose is gradually reduced or stopped. However, do not reduce the dose without first consulting your doctor. Contact your doctor if you experience these side effects.
• Suicidal attempts.
• Other eye problems such as retinal disorders.

Very rare side effects (may affect up to 1 in 10,000 people)

• Other eye problems such as optic neuritis and optic nerve atrophy.
• Hallucinations.
• Liver disorders.

Frequency not known (the frequency cannot be estimated from the available data)

• Decreased visual acuity.
• Abnormal changes in brain images obtained with magnetic resonance imaging.
• Swelling of the protective layer of nerve cells in part of the brain, as observed in brain magnetic resonance imaging. Additional side effects in childrenVery common side effects (may affect more than 1 in 10 people)
• Excitement or agitation

Frequency not known (the frequency cannot be estimated from the available data)

• Movement disorders in young children treated for infantile spasms.
• Abnormal changes in brain images obtained with magnetic resonance imaging, especially in infants.
• Swelling of the protective layer of nerve cells in part of the brain, as observed in brain magnetic resonance imaging, especially in infants.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Sabril

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and on the
sachets. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sabril contains

• The active ingredient is vigabatrin. One sachet contains 500 mg of vigabatrin.
• The other ingredients are: Povidone K30 (E1201)

Description of the appearance of Sabril and contents of the pack
Sabril appears as a granular powder from white to almost white in color.
It is available in packs of 50, 60 or 100 sachets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Sanofi S.r.l.
viale L. Bodio, 37/B
20158 Milano

Manufacturer
Granules for oral solution:
PATHEON FRANCE S.A.S.
40, Boulevard de Champaret - 38317 Bourgoin-Jallieu (France)
For further information on Sabril, contact the local representative of the marketing authorisation holder
.

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria:Sabril 500 mg soluble powder

Denmark:Sabrilex

Finland:Sabrilex 500 mg powder for oral solution

France:Sabril 500 mg granules for drinkable solution in single-dose sachets

Germany:Sabril Sachets

Ireland:Sabril 500 mg granules for oral solution

Italy:Sabril 500 mg granules for oral solution

Netherlands:Sabril 500 mg granules for drink

Portugal:Sabril 500 mg granules for oral solution

Spain:Sabrilex 500 mg granules for oral solution

Sweden:Sabrilex 500 mg granules for oral solution

United Kingdom:Sabril 500 mg granules for oral solution

This leaflet was last approved: