270 mm

Package leaflet: Information for the user Levetiracetam Bristol Lab 250 mg film-coated tablets Levetiracetam Bristol Lab 500 mg film-coated tablets Levetiracetam Bristol Lab 750 mg film-coated tablets Levetiracetam Bristol Lab 1000 mg film-coated tablets

Read all of this leaflet carefully before you or your

child start taking this medicine because it contains

important information for you

-    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 signs of illness are the same as yours.

-    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet see section 4.

What is in this leaflet:

1.    What Levetiracetam is and what it is used for

2.    What you need to know before you take Levetiracetam

3.    How to take Levetiracetam

4.    Possible side effects

5.    How to store Levetiracetam

6.    Contents of the pack and other information

1. What Levetiracetam is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine

used to treat seizures in epilepsy).

Levetiracetam is used:

•    on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

•    as an add-on to other antiepileptic medicines to treat:

•    partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age;

•    myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;

•    primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Levetiracetam

Do not take Levetiracetam:

•    if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor before taking Levetiracetam

•    if you suffer from kidney problems, follow your doctor's instructions. He/she may decide if your dose should be adjusted.

•    If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor

•    A small number of people being treated with antiepileptics such as levetiracetam have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for a advice before taking this medicine.

Levetiracetam should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetiracetam has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment. Driving and using machines

Levetiracetam may impair your ability to drive or operate any tools or machinery, as levetiracetam may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam 750mg contains Sunset Yellow FCF (E110)

Sunset yellow FCF (E110 colouring agent), which may cause allergic reactions.

_3. How to take Levetiracetam_

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets following your doctor's instructions.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

250mg and 750mg tablets: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

500mg and 1000mg tablets: The tablets can be divided into equal halves

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1000 mg and 3,000 mg each day.

When you will first start taking levetiracetam, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1000 mg.

Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of250 mg in the morning and 2 tablets of250 mg in the evening.

Add-on therapy

Dosage in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg each day.

Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dosage in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.

An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dosage.

Method of administration:

Swallow Levetiracetam with a sufficient quantity of liquid (e.g. a glass of water). You may take levetiracetam with or without food.

Duration of treatment:

•    Levetiracetam is used as a chronic treatment. You should continue levetiracetam treatment for as long as your doctor has told you.

•    Do not stop your treatment without your doctor's advice as this could increase your seizures.

If you take more Levetiracetam than you should:

The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.

Contact your doctor if you took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten

dose.

If you stop taking Levetiracetam:

If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Stop taking this medicine and contact your doctor immediately, if you notice any of the following side effects:

•    severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);

Very common: may affect more than 1 in 10 people

•    somnolence (sleepiness); headache

•    nasopharyngitis

Common: may affect up to 1 in 10 people

•    anorexia (loss of appetite);

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•    convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

•    vertigo (sensation of rotation);

•    cough;

•    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

•    rash;

•    asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

•    decreased number of blood platelets, decreased number of white blood cells;

•    weight decrease, weight increase;

•    suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

•    amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

•    diplopia (double vision), vision blurred;

•    elevated/abnormal values in a liver function test

•    hair loss, eczema, pruritus;

•    muscle weakness, myalgia (muscle pain);

•    injury.

Rare: may affect up to 1 in 1,000 people

•    infection;

•    decreased number of all blood cell types;

•    suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);

•    uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

•    pancreatitis;

•    liver failure, hepatitis;

•    skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

•    Decreased blood sodium concentration Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at

'www.mhra.gov.uk/yellowcard.' By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam

•    Keep this medicine out of the sight and reach of children.

•    This medicinal product does not require any special storage conditions.

•    Do not use this medicine after the expiry date stated on the carton box and blister after “EXP.” The expiry date refers to that last day of the month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment

6. Contents of the pack and other information What Levetiracetam contains The active substance is Levetiracetam.

Each 250 mg tablet contains 250 mg Levetiracetam.

Each 500 mg tablet contains 500 mg Levetiracetam.

Each 750 mg tablet contains 750 mg Levetiracetam.

Each 1000 mg tablet contains 1000 mg Levetiracetam. The other ingredients are:

Tablet core:

Maize starch, Croscarmellose sodium, Povidone (kollidon 30), Silica colloidal anhydrous, Talc and Magnesium Stearate.

Tablet coating:

Levetiracetam Bristol Lab 250 mg film-coated tablets: Talc, Polyvinyl alcohol, Indigo carmine (E132),

Macrogol (3350) and Titanium dioxide (E171). Levetiracetam Bristol Lab 500 mg film-coated tablets:

Talc, Polyvinyl alcohol, Yellow Iron Oxide (E172), Macrogol 3350 and Titanium dioxide (E171). Levetiracetam Bristol Lab 750 mg film-coated tablets: Talc, Polyvinyl alcohol, Sunset yellow FCF (E110), Macrogol (3350) and Titanium dioxide (E171), Iron oxide red (E172).

Levetiracetam Bristol Lab 1000 mg film-coated tablets: Talc, Polyvinyl alcohol, Macrogol (3350) and Titanium dioxide (E171).

What Levetiracetam tablets look like and contents of the pack

Levetiracetam Bristol Lab 250 mg film-coated tablets are blue coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and "87" on other side.

Levetiracetam Bristol Lab 500 mg film-coated tablets are yellow coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “88” on the other side.

Levetiracetam Bristol Lab 750 mg film-coated tablets are orange coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “90” on the other side.

Levetiracetam Bristol Lab 1000 mg film-coated tablets are white coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “91” on the other side.

Levetiracetam is available in the cardboard boxes containing 10, 20, 30, 50, 60, 100 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Limited

Unit 3, Canalside, Northbridge Road Berkhamsted,

Hertfordshire, HP4 1EG, UK

Telephone: 0044 (0) 1442 200922, Fax: 0044 (0) 1442 873717 Email : info@bristol-labs.co.uk

Levetiracetam Bristol Lab 250 mg film-coated tablets; PL 17907/0388

Levetiracetam Bristol Lab 500 mg film-coated tablets; PL 17907/0389

Levetiracetam Bristol Lab 750 mg film-coated tablets; PL 17907/0390

Levetiracetam Bristol Lab 1000 mg film-coated tablets; PL 17907/0391

This leaflet was last revised in May 2016.

V1 16-03-16 D0

Package leaflet: Information for the user Levetiracetam Bristol Lab 250 mg film-coated tablets Levetiracetam Bristol Lab 500 mg film-coated tablets Levetiracetam Bristol Lab 750 mg film-coated tablets Levetiracetam Bristol Lab 1000 mg film-coated tablets

Read all of this leaflet carefully before you or your

child start taking this medicine because it contains

important information for you

-    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 signs of illness are the same as yours.

-    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet see section 4.

What is in this leaflet:

1.    What Levetiracetam is and what it is used for

2.    What you need to know before you take Levetiracetam

3.    How to take Levetiracetam

4.    Possible side effects

5.    How to store Levetiracetam

6.    Contents of the pack and other information

1. What Levetiracetam is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine

used to treat seizures in epilepsy).

Levetiracetam is used:

•    on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

•    as an add-on to other antiepileptic medicines to treat:

•    partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age;

•    myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;

•    primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take _Levetiracetam_

Do not take Levetiracetam:

•    if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor before taking Levetiracetam

•    if you suffer from kidney problems, follow your doctor's instructions. He/she may decide if your dose should be adjusted.

•    If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor

•    A small number of people being treated with antiepileptics such as levetiracetam have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for a advice before taking this medicine.

Levetiracetam should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetiracetam has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment. Driving and using machines

Levetiracetam may impair your ability to drive or operate any tools or machinery, as levetiracetam may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam 750mg contains Sunset Yellow FCF (E110)

Sunset yellow FCF (E110 colouring agent), which may cause allergic reactions.

3. How to take Levetiracetam

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets following your doctor's instructions.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

250mg and 750mg tablets: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

500mg and 1000mg tablets: The tablets can be divided into equal halves

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1000 mg and 3,000 mg each day.

When you will first start taking levetiracetam, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1000 mg.

Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of250 mg in the morning and 2 tablets of250 mg in the evening.

Add-on therapy

Dosage in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg each day.

Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dosage in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.

An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dosage.

Method of administration:

Swallow Levetiracetam with a sufficient quantity of liquid (e.g. a glass of water). You may take levetiracetam with or without food.

Duration of treatment:

•    Levetiracetam is used as a chronic treatment. You should continue levetiracetam treatment for as long as your doctor has told you.

•    Do not stop your treatment without your doctor's advice as this could increase your seizures.

If you take more Levetiracetam than you should:

The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.

Contact your doctor if you took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam:

If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Stop taking this medicine and contact your doctor immediately, if you notice any of the following side effects:

• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);

Very common: may affect more than 1 in 10 people

•    somnolence (sleepiness); headache

•    nasopharyngitis

Common: may affect up to 1 in 10 people

•    anorexia (loss of appetite);

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•    convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

•    vertigo (sensation of rotation);

•    cough;

•    abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

•    rash;

•    asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

•    decreased number of blood platelets, decreased number of white blood cells;

•    weight decrease, weight increase;

•    suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

•    amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

•    diplopia (double vision), vision blurred;

•    elevated/abnormal values in a liver function test

•    hair loss, eczema, pruritus;

•    muscle weakness, myalgia (muscle pain);

•    injury.

Rare: may affect up to 1 in 1,000 people

•    infection;

•    decreased number of all blood cell types;

•    suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);

•    uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

•    pancreatitis;

•    liver failure, hepatitis;

•    skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

•    Decreased blood sodium concentration Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 'www.mhra.gov.uk/yellowcard.' By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam

•    Keep this medicine out of the sight and reach of children.

•    This medicinal product does not require any special storage conditions.

•    Do not use this medicine after the expiry date stated on the carton box and blister after “EXP.” The expiry date refers to that last day of the month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment

6. Contents of the pack and other information What Levetiracetam contains The active substance is Levetiracetam.

Each 250 mg tablet contains 250 mg Levetiracetam.

Each 500 mg tablet contains 500 mg Levetiracetam.

Each 750 mg tablet contains 750 mg Levetiracetam.

Each 1000 mg tablet contains 1000 mg Levetiracetam. The other ingredients are:

Tablet core:

Maize starch, Croscarmellose sodium, Povidone (kollidon 30), Silica colloidal anhydrous, Talc and

Magnesium Stearate.

Tablet coating:

Levetiracetam Bristol Lab 250 mg film-coated tablets: Talc, Polyvinyl alcohol, Indigo carmine (E132), Macrogol (3350) and Titanium dioxide (E171). Levetiracetam Bristol Lab 500 mg film-coated tablets: Talc, Polyvinyl alcohol, Yellow Iron Oxide (E172), Macrogol 3350 and Titanium dioxide (E171). Levetiracetam Bristol Lab 750 mg film-coated tablets: Talc, Polyvinyl alcohol, Sunset yellow FCF (E110), Macrogol (3350) and Titanium dioxide (E171), Iron oxide red (E172).

Levetiracetam Bristol Lab 1000 mg film-coated tablets: Talc, Polyvinyl alcohol, Macrogol (3350) and Titanium dioxide (E171).

What Levetiracetam tablets look like and contents of the pack

Levetiracetam Bristol Lab 250 mg film-coated tablets are blue coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and "87" on other side.

Levetiracetam Bristol Lab 500 mg film-coated tablets are yellow coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “88” on the other side.

Levetiracetam Bristol Lab 750 mg film-coated tablets are orange coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “90” on the other side.

Levetiracetam Bristol Lab 1000 mg film-coated tablets are white coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “91” on the other side.

Levetiracetam is available in the cardboard boxes containing 10, 20, 30, 50, 60, 100 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Limited

Unit 3, Canalside, Northbridge Road Berkhamsted,

Hertfordshire, HP4 1EG, UK

Telephone: 0044 (0) 1442 200922, Fax: 0044 (0) 1442 873717 Email : info@bristol-labs.co.uk

Levetiracetam Bristol Lab 250 mg film-coated tablets; PL 17907/0388

Levetiracetam Bristol Lab 500 mg film-coated tablets; PL 17907/0389

Levetiracetam Bristol Lab 750 mg film-coated tablets; PL 17907/0390

Levetiracetam Bristol Lab 1000 mg film-coated tablets; PL 17907/0391

This leaflet was last revised in May 2016.

V9 26-05-16 D0