Patient leaflet - Keppra

B. PACKAGE LEAFLET

Package Leaflet: Information for the patient

Keppra 250 mg film-coated tablets Keppra 500 mg film-coated tablets Keppra 750 mg film-coated tablets Keppra 1000 mg film-coated tablets Levetiracetam

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 Keppra is and what it is used for
2. What you need to know before you take Keppra
3. How to take Keppra
4. Possible side effects
5. How to store Keppra
6. Contents of the pack and other information

1. What Keppra is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra 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 Keppra

Do not take Keppra

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 Keppra

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 slowdown in the growth or unexpected puberty development of your child,

please contact your doctor.

A small number of people being treated with anti-epileptics such as Keppra have had thoughts

of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

If you have a family or medical history of irregular heart rhythm (visible on an

electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or

your family and friends notice important changes in mood or behaviour.

Aggravation of epilepsy

Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Keppra, see a doctor as soon as possible.

Children and adolescents

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

Other medicines and Keppra

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 breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.

You should not stop your treatment without discussing this with your doctor.

A risk of birth defects for your unborn child cannot be completely excluded.

Breast-feeding is not recommended during treatment.

Driving and using machines

Keppra may impair your ability to drive or operate any tools or machinery, as it 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.

Keppra 750 mg tablets contain Sunset Yellow FCF (E110).

Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.

3. How to take Keppra

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

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

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

Adjunctive Therapy and monotherapy (from 16 years of age)

Adults (>18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

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

When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Example: if your daily dose is intended to be 1000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually incremented to reach 1000 mg daily after 2 weeks.

Adolescents (12 to 17 years) weighing 50 kg or less:

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

Dose in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50

kg:

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

Keppra 100 mg/ml 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 50kg and when tablets don’t allow accurate dosage.

Method of administration

Swallow Keppra tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Keppra with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

Duration of treatment

Keppra is used as a chronic treatment. You should continue Keppra 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 Keppra than you should

The possible side effects of an overdose of Keppra 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 Keppra:

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

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

If you stop taking Keppra:

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

If you have any further questions on 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.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
swelling of the face, lips, tongue and throat (Quincke’s oedema)
flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
a skin rash which may form blisters and look 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)
a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

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.

Very common : may affect more than 1 in 10 people

nasopharyngitis;
somnolence (sleepiness), headache.

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;
severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic

reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;
suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable

to concentrate);

delirium;
encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of

symptoms);

seizures may become worse or happen more often;
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling

movements, hyperkinesia (hyperactivity);

change of the heart rhythm (Electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
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 );

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase

increase. Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.

limp or difficulty walking.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Keppra

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

Do not use this medicine after the expiry date stated on the carton box and blister after EXP.

The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

What Keppra contains

The active substance is called levetiracetam.

One tablet of Keppra 250 mg contains 250 mg of levetiracetam.

One tablet of Keppra 500 mg contains 500 mg of levetiracetam.

One tablet of Keppra 750 mg contains 750 mg of levetiracetam.

One tablet of Keppra 1,000 mg contains 1,000 mg of levetiracetam.

The other ingredients are:

Tablet core : croscarmellose sodium, macrogol 6000, silica colloidal anhydrous, magnesium stearate. Film-coating : Polyvinyl alcohol-part. hydrolyzed, titanium dioxide (E171), macrogol 3350, talc, colourants*.

* The colourants are:

250 mg tablet: indigo carmine aluminium lake (E132)

500 mg tablet: iron oxide yellow (E172)

750 mg tablet: sunset yellow FCF aluminium lake (E110), iron oxide red (E172)

What Keppra looks like and contents of the pack

Keppra 250 mg film-coated tablets are blue, 13 mm oblong, scored and debossed with the code “ucb” and “250” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 500 mg film-coated tablets are yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 750 mg film-coated tablets are orange, 18 mm oblong, scored and debossed with the code “ucb” and “750” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra 1000 mg film-coated tablets are white, 19 mm oblong, scored and debossed with the code “ucb” and “1000” on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Keppra tablets are packaged in blister packs supplied in cardboard boxes containing:

250 mg: 20, 30, 50, 60, 100 × 1, 100 film-coated tablets and multipacks containing 200 (2 packs

of 100) film-coated tablets

500 mg: 10, 20, 30, 50, 60, 100 × 1, 100, 120 film-coated tablets and multipacks containing 200

(2 packs of 100) film-coated tablets

750 mg: 20, 30, 50, 60, 80, 100 × 1, 100 film-coated tablets and multipacks containing 200 (2

packs of 100) film-coated tablets

1000 mg: 10, 20, 30, 50, 60, 100 × 1, 100 film-coated tablets and multipacks containing 200 (2

packs of 100) film-coated tablets

The 100 × 1 tablet packs are available in aluminium/PVC perforated unit dose blisters. All other packs are available in standard aluminium/PVC blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer

UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

or Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgie/Belgique/Belgien

UCB Pharma SA/NV

Tel/Tél: + 32 / (0)2 559 92 00

Lietuva

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (Suomija)

Efc^rapufl

TO CH EH Etnrapua EOOfl

Tea.: + 359 (0) 2 962 30 49

Luxembourg/Luxemburg

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Magyarország

UCB Magyarország Kft.

Tel.: + 36-(1) 391 0060

Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Malta

Pharmasud Ltd.

Tel: + 356 / 21 37 64 36

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Nederland

UCB Pharma B.V.

Tel.: + 31 / (0)76–573 11 40

Eesti

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (Soome)

Norge

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

EZZáSa

UCB A.E.

Tql: + 30 /2109974000

Österreich

UCB Pharma GmbH

Tel: + 43 (0)1 291 80 00

España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

Polska

UCB Pharma Sp. z o.o.

Tel: + 48 22 696 99 20

France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35

Portugal

UCB Pharma (Produtos Farmacéuticos), Lda

Tel: + 351 / 21 302 5300

Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

Romania

UCB Pharma Romania S.R.L.

Tel: + 40 21 300 29 04

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1–46 37 395

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00

Ísland

Vistor hf.

Tel: + 354 535 7000

Slovenská republika

UCB s.r.o., organizačná zložka

Tel: + 421 (0) 2 5920 2020

Italia

UCB Pharma S.p.A.

Tel: + 39 / 02 300 791

Suomi/Finland

UCB Pharma Oy Finland

Puh/Tel: +358 9 2514 4221

Kûnpoç

Lifepharma (Z.A.M.) Ltd

Tql: + 357 22 34 74 40

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (Somija)

United Kingdom

UCB Pharma Ltd.

Tel: + 44 / (0)1753 534 655

This leaflet was last revised in {month/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package Leaflet: Information for the patient

Keppra 100 mg/ml oral solution Levetiracetam

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 Keppra is and what it is used for
2. What you need to know before you take Keppra
3. How to take Keppra
4. Possible side effects
5. How to store Keppra
6. Contents of the pack and other information

1. What Keppra is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra 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 Keppra

Do not take Keppra

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 Keppra

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 slowdown in the growth or unexpected puberty development of your child,

please contact your doctor.

A small number of people being treated with anti-epileptics such as Keppra have had thoughts

of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

If you have a family or medical history of irregular heart rhythm (visible on an

electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or

your family and friends notice important changes in mood or behaviour.

Aggravation of epilepsy

Children and adolescents

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

Other medicines and Keppra

Tell your doctor or pharmacist if you are taking or 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 reduction of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.

You should not stop your treatment without discussing this with your doctor.

A risk of birth defects for your unborn child cannot be completely excluded.

Breast-feeding is not recommended during treatment.

Driving and using machines

Keppra contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol

Keppra oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Keppra oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Keppra

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

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

Take the oral solution following your doctor’s instructions.

Monotherapy (from 16 years of age)

Adults (>18 years) and adolescents (from 16 years of age):

Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.

General dose : Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).

When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years):

Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.

General dose : Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).

Dose in children 6 months and older:

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

For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.

For children above 4 years , measure the appropriate dosage using the 10 ml syringe included in the package.

General dose : Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).

Dose in children 6 months and older:

Weight	Starting dose: 0.1 ml/kg twice daily	Maximum dose: 0.3 ml/kg twice daily
6 kg	0.6 ml twice daily	1.8 ml twice daily
8 kg	0.8 ml twice daily	2.4 ml twice daily
10 kg	1 ml twice daily	3 ml twice daily
15 kg	1.5 ml twice daily	4.5 ml twice daily
20 kg	2 ml twice daily	6 ml twice daily
25 kg	2.5 ml twice daily	7.5 ml twice daily
From 50 kg	5 ml twice daily	15 ml twice daily

Dose in infants (1 month to less than 6 months):

For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.

General dose : Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant. (see table below for dose examples).

Dose in infants (1 month to less than 6 months):

Weight	Starting dose: 0.07 ml/kg twice daily	Maximum dose: 0.21 ml/kg twice daily
4 kg	0.3 ml twice daily	0.85 ml twice daily
5 kg	0.35 ml twice daily	1.05 ml twice daily
6 kg	0.45 ml twice daily	1.25 ml twice daily
7 kg	0.5 ml twice daily	1.5 ml twice daily

Method of administration:

After measuring the correct dosage with an appropriate syringe, Keppra oral solution may be diluted in a glass of water or baby’s bottle. You may take Keppra with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

Instructions for use:

Open the bottle: press the cap and turn it anticlockwise (figure 1)
Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure

3). Ensure it is well fixed.

Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down

(figure 5).

Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to

the bottom of the syringe (figure 7).

antents of the glass/baby’s bottle.

ith the plastic screw cap.

Wash the syringe with water only (figure 8).

Duration of treatment:

Keppra is used as a chronic treatment. You should continue Keppra 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 Keppra than you should

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

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

If you forget to take Keppra:

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 Keppra:

If you have any further questions on 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.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
swelling of the face, lips, tongue and throat (Quincke’s oedema)
flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]),.
symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
a skin rash which may form blisters and look 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)
a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported adverse reactions were 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.

Very common : may affect more than 1 in 10 people

nasopharyngitis;
somnolence (sleepiness), headache.

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;
severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic

reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;
suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable

to concentrate);

delirium;
encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of

symptoms);

seizures may become worse or happen more often;
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling

movements, hyperkinesia (hyperactivity);

change of the heart rhythm (Electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
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 );

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase

increase. Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.

limp or difficulty walking.

Reporting of side effects

5. How to store Keppra

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

Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP:

The expiry date refers to the last day of the month.

Do not use after 7 months of first opening the bottle.

Store in the original bottle, in order to protect from light.

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 protect the environment.

6. Contents of the pack and other information

What Keppra contains

The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.

The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.

What Keppra looks like and contents of the pack

Keppra 100 mg/ml oral solution is a clear liquid.

The 300 ml glass bottle of Keppra (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Keppra (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Keppra (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.

Marketing Authorisation Holder

UCB Pharma S.A. Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer

NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France.

or UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgie/Belgique/Belgien

UCB Pharma SA/NV

Tel/Tél: + 32 / (0)2 559 92 00

Lietuva

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (Suomija)

Efc^rapufl

TO CH EH Etnrapua EOOfl

Ten.: + 359 (0) 2 962 30 49

Luxembourg/Luxemburg

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Magyarország

UCB Magyarország Kft.

Tel.: + 36-(1) 391 0060

Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Malta

Pharmasud Ltd.

Tel: + 356 / 21 37 64 36

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Nederland

UCB Pharma B.V.

Tel.: + 31 / (0)76–573 11 40

Eesti

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (Soome)

Norge

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

EXXáSa

UCB A.E.

Tql: + 30 /2109974000

Österreich

UCB Pharma GmbH

Tel: + 43 (0)1 291 80 00

España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

Polska

UCB Pharma Sp. z o.o.

Tel: + 48 22 696 99 20

France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35

Portugal

UCB Pharma (Produtos Farmacéuticos), Lda

Tel: + 351 / 21 302 5300

Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

Romania

UCB Pharma Romania S.R.L.

Tel: + 40 21 300 29 04

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1–46 37 395

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00

Island

Vistor hf.

Tel: + 354 535 7000

Slovenská republika

UCB s.r.o., organizačná zložka

Tel: + 421 (0) 2 5920 2020

Italia

UCB Pharma S.p.A.

Tel: + 39 / 02 300 791

Suomi/Finland

UCB Pharma Oy Finland

Puh/Tel: +358 9 2514 4221

Knnpog

Lifepharma (Z.A.M.) Ltd

Tql: + 357 22 34 74 40

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00

Latvija

UCB Pharma Oy Finland

Tel: +358 9 2514 4231 (Somija)

United Kingdom

UCB Pharma Ltd.

Tel: + 44 / (0)1753 534 655

This leaflet was last revised in {month/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package Leaflet: Information for the patient

Keppra 100 mg/ml concentrate for solution for infusion Levetiracetam

Read all of this leaflet carefully before you or your child start using 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 Keppra is and what it is used for
2. What you need to know before you are given Keppra
3. How Keppra is given
4. Possible side effects
5. How to store Keppra
6. Contents of the pack and other information

1. What Keppra is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra 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 in adults, adolescents and children from 4 years 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).

Keppra concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic oral Keppra medicine is temporarily not feasible.

2. What you need to know before you are given Keppra

Do not use Keppra

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 you are given Keppra

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 slowdown in the growth or unexpected puberty development of your child,

please contact your doctor.

A small number of people being treated with anti-epileptics such as Keppra have had thoughts

of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

If you have a family or medical history of irregular heart rhythm (visible on an

electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or

your family and friends notice important changes in mood or behaviour.

Aggravation of epilepsy

Children and adolescents

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

Other medicines and Keppra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

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 reduction of its effect.

Pregnancy and breast-feeding

You should not stop your treatment without discussing this with your doctor.

A risk of birth defects for your unborn child cannot be completely excluded.

Breast-feeding is not recommended during treatment.

Driving and using machines

Keppra contains sodium

One maximum single dose of Keppra concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into consideration if you are on a controlled sodium diet.

3. How Keppra is given

A doctor or a nurse will administer you Keppra as an intravenous infusion.

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

The intravenous formulation is an alternative to your oral administration. You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. Your total daily dose and frequency of administration remain identical.

Adjunctive therapy and Monotherapy (from 16 years of age).

Adults (>18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

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

When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg: General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.

Method and route of administration:

Keppra is for intravenous use.

The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15-minutes.

For doctors and nurses, more detailed direction for the proper use of Keppra is provided in section 6.

Duration of treatment:

There is no experience with administration of intravenous levetiracetam for a longer period

than 4 days.

If you stop using Keppra:

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

If you have any further questions on 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.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
swelling of the face, lips, tongue and throat (Quincke’s oedema)
flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]).
symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
a skin rash which may form blisters and look 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)
a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

Very common : may affect more than 1 in 10 people

nasopharyngitis;
somnolence (sleepiness), headache.

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;
severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic

reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;
suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable

to concentrate);

delirium;
encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of

symptoms);

seizures may become worse or happen more often;
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling

movements, hyperkinesia (hyperactivity);

change of the heart rhythm (Electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
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 );

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase

increase. Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.

limp or difficulty walking.

Reporting of side effects

5. How to store Keppra

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

Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Keppra contains

The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.

The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride, water for injections.