Patient Information Leaflet: Information for the Patient

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

Levetiracetam
Please read this leaflet carefully before you or your child starts taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Keppra is and what it is used for
What you need to know before taking Keppra
How to take Keppra
Possible side effects
How to store Keppra
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 epileptic seizures).
Keppra is used:

as monotherapy in adults and adolescents from the age of 16 years with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients experience repeated seizures. Levetiracetam is used for the type of epilepsy in which the seizure initially affects only one part of the brain but may subsequently spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed Levetiracetam to reduce the number of seizures.
as an add-on therapy to other antiepileptic medicines to treat:
- partial-onset seizures, with or without secondary generalization, in adults, adolescents, children, and infants from 1 month of age
- myoclonic seizures (brief, shock-like spasms of a muscle or muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking 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 have kidney problems, follow your doctor's instructions. Your doctor may decide whether the dose needs to be adjusted.
If you notice slowed growth or unexpected development of puberty in the child, contact your doctor.
A small number of people taking antiepileptic medicines such as Keppra have experienced self-harming thoughts or suicidal ideas. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
If you or a family member has a heart rhythm disorder (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a
few days:

Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you or your family and friends notice significant changes in mood or behaviour.
Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of existing abilities, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while taking Keppra, consult a
doctor as soon as possible.
Children and adolescents

Keppra used alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Keppra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may cause a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
You must not stop your treatment without discussing it with your doctor.
A risk of birth defects for the unborn child cannot be completely ruled out. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on children's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and using machines
Keppra may reduce your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive or operate machinery until you have determined that your ability to perform these activities is not impaired.
Keppra 750 mg film-coated tablets contain Sunset Yellow FCF (E110)
The colouring agent Sunset Yellow FCF (E110) may cause allergic reactions.
Keppra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Keppra

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Keppra should be taken twice daily, once in the morning and once in the evening, approximately at the
same time each day.
Adjunctive therapy and monotherapy (from age 16 onwards)

Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When you first start taking Keppra, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced 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 increased to reach 1000 mg per day after 2 weeks.
Adolescents (12 to 17 years) weighing less than or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Keppra depending on weight and dose.
Dose for 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 depending on age, weight, and dose.

Keppra 100 mg/mL oral solution is the most suitable formulation for infants and children under
6 years of age, for children and adolescents (6 to 17 years) weighing less than 50 kg, and
when tablets do not allow accurate dosing.
Method of administration:
Swallow Keppra tablets with a sufficient amount of liquid (e.g. a glass of water). You may
take Keppra with or without food. After oral administration, you may experience a bitter taste of levetiracetam.
Duration of treatment:

Keppra is used as a chronic treatment. Treatment with Keppra should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures.

If you take more Keppra than you should:
Possible adverse effects of an overdose of Keppra include drowsiness, agitation, aggression,
reduced attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. The doctor will determine the most
appropriate treatment for the overdose.
If you forget to take Keppra:
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed tablet.
If you stop taking Keppra:
If treatment with Keppra is to be discontinued, it should be gradually tapered to avoid an
increase in seizures. If your doctor decides to stop treatment with Keppra, they will provide you with instructions for the gradual withdrawal of Keppra.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, lightheadedness or dizziness, or if you have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
swelling of the face, lips, tongue, and throat (Quincke's edema)
flu-like symptoms and facial rash followed by widespread rash with high fever, increased liver enzyme levels in blood tests, increased levels of a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden kidney dysfunction
a skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
a widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
a more severe form of skin rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more common. However, these effects should decrease over time.
Very common: may affect more than 1 in 10 people

nasopharyngitis
drowsiness, headache

Common: may affect up to 1 in 10 people

anorexia (loss of appetite)
depression, hostility or aggression, anxiety, insomnia, restlessness or irritability
seizures, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
vertigo (sensation of spinning)
cough
abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea
rash
asthenia/fatigue (feeling weak)

Uncommon: may affect up to 1 in 100 people

decreased number of platelets in the blood, decreased number of white blood cells in the blood
weight loss, weight gain
suicidal attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration)
diplopia (double vision), blurred vision
elevated/abnormal liver function test results
hair loss, eczema, pruritus (itching)
muscle weakness, myalgia (muscle pain)
trauma

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

infection
decreased number of all types of blood cells
severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's edema [swelling of face, lips, tongue, and throat])
decreased sodium concentration in the blood
suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate)
delirium
encephalopathy (see the subsection "Contact your doctor immediately" for a detailed description of symptoms)
seizures may worsen or occur more frequently
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
change in heart rhythm (electrocardiogram)
pancreatitis
liver failure, hepatitis
sudden decrease in kidney function
skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
rhabdomyolysis (breakdown of muscle tissue) and associated increase in serum creatine phosphokinase. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients
limping or difficulty walking
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

repetitive unwanted thoughts or sensations, or an urge to repeatedly perform certain actions (obsessive-compulsive disorder)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 which is stated on the carton after Exp.: and on the
blister after EXP:.
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 via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Keppra contains
The active substance is called levetiracetam.
Each tablet of Keppra 250 mg contains 250 mg of levetiracetam.
Each tablet of Keppra 500 mg contains 500 mg of levetiracetam.
Each tablet of Keppra 750 mg contains 750 mg of levetiracetam.
Each tablet of Keppra 1000 mg contains 1000 mg of levetiracetam.

The other components are:
Tablet core: croscarmellose sodium, macrogol 6000, anhydrous colloidal silica, magnesium stearate.
Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, colourings*.
* The colourings are:
250 mg tablets: indigo carmine aluminium lake (E132)
500 mg tablets: yellow iron oxide (E172)
750 mg tablets: sunset yellow FCF aluminium lake (E110), red iron oxide (E172)

Description of the appearance of Keppra and contents of the pack
Keppra 250 mg film-coated tablets are blue, oval-shaped, 13 mm in size, biconvex, scored, and marked with “ucb” and “250” on one side.
The break line is intended only to facilitate breaking the tablet for ease of swallowing and does not allow division into equal doses.

Keppra 500 mg film-coated tablets are yellow, oval-shaped, 16 mm in size, biconvex, scored, and marked with “ucb” and “500” on one side.
The break line is intended only to facilitate breaking the tablet for ease of swallowing and does not allow division into equal doses.

Keppra 750 mg film-coated tablets are orange, oval-shaped, 18 mm in size, biconvex, scored, and marked with “ucb” and “750” on one side.
The break line is intended only to facilitate breaking the tablet for ease of swallowing and does not allow division into equal doses.

Keppra 1000 mg film-coated tablets are white, oval-shaped, 19 mm in size, biconvex, scored, and marked with “ucb” and “1000” on one side.
The break line is intended only to facilitate breaking the tablet for ease of swallowing and does not allow division into equal doses.

Keppra tablets are packed in blisters in cardboard boxes containing:

250 mg: 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multiple packs containing 200 (2 packs of 100) film-coated tablets.
500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 film-coated tablets and multiple packs containing 200 (2 packs of 100) film-coated tablets.
750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 film-coated tablets and multiple packs containing 200 (2 packs of 100) film-coated tablets.
1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multiple packs containing 200 (2 packs of 100) film-coated tablets.

Packs of 100 x 1 tablet are available in aluminium/PVC blisters divisible into single doses. All other packs are available in standard aluminium/PVC blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
UCB Pharma SA/NV
Tel/Tél: + 32 / (0)2 559 92 00

България Luxembourg/Luxemburg
UCB Bulgaria EOOD UCB Pharma SA/NV
Tel.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00

Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060

Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf.: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36

Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel: + 31 / (0)76-573 11 40

Eesti Norge
OÜ Medfiles UCB Nordic A/S
Tel: +372 730 5415 Tlf: + 45 / 32 46 24 00

Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43 (0)1 291 80 00

España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel.: + 48 22 696 99 20

France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 / 21 302 5300

Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04

Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00

Ísland Slovenská republika
UCB s.r.o., organizačná zložka
Tel: + 421 (0) 2 5920 2020

Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: +358 9 2514 4221

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 34 74 40 Tel: + 46 / (0) 40 29 49 00

Latvija

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Patient information leaflet

Keppra 100 mg/mL oral solution

Levetiracetam
Please read this leaflet carefully before you or your child starts 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Keppra is and what it is used for
What you need to know before taking Keppra
How to take Keppra
Possible side effects
How to store Keppra
Contents of the pack and other information

1. What Keppra is and what it is used for

Levetiracetam 100 mg/mL oral solution is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Keppra is used:

as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients experience repeated seizures. Levetiracetam is used for the type of epilepsy in which the seizure starts in only one part of the brain but may subsequently spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures you experience.
as add-on therapy to other antiepileptic medicines to treat:
- partial-onset seizures, with or without generalization, in adults, adolescents, children, and infants from 1 month of age
- myoclonic seizures (brief, shock-like jerks of a muscle or muscle group) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking 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 have kidney problems, follow your doctor's instructions. Your doctor may decide whether the dose needs to be adjusted.
If you notice slowed growth or unexpected onset of puberty in your child, contact your doctor.
A small number of people taking antiepileptic medicines such as Keppra have had thoughts of self-harm or suicidal thoughts. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
If you or a family member has a heart rhythm disorder (visible on electrocardiogram) or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a
few days:

Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you or your family and friends notice significant changes in mood or behaviour.
Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of existing abilities, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Keppra, consult a
doctor as soon as possible.
Children and adolescents

Keppra used alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Keppra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may cause a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, inform your doctor before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
Do not stop your treatment without discussing it with your doctor.
A risk of birth defects in the unborn child cannot be completely excluded. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on children's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and using machines
Keppra may reduce your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive or use machinery until you are sure that your ability to perform these activities is not affected.
Keppra contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and maltitol
Keppra oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
Keppra oral solution also contains maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Keppra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. essentially 'sodium-free'.

3. How to take Keppra

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Keppra should be taken twice daily, once in the morning and once in the evening, approximately at the
same time each day.
Take the oral solution as instructed by your doctor.

Monotherapy (from 16 years of age)
Adults (≥ 18 years) and adolescents (from 16 years of age):
Measure the appropriate dose using the 10 mL syringe supplied in the package for patients aged
4 years and older.
Recommended dose: Keppra should be taken twice daily, in two equal doses, each ranging between 5 mL (500 mg) and 15 mL (1500 mg).
When you first start taking Keppra, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose.

Adjunctive therapy
Dose for adults and adolescents (12 to 17 years of age):
Measure the appropriate dose using the 10 mL syringe supplied in the package for patients aged
4 years and older.
Recommended dose: Keppra should be taken twice daily, in two equal doses, each ranging between 5 mL (500 mg) and 15 mL (1500 mg).

Dose for children aged 6 months and older:
Your doctor will prescribe the most appropriate pharmaceutical form of Keppra depending on age, body weight, and required dose.
For children from 6 months to 4 years of age, measure the appropriate dose using the 5 mL syringe supplied in the package.
For children older than 4 years, measure the appropriate dose using the 10 mL syringe supplied in the package.
Recommended dose: Keppra should be taken twice daily, in two equal doses, each ranging between 0.1 mL (10 mg) and 0.3 mL (30 mg) per kg of the child's body weight (see table below for some examples of doses).
Dose for children aged 6 months and older:

Weight	Initial 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
50 kg and above	5 mL twice daily	15 mL twice daily

Dose for infants (from 1 month to less than 6 months):
For infants from 1 month to less than 6 months, measure the appropriate dose using the 1 mL syringe
provided in the package.
Recommended dose: Keppra should be taken twice daily, in two equal doses, each ranging between 0.07 mL (7 mg) and 0.21 mL (21 mg) per kg of the infant's body weight (see table below for some examples of doses).
Dose for infants (from 1 month to less than 6 months):

Weight	Initial 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

Administration method:
After measuring the correct dose with the appropriate oral dosing syringe, Keppra oral solution may be
diluted in a glass of water or in a baby bottle. Keppra may be taken with or without food. After oral
administration, a bitter taste of levetiracetam may be perceived.
Instructions on how to use the syringe:

Open the bottle: press the cap and turn counterclockwise (Figure 1).

Technical drawing showing a hand rotating the cap of a vial clockwise, indicated by a black arrow and the number one in a circle

Follow this procedure for the first administration of Keppra:
- Remove the adapter from the oral dosing syringe (Figure 2).
- Insert the adapter into the top of the bottle (Figure 3). Make sure it is securely in place. It is not necessary to remove the adapter after use.

Diagram with number 3 showing a hand pressing a cap downward onto a vial, indicated by two vertical black arrows

Black and white drawing showing a hand moving a syringe vertically toward a container, with the number 2 in a circle

Follow this procedure for each administration of Keppra:
- Insert the oral dosing syringe into the opening of the adapter (Figure 4).
- Invert the bottle (Figure 5).

A hand holds a syringe and pushes it downward, with a black arrow indicating movement toward the open vial

Hold the inverted bottle in one hand while filling the oral dosing syringe with the other.
Pull the plunger down to fill the oral dosing syringe with a small amount of solution (Figure 5A).
Then push the plunger up to remove any air bubbles (Figure 5B).
Pull the plunger down to the mark on the oral dosing syringe corresponding to the millilitres (mL) of the dose prescribed by your doctor (Figure 5C). The plunger may rise up along the barrel of the syringe on the first dose. Therefore, ensure that the plunger remains in position until the dosing syringe is removed from the bottle.

Technical drawing showing two hands manipulating a syringe inserted into a vial, with a black arrow pointing downward

Technical drawing showing two hands holding a syringe to withdraw liquid from a vial, with a black arrow pointing downward

Technical drawing showing two hands operating a syringe with a plunger being pulled downward, indicated by a black arrow

Turn the bottle upright (Figure 6A). Remove the syringe from the adapter (Figure 6B).

A hand holds a vial while a syringe with needle is inserted vertically through the cap to withdraw the contents

A hand holds a syringe and lifts it vertically upward toward the

Pour the contents of the syringe into a glass of water or a baby bottle by pressing the plunger fully (Figure 7).

A hand holds a syringe to dispense drops of liquid into the

Drink the entire contents of the glass/baby bottle.
Close the bottle with the plastic screw cap (there is no need to

Technical drawing showing a hand inserting a syringe into a glass

remove the adapter).

To clean the syringe, rinse it only with cold water, moving the plunger up and down several times to draw in and expel water, without separating the two components (Figure 8).
Store the bottle, the oral dosing syringe, and the instruction leaflet inside the carton.

Duration of treatment:

Keppra is used as a chronic treatment. Treatment with Keppra should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures.

If you forget to take Keppra:
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed dose.

If you stop taking Keppra:
If treatment with Keppra is to be discontinued, it should be gradually withdrawn to avoid an increase in seizures.
If your doctor decides to stop treatment with Keppra, they will provide you with instructions on how to gradually discontinue Keppra.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
swelling of the face, lips, tongue, and throat (Quincke's oedema)
flu-like symptoms and facial rash followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, and increased levels of a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden worsening of kidney function
a skin rash that may appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
a widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
a more severe form of skin rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behaviour, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

nasopharyngitis;
drowsiness, headache.

Common: may affect up to 1 in 10 people

anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
seizure, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
vertigo (sensation of spinning);
cough;
abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia/fatigue (feeling weak).

Uncommon: may affect up to 1 in 100 people

decreased number of platelets in the blood, decreased number of white blood cells in the blood;
weight loss, weight gain;
suicidal attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, affective lability/mood swings, agitation;
amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paraesthesia (tingling), attention disturbance (loss of concentration);
diplopia (double vision), blurred vision;
elevated/abnormal liver function test results;
hair loss, eczema, pruritus (itching);
muscle weakness, myalgia (muscle pain);
trauma.

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

infection;
decreased number of all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke's oedema [swelling of face, lips, tongue, and throat]);
decreased sodium concentration in the blood;
suicide, personality disorder (behavioural problems), thought disturbances (slowed thinking, inability to concentrate);
delirium;
encephalopathy (see the subsection “Contact your doctor immediately” for a detailed description of symptoms);
seizures may worsen or occur more frequently;
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
change in heart rhythm (electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden worsening of kidney function;
skin rash that may appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase levels. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
limping gait or difficulty walking;
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

repetitive unwanted thoughts or urges to perform actions repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 and on the bottle after
Exp.:.
The expiry date refers to the last day of that month.
Do not use more than 7 months after first opening the bottle.
Store in the original bottle, to protect from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Keppra contains
The active substance is called levetiracetam. Each mL contains 100 mg of levetiracetam.
The other components are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), ammonium glycyrrhizinate, glycerol (E422), liquid maltitol (E965),
potassium acesulfame (E950), grape flavour, purified water.

Description of the appearance of Keppra and contents of the pack
Keppra 100 mg/mL oral solution is a clear liquid.
The 300 mL glass bottle of Keppra (for children from 4 years of age, adolescents and adults) is packaged in a cardboard box containing a 10 mL oral dosing syringe (graduated every 0.25 mL) and a syringe adapter.
The 150 mL glass bottle of Keppra (for infants and young children from 6 months up to less than 4 years of age) is packaged in a cardboard box containing a 5 mL oral dosing syringe (graduated every 0.1 mL) and a syringe adapter.
The 150 mL glass bottle of Keppra (for infants from 1 month up to less than 6 months of age) is packaged in a cardboard box containing a 1 mL oral dosing syringe (graduated every 0.05 mL) and a syringe adapter.

Marketing Authorisation Holder
UCB Pharma SA, Allée de la Recherche 60, B-1070 Bruxelles, 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
UCB Pharma SA/NV
Tel/Tél: + 32 / (0)2 559 92 00

България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00