KEPPRA 1000 mg FILM-COATED TABLETS

Introduction

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, as 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.

Contents of the pack

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

1. What is Keppra and what is it 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 you have attacks (seizures). Levetiracetam is used for a form of epilepsy where the seizures initially affect only one side of the brain but may subsequently spread to other parts of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of seizures.
• with other antiepileptic medicines to treat:

• partial onset seizures with or without generalisation in adults, adolescents, children and infants from 1 month of age
• myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalised tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a 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, to any other pyrrolidone derivative or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor before you start taking Keppra

• If you have kidney problems, follow the advice of your doctor who will decide if you need a dose adjustment.
• If you notice any decrease in your child’s growth rate or an unexpected pubertal delay, contact your doctor.
• A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor.
• If you have a history of heart rhythm problems (abnormal electrocardiogram, ECG) or if you are taking any medicines that may cause heart rhythm problems or if you have any other conditions that may increase the risk of heart rhythm problems.

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

• abnormal thoughts, feeling irritable or more aggressive than usual or if you or your family and friends notice any changes in your mood or behaviour
• worsening of epilepsy:

On rare occasions, epilepsy may become worse or more seizures may occur, mainly at the beginning of the treatment or when the dose is increased.

In very rare cases, a very early form of epilepsy (early childhood epilepsy associated with SCN8A gene mutations) that causes multiple types of seizures and loss of skills may not improve and may even worsen during treatment.

If you experience any of these new symptoms while taking Keppra, contact your doctor as soon as possible.

Children and adolescents

• Monotherapy (Keppra used on its own) is not indicated for children and adolescents under 16 years of age.

Using Keppra with other medicines

Tell 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) for one hour before and one hour after taking levetiracetam as it may reduce the effect of levetiracetam.

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 advice before taking this medicine. Levetiracetam should only be used during pregnancy if a doctor considers it essential.

Do not stop your treatment without discussing it with your doctor.

It is not known whether the possible risk of birth defects in the baby is higher than for other anti-epileptic medicines.

It is recommended to avoid breast-feeding while taking this medicine.

Driving and using machines

Keppra may impair your ability to drive or operate tools or machinery, as it may cause somnolence (sleepiness). This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Keppra 750 mg film-coated tablets contain the colouring agent sunset yellow FCF (E110).

Sunset yellow FCF (E110) may cause allergic reactions.

Keppra contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Keppra

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Take the number of tablets as instructed by your doctor.

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

Concomitant therapy and monotherapy (from 16 years of age)

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

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

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

For example: for a daily dose of 1,000 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 should be gradually increased to 1,000 mg per day after 2 weeks of treatment.

• Adolescents (from 12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Keppra based on the weight and dose.

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

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

Keppra 100 mg/ml oral solution is a more appropriate formulation for infants and children under 6 years and for children and adolescents (from 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, the bitter taste of levetiracetam may be experienced.

Duration of treatment

• Keppra is used as chronic treatment. You should continue to take Keppra for as long as your doctor has told you.
• Do not stop your treatment without your doctor’s advice, as this may increase your seizures.

If you take more Keppra than you should

Possible side effects of an overdose of Keppra are somnolence, agitation, aggression, decreased alertness, respiratory depression and coma.

Contact your doctor if you have taken more tablets than you should. Your doctor will decide on the best course of action to take.

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

Stopping treatment with Keppra should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Keppra, he will tell you how to gradually reduce the dose.

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

4. Possible side effects

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

Tell your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue or throat (Quincke’s oedema)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high fever, high levels of liver enzymes in the blood tests and an increased number of a type of white blood cell (eosinophilia), swollen lymph nodes and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of the feet, ankles, face, hands or eyes, as these may be signs of sudden kidney failure
• a skin rash which may form blisters and may be accompanied by fever (erythema multiforme), a widespread 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 over 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 (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal coordination, paraesthesia (tingling), changes in mental status (loss of concentration)

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. Side effects like sleepiness, fatigue and dizziness are more likely to occur when you first start treatment or when the dose is increased. However, these side effects should 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
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (uncontrollable shaking)
• vertigo (feeling of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommon: may affect up to 1 in 100 people

• decrease in the number of platelets, decrease in the number of white blood cells
• weight decrease, weight increase
• suicidal thoughts and behaviour, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attacks, emotional instability/mood swings, agitation
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), changes in mental status (loss of concentration)
• diplopia (double vision), blurred vision
• abnormal liver function tests
• hair loss, eczema, pruritus (itching)
• muscle weakness, myalgia (muscle pain)
• injury

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

• infection
• decrease in all blood cell types
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema)
• decrease in sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thoughts (slow thinking, difficulty concentrating)
• delirium
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the symptoms)
• seizures may become worse or more frequent
• uncontrolled muscle spasms affecting the face, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• change in heart rhythm (electrocardiogram)
• pancreatitis (inflammation of the pancreas)
• liver failure, hepatitis (inflammation of the liver)
• sudden kidney failure
• skin rash which may form blisters and may be accompanied by fever, a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals, and a more severe form causing skin peeling over more than 30% of the body surface
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping or difficulty walking
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased consciousness (these may be signs of a condition 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

• unwanted thoughts or feelings and repetitive or compulsive actions

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. Storing 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Keppra

The active ingredient is levetiracetam. Each tablet contains 250 mg of levetiracetam.

A 250 mg Keppra tablet contains 250 mg of levetiracetam.

A 500 mg Keppra tablet contains 500 mg of levetiracetam.

A 750 mg Keppra tablet contains 750 mg of levetiracetam.

A 1000 mg Keppra tablet contains 1000 mg of levetiracetam.

The other components are:

Core of the tablet: sodium croscarmellose, macrogol 6000, anhydrous colloidal silica, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, colorants*.

• The colorants are:

250 mg tablets: aluminum lake with carmine indigo (E132)

500 mg tablets: yellow iron oxide (E172)

750 mg tablets: aluminum lake with orange yellow S (E110), red iron oxide (E172)

Appearance of the Product and Package Contents

Keppra 250 mg film-coated tablets are blue, 13 mm, oblong, scored and with the code “ucb” and “250” engraved 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 with the code “ucb” and “500” engraved 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 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 with the code “ucb” and “1.000” 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 blisters included 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

The pack of 100 x 1 tablets is available in precut unit-dose Aluminum/PVC blisters. The other packs are available in standard Aluminum/PVC blisters.

Not all pack sizes may be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.