KEPPRA 500 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, 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. Storage of 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 repeated seizures (fits). Levetiracetam is used for a form of epilepsy where the seizures initially affect only one side of the brain but may subsequently spread to larger areas on both sides 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 secondary 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 fits, 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 of the other ingredients of this medicine (listed in section 6), or to other pyrrolidone derivatives

Warnings and precautions

Consult your doctor before taking Keppra

• if you have kidney problems, your doctor may need to adjust your dose
• if you notice any slowing of growth or unexpected pubertal delay in your child, 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 at any time you have these thoughts, contact your doctor
• if you have a history of heart rhythm problems, or if you are taking medicines that may affect the heart rhythm, or if you have a condition which may affect the heart rhythm

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 changes in your mood or behaviour
• worsening of seizures:

Rarely, the seizures may become worse or more frequent, mainly during the first month after the start of treatment or the increase of the dose.

In very rare cases, a severe form of epilepsy, characterised by a high number of seizures, which are often severe, may occur at the start of treatment with Keppra. In these cases, the seizures may not respond to the treatment.

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

Children and adolescents

• monotherapy (use of only one medicine to treat epilepsy) with Keppra is not indicated for children and adolescents below 16 years of age

Use of 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 laxative medicine) for one hour before and one hour after taking levetiracetam as it may reduce the effectiveness of the treatment.

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 may be used during pregnancy only if your doctor considers it to be clearly necessary.

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

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

It is not recommended to breast-feed while taking this medicine.

Driving and using machines

Keppra may impair your ability to drive or operate machinery, as it may cause somnolence (drowsiness). This is more likely at the start of the 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 tablets contain sunset yellow FCF (E110)

Sunset yellow FCF (E110) 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 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 (12-17 years) weighing 50 kg or more:

Recommended dose: 1000-3000 mg per 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 1000 mg daily dose, your initial reduced dose is 250 mg in the morning and 250 mg in the evening, and should be gradually increased to 1000 mg per day after 2 weeks of treatment.

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

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

• Dose in infants (1-23 months) and children (2-11 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 more appropriate formulation for infants and children under 6 years and for children and adolescents (6-17 years) weighing less than 50 kg and when tablets are not suitable.

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 a long-term treatment. You should continue to take it 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

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 have taken more tablets than you should. Your doctor will decide on the best course of action.

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

The treatment should be gradually discontinued as stated by your doctor. If your doctor decides to stop your treatment with Keppra, he/she will instruct you on 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, 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
• swelling of the face, lips, tongue or throat (Quincke’s oedema)
• symptoms of flu and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests and an increased number of a type of white blood cell (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of the feet, ankles or hands, as these may be signs of acute kidney injury
• a rash that may form blisters and may look like targets (red circle around a red centre) (erythema multiforme)
• a widespread rash with blisters and skin peeling on much of the body surface (Stevens-Johnson syndrome) and a more severe form 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 (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects like somnolence, fatigue and dizziness are more likely to occur in the first few weeks of treatment and usually decrease over time.

Verycommon: may affect more than 1 in 10 people

• nasopharyngitis
• somnolence (feeling drowsy), headache

Common: may affect up to 1 in 10 people

• 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 (involuntary shaking)
• vertigo (feeling of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommon: may affect up to 1 in 100 people

• decrease in the number of blood 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, mood swings, personality disorders
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination of movements), paraesthesia (tingling sensation), attention deficit/hyperactivity disorder
• 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 counts
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema)
• decrease in blood sodium levels
• suicide, personality disorders (behavioural problems), abnormal thoughts (slow thinking, difficulty in 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 head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)
• abnormal heart rhythm (electrocardiogram)
• pancreatitis (inflammation of the pancreas)
• liver failure, hepatitis (inflammation of the liver)
• sudden decrease in kidney function
• skin rash which may form blisters and may look like targets (red circle around a red centre) (erythema multiforme), a widespread rash with blisters and skin peeling on much of the body surface (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 increase in creatine phosphokinase in blood, more frequently observed in Japanese patients compared to non-Japanese patients
• limping or difficulty walking
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate and confusion, a condition called neuroleptic malignant syndrome, more frequently observed in Japanese patients compared to non-Japanese patients

Veryrare: may affect up to 1 in 10,000 people

• unwanted thoughts or impulses and repetitive thoughts or a desire to repeat certain 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. Storage of 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. Contents of the pack and additional information

Composition of Keppra

The active substance 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 1,000 mg Keppra tablet contains 1,000 mg of levetiracetam.

The other ingredients are:

Tablet core: 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 indigo carmine (E132)

500 mg tablets: yellow iron oxide (E172)

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

Appearance and packaging of the product

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

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

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

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

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

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

Keppra 1,000 mg film-coated tablets are white, 19 mm, oblong, scored and marked with “ucb” and “1,000” on one side.

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

Keppra tablets are packaged in blister packs 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

• 1,000 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: http://www.ema.europa.eu