LEVETIRACETAM ACCORD 1000 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Levetiracetam Accord 250 mg film-coated tablets EFG

Levetiracetam Accord 500 mg film-coated tablets EFG

Levetiracetam Accord 750 mg film-coated tablets EFG

Levetiracetam Accord 1000 mg film-coated tablets EFG

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 and other information

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

1. What is Levetiracetam Accord and what is it used for

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

Levetiracetam Accord is used:

• on its own (monotherapy) 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 fits (seizures). Levetiracetam is used to treat a form of epilepsy where the seizures initially only affect one side of the brain but may subsequently spread to wider 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.

• in combination with other antiepileptic medicines to treat:

• partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants
• myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in patients 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 Levetiracetam Accord

Do not take Levetiracetam Accord

• 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 Levetiracetam Accord

• 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 or an unexpected delay in puberty, contact your doctor
• a small number of people being treated with anti-epileptics such as Levetiracetam Accord 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 any other medicines that may affect the heart rhythm

Tell your doctor or pharmacist if any of the following side effects get serious or last 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

In rare cases, seizures may become worse or more frequent, mainly during the first month after start of treatment or after a dose increase. If you experience any of these new symptoms while taking Levetiracetam Accord, contact your doctor as soon as possible.

In a very rare form of epilepsy (early onset epilepsy associated with SCN8A mutations) that causes multiple seizure types and developmental delays, you may notice that seizures persist or worsen during treatment.

Children and adolescents

• Monotherapy with Levetiracetam Accord is not indicated for children and adolescents below 16 years of age.

Using Levetiracetam Accord 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 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 can 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 baby cannot be completely excluded.

Breast-feeding is not recommended during treatment with Levetiracetam Accord.

Driving and using machines

Levetiracetam Accord may impair your ability to drive or operate tools or machinery, as it may cause somnolence (sleepiness). This is more likely at the start 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.

Important information about some of the ingredients of Levetiracetam AccordLevetiracetam Accord 750 mg film-coated tablet contains orange yellow S (E110) which may cause allergic reactions. The other strengths of Levetiracetam Accord do not contain this ingredient.

3. How to take Levetiracetam Accord

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 prescribed by your doctor.

Levetiracetam Accord 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 to 17 years) weighing 50 kg or more:

Recommended dose: 1000 to 3000 mg per day.

When you first start taking Levetiracetam Accord, your doctor will prescribe you a lower dose(500 mg per day) for 2 weeks before increasing the dose to the recommended daily dose of 1000 mg.

For example: for a daily dose of 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 should be gradually increased to 1000 mg per day after 2 weeks of treatment.

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

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

An oral solution is a more appropriate formulation for infants and children under 6 years and 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 Levetiracetam Accord tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Levetiracetam Accord with or without food. After oral administration, the bitter taste of levetiracetam may be experienced.

Duration of treatment:

• Levetiracetam Accord is used as chronic treatment. You should continue to take Levetiracetam Accord 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 Levetiracetam Accord than you should:

The possible side effects of an overdose of Levetiracetam 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.

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

If you stop taking Levetiracetam Accord:

It is very important that you do not stop taking Levetiracetam Accord unless your doctor tells you to. If your doctor decides to stop your treatment with Levetiracetam Accord, they 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, this medicine can cause side effects, although not everybody gets them.

Contact 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) 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, 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 skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• 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 behaviour or other neurological signs including involuntary movements or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as somnolence, fatigue and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these effects should decrease over time.

Very commonmay affect more than 1 in 10 people:

• nasopharyngitis
• somnolence (feeling drowsy), headache

Commonmay affect up to 1 in 100 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 (involuntary shaking)
• vertigo (feeling of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn and acid regurgitation), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommonmay affect up to 1 in 1000 people:

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

Raremay affect up to 1 in 1000 people:

• infection
• decrease in all blood cell types
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema)
• decreased sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thoughts (slow thinking, difficulty in concentrating)
• delirium
• encephalopathy (see section “Contact 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 kidney failure
• skin rash which may form blisters and may be accompanied by fever, a widespread rash with blisters and peeling 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 and confusion, a low level of 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 raremay affect up to 1 in 10,000 people:

• unwanted thoughts or impulses or the urge to do something repetitive (obsessive-compulsive disorder)

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 Levetiracetam Accord

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 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 Information

Composition of Levetiracetam Accord:

The active ingredient is levetiracetam.

Each film-coated tablet contains 250 mg, 500 mg, 750 mg, or 1,000 mg of levetiracetam.

Levetiracetam Accord 250mg film-coated tablets EFG:

Tablet core: sodium croscarmellose, povidone K-30, anhydrous colloidal silica, magnesium stearate (E470b)

Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc

Levetiracetam Accord 500 mg film-coated tablets EFG:Tablet core: sodium croscarmellose, povidone K-30, anhydrous colloidal silica, magnesium stearate (E470b)

Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)

Levetiracetam Accord 750 mg film-coated tablets EFG:Tablet core: sodium croscarmellose, povidone K-30, anhydrous colloidal silica, magnesium stearate (E470b)

Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), orange yellow FCF (E110)

Levetiracetam Accord 1,000 mg film-coated tablets EFG:Tablet core: sodium croscarmellose, povidone K-30, anhydrous colloidal silica, magnesium stearate (E470b)

Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc

Appearance of Levetiracetam Accord and Package Contents

Levetiracetam Accord 250 mg film-coated tablets EFG:

White to off-white, oval, biconvex, film-coated tablet, engraved "L 64" and score line on one side and smooth on the other side.

Levetiracetam Accord 500 mg film-coated tablets EFG:

Yellow in color, oval, biconvex, film-coated tablet, engraved "L 65" and score line on one side and smooth on the other side.

Levetiracetam Accord 750 mg film-coated tablets EFG:

Pink in color, oval, biconvex, film-coated tablet, engraved "L 66" and score line on one side and smooth on the other side.

Levetiracetam Accord 1,000 mg film-coated tablets EFG:

White to off-white, oval, biconvex, film-coated tablet, engraved "L 67" and score line on one side and smooth on the other side.

Levetiracetam Accord film-coated tablets 250 mg, 500 mg, 750 mg, and 1,000 mg are packaged in PVC-Aluminum blisters. The blisters are packaged in a box with a leaflet in package sizes of 10, 20, 30, 50, 60, 100, and 200 tablets per package. Additionally, the tablets are also available in unit-dose blisters for package sizes of 30x1, 60x1, and 100x1 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009,

Greece

Date of the Last Revision of this Leaflet: November 2024

Other Sources of Information

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