LEVETIRACETAM ACCORD 500 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 the entire leaflet carefully before you or your child starts taking the 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 and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Levetiracetam Accord and what is it used for
2. What you need to know before taking Levetiracetam Accord
3. How to take Levetiracetam Accord
4. Possible side effects
5. Storage of Levetiracetam Accord
6. Pack contents and further 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 type of epilepsy. Epilepsy is a condition where patients have seizures. Levetiracetam is used for a type of epilepsy where the seizures initially affect only one side of the brain but may then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam 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 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 taking Levetiracetam Accord

Do not take Levetiracetam Accord

• if you are allergic to levetiracetam, to pyrrolidone derivatives or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Levetiracetam Accord

• if you have kidney problems, follow the instructions of your doctor who will decide if you need to adjust the dose.
• if you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• a small number of people taking antiepileptics such as Levetiracetam Accord have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• if you have a medical history or a family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

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

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or after increasing the dose. If you experience any of these new symptoms while taking Levetiracetam Accord, contact a doctor as soon as possible.

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

Children and adolescents

• Monotherapy with Levetiracetam Accord is not indicated in children and adolescents under 16 years.

Using Levetiracetam Accord with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use 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 lose its effect.

Pregnancy and breastfeeding

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 only be used during pregnancy if, after a careful evaluation, your doctor considers it necessary.

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

The risk of birth defects for your baby cannot be completely excluded. Breastfeeding is not recommended during treatment with Levetiracetam Accord.

Driving and using machines

Levetiracetam Accord may affect your ability to drive or use tools or machines, as it may cause drowsiness. 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 the colouring agent orange yellow FCF (E110) which may cause allergic reactions. The other strengths of Levetiracetam Accord do not contain this excipient.

3. How to take Levetiracetam Accord

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

Take the number of tablets that your doctor has prescribed for you.

Levetiracetam Accord must be taken twice a day, once in the morning and once in the evening, approximately at 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: between 1000 mg and 3000 mg per day.

When starting Levetiracetam Accord, your doctor will prescribe a lower dose(500 mg per day) for 2 weeks before giving you the lowest 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 50 kg or less:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Accord according to your 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 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 (from 6 to 17 years) weighing less than 50 kg and when tablets do not allow for precise 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 of levetiracetam, a bitter taste may be experienced.

Duration of treatment:

• Levetiracetam Accord is used as a chronic treatment. You should continue to take Levetiracetam Accord for as long as your doctor has prescribed it.

Do not stop your treatment without your doctor's advice, as your seizures may increase.

If you take more Levetiracetam Accord than you should:

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

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best treatment for the overdose.

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

If you stop taking Levetiracetam Accord:

Stopping treatment with Levetiracetam Accord should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Accord, he/she will give you instructions for the gradual withdrawal of Levetiracetam Accord.

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

4. Possible side effects

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

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 rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes 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 output, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as this may be a sign of sudden decrease in kidney function
• a skin rash that may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially 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 severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs including involuntary 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 drowsiness, weakness, and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these side 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), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommonmay affect up to 1 in 1000 patients:

• decreased platelet count, decreased white blood cell count
• weight loss, weight gain
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention disturbances (loss of concentration)
• diplopia (double vision), blurred vision
• elevated liver enzymes
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

Raremay affect up to 1 in 1,000 people:

• infection
• decrease in all types of blood cells
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema)
• decreased sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating)
• delirium
• encephalopathy (see the subsection "Tell your doctor immediately" for a detailed description of the symptoms)
• epileptic seizures may worsen or occur more frequently
• uncontrolled muscle spasms affecting the head, torso, 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 decrease in kidney function
• skin rash that may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme), a widespread 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 over more than 30% of the body surface (toxic epidermal necrolysis)
• 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 level of consciousness (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 and repetitive thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 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 blister after EXP. The expiry date is the last day of the month stated.

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. Container Content and Additional 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 Container Content

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