Levetiracetam Accord: detailed information

Package leaflet: Information for the patient

Levetiracetam Accord 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets

levetiracetam
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 any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Levetiracetam Accord is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Accord 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 have 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). Levetiracetam has been prescribed to you to reduce the number of seizures.
as 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 jerks of a muscle or muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (major 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 Levetiracetam Accord

Do not take Levetiracetam Accord

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 Levetiracetam Accord

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your 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 Levetiracetam Accord have experienced suicidal thoughts or self-harming thoughts. If you have 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 for more than a few days:

Unusual thoughts, feeling irritable or more aggressive than usual, or if you, your family, or 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. If you experience any of these new symptoms while taking Levetiracetam Accord, consult a doctor as soon as possible. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of developmental skills, you may notice that seizures persist or worsen during treatment.

Children and adolescents

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

Other medicines and Levetiracetam Accord
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 reduce the effectiveness of levetiracetam.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor 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. Breastfeeding is not recommended during treatment.

Driving and using machines
Levetiracetam Accord 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 certain that your ability to perform these activities is not impaired.

Levetiracetam Accord 750 mg film-coated tablets contain Sunset Yellow FCF (E110)
The colouring agent Sunset Yellow FCF (E110) may cause allergic reactions.
Other strengths of Levetiracetam Accord tablets do not contain this ingredient.

3. How to take Levetiracetam Accord

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take the number of tablets as directed by your doctor.
Levetiracetam Accord must 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 Levetiracetam Accord, your doctor will prescribe a lower starting dose for 2 weeks before increasing to your intended 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 Levetiracetam Accord based on weight and required 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 Levetiracetam Accord based on
age, weight, and required dose.
An 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 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,
a bitter taste of levetiracetam may be perceived.
Duration of treatment:

Levetiracetam Accord is used as a chronic treatment. Treatment with Levetiracetam Accord 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 Levetiracetam Accord than you should:
Possible adverse effects of an overdose of Levetiracetam Accord include drowsiness,
agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for the overdose.
If you forget to take Levetiracetam Accord:
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 Levetiracetam Accord:
If treatment needs to be discontinued, Levetiracetam Accord should be withdrawn gradually to avoid an increase in seizure frequency.
If your doctor decides to stop treatment with Levetiracetam Accord, they will provide you with instructions on how to taper off Levetiracetam Accord gradually.
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 everybody gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, dizziness or lightheadedness, or have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
swelling of the face, lips, tongue, or throat (angioedema)
flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in 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 in the legs, ankles, or feet, as these may indicate sudden decrease in kidney function
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 severe mental changes or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (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: rhinopharyngitis, 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, nervousness or irritability;
seizure, balance disorder, dizziness (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary tremors);
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 changes, 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 significant allergic reaction], angioedema [swelling of face, lips, tongue, and throat]);
decreased concentration of sodium 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 skin peeling, 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 blood creatine phosphokinase. The 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). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. 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 Levetiracetam Accord

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 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 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 Levetiracetam Accord contains:
The active substance is levetiracetam.
Each film-coated tablet contains 250 mg, 500 mg, 750 mg, or 1000 mg of levetiracetam.
Other ingredients in the tablet core are:
croscarmellose sodium, povidone K-30, colloidal anhydrous silica, magnesium stearate (E470b)
The film coating contains:
250 mg:
polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
500 mg:
polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)
750 mg:
polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), sunset yellow
FCF (E110)
1000 mg:
polyvinyl alcohol, titanium dioxide (E171), macrogol, talc

Description of the appearance of Levetiracetam Accord and contents of the pack
250 mg:
Film-coated tablet, biconvex, white to off-white, oval-shaped, with the imprint 'L 64' on one side and a breakline, smooth on the other side.
500 mg:
Film-coated tablet, biconvex, yellow, oval-shaped, with the imprint 'L 65' on one side and a breakline, smooth on the other side.
750 mg:
Film-coated tablet, biconvex, pink, oval-shaped, with the imprint 'L 66' on one side and a breakline, smooth on the other side.
1000 mg:
Film-coated tablet, biconvex, white to off-white, oval-shaped, with the imprint 'L 67' on one side and a breakline, smooth on the other side.

Levetiracetam Accord film-coated tablets 250 mg, 500 mg, 750 mg, and 1000 mg are packed in PVC-aluminum blister packs. The blisters are further packaged in cardboard with a leaflet, in pack sizes of 10, 20, 30, 50, 60, 100, and 200 tablets per pack. Additionally, the tablets are also available in unit-dose blisters in pack sizes of 30x1, 60x1, and 100x1 tablets.
It is possible that not all pack sizes are 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

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.