Levetiracetam Accord Healthcare

Package leaflet: Information for the patient

Levetiracetam Accord Healthcare 100 mg/ml oral solution

Equivalent medicine
Please 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, pharmacist, or nurse.
• 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 you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Levetiracetam Accord Healthcare is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Accord Healthcare is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have recurrent 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 by your doctor 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 aged 12 years and older with juvenile myoclonic epilepsy
  • primary generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Levetiracetam Accord Healthcare

Do not take Levetiracetam Accord Healthcare

• 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, pharmacist, or nurse before taking Levetiracetam Accord Healthcare.

• 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 a child, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Accord Healthcare have had thoughts about harming themselves or thoughts about suicide. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
• If you have a personal or family history of irregular heartbeat (as seen on an electrocardiogram), or if you have a disease and/or are taking treatment that makes you prone to irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than
a few days:

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

Children and adolescents
Levetiracetam Accord Healthcare as monotherapy (used alone) is not indicated in children and adolescents under
16 years of age.
Other medicines and Levetiracetam Accord Healthcare
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 cause a loss of effectiveness of levetiracetam.
Levetiracetam Accord Healthcare with food, drinks and alcohol
You may take Levetiracetam Accord Healthcare with or without food. As a precautionary safety measure, do not take it with alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Levetiracetam Accord Healthcare 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.
Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, data on the effects of levetiracetam on the child's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Accord Healthcare may reduce your ability to drive or use 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 Healthcare oral solution contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol.
Levetiracetam Accord Healthcare oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
Levetiracetam Accord Healthcare oral solution also contains maltitol (E965). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Levetiracetam Accord Healthcare

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your
doctor or pharmacist.
Levetiracetam Accord Healthcare should be taken twice daily, once in the morning and once in the
evening, approximately at the same time each day.
Take the oral solution according to your doctor's instructions.

Monotherapy (from 16 years of age)

• Adults and adolescents (from 16 years of age): Measure the appropriate dose using the 10 ml syringe provided in the package for patients aged 4 years and older. Recommended dose: Levetiracetam Accord Healthcare is taken twice daily in two equally divided doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg). When you first start taking Levetiracetam Accord Healthcare, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest recommended daily dose.

Adjunctive therapy

• Dose for adults and adolescents (from 12 to 17 years of age): Measure the appropriate dose using the 10 ml syringe provided in the package for patients aged 4 years and older.

Recommended dose: Levetiracetam Accord Healthcare is taken twice daily in two equally divided doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

• Dose for children from 6 months of age:

Your doctor will prescribe the most appropriate formulation of Levetiracetam Accord Healthcare depending on the child's age, weight and required dose.
For children from 6 months to 4 years of age: Measure the appropriate dose using the 3 ml syringe provided in the package.
For children above 4 years of age: Measure the appropriate dose using the 10 ml syringe provided in the package.
Recommended dose: Levetiracetam Accord Healthcare is taken twice daily in two equally divided doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (300 mg) per kg of the child's body weight (see the following table for dose examples).
Dose for children aged 6 months and older:

• Dosage for infants (from 1 month to less than 6 months): For infants from 1 month to less than 6 months: measure the appropriate dose using the 1 ml syringe provided in the package. Recommended dose: Levetiracetam Accord Healthcare should be taken twice daily in two equally divided doses, each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see the table below for examples of dosing).

Dosage for infants (from 1 month to less than 6 months):

Method of administration:
After measuring the correct dose with an appropriate syringe, Levetiracetam Accord Healthcare oral solution may be diluted in a glass of water or in a feeding bottle. Levetiracetam Accord Healthcare may be taken with or without food. After oral administration, a bitter taste of levetiracetam may be noticed.

Instructions for use

• Opening the bottle: press down on the cap and turn counterclockwise (Figure 1)

• Separate the adapter from the syringe (Figure 2). Insert the adapter into the neck of the bottle (Figure 3). Make sure it is securely attached.

• Take the syringe and place it onto the opening of the adapter (Figure 4). Turn the bottle upside down (Figure 5).

• Fill the syringe with a small amount of solution by pulling the plunger down (Figure 5A), then push the plunger upward to remove any air bubbles (Figure 5B). Pull the plunger down to the graduation mark corresponding to the amount in millilitres (ml) prescribed by the doctor (Figure 5C).

• Turn the bottle back to the upright position (Figure 6A). Remove the syringe from the adapter (Figure 6B).

• Empty the syringe contents into a glass of water or into a feeding bottle by pressing the syringe plunger (Figure 7).

• Drink all the contents of the glass or feeding bottle.
• Close the bottle with the plastic screw cap.
• Wash the syringe using only water (Figure 8).

Duration of treatment:

• Levetiracetam Accord Healthcare is used as a chronic treatment. Treatment with Levetiracetam Accord Healthcare 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 Healthcare than you should:
Possible adverse effects of an overdose of Levetiracetam Accord Healthcare include drowsiness, agitation, aggressiveness, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more Levetiracetam Accord Healthcare than you should. Your doctor will determine the most appropriate treatment for the overdose.

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

If you stop taking Levetiracetam Accord Healthcare:
If treatment needs to be discontinued, Levetiracetam Accord Healthcare must be stopped gradually to avoid an increase in seizures. If your doctor decides to stop treatment with Levetiracetam Accord Healthcare, they will provide you with specific instructions on how to gradually discontinue the medication.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

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, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue, and throat (angioedema, also known as Quincke's edema)
• 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])
• symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden worsening of kidney function
• a skin rash that may appear as blisters resembling "target lesions" (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form of skin rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, 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. These effects should, however, decrease over time.

Very common: may affect more than 1 in 10 people

• rhinopharyngitis
• 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 (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (spinning sensation)
• cough
• abdominal pain, diarrhoea, 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
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, 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 or 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 serious allergic reaction], angioedema [swelling of face, lips, tongue, and throat])
• decreased sodium concentration in the blood
• suicide, personality disorders (behavioural problems), thought disturbances (slowed thinking, inability to concentrate)
• epileptic seizures may worsen or occur more frequently
• delirium
• encephalopathy (see the section "Contact your doctor immediately" for a detailed description of symptoms)
• convulsive seizures may worsen or occur more frequently
• uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• changes in heart rhythm (electrocardiogram)
• pancreatitis
• liver failure, hepatitis
• sudden worsening of kidney function
• skin rash that may form blisters and appear as small target-like lesions (central dark spot surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, 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)
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in serum creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping gait or difficulty walking
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, 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.

Very rare: may affect up to 1 in 10,000 people

• repeated unwanted thoughts or sensations, or an urge to do something repeatedly (obsessive-compulsive disorder)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Accord Healthcare

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 bottle after "Exp.".
The expiry date refers to the last day of that month.
Do not use more than 4 months after first opening the bottle.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not dispose of this medicine 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 Healthcare oral solution contains:
The active substance is levetiracetam.

• Each ml contains 100 mg of levetiracetam.
• The other components are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizinate, glycerol (E422), liquid maltitol (E965), acesulfame potassium (E950), grape flavour containing flavouring agents and propylene glycol, purified water.

Description of the appearance of Levetiracetam Accord Healthcare oral solution and contents of the pack
Levetiracetam Accord Healthcare oral solution is a clear, colourless liquid with a grape flavour. pH between 5.0 and 7.0.
The 300 ml bottle of Levetiracetam Accord Healthcare oral solution (for children from 4 years of age, adolescents and adults) is packaged in a cardboard carton containing a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.
The 150 ml bottle of Levetiracetam Accord Healthcare oral solution (for infants and young children from 6 months up to less than 4 years of age) is packaged in a cardboard carton containing a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.
The 150 ml bottle of Levetiracetam Accord Healthcare oral solution (for infants from 1 month up to less than 6 months of age) is packaged in a cardboard carton containing a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.
Marketing Authorisation 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
This medicinal product is authorised in the Member States of the European Economic Area under the following names: