Levetiracetam accord

Package leaflet: Information for the patient

Levetiracetam Accord, 100 mg/ml, oral solution
Levetiracetamum
Please read carefully the entire leaflet before taking the medicine or giving it to a child, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Levetiracetam Accord is and what it is used for
2. Important information before taking Levetiracetam Accord
3. How to take Levetiracetam Accord
4. Possible side effects
5. How to store Levetiracetam Accord
6. 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 seizures in epilepsy).
Levetiracetam Accord is used:

• as monotherapy (treatment with only one medicine) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for certain types of seizures. Epilepsy is a condition in which patients have recurrent seizures (fits). Levetiracetam is used to treat forms of epilepsy where seizures start in one part of the brain but may then spread to larger areas of both brain hemispheres (secondarily generalized or partial seizures without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures;
• as an add-on medicine to another antiepileptic medicine:
  • in adults, adolescents, children and infants from 1 month of age for the treatment of partial seizures with or without secondary generalization;
  • in adults and adolescents aged 12 years and older for the treatment of myoclonic seizures in juvenile myoclonic epilepsy (brief, shock-like jerks of single muscles or muscle groups);
  • in adults and adolescents aged 12 years and older for the treatment of generalized tonic-clonic seizures in idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis) (major seizures, including loss of consciousness).

2. Important information before taking Levetiracetam Accord

When not to take Levetiracetam Accord

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

Warnings and precautions
Before starting treatment with Levetiracetam Accord, consult your doctor:

• If the patient has kidney disease, Levetiracetam Accord should be used according to the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any slowing of growth or unexpected early puberty in a child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as Levetiracetam Accord, thoughts about self-harm or suicidal thoughts have occurred. In case of symptoms of depression and (or) suicidal thoughts, contact the doctor.
• If the patient has a family history of, or previously diagnosed irregular heart rhythm (seen on electrocardiogram), or if the patient has a disease and (or) takes medicines that may predispose to irregular heart rhythm or electrolyte imbalance.

Inform the doctor or pharmacist if any of the following adverse reactions become severe or persist for more than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant changes in mood or behaviour noticed by the patient or their family and friends.
• Worsening of epilepsy. In rare cases, seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. If any of these new symptoms occur while taking Levetiracetam Accord, contact the doctor as soon as possible. In a very rare early-onset form of epilepsy (epilepsy associated with mutations in the SCN8A gene) causing various seizure types and loss of skills, the patient may notice that seizures continue or worsen during treatment.

Children and adolescents
Use of Levetiracetam Accord as monotherapy is not recommended in children and adolescents under 16 years of age.
Levetiracetam Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take macrogol (a medicine used for constipation) one hour before or one hour after taking levetiracetam, as this may reduce the effectiveness of levetiracetam.
Levetiracetam Accord with food, drink and alcohol
Levetiracetam Accord can be taken with or without food. For safety reasons, alcohol should not be consumed during treatment with this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Levetiracetam Accord may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary.
Do not stop treatment without discussing it with the treating doctor.
A risk of congenital malformations in the unborn child cannot be completely ruled out. Results from two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the effect of levetiracetam on neurodevelopment in children are limited.
Breastfeeding is not recommended during treatment.
Driving and operating machinery
Levetiracetam Accord may impair the ability to drive and operate tools or machinery, as use of this medicine may cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. Do not drive or operate machinery until you know how the medicine affects your ability to perform these activities.
Levetiracetam Accord contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol
Levetiracetam Accord oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed-type reactions).
Levetiracetam Accord also contains maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to take Levetiracetam Accord

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the
doctor or pharmacist.
Take the number of tablets as prescribed by the doctor.
Levetiracetam Accord must be taken twice daily, in the morning and evening, approximately at the
same time each day.
The oral solution should be taken according to the doctor's instructions.
Monotherapy (from 16 years of age)
Adults (from 18 years of age) and adolescents (from 16 years of age):
To measure the correct dose, use the 10 ml syringe provided in the medicine pack intended for children aged 4 years and older patients.
Recommended dose:
Levetiracetam Accord should be taken twice daily, in two equal divided doses, each dose ranging between 5 ml (500 mg) and 15 ml (1500 mg).
If the patient is taking Levetiracetam Accord for the first time, the doctor will initially prescribe a lower dose for 2 weeks, followed by the lowest daily dose.
Adjunctive therapy
Dose in adults and adolescents (from 12 to 17 years of age):
To measure the correct dose, use the 10 ml syringe provided in the medicine pack intended for children aged 4 years and older patients.
Recommended dose:
Levetiracetam Accord should be taken twice daily, in two equal divided doses, each dose ranging between 5 ml (500 mg) and 15 ml (1500 mg).
Dose in children aged 6 months and older
The doctor will prescribe the most appropriate formulation of Levetiracetam Accord depending on age, body weight, and dose required.
For children aged 6 months to 4 years, measure the correct dose using the 3 ml syringe provided in the pack.
For children aged above 4 years, measure the correct dose using the 10 ml syringe provided in the pack.
Recommended dose:
Levetiracetam Accord should be taken twice daily, in two equal divided doses, each dose ranging between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kg of the child's body weight (example dosing in the table below).
Dose in children aged 6 months and older

Dose in infants (from 1 month of age to below 6 months)
For infants from 1 month of age to below 6 months, the appropriate dose should be measured
using the 1 ml syringe provided in the package.
Recommended dose:
Levetiracetam Accord should be taken twice daily, in two equal divided doses,
each dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of the infant's body weight
(examples of dosing in the table below).
Dose in infants (from 1 month of age to below 6 months)

Administration method:
After measuring the correct dose using the appropriate syringe, the oral solution of Levetiracetam Accord may be diluted in a glass of water or in a baby feeding bottle.
Levetiracetam Accord can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.
Instructions for preparing the medicine for use:

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

• Detach the connector from the syringe (Figure 2). Place the connector into the neck of the bottle (Figure 3). Ensure it is securely attached.

• Push the dosing syringe into the connector opening (Figure 4). Turn the bottle upside down (Figure 5)

• Draw a small amount of solution into the syringe by pulling the plunger down (Figure 5A), then push the plunger to expel air bubbles from the syringe (Figure 5B). Pull the plunger down to the mark corresponding to the dose prescribed by the doctor in millilitres (ml) (Figure 5C).

• Turn the bottle upright (Figure 6A). Remove the syringe from the connector (Figure 6B).

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

• Drink the entire contents of the glass or baby feeding bottle.
• Close the bottle with the plastic cap.
• Rinse the syringe with water (Figure 8).

Duration of treatment:

• Levetiracetam Accord is used for long-term treatment. Treatment with Levetiracetam Accord should be continued for as long as directed by the physician.
• Do not discontinue treatment without consulting the physician, as this may result in increased frequency of epileptic seizures.

Overdose of Levetiracetam Accord
Possible adverse effects after overdose of Levetiracetam Accord include drowsiness,
agitation, aggression, decreased alertness, respiratory depression, and coma.
In case of ingestion of a dose higher than recommended, seek immediate medical advice from a doctor or pharmacist. The doctor will advise on the most appropriate treatment for overdose.
Missed dose of Levetiracetam Accord
Contact the physician if one or more doses of the medicine have been missed.
Do not take a double dose to make up for a missed dose.
Discontinuation of Levetiracetam Accord
If treatment with Levetiracetam Accord is to be discontinued, the medicine should be gradually withdrawn in order to avoid increased frequency of epileptic seizures.
If the physician decides to discontinue treatment, instructions will be provided on how to taper the medicine gradually.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should immediately inform your doctor or contact the nearest hospital emergency department if the patient experiences:

• weakness, dizziness or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue or throat (angioedema, Quincke's oedema);
• flu-like symptoms and facial rash, followed by a rash spreading over the whole body, accompanied by high fever, increased liver enzyme activity observed in blood tests, increase in certain white blood cells (eosinophilia), swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms - DRESS syndrome);
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles or feet, as these may indicate sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (dark centre surrounded by a lighter area and a dark ring around it) (erythema
  multiforme);
• extensive rash with blisters and peeling skin, mainly affecting the area around the mouth, eyes, nose and genital organs (Stevens-Johnson syndrome);
• a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes, or if you notice signs of disorientation, drowsiness, amnesia (memory loss), memory disturbances (forgetfulness), behavioural disturbances or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported adverse reactions are: inflammation of the mucous membranes of the nose and throat, drowsiness, headache, fatigue and dizziness. At the beginning of treatment or after increasing the dose, adverse reactions such as drowsiness, fatigue or dizziness may occur more frequently. These effects should gradually diminish over time.
Very common: may affect more than 1 in 10 patients

• inflammation of the mucous membranes of the nose and throat;
• drowsiness, headache.

Common: may affect less than 1 in 10 patients

• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, loss of balance, dizziness (feeling of swaying), lethargy (lack of energy and motivation), tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon: may affect less than 1 in 100 patients

• decrease in platelet count, decrease in white blood cell count;
• weight decrease, weight increase;
• suicidal thoughts and suicide attempts, mental disorders, abnormal behaviour, hallucinations, feeling of anger, disorientation, panic attacks, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory disturbances (forgetting), ataxia (lack of coordination of movements), paraesthesia (tingling), difficulty concentrating;
• double vision, blurred vision;
• elevated/abnormal liver function tests;
• hair loss, skin rash, itching;
• muscle weakness, muscle pain;
• injuries.

Rare: may affect less than 1 in 1000 patients

• infections;
• decrease in all types of blood cells;
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), angioedema (swelling of the face, lips, tongue and throat);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioural disturbances), thought disturbances (slow thinking, inability to concentrate);
• seizures may worsen or occur more frequently;
• delirium;
• encephalopathy (a detailed description of symptoms is provided in the section "You should immediately inform your doctor");
• involuntary muscle contractions of the head, trunk and limbs, difficulty controlling movements, hyperkinesia (excessive activity);
• change in heart rhythm (electrocardiographic examination);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, mainly affecting the area around the mouth, eyes, nose and genital organs (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine phosphokinase activity in the blood. Occurrence is significantly more frequent in Japanese patients compared to other patients (not of Japanese origin);
• limping or difficulty walking;
• occurrence of fever, muscle stiffness, unstable blood pressure and heart rate, disorientation, low level of consciousness (these may be symptoms of a disorder known as neuroleptic malignant syndrome). The frequency of occurrence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• recurrent unwanted thoughts or feelings, or an inner compulsion to repeatedly perform the same action (obsessive-compulsive disorders).

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, you should consult your doctor or pharmacist. You can also report adverse reactions directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 outer carton and bottle after "Expiry date" and (or) "EXP". The expiry date refers to the last day of the stated month.
Do not use after 4 months from the first opening of the bottle.
No special storage temperature requirements.
Store in the original bottle to protect from light.
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 other information

What Levetiracetam Accord contains:
The active substance is levetiracetam. Each millilitre contains 100 mg of levetiracetam.
Other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E
218), propyl parahydroxybenzoate (E 216), ammonium glycyrrhizinate, glycerol (E422), maltitol liquid
(E 965), potassium acesulfame (E 950), grape flavour containing propylene glycol (E 1520) and
flavouring substances, purified water.
What Levetiracetam Accord looks like and contents of the pack
Levetiracetam Accord is a colourless liquid with a grape flavour, with a pH of 5.0–7.0.
A 300 ml bottle made of amber glass type III with PP and a child-resistant closure (for children from 4 years of age, adolescents and adults) is placed in a cardboard box containing an oral syringe with a capacity of 10 ml made of PE/PS, graduated every 0.25 ml, and a connector made of PE.
A 150 ml bottle made of amber glass type III with PP and a child-resistant closure (for infants and young children from 6 months up to below 4 years of age) is placed in a cardboard box containing an oral syringe with a capacity of 3 ml made of PE/PS, graduated every 0.1 ml, and a connector made of PE.
A 150 ml bottle made of amber glass type III with PP and a child-resistant closure (for infants from 1 month up to below 6 months of age) is placed in a cardboard box containing an oral syringe with a capacity of 1 ml made of PE/PS, graduated every 0.05 ml, and a connector made of PE.
Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer/Importer:
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice

This medicinal product is authorised for supply in the Member States of the European
Economic Area and the United Kingdom (Northern Ireland) under the following
names: