Normeg

Package Leaflet: Information for the Patient

Normeg, 250 mg, Film-Coated Tablets

Normeg, 500 mg, Film-Coated Tablets

Normeg, 750 mg, Film-Coated Tablets

Normeg, 1000 mg, Film-Coated Tablets

Levetiracetam

Read the package leaflet carefully before taking the medicine or giving it to a child, as it contains important information for the patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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 side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Normeg and what is it used for
• 2. Important information before taking Normeg
• 3. How to take Normeg
• 4. Possible side effects
• 5. How to store Normeg
• 6. Contents of the package and other information

1. What is Normeg and what is it used for

Normeg is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Normeg is used:

• as the only medicine to treat certain types of epilepsy in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Epilepsy is a condition where patients have repeated seizures. Levetiracetam is used to treat a type of epilepsy where seizures initially occur in one part of the brain and then may spread to larger areas of both hemispheres of the brain (partial seizures with or without secondary generalization). Levetiracetam has been prescribed by a doctor to reduce the number of seizures.
• as an additional medicine alongside another antiepileptic medicine:
• in adults, adolescents, children, and infants from 1 month of age to treat partial seizures with or without secondary generalization,
• in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy to treat myoclonic seizures (short, shock-like muscle contractions),
• in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy that is likely to have a genetic basis) to treat tonic-clonic seizures (large seizures, including loss of consciousness) that are primarily generalized.

2. Important information before taking Normeg

When not to take Normeg:

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

Warnings and precautions

Before starting treatment with Normeg, the patient should discuss the following with their doctor:

• If kidney disease has been diagnosed in the patient, Normeg should be taken as directed by the doctor. The doctor may decide to adjust the dose.
• If any slowing of growth or unexpected premature puberty in the child is observed, the patient should contact their doctor.
• In some patients treated with antiepileptic medicines, such as Normeg, thoughts of self-harm or suicide have occurred. In case of symptoms of depression and/or suicidal thoughts, the patient should contact their doctor.
• If there is a history of irregular heart rhythm (visible on an electrocardiogram) in the patient's family or if the patient has experienced it before, or if the patient has a disease and/or is taking medicines that may cause irregular heart rhythm or electrolyte imbalance.

The patient should inform their doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant mood or behavioral changes noticed by the patient or their family and friends.
• Worsening of epilepsy. In rare cases, seizures may worsen or occur more frequently, especially in the first month after starting treatment or increasing the dose. In a very rare form of epilepsy with an early onset (epilepsy associated with mutations in the SCN8A gene) causing various types of seizures and loss of skills, the patient may notice that seizures continue or worsen during treatment.

If any of these new symptoms occur while taking Normeg, the patient should contact their doctor as soon as possible.

Children and adolescents

Normeg is not indicated for use in children and adolescents under 16 years of age as the only medicine (monotherapy).

Normeg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Macrogol (used as a laxative) should not be taken within 1 hour before or 1 hour after taking levetiracetam, as it may prevent levetiracetam from working.

Normeg and alcohol

For safety reasons, the patient should not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Normeg can be used during pregnancy only if the treating doctor considers it necessary after careful evaluation.
The patient should not stop treatment without discussing it with their treating doctor.
The risk of birth defects in the fetus cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines

Normeg may affect the patient's ability to drive or operate tools or machines, as it can cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. The patient should not drive or operate machines until they know how the medicine affects them.

Normeg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Normeg

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should take the number of tablets as directed by their doctor.
Normeg must be taken twice a day, with half of the daily dose in the morning and half in the evening, at approximately the same time every day.
Additional treatment and monotherapy (from 16 years of age)

• Adults (18 years and older) and adolescents (12 to 17 years) with a body weight of 50 kg or more:The recommended dose is 1000 mg to 3000 mg per day. If the patient is taking Normeg for the first time, the doctor will initially prescribe a lower dosefor 2 weeks, and then the lowest daily dose. For example, if the daily dose is 1000 mg, the initial lower dose is1 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) with a body weight of less than 50 kg.The doctor will prescribe the most suitable pharmaceutical form of Normeg based on the patient's body weight and dose.
• Dose in infants and children (1 to 23 months) and children (2 to 11 years) with a body weight below 50 kg:The doctor will prescribe the most suitable pharmaceutical form of Normeg based on the patient's age, body weight, and dose.

The oral solution is a more suitable form of the medicine for infants and children under 6 years of age, as well as for children and adolescents (6 to 17 years) with a body weight below 50 kg, and in situations where the appropriate dose cannot be administered in tablets.

Method of administration

Normeg tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).
Normeg can be taken with or without food.
After oral administration, levetiracetam may leave a bitter taste.
The dividing line on the tablet is only to facilitate breaking it into two halves.

Duration of treatment:

• Normeg is used for long-term treatment. The patient should continue treatment with Normeg for as long as their doctor recommends.
• The patient should not stop treatment without consulting their doctor, as this may cause an increase in the frequency of seizures.

Taking a higher dose of Normeg than recommended

Possible side effects after overdosing on levetiracetam include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If a higher dose of Normeg than recommended is taken, the patient should immediately consult their doctor. The doctor will recommend the best possible treatment for the overdose.

Missing a dose of Normeg

The patient should contact their treating doctor if they miss one or more doses of Normeg.
The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Normeg

If treatment with Normeg is to be stopped, the medicine should be gradually discontinued to avoid increasing the frequency of epileptic seizures. If the doctor decides to stop treatment, they will also inform the patient how to gradually discontinue the medicine.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Normeg can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor or contact the nearest hospital emergency department if they experience:

• weakness, feeling of emptiness in the head, or dizziness, or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, and throat (Quincke's edema);
• flu-like symptoms and rash on the face and then on the rest of the body, accompanied by high fever, increased liver enzyme activity, increased white blood cell count (eosinophilia), and swollen lymph nodes (drug rash with eosinophilia and systemic symptoms - DRESS);
• symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles, or legs, as this may be a sign of sudden kidney function deterioration;
• a skin rash that can cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme);
• a widespread rash with blisters and peeling skin, occurring mainly in the area around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or noticing signs of disorientation, drowsiness, memory loss (amnesia), memory disorders (forgetfulness), behavioral disorders, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most common side effects reported are nasal congestion and throat inflammation, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, or dizziness may occur more frequently. These effects should weaken over time.

Very common (may affect more than 1 in 10 people):

• nasal congestion and throat inflammation
• drowsiness, headache

Common (may affect up to 1 in 10 people):

• loss of appetite (anorexia)
• depression, hostility, or aggression, anxiety, insomnia, nervousness, or irritability
• seizures, balance disorders, dizziness (feeling of swaying), lethargy (lack of energy and enthusiasm), tremors (involuntary tremors)
• dizziness of vestibular origin (feeling of spinning)
• cough
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (exhaustion)

Uncommon (may affect up to 1 in 100 people):

• decreased platelet count, decreased white blood cell count
• weight loss, weight gain
• suicidal thoughts and attempts, mental disorders, abnormal behavior, hallucinations, anger, disorientation, panic attacks, emotional instability/mood swings, agitation
• memory loss (amnesia), memory disorders (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disorders
• double vision, blurred vision
• abnormal liver test results
• hair loss, rash, itching
• muscle weakness, muscle pain
• injuries

Rare (may affect up to 1 in 1000 people):

• infection
• decreased count of all types of blood cells
• severe allergic reactions (DRESS - drug rash with eosinophilia and systemic symptoms, anaphylactic reaction [severe allergic reaction], Quincke's edema [swelling of the face, lips, tongue, and throat])
• decreased sodium levels in the blood
• suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate)
• delirium
• encephalopathy (detailed description of symptoms can be found in the subsection "The patient should immediately inform their doctor")
• seizures may worsen or occur more frequently
• involuntary muscle contractions in the head, torso, and limbs, difficulty controlling movements, hyperkinesia (overactivity)
• change in heart rhythm (electrocardiogram)
• pancreatitis
• liver dysfunction, hepatitis
• sudden worsening of kidney function
• a skin rash that can cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme), a widespread rash with blisters and peeling skin, occurring mainly in the area around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of striated muscle) and associated increased creatine phosphokinase activity in the blood. The incidence is significantly higher in Japanese patients compared to other patients (non-Japanese)
• stuttering or difficulty walking;
• occurring simultaneously: fever, muscle stiffness, unstable blood pressure

and heart rate, disorientation, low level of consciousness (these may be symptoms of a disorder called malignant neuroleptic syndrome). The incidence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• repetitive unwanted thoughts or feelings, or an internal compulsion to constantly perform the same action (obsessive-compulsive disorder).

Reporting side effects

If side effects occur, including those not listed in the package leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder or their representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Normeg

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date (EXP) stated on the carton, blister, and label after "EXP". The expiration date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Normeg contains

The active substance of Normeg is levetiracetam.
Normeg, 250 mg: each film-coated tablet contains 250 mg of levetiracetam.
Normeg, 500 mg: each film-coated tablet contains 500 mg of levetiracetam.
Normeg, 750 mg: each film-coated tablet contains 750 mg of levetiracetam.
Normeg, 1000 mg: each film-coated tablet contains 1000 mg of levetiracetam.
Other ingredients are:
Tablet core:
Povidone 30, sodium croscarmellose, colloidal silicon dioxide, anhydrous, sodium stearyl fumarate.
Tablet coating:
Hypromellose 2910/5, macrogol 6000, talc, titanium dioxide (E171), simethicone emulsion (purified water 67.4%, simethicone 30.0%, methylcellulose 2.5%, sorbic acid 0.1%) and
Normeg, 250 mg:indigo carmine, lake (E132)
Normeg, 500 mg:yellow iron oxide (E172)
Normeg, 750 mg:red iron oxide (E172), yellow iron oxide (E172).

What Normeg looks like and contents of the package

Normeg, 250 mg: blue, elongated film-coated tablets with a length of 12.6 mm and a width of 6.1 mm with a dividing line on both sides.
Normeg, 500 mg: yellow, elongated film-coated tablets with a length of 16.1 mm and a width of 7.6 mm with a dividing line on both sides.
Normeg, 750 mg: orange, elongated film-coated tablets with a length of 18.6 mm and a width of 8.6 mm with a dividing line on both sides.
Normeg, 1000 mg: white to almost white, elongated film-coated tablets with a length of 19.1 mm and a width of 10.1 mm with a dividing line on both sides.
Pack sizes: 30, 50, 60, 100, 120, or 200 film-coated tablets, packaged in PVC/Aluminum blisters of 10 tablets in a cardboard box.
Normeg, 250 mg, 500 mg may be packaged in an HDPE bottle with a PE cap with a tamper-evident seal, containing 100 or 200 tablets.
Normeg, 750 mg, 1000 mg may be packaged in an HDPE bottle with a PE cap with a tamper-evident seal, containing 100 tablets, or in a PET bottle with a PP cap, containing 200 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva k.s., Dolní Měcholupy, U kabelovny 130, 102 37 Prague 10, Czech Republic.