Normeg

Package Leaflet: Information for the Patient

Normeg, 250 mg, Coated Tablets

Normeg, 500 mg, Coated Tablets

Normeg, 750 mg, Coated Tablets

Normeg, 1000 mg, 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, 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. Do 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, including those not listed in this package leaflet, tell your 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 pack and other information

1. What is Normeg and what is it used for

Normeg is an antiepileptic 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 (fits). Levetiracetam is used to treat a type of epilepsy where seizures first start in one part of the brain and then spread to other parts of the brain (partial onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of fits.
• as an additional medicine with other antiepileptic medicines:
• in adults, adolescents, children, and infants from 1 month of age for the treatment of partial onset seizures with or without secondary generalization,
• in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy for the treatment of myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles),
• in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy that is thought to have a genetic basis) for the treatment of primary generalized tonic-clonic seizures (major fits with loss of consciousness).

2. Important information before taking Normeg

When not to take Normeg:

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

Warnings and precautions

Before taking Normeg, discuss with your doctor:

• If kidney problems have been diagnosed, Normeg should be taken as directed by your doctor. Your doctor may decide to adjust the dose.
• If any slowing of growth or unexpected early puberty has been observed in a child, contact your doctor.
• In some patients, antiepileptic medicines such as Normeg have been associated with thoughts of self-harm or suicide. If signs of depression and/or suicidal thoughts or behaviors are observed, contact your doctor.
• If there is a history of an irregular heart rhythm (seen on an electrocardiogram) in your family or if you have had such a condition, or if you have a condition or are taking a medicine that may lead to an irregular heart rhythm or electrolyte disturbances.

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

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant mood changes or behavior changes noticed by you or your family and friends.
• Worsening of seizures. In rare cases, seizures may worsen or become more frequent, especially in the first month after starting treatment or increasing the dose. In a very rare form of epilepsy (early-onset epilepsy associated with SCN8A gene mutations) that causes 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, contact your 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

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take.
Do not take macrogol (used as a laxative) one hour before and one hour after taking levetiracetam, as it may prevent levetiracetam from working.

Normeg with alcohol

For safety reasons, do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Normeg can be used during pregnancy only if your doctor considers it necessary.
Do not stop treatment without discussing it with your doctor.
The risk of birth defects cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines

Normeg 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. Do not drive or use machines until you know how the medicine affects you.

Normeg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially 'sodium-free'.

3. How to take Normeg

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Take the number of tablets as directed by your doctor.
Normeg must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Adjunctive therapy and monotherapy (from 16 years)

• Adults (≥ 18 years) 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 you are taking Normeg for the first time, your doctor will 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 50 kg or less.Your doctor will prescribe the most suitable pharmaceutical form of Normeg based on your 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:Your doctor will prescribe the most suitable pharmaceutical form of Normeg based on 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 and for children and adolescents (6 to 17 years) with a body weight below 50 kg, as well as 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 score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Duration of treatment:

• Normeg is used for long-term treatment. Continue treatment with Normeg for as long as your doctor tells you.
• Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures.

Taking more Normeg than prescribed

Possible side effects after overdose of levetiracetam include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If you have taken more than the prescribed dose, contact your doctor immediately. Your doctor will recommend the best possible treatment for overdose.

Missing a dose of Normeg

Contact your doctor if you have missed one or more doses of Normeg.
Do not take a double dose to make up for a missed dose.

Stopping Normeg treatment

If treatment with Normeg is to be stopped, the medicine should be discontinued gradually to avoid increasing the frequency of epileptic seizures. If your doctor decides to stop treatment, he will also tell you how to gradually stop taking the medicine.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek immediate medical attention if you experience any of the following:

• 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 (angioedema);
• flu-like symptoms and rash on the face and then on the rest of the body, with high fever, increased liver enzyme activity observed in blood tests, increased number of certain white blood cells (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 indicate sudden worsening of kidney function;
• rash on the skin that may lead to blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme);
• widespread rash with blisters and peeling skin, mainly on the lips, eyes, mouth, and genitals (Stevens-Johnson syndrome);
• a more severe form of rash with skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or if you notice signs of disorientation, drowsiness, memory loss (amnesia), memory disturbances (forgetfulness), behavioral disturbances, or other neurological symptoms, including involuntary or uncontrolled movements. These may be signs of encephalopathy.

The most common side effects are: runny nose and throat, drowsiness, headache, fatigue, and dizziness. At the start of treatment or when the dose is increased, side effects such as drowsiness, fatigue, or dizziness may occur more frequently. These effects should decrease over time.

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

• runny nose and throat
• drowsiness, headaches

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

• loss of appetite (anorexia)
• depression, hostility, or aggression, anxiety, insomnia, nervousness, or irritability
• seizures, balance disturbances, dizziness (feeling of spinning), lethargy (lack of energy and enthusiasm), tremors (involuntary tremors)
• vertigo (dizziness of inner ear origin)
• 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 decrease, weight increase
• suicidal thoughts and attempts, mental disorders, abnormal behavior, hallucinations, anger, disorientation, panic attacks, emotional instability/mood changes, agitation
• memory loss (amnesia), memory disturbances (forgetfulness), ataxia (coordination disorder), paresthesia (tingling), attention disturbances
• double vision, blurred vision
• abnormal liver function tests
• hair loss, rash, itching
• muscle weakness, muscle pain
• injuries

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

• infection
• decreased blood cell count
• severe allergic reactions (DRESS - drug rash with eosinophilia and systemic symptoms, anaphylactic reaction [severe allergic reaction], angioedema [swelling of the face, lips, tongue, and throat])
• decreased sodium levels in the blood
• suicide, personality disorders (behavioral disorders), thought disorders (slow thinking, inability to concentrate)
• delirium
• encephalopathy (detailed description of symptoms can be found in the subsection "Seek immediate medical attention")
• seizures may worsen or become more frequent
• involuntary muscle contractions in the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity)
• changes in heart rhythm (electrocardiogram)
• pancreatitis
• liver dysfunction, hepatitis
• sudden worsening of kidney function
• rash on the skin that may lead to blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme), widespread rash with blisters and peeling skin, mainly on the lips, eyes, mouth, and genitals (Stevens-Johnson syndrome), and a more severe form of rash with skin peeling on 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 non-Japanese patients
• 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):

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring 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 its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Normeg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton, blister, and label after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Normeg contains

The active substance is levetiracetam.
Normeg, 250 mg: each coated tablet contains 250 mg of levetiracetam.
Normeg, 500 mg: each coated tablet contains 500 mg of levetiracetam.
Normeg, 750 mg: each coated tablet contains 750 mg of levetiracetam.
Normeg, 1000 mg: each coated tablet contains 1000 mg of levetiracetam.
Other ingredients are:
Tablet core:
Povidone 30, croscarmellose sodium, 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 pack

Normeg, 250 mg: blue, elongated, coated tablets, 12.6 mm long and 6.1 mm wide, with a score line on both sides.
Normeg, 500 mg: yellow, elongated, coated tablets, 16.1 mm long and 7.6 mm wide, with a score line on both sides.
Normeg, 750 mg: orange, elongated, coated tablets, 18.6 mm long and 8.6 mm wide, with a score line on both sides.
Normeg, 1000 mg: white to almost white, elongated, coated tablets, 19.1 mm long and 10.1 mm wide, with a score line on both sides.
Pack sizes: 30, 50, 60, 100, 120, or 200 coated tablets, packaged in PVC/Aluminum blisters of 10, in a cardboard box.
Normeg, 250 mg, 500 mg may be packaged in an HDPE bottle with a PE cap and a safety seal, containing 100 or 200 tablets.
Normeg, 750 mg, 1000 mg may be packaged in an HDPE bottle with a PE cap and a safety 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.