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, 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Normeg is and what it is 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 Normeg is and what it is 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 (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 generalisation). Levetiracetam has been prescribed by your doctor to reduce the number of seizures.
• in combination 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 generalisation,
• 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 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, talk to your doctor:

• if you have kidney problems, your doctor may decide to adjust your dose.
• if you notice any slowing of growth or unexpected early puberty in your child, contact your doctor.
• some patients taking antiepileptic medicines such as Normeg have had thoughts of harming themselves or ending their lives. If at any time you have these thoughts, talk to your doctor.
• if you have a history of heart rhythm problems (abnormal electrocardiogram) or if you are taking medicines that may affect heart rhythm, or if you have disturbed electrolyte balance.

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

• abnormal thoughts, hostility or aggression, or changes in mood or behaviour, noticed by you or your relatives and friends.
• worsening of seizures, in rare cases, seizures may become worse or more frequent, especially during the first month of treatment or when the dose is increased. In very rare cases of a severe form of epilepsy (epilepsy with myoclonic seizures, with or without other seizure types), patients may notice an increase in seizures.

If you experience any of these new symptoms while taking Normeg, contact your doctor immediately.

Children and adolescents

Normeg is not indicated for use in children and adolescents below 16 years as the only treatment (monotherapy).

Normeg with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including medicines obtained without a prescription.
Do not take macrogol (used as a laxative) for one hour before and one hour after taking levetiracetam, as it may reduce the effect of levetiracetam.

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 are planning 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 essential.
Do not stop treatment without discussing it with your doctor.
The risk of birth defects cannot be completely excluded.
Breastfeeding is not recommended during treatment.

Driving and using machines

Normeg may affect your ability to drive or use 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 Normeg 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. Check with your doctor or pharmacist if you are not sure.
Take the number of tablets as instructed 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 dose for the first two weeks and then increase it to 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.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.

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 for easier swallowing.

Duration of treatment:

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

Overdose of Normeg

Possible side effects after overdose of levetiracetam are somnolence, agitation, aggression, decreased consciousness, respiratory depression, and coma.
If you have taken more than the prescribed dose, contact your doctor immediately. Your doctor will decide on the best course of action.

Missed dose of Normeg

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

Stopping Normeg treatment

If treatment with Normeg is to be stopped, it should be done gradually to avoid increasing the frequency of 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Immediately contact your doctor or go to the nearest hospital emergency department if you 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 oedema);
• flu-like symptoms and rash on the face and then on the rest of the body, accompanied by high fever, increased liver enzymes in the blood, 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 hands, as this may indicate sudden kidney failure;
• a skin rash that may lead to blistering and peeling of the skin, looking like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme);
• widespread rash with blisters and peeling skin, especially 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 changes or if you notice signs of confusion, drowsiness, loss of memory (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 nasal congestion and sore throat, somnolence, headache, fatigue, and dizziness. At the start of treatment or when the dose is increased, side effects such as somnolence, fatigue, or dizziness may occur more frequently. These effects should decrease over time.

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

• nasal congestion and sore throat
• fatigue, 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 disturbances, dizziness (feeling of spinning), lethargy (lack of energy and enthusiasm), tremors (involuntary trembling)
• vertigo (dizziness due to inner ear problems)
• 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, mood swings, and excitement
• memory loss (amnesia), memory disturbances (forgetfulness), ataxia (lack of coordination), 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 count of all blood cell types
• severe allergic reactions (DRESS - drug rash with eosinophilia and systemic symptoms, anaphylactic reaction [severe allergic reaction], Quincke's oedema [swelling of the face, lips, tongue, and throat])
• decreased sodium levels in the blood
• suicide, personality disorders (behavioral disturbances), thought disturbances (slow thinking, inability to concentrate)
• delirium
• encephalopathy (detailed description of symptoms can be found in the subsection "Contact your doctor immediately")
• 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 kidney failure
• rash on the skin that may lead to blistering and peeling, looking like small targets (dark spot surrounded by a lighter area and a dark ring around) (erythema multiforme), widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form of skin rash, causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of muscle tissue) and associated increased creatine phosphokinase activity in the blood. The occurrence is significantly more frequent 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 frequency of occurrence 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 urges to perform the same action over and over again (obsessive-compulsive disorder).

Reporting of side effects

If you experience any side effects, talk to 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: 22 49 21 301, fax: 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.
Reporting side effects will help to gather 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 which is stated on the carton, blister, and label after "EXP". The expiry date refers to the last day of that 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. These measures 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 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.
The other ingredients are:
Core:
Povidone 30, croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate.
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, film-coated tablets, 12.6 mm long and 6.1 mm wide, with a score line on both sides.
Normeg, 500 mg: yellow, elongated, film-coated tablets, 16.1 mm long and 7.6 mm wide, with a score line on both sides.
Normeg, 750 mg: orange, elongated, film-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, film-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 film-coated tablets, packaged in PVC/Aluminium 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 guarantee seal, containing 100 or 200 tablets.
Normeg, 750 mg, 1000 mg may be packaged in an HDPE bottle with a PE cap and a guarantee seal, containing 100 tablets, or in a PET bottle with a PP cap, containing 200 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

For more detailed information on this medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorisation holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:November 2024