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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 monotherapy in the treatment of certain types of epilepsy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy. Epilepsy is a condition in which patients have recurrent seizures. Levetiracetam is used to treat a type of epilepsy in which seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (secondarily generalized partial seizures or partial seizures without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of epileptic seizures.
• as an add-on therapy 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 from 12 years of age with juvenile myoclonic epilepsy for the treatment of myoclonic seizures (brief, shock-like contractions of single muscles or muscle groups),
  • in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis) for the treatment of primary generalized tonic-clonic seizures (generalized seizures involving loss of consciousness).

2. Important information before using Normeg

When not to use Normeg:

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

Warnings and precautions
Before starting treatment with Normeg, discuss the following with your doctor:

• If the patient has kidney disease, Normeg should be used according to the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any growth retardation or unexpected premature development in the child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as Normeg, thoughts about self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, contact your doctor.
• If the patient has a family history or personal history of irregular heart rhythm (seen on electrocardiogram), or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalances.

Inform your 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. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A gene mutations) causing various seizure types 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 monotherapy (i.e. as the only medicine).
Normeg and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take macrogol (used as a bowel cleanser) within one hour before or one hour after taking levetiracetam, as this may interfere with the action of levetiracetam.
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 or pharmacist before using this medicine. Normeg may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary.
Do not stop treatment without discussing it with your treating doctor.
The 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
Normeg may impair the ability to drive or operate tools or machinery, as use of Normeg may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Driving or operating machinery is not recommended until the effect of the medicine on the patient's ability to perform these activities is known.
Normeg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; i.e. the medicine is considered "sodium-free".

3. How to take Normeg

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
You should take the number of tablets as recommended by your doctor.
Normeg must be taken twice daily, half of the daily dose in the morning and in the evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (from 16 years of age)

• Adults (aged ≥ 18 years) and adolescents (12 to 17 years) with body weight of 50 kg or more: Recommended dose: 1000 mg to 3000 mg per day. If the patient is taking Normeg for the first time, the doctor will initially prescribe a lower starting dose for 2 weeks, followed by the lowest daily maintenance dose. For example, if the daily dose is 1000 mg, the lower initial dose would be 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased so that after 2 weeks the daily dose of 1000 mg is reached.
• Adolescents (aged 12 to 17 years) with body weight less than 50 kg: The doctor will prescribe the most appropriate pharmaceutical form of Normeg based on body weight and required dose.
• Dosage in infants and children (aged 1 to 23 months) and children (aged 2 to 11 years) with body weight below 50 kg: The doctor will recommend the most appropriate pharmaceutical form of Normeg depending on age, body weight, and required dose.

The oral solution is a more suitable formulation for infants and children under 6 years of age, as well as for children and adolescents (aged 6 to 17 years) with body weight below 50 kg, and also when the required dose cannot be accurately administered in tablets.

Instructions for use
Normeg tablets should be swallowed whole with an adequate 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 intended only to facilitate breaking the tablet for easier swallowing.

Duration of treatment:

• Normeg is used for long-term treatment. Treatment with Normeg should be continued for as long as directed by your doctor.
• Do not discontinue treatment without consulting your doctor, as this may lead to an increase in seizure frequency.

Overdose of Normeg
Possible adverse effects following levetiracetam overdose include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If an overdose has been taken, seek immediate medical advice. The doctor will recommend the most appropriate treatment for overdose.

Missed dose of Normeg
You should contact your doctor if one or more doses have been missed.
Do not take a double dose to make up for a missed dose.

Stopping Normeg
If treatment with Normeg is to be discontinued, the medicine should be withdrawn gradually to avoid an increase in seizure frequency. If your doctor decides to stop treatment, they will also advise you on how to taper off the medicine gradually.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• weakness, feeling faint or dizzy, or breathing difficulties, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, or throat (Quincke's oedema);
• flu-like symptoms and rash on the face, followed by a rash spreading over the entire body, accompanied by high fever, increased liver enzyme activity observed in blood tests, increase in certain white blood cells (eosinophilia), enlarged 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, which may indicate sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (a dark center 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, nose, eyes, and genital organs (Stevens-Johnson syndrome);
• a more severe form of rash causing skin detachment affecting more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disturbances, or if the patient shows symptoms of disorientation, drowsiness, amnesia (memory loss), memory disorders (forgetfulness), behavioural disturbances, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse reactions include inflammation of the mucous membranes of the nose and throat,
drowsiness, headache, feeling of fatigue, and dizziness. At the beginning of treatment or when the dose is increased,
adverse reactions such as drowsiness, fatigue, or dizziness may occur more frequently. These effects should gradually diminish over time.
Very common (may occur in more than 1 in 10 people):

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

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

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

Uncommon (may occur in 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 behaviour, hallucinations, feelings of anger, disorientation, panic attacks, emotional instability/mood swings, agitation
• amnesia (memory loss), memory disorders (forgetfulness), ataxia (impaired coordination of movement), paraesthesia (tingling), difficulty concentrating
• double vision, blurred vision
• elevated/abnormal liver function test results
• hair loss, skin eruption, itching
• muscle weakness, muscle pain
• injuries

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

• infection
• decreased number of all types of blood cells
• severe allergic reactions (DRESS syndrome - 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 concentration in the blood
• suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate)
• delirium
• encephalopathy (a detailed description of symptoms is provided in the section "You should immediately inform a doctor")
• seizures may worsen or occur more frequently
• involuntary muscle contractions in the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• 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 (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, particularly affecting the area around the mouth, nose, eyes, 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 blood creatine phosphokinase activity. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients.
• limping or difficulty walking;
• occurrence of the following symptoms simultaneously: fever, muscle rigidity, unstable blood pressure and heart rate, disorientation, reduced 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 occur in up to 1 in 10,000 people):

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported 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.
Tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 container label after: "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.

Other ingredients are:
Tablet core:
Povidone 30, sodium croscarmellose, colloidal anhydrous silica, 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, lac (E132)
Normeg 500 mg: iron oxide yellow (E172)
Normeg 750 mg: iron oxide red (E172), iron oxide yellow (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, packed in PVC/Aluminium blisters of 10 tablets per cardboard box.
Normeg 250 mg, 500 mg may be packed in HDPE bottles with a PE screw cap with tamper-evident seal containing 100 or 200 tablets.
Normeg 750 mg, 1000 mg may be packed in HDPE bottles with a PE screw cap with tamper-evident seal containing 100 tablets or in PET bottles with a PP screw 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 further information about this medicinal product and its trade names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00