Levetiracetam neuropharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levetiracetam NeuroPharma, 250 mg, film-coated tablets
Levetiracetam NeuroPharma, 500 mg, film-coated tablets
Levetiracetam NeuroPharma, 750 mg, film-coated tablets
Levetiracetam NeuroPharma, 1000 mg, film-coated tablets
Levetiracetamum
Please read this leaflet carefully before taking this medicine or giving it to your child, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Levetiracetam NeuroPharma is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam NeuroPharma is used:

• as monotherapy (treatment with Levetiracetam NeuroPharma alone) in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for the treatment of certain types of 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). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• as an add-on therapy in addition to other antiepileptic medicines:
  • 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 juvenile myoclonic epilepsy,

for the treatment of myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles),

• for the treatment of primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (a type of epilepsy that is likely to have a genetic basis).

2. Important information before using Levetiracetam NeuroPharma

When not to use Levetiracetam NeuroPharma:

• 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 Levetiracetam NeuroPharma, consult a doctor:

• If the patient has a kidney disease, Levetiracetam NeuroPharma 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 a child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as Levetiracetam NeuroPharma, suicidal thoughts or thoughts about self-harm have occurred. In case of symptoms of depression and/or suicidal thoughts, contact the doctor. Inform the doctor or pharmacist if any of the following adverse reactions worsen or persist for more than a few days:
  • Abnormal thoughts, irritability, more aggressive behaviour than usual, or significant changes in mood or behaviour noticed by the patient or their family and friends.

Children and adolescents

• Levetiracetam NeuroPharma is not indicated for monotherapy (using Levetiracetam NeuroPharma alone) in children and adolescents under 16 years of age.

Levetiracetam NeuroPharma and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as it 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 child, she should consult a doctor or pharmacist before using this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, the treating physician considers it necessary. Do not discontinue treatment without discussing it with the treating physician. A risk of congenital malformations in the fetus cannot be completely ruled out. Breastfeeding is not recommended during treatment.

Driving and operating machinery
Levetiracetam NeuroPharma may impair the ability to drive
and operate tools or machinery, as use of Levetiracetam NeuroPharma may
cause drowsiness. This is more likely at the beginning of treatment or after increasing
the dose of the medicine. It is not recommended to drive or operate machinery until
the effect of the medicine on the patient's ability to perform these activities is known.

Levetiracetam NeuroPharma 750 mg film-coated tablets contain sunset yellow FCF (E 110).
Sunset yellow FCF (E 110) may cause allergic reactions.

3. How to take Levetiracetam NeuroPharma

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Take the number of tablets as directed by your doctor.
Levetiracetam NeuroPharma must be taken twice daily, in the morning and evening,
approximately at the same time each day.

Monotherapy:
Dose in adults and adolescents (aged 16 years and older)
The usual dose is 1000 mg to 3000 mg per day. If the patient is taking the medicine for the
first time, the doctor will initially prescribe a lower dose for 2 weeks, followed by the
lowest commonly used dose.
For example, if the daily dose is 1000 mg, the initial lower dose is 2 tablets of 250 mg in the
morning and 2 tablets of 250 mg in the evening.

Adjunctive therapy:
Dose in adults and adolescents (aged 12 to 17 years) with body weight of 50 kg or more
The usual dose is 1000 mg to 3000 mg per day.
For example, if the daily dose is 1000 mg, take 2 tablets of 250 mg in the morning and
2 tablets of 250 mg in the evening.

Dose in infants and children (aged 1 to 23 months), children (aged 2 to 11 years),
and adolescents (aged 12 to 17 years) with body weight less than 50 kg
The doctor will prescribe the most appropriate formulation of Levetiracetam NeuroPharma, depending on
the patient's age, body weight, and required dose.
Levetiracetam NeuroPharma 100 mg/ml oral solution is the more suitable formulation for infants and children under 6 years of age, and for children and adolescents (aged 6 to 17 years) with body weight below 50 kg, as well as when the required dose cannot be administered using tablets.

Instructions for use
Tablets should be swallowed with sufficient fluid (e.g. a glass of water). Levetiracetam NeuroPharma may be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.

Duration of treatment
Levetiracetam NeuroPharma is used for long-term treatment. Continue taking Levetiracetam NeuroPharma for as long as your doctor recommends.
Do not discontinue treatment without consulting your doctor, as this may lead to an increase in seizure frequency.

Overdose of Levetiracetam NeuroPharma
Possible adverse effects following overdose of Levetiracetam NeuroPharma include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If an overdose has been taken, seek immediate medical advice from a doctor or pharmacist. The doctor will advise on the best possible treatment for overdose.

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

Stopping Levetiracetam NeuroPharma
If treatment with Levetiracetam NeuroPharma needs to be discontinued, the medicine should be tapered gradually to avoid increased seizure frequency. If your doctor decides to stop treatment, they will also advise you on how to taper the medicine appropriately.

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

4. Possible adverse reactions

Like any medicine, 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, faintness 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 rash on the face followed by a rash over the entire body, accompanied by high fever, elevated liver enzymes observed in blood tests, increased count of one type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS syndrome);
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles or feet, as these may indicate sudden worsening of kidney function;
• skin rash which may lead to blister formation and appear as small target-like lesions (a dark central spot 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 disturbances, or if the patient shows signs of disorientation, drowsiness (excessive sleepiness), amnesia (memory loss), memory impairment (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: nasopharyngitis, somnolence,
headache, fatigue and dizziness. At the beginning of treatment or when the dose is increased,
adverse reactions such as: somnolence, fatigue or dizziness, may occur more frequently.
These effects should gradually diminish over time.
Very common: may affect more than 1 in 10 patients

• nasopharyngitis;
• somnolence, headache. Common: may affect up to 1 in 10 patients
• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizures, balance disorders, dizziness (feeling of unsteadiness), lethargy (lack of energy and motivation), tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue. Uncommon: may affect up to 1 in 100 patients
• decreased platelet count, decreased 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 lability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), ataxia (lack of coordination of movements), paraesthesia (tingling), attention disorders;
• double vision, blurred vision;
• elevated/abnormal liver function test results;
• hair loss, acne, itching;
• muscle weakness, muscle pain;
• injuries. Rare: may affect up to 1 in 1,000 patients
• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (DRESS syndrome [drug-induced rash with increased count of a certain type of white blood cells and systemic symptoms], anaphylactic reaction [severe and serious allergic reaction], Quincke's oedema [swelling of the face, lips, tongue and throat]);
• decreased sodium concentration in 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 your doctor");
• involuntary muscle contractions of the head, trunk and limbs, difficulty controlling movements, hyperkinesia (excessive activity);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash which may lead to blister formation 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, 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 blood creatine phosphokinase levels. The frequency of occurrence is significantly higher in Japanese patients compared to patients not originating from Japan;
• limping or difficulty walking.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Levetiracetam NeuroPharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following
"Expiry date" and (or) "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Doing so helps protect the environment.

6. Contents of the pack and other information

• The active substance is levetiracetam. Levetiracetam NeuroPharma 250 mg, coated tablets. One coated tablet contains 250 mg of levetiracetam.

Other ingredients are:
Tablet core: microcrystalline cellulose, maize starch, copovidone, sodium starch glycolate (type A), talc, anhydrous colloidal silica.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, indigo carmine aluminium lake (E132).
Levetiracetam NeuroPharma 500 mg, coated tablets
One coated tablet contains 500 mg of levetiracetam.
Other ingredients are:
Tablet core: microcrystalline cellulose, maize starch, copovidone, sodium starch glycolate (type A), talc, anhydrous colloidal silica.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, iron oxide yellow (E 172).
Levetiracetam NeuroPharma 750 mg, coated tablets
One coated tablet contains 750 mg of levetiracetam.
Other ingredients are:
Tablet core: microcrystalline cellulose, maize starch, copovidone, sodium starch glycolate (type A), talc, anhydrous colloidal silica.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, sunset yellow FCF (E 110), iron oxide red (E 172).
Levetiracetam NeuroPharma 1000 mg, coated tablets
One coated tablet contains 1000 mg of levetiracetam.
Other ingredients are:
Tablet core: microcrystalline cellulose, maize starch, copovidone, sodium starch glycolate (type A), talc, anhydrous colloidal silica.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350,
What Levetiracetam NeuroPharma looks like and contents of the pack
Levetiracetam NeuroPharma 250 mg, coated tablets
Levetiracetam NeuroPharma 250 mg are blue, elongated coated tablets with a score line on both sides, measuring 12.6 ± 0.2 mm x 5.8 ± 0.4 mm x 4.6 ± 0.2 mm. The coated tablets can be divided into equal doses.
Levetiracetam NeuroPharma 500 mg, coated tablets
Levetiracetam NeuroPharma 500 mg are yellow, elongated coated tablets with three score lines on both sides, measuring 19.2 ± 0.2 mm x 8.2 ± 0.2 mm. The coated tablets can be divided into four equal doses.
Levetiracetam NeuroPharma 750 mg, coated tablets
Levetiracetam NeuroPharma 750 mg are pink, elongated coated tablets with a score line on both sides, measuring 18.7 ± 0.2 mm x 8.8 ± 0.2 mm x 7.0 ± 0.2 mm. The coated tablets can be divided into equal doses.
Levetiracetam NeuroPharma 1000 mg, coated tablets
Levetiracetam NeuroPharma 1000 mg are white, elongated coated tablets with three score lines on both sides, measuring 23.2 ± 0.2 mm x 10.4 ± 0.2 mm. The coated tablets can be divided into four equal doses.
PVC/Aluminium blisters, placed in cardboard boxes.
Pack sizes of 10, 20, 30, 50, 60, 80, 90, 100, 120, 160, 180 and 200 coated tablets.
Hospital packs of 1000 (5 x 200) coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany
For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]