Levetiracetam neuropharma

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Levetiracetam NeuroPharma, 100 mg/ml, oral solution
Levetiracetamum
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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of 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 seizures in epilepsy).
Levetiracetam NeuroPharma is used:

• as monotherapy (treatment with Levetiracetam NeuroPharma alone) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for 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 or non-secondarily generalized partial seizures). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• as an add-on therapy 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 and 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 to 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, thoughts of self-harm or suicidal thoughts 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
become severe 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 recommended for monotherapy (use of 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 take. Do not take macrogol (a medicine used for constipation) within one hour before or one hour after taking levetiracetam, as this may reduce the effect 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 a doctor or pharmacist before using this medicine. Levetiracetam NeuroPharma may be used during pregnancy only if, after careful assessment, the treating doctor considers it necessary. Do not stop treatment without discussing it with the treating doctor. A 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
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 an increase in dose.

Driving and operating machinery are not recommended until the effect of the medicine
on the patient's ability to perform these activities is known.

Levetiracetam NeuroPharma contains maltitol
Levetiracetam NeuroPharma oral solution contains maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

Levetiracetam NeuroPharma oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
Levetiracetam NeuroPharma oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (delayed).

3. How to use Levetiracetam NeuroPharma

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Levetiracetam NeuroPharma should be taken twice daily, in the morning and evening,
approximately at the same time each day.
The oral solution should be taken according to the doctor's instructions.

Monotherapy:
Dosage for adults and adolescents (aged 16 years and older)
For patients aged 4 years and above, the appropriate dose should be measured using the
syringe supplied with the package, with a capacity of 10 ml.
Usual dosage:
Levetiracetam NeuroPharma should be taken twice daily in two equal doses; the single dose ranges between 5 ml (500 mg) and 15 ml (1500 mg).
If the patient is taking the medicine for the first time, the doctor will usually recommend starting with a lower dose for 2 weeks, followed by the lowest commonly used dose.

Adjunctive therapy:
Dosage for adults and adolescents (aged 12 to 17 years)
For patients aged 4 years and above, the appropriate dose should be measured using the
syringe supplied with the package, with a capacity of 10 ml.
Usual dosage:
Levetiracetam NeuroPharma should be taken twice daily in two equal doses; the single dose ranges between 5 ml (500 mg) and 15 ml (1500 mg).

Dosage for children aged 6 months and older
The doctor will recommend the most appropriate formulation of Levetiracetam NeuroPharma depending on the patient's age, body weight, and required dose.
For children aged between 6 months and 4 years, the appropriate dose should be measured using the syringe supplied with the package, with a capacity of 3 ml.
For children above 4 years of age, the appropriate dose should be measured using the syringe supplied with the package, with a capacity of 10 ml.
Usual dosage:
Levetiracetam NeuroPharma should be taken twice daily in two equal doses; the single dose ranges between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kg of the child's body weight. (Examples of dosing are shown in the table below).
Dosage for children aged 6 months and older

Dosage for infants (from 1 to below 6 months of age):
For children from 1 month to below 6 months of age, the appropriate dose should be
measured using the 1 ml oral syringe provided in the package.
Typical dosage:
Levetiracetam NeuroPharma should be taken twice daily, in two equal doses;
the single dose ranges from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight.
(Dosage examples are provided in the table below).
Dosage for infants (from 1 month to below 6 months of age)

Method of administration
After measuring the correct dose using the appropriate oral syringe, Levetiracetam NeuroPharma oral solution may be diluted in a glass of water or in a baby feeding bottle. Levetiracetam NeuroPharma oral solution can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.
Instructions for preparing the medicine for use:

• Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).

• Place the oral syringe adapter into the neck of the bottle (Figure 2). Ensure it is securely attached.
• Push the dosing syringe firmly into the opening of the adapter (Figure 2).

• Turn the bottle upside down (Figure 3).

• Draw a small amount of solution into the oral syringe by pulling the plunger down (Figure 4A). Then, by pushing the plunger, remove any air bubbles from the syringe (Figure 4B). Finally, pull the plunger down to the mark on the syringe scale corresponding to the dose prescribed by the doctor in millilitres (ml) (Figure 4C).

• Turn the bottle upright. Remove the oral syringe from the adapter.
• Squeeze the contents of the oral syringe into a glass of water or into a baby feeding bottle by pressing the syringe plunger (Figure 5).

• Drink the entire contents of the glass/feeding bottle.
• Rinse the oral syringe with water (Figure 6).

• Close the bottle with the plastic cap. Duration of treatment Levetiracetam NeuroPharma is intended for long-term treatment. Treatment with Levetiracetam NeuroPharma should be continued for as long as directed by the treating physician. 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. In case of overdose, seek immediate medical advice from a doctor or pharmacist. The doctor will recommend the most appropriate treatment for overdose.

Missed dose of Levetiracetam NeuroPharma
If one or more doses have been missed, contact your treating physician.
Do not take a double dose to make up for a missed dose.

Discontinuation of Levetiracetam NeuroPharma
If treatment with Levetiracetam NeuroPharma needs to be discontinued, the medicine should be gradually withdrawn in order to avoid increased seizure frequency. If the doctor decides to discontinue treatment, they will also advise on how to taper the medicine gradually.
Should you have any further questions regarding 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 must 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 and throat (angioedema, 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 enzymes observed in blood tests, increase in 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 the legs, ankles or feet, as these may indicate sudden worsening of kidney function;
• skin rash which may lead to blistering 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 affecting more than 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: inflammation of the nasal and throat mucosa, drowsiness, headache, 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 affect more than 1 in 10 patients

• inflammation of the nasal and throat mucosa;
• drowsiness, headache.

Common: may affect up to 1 in 10 patients

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

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, psychiatric disorders, abnormal behaviour, hallucinations, feelings of anger, disorientation, panic attacks, emotional lability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), ataxia (impaired coordination of movement), paresthesia (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 affect up to 1 in 1000 patients

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (DRESS syndrome [drug-induced rash with increased levels 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 levels 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 must immediately inform your doctor");
• involuntary muscle contractions of the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• 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, 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 affecting more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of skeletal muscle) accompanied by increased blood levels of creatine kinase. 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 reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Levetiracetam NeuroPharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Expiry date" and (or) "EXP". The expiry date refers to the last day of the specified month.
Do not use after 6 months from the date of first opening of the bottle.
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 will help protect the environment.

6. Contents of the pack and other information

What Levetiracetam NeuroPharma 100 mg/ml contains

• The active substance is levetiracetam. Each millilitre contains 100 mg of levetiracetam.
• The other ingredients are: sodium citrate, anhydrous citric acid, purified water, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), ammonium glycyrrhizinate, glycerol, maltitol (E 965), potassium acesulfame (E 950), flavouring agent Fantasie, flavouring agent Contramarum.

What Levetiracetam NeuroPharma 100 mg/ml looks like and contents of the pack

A clear, colourless or slightly brown, oral solution.

A glass bottle containing 300 ml of Levetiracetam NeuroPharma (for children aged 4 years and older, adolescents and adults), packed in a cardboard box with a 10 ml oral syringe graduated in 0.25 ml increments and a syringe connector.

A glass bottle containing 150 ml of Levetiracetam NeuroPharma (for infants and children aged from 6 months to 4 years), packed in a cardboard box with a 3 ml oral syringe graduated in 0.1 ml increments and a syringe connector.

A glass bottle containing 150 ml of Levetiracetam NeuroPharma (for infants aged from 1 month to 6 months), packed in a cardboard box with a 1 ml oral syringe graduated in 0.05 ml increments and a syringe connector.

Pack sizes of 150 ml and 300 ml.

Hospital packs of 1500 ml (5 x 300 ml or 10 x 150 ml).

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 local representative of the Marketing Authorisation Holder in Poland:

Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]