Levetiracetam Aurobindo Italia

Package leaflet: Information for the user

Levetiracetam Aurobindo Italia 100 mg/ml concentrate for solution for infusion

Generic medicine
Read this leaflet carefully before you or your child start taking this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If any side effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levetiracetam Aurobindo Italia is and what it is used for

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

• As monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a specific type of epilepsy. Epilepsy is a condition in which patients experience repeated seizures. Levetiracetam is used for the type of epilepsy in which the seizure starts in only one part of the brain but may subsequently spread to broader areas of both sides of the brain (partial-onset seizure with or without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of seizures.
• As an add-on to other antiepileptic medicines to treat:
  • Partial-onset seizures, with or without secondary generalization, in adults, adolescents, and children from 4 years of age;
  • Myoclonic seizures (brief, shock-like spasms of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;
  • Primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

Levetiracetam Aurobindo Italia concentrate for solution for infusion is an alternative for patients when oral administration of levetiracetam-based antiepileptic medicine is temporarily not possible.

2. What you should know before taking Levetiracetam Aurobindo Italia

Do not use Levetiracetam Aurobindo Italia

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

Warnings and precautions
Talk to your doctor before being administered Levetiracetam Aurobindo Italia.

• If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you notice slowed growth or unexpected onset of puberty in a child, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Aurobindo Italia have experienced self-harming thoughts or suicidal ideation. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
• If you or a family member has a cardiac arrhythmia (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a
few days:

• Unusual thoughts, feeling irritable or more aggressive than usual, or if you, your family, or friends notice significant changes in mood or behaviour.
• Worsening of epilepsy. Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam Aurobindo Italia,
consult a doctor as soon as possible.
Children and adolescents
Levetiracetam Aurobindo Italia used alone (monotherapy) is not indicated in children and adolescents under 16 years of age.
Other medicines and Levetiracetam Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines, including those obtained without a prescription.
Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking
levetiracetam, as it may cause loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it
necessary. You must not stop your treatment without discussing it with your doctor. A risk of birth defects for the unborn child cannot be completely excluded. 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 impact of levetiracetam on children's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Aurobindo Italia may reduce your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive or use machinery until you are certain that your ability to perform these activities is not impaired.
Levetiracetam Aurobindo Italia contains sodium
For 250 mg and 500 mg doses:
This medicine contains less than 1 mmol (23 mg) of sodium per unit of volume, i.e. it is essentially ‘sodium-free’.
For 1000 mg dose:
This medicine contains 38 mg of sodium (the main component of table salt) per unit of volume. This corresponds to 1.9% of the maximum daily recommended dietary intake for an adult.
For 1500 mg dose:
This medicine contains 57 mg of sodium (the main component of table salt) per unit of volume. This corresponds to 2.85% of the maximum daily recommended dietary intake for an adult.

3. How to take Levetiracetam Aurobindo Italia

A doctor or nurse will administer Levetiracetam Aurobindo Italia to you as an intravenous infusion.
Levetiracetam Aurobindo Italia must be administered twice daily, once in the morning and once in the evening, approximately at the same time each day.
The intravenous formulation is an alternative to oral administration. You may switch directly from film-coated tablets or oral solution to the intravenous formulation, or vice versa, without dose adjustment. The total daily dose and frequency of administration remain unchanged.
Adjunctive and monotherapy (from age 16 onwards)
Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
Recommended dose: between 1000 mg and 3000 mg per day.
When starting Levetiracetam Aurobindo Italia for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose.
Dose for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Recommended dose: between 20 mg/kg and 60 mg/kg of body weight per day.
Method of administration:
Levetiracetam Aurobindo Italia is for intravenous use.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
More detailed instructions for appropriate use of Levetiracetam Aurobindo Italia are provided for doctors and nurses in section 6.
Duration of treatment:

• There is no experience with intravenous administration of levetiracetam for periods longer than 4 days.

If you stop treatment with Levetiracetam Aurobindo Italia:
If you discontinue treatment, as with other antiepileptic medicines, Levetiracetam Aurobindo Italia should be withdrawn gradually to avoid an increase in epileptic seizures. If your doctor decides to discontinue treatment with Levetiracetam Aurobindo Italia, they will provide you with instructions on how to gradually taper off the medication.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

• weakness, lightheadedness or dizziness, or if you have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction;
• swelling of the face, lips, tongue, or throat (angioedema, Quincke's edema);
• flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), lymph node enlargement, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms [DRESS]);
• symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles, or feet, as these may be signs of sudden kidney function impairment;
• a skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
• widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more common. However, these effects should decrease over time.
Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness, headache.

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizure, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal ideation, mental disorder, abnormal behavior, hallucination, rage, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paresthesia (tingling), attention disturbance (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function tests;
• hair loss, eczema, pruritus (itching);
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect up to 1 in 1,000 people

• infection;
• decreased number of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], angioedema [swelling of the face, lips, tongue, and throat]);
• reduced sodium concentration in the blood;
• suicide, personality disorders (behavioral problems), altered thinking (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (see the subsection "Contact your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• changes in heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash that may form blisters and appear as small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence 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 actions repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Aurobindo Italia

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and on the outer packaging after
EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2–8 °C and at 15–25 °C.
From a microbiological standpoint, the product should be used immediately, unless the method of opening/dilution prevents the risk of microbial contamination. If not used immediately, the duration of storage during use and the conditions prior to use are the responsibility of the user.
Do not use Levetiracetam Aurobindo Italia if you notice the presence of particles or any change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Aurobindo Italia contains

• The active substance is called levetiracetam. Each ml of infusion solution contains 100 mg of levetiracetam.
• The excipients are: Sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injections.

Description of the appearance of Levetiracetam Aurobindo Italia and the contents of the pack
Levetiracetam Aurobindo Italia concentrate for solution for infusion is a clear, colourless solution.
Levetiracetam Aurobindo Italia concentrate for solution for infusion in 5 ml vials is packaged
in a cardboard box containing 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1914, Malta

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Levetiracetam AB 100 mg/ml, concentrate for solution for infusion
France: Levetiracetam Arrow Lab 100 mg/ml, solution to be diluted for perfusion
Italy: Levetiracetam Aurobindo Italia
Netherlands: Levetiracetam Eugia 100 mg/ml, concentrate for solution for infusion
Poland: Levetiracetam Eugia
Portugal: Levetiracetam Aurovitas
Spain: Levetiracetam Aurovitas 100 mg/ml concentrate for solution for perfusion EFG

The following information is intended exclusively for healthcare professionals:

Instructions for the correct use of Levetiracetam Aurobindo Italia are provided in section 3.
A vial of Levetiracetam Aurobindo Italia concentrate contains 500 mg of levetiracetam (5 ml of
concentrate at 100 mg/ml). See Table 1 for the recommended preparation and administration of
Levetiracetam Aurobindo Italia concentrate to achieve a total daily dose of 500 mg, 1000 mg,
2000 mg, or 3000 mg divided into two doses.
Table 1. Preparation and administration of Levetiracetam Aurobindo Italia concentrate.

This medicinal product is intended for single use and any unused solution must be discarded.
Levetiracetam concentrate for solution for infusion has been shown to be physically compatible and chemically stable for at least 24 hours when mixed with the following infusion diluents within the concentration range of 2.5 mg/ml to 13 mg/ml at controlled room temperature of 15–25°C.

Diluents:

• Sodium chloride 9 mg/ml (0.9%) injection
• Ringer lactate injection
• Dextrose 50 mg/ml (5%) injection