LEVETIRACETAM 100 mg /Ml Concentrate For Infusion Solution

Зміст інструкції

1. Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion
   1. What Levetiracetam Eignapharma is and what it is used for
   2. What you need to know before you are given Levetiracetam Eignapharma
   3. How Levetiracetam Eignapharma is administered
   4. Possible side effects
   5. How to store Levetiracetam Eignapharma
   6. Package Contents and Other Information

Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion

Generic medicine

Read this leaflet carefully before you or your child start using 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Levetiracetam Eignapharma is an antiepileptic drug (a medicine used to treat seizures).
Levetiracetam Eignapharma is used:

• alone in adults and adolescents starting from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition in which patients have repeated attacks (seizures). Levetiracetam is used for the epileptic form in which the initial attack affects only one part of the brain but may subsequently extend to wider areas of both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been given to you by your doctor to reduce the number of attacks.
• as an addition to other antiepileptic medicines to treat:
• partial-onset seizures, with or without generalization, in adults, adolescents and children starting from 4 years of age
• myoclonic seizures (brief, shock-like spasm of a muscle or muscle group) in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures (major attacks, including loss of consciousness) in adults and adolescents starting from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is believed to have a genetic cause).

Levetiracetam Eignapharma as a concentrate for infusion solution is an alternative for
patients when the oral administration of the antiepileptic medicine levetiracetam is
temporarily not possible.

2. What you need to know before you are given Levetiracetam Eignapharma

Do not use Levetiracetam Eignapharma

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

Warnings and precautions
Talk to your doctor before you are given Levetiracetam Eignapharma

• If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you notice a slowing of growth or an unexpected development of puberty in a child, contact your doctor.
• A limited number of people treated with antiepileptic drugs such as Levetiracetam Eignapharma have experienced self-harming thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you or a family member suffers from heart rhythm disturbances (visible on an electrocardiogram) or if you have a disease and/or are taking medicines that can cause irregular heartbeats or electrolyte imbalances.

Tell your doctor or pharmacist if any of the following side effects worsen or last for more than a few
days:

• Abnormal thoughts, feeling irritable or more aggressive than usual, or if you or your family and friends notice the appearance of 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 types of seizures and loss of abilities, you may notice that seizures remain present or worsen during treatment.

If you experience any of these new symptoms during treatment with Levetiracetam
Eignapharma, consult a doctor as soon as possible.

Children and adolescents

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

Other medicines and Levetiracetam Eignapharma
Tell 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) for one hour before and for one hour after
taking levetiracetam because it may cause a loss of the effect of the latter.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before taking this medicine. Levetiracetam may
be used during pregnancy, only if, after careful evaluation, this is considered necessary
by the doctor.
Do not stop your treatment without discussing it with your doctor. A risk of birth defects for the fetus cannot be completely excluded. Breastfeeding is not recommended during
treatment.

Driving and using machines
Levetiracetam Eignapharma may reduce the ability to drive vehicles or use tools or
machinery as it may cause drowsiness. This is more likely at the beginning of treatment or after
an increase in dose. Do not drive or use machines until you have verified that your
ability to perform these activities is not affected.

Levetiracetam Eignapharma contains sodium
A single maximum dose of Levetiracetam Eignapharma concentrate contains 2.5 mmol (or 57
mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into consideration in
patients on a low-sodium diet.

3. How Levetiracetam Eignapharma is administered

A doctor or nurse will administer Levetiracetam Eignapharma to you as an intravenous
infusion.
This medicine must be administered twice a day, once in the morning and once
in the evening, at approximately the same time each day.
The intravenous formulation is an alternative to oral administration. It can be switched from
film-coated tablets or oral solution to the intravenous formulation or vice versa
directly without dose adjustment. The total daily dose and frequency of
administration remain identical.

Add-on therapy and monotherapy (starting from 16 years of age)
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 you start taking Levetiracetam Eignapharma for the first time, the doctor will prescribe

a lower dosefor 2 weeks before giving you the lowest daily dose.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Recommended dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

Method and route of administration:
Levetiracetam Aurobindo is for intravenous use.
The recommended dose should be diluted in at least 100 ml of a compatible diluent and infused
over 15 minutes.
More detailed instructions for appropriate use of Levetiracetam Eignapharma are provided, for
doctors and nurses, in section 6.

Duration of treatment:

• There is no experience regarding the intravenous administration of levetiracetam for a period longer than 4 days.

If you stop taking Levetiracetam Eignapharma
If you stop treatment, as with other antiepileptic drugs, Levetiracetam Eignapharma
must be discontinued gradually to avoid an increase in seizures. If the doctor decides to
stop treatment with this medicine, he/she will give you instructions regarding the gradual
discontinuation of Levetiracetam Eignapharma.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately inform your doctor or go to the nearest emergency room if you experience:

• weakness, dizziness or feeling faint, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue and throat (angioedema)
• flu-like symptoms and a rash on the face followed by widespread rash with high fever, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells in the blood (eosinophilia) and swollen lymph nodes (drug reaction

with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic
Symptoms])

• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion and swelling of legs, ankles or feet, as these may be a sign of sudden decrease in kidney function
• a rash that may appear with blisters that look like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme)
• a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome)
• a more severe form of rash that causes skin peeling in more than 30% of the body surface area ( toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior or other neurological signs, including involuntary or uncontrolled movements. These could 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. These effects should,
however, 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;
• convulsion, balance disorder, dizziness (feeling unstable), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (feeling weak).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells in the blood;
• weight loss, weight gain;
• attempted suicide and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation;
• amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), impaired attention (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal values in liver function tests,
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect up to 1 in 1000 people

• infection;
• decreased number of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], angioedema [swelling of face, lips, tongue and throat]))
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioral problems), altered thinking (slowed thinking, inability to concentrate);
• delirium;
• encephalopathy (see the subsection “Immediately inform your doctor” for a detailed description of the symptoms);
• seizures may worsen or occur more frequently;
• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• altered heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• a rash that may appear with blisters that look like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythemamultiforme), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome) and a more severe form that causes skin peeling in more than 30% of the body surface area ( toxicepidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and increased blood creatine phosphokinase associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping gait 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 10000 people

• repetitive unwanted thoughts or sensations or the urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 Eignapharma

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 vial and the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
After first opening, the medicine must be used immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Levetiracetam Eignapharma Contains
The active ingredient is called levetiracetam. Each ml contains 100 mg of levetiracetam.
The excipients are: sodium acetate, glacial acetic acid, sodium chloride, water for injections.

Description of the Appearance of Levetiracetam Eignapharma and Package Contents
Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion (sterile concentrate) is
a clear liquid, from colourless to yellow.
Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion is packaged in a
box containing 10 vials of 5 ml.

Marketing Authorisation Holder
Eignapharma S.L.
Avda. Ernest Lluch 32 Tecnocampus, TCM Tower 2, 6th Floor
08302 Mataró, Barcelona - Spain

Manufacturer
Netpharmalab Consulting Services
Carretera Fuencarral 22, Alcobendas
28108, Madrid - Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
<{Member State Name}> <{Medicinal Product Name}>
---------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for the correct use of Levetiracetam Eignapharma 100 mg/ml are provided in section

• 3.

One vial of Levetiracetam Eignapharma 100 mg/ml 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 Eignapharma 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 Eignapharma 100 mg/ml concentrate.

This medicine must not be mixed with other medicines or infused with other medicines.
This medicine is intended for single use only and any unused solution must be discarded.
Validity in use: from a microbiological point of view, the product must be used immediately after
dilution. If not used immediately, the storage time during use and the conditions prior to use are the
responsibility of the user and normally do not exceed 24 hours at 2-8°C, unless the dilution takes place
under controlled and validated aseptic conditions.
Levetiracetam Eignapharma 100 mg/ml concentrate for solution for infusion has been found to be
physically and chemically stable for at least 24 hours when mixed with the following diluents and stored
in PVC bags at a controlled room temperature of 15-25°C.
Diluents:

• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Ringer's lactate solution for injection
• Glucose 50 mg/ml (5%) solution for injection