Package leaflet: Information for the user

Levetiracetam Mylan 100 mg/ml concentrate for solution for infusion

levetiracetam
Generic medicine
Please read all of 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 (or your child) only. Do not pass it on to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Levetiracetam Mylan is and what it is used for
What you need to know before Levetiracetam Mylan is given to you
How Levetiracetam Mylan is given to you
Possible side effects
How to store Levetiracetam Mylan
Contents of the pack and other information

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

Levetiracetam is an antiepileptic (a medicine used to treat epileptic seizures).
Levetiracetam Mylan 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 initial seizure affects only one part of the brain but may subsequently spread to wider areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of seizures.
as add-on therapy to other antiepileptic medicines to treat:
partial-onset convulsive seizures, with or without secondary generalization, in adults, adolescents and children from 4 years of age
myoclonic seizures (brief, shock-like jerks 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 Mylan concentrate for solution for infusion is an alternative for patients when
oral administration of the antiepileptic medicine Levetiracetam Mylan is temporarily not feasible.

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

Do not use Levetiracetam Mylan

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 Mylan

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 development of puberty in the child, contact your doctor.
A small number of people taking antiepileptic medicines such as levetiracetam have had thoughts of self-harm or suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
If you or a family member has a heart rhythm disorder (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 become severe 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, mainly during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A gene mutations) causing various types of seizures and loss of abilities, you may notice that seizures persist or worsen during treatment. If any of these new symptoms occur while taking Levetiracetam Mylan, consult a doctor as soon as possible.

Children and adolescents

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

Other medicines and Levetiracetam Mylan
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) within one hour before or one hour after taking
levetiracetam, as it may reduce the effect of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before using this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it
necessary.
Do not stop your treatment without discussing it with your doctor.
A risk of birth defects for the unborn child cannot be completely ruled out. 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 Mylan may reduce your ability to drive or use 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 operate machinery until you have determined that your ability to perform these activities is not affected.
Levetiracetam Mylan contains sodium
This medicine contains 19 mg of sodium (the main component of table salt) per vial.
This is equivalent to 0.95% of the maximum daily recommended intake of sodium for an adult.

3. How Levetiracetam Mylan is administered to you

A doctor or nurse will administer levetiracetam to you as an intravenous infusion.
Levetiracetam 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 can 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 the same.
Adjunctive therapy and monotherapy (from age 16)
Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
Typical dose: between 1000 mg and 3000 mg per day.
When starting levetiracetam for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest typical dose.
Dose for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Typical 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 Mylan is for intravenous use only.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
More detailed instructions for the appropriate use of Levetiracetam Mylan for doctors and nurses are provided in section 6.
Duration of treatment:

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

If you interrupt treatment with Levetiracetam Mylan:
As with any other antiepileptic drug, levetiracetam should be discontinued gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with levetiracetam, they will provide you with instructions on how to gradually withdraw 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 everyone gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, lightheadedness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reaction)
swelling of the face, lips, tongue, or throat (angioedema, also known as Quincke's edema)
flu-like symptoms and facial rash followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), swollen lymph nodes, 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 legs, ankles, or feet, as these may indicate sudden worsening of kidney function
a skin rash that may appear as blisters forming small target-like spots (dark central spots surrounded by a lighter 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)
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 close to you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrollable movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are: nasopharyngitis, somnolence, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as somnolence, 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
somnolence (drowsiness), insomnia, headache

Common: may affect up to 1 in 10 people

anorexia (loss of appetite)
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
seizures, balance disorders, 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 number of white blood cells
weight decrease, weight increase
suicide attempts and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, rage, confusion, panic attacks, emotional instability/mood swings, agitation
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling sensations), attention disorders (loss of concentration)
diplopia (double vision), blurred vision
elevated or abnormal liver function test results
hair loss, eczema, pruritus (itching)
muscle weakness, myalgia (muscle pain)
injuries

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

infections
decreased number of all types of blood cells
severe allergic reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], angioedema [swelling of face, lips, tongue, and throat])
decreased sodium concentration in the blood (hyponatremia)
suicide, personality disorders (behavioral problems), alterations in thinking (slowed thinking, inability to concentrate)
delirium
encephalopathy (see the section “Contact your doctor immediately” for a detailed description of symptoms)
seizures may worsen or occur more frequently
uncontrolled muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
changes in heart rhythm (electrocardiogram abnormalities)
pancreatitis
liver failure, hepatitis
sudden worsening of kidney function
skin rash, which may lead to blistering and appears as small target-like spots (dark central spots surrounded by a pale 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), 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 levels. 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, and reduced 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 certain 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 national reporting system at 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 Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The chemical and physical stability of the diluted product has been demonstrated for 24 hours at controlled room temperature of 15–25 °C.
From a microbiological standpoint, the product should be used immediately after dilution. If not used immediately, the conditions of storage and duration of storage are the responsibility of the user and must not exceed 24 hours at 2–8°C, unless the product is kept under controlled and validated aseptic conditions.
Do not use the medicine if it contains particulate matter or appears cloudy.
Do not dispose of any medicine 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 Mylan contains
The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
Each 5 ml vial contains 500 mg of levetiracetam.
The excipients are: sodium acetate, sodium hydroxide, glacial acetic acid, sodium chloride (see section 2
“ Levetiracetam Mylan contains sodium ”), water for injections.
Description of the appearance of Levetiracetam Mylan and package contents
Levetiracetam Mylan concentrate for solution for infusion is a clear, colourless, sterile liquid.
Levetiracetam Mylan concentrate is contained in 5 ml glass vials.
The vials are packaged in cartons containing 1, 5, 10 or 20 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.p.A., via Vittor Pisani 20, 20124 Milano (Italy)
Batch release responsible:
Cenexi
52 Rue Marcel et Jacques Gaucher – 94120 Fontenay-Sous-Bois
France
Viatris Sante,
1 Rue de Turin
69007 Lyon France.
Steriscience Sp. Zo.o.10, Daniszewska Str.,
03-230 Warsaw
Poland

The following information is intended exclusively for healthcare professionals:

Instructions for the correct use of Levetiracetam Mylan are provided in paragraph 3.
1 vial of Levetiracetam Mylan contains 500 mg of levetiracetam (5 ml concentrate at 100 mg/ml).
See Table 1 for the recommended preparation and administration of Levetiracetam Mylan concentrate for infusion solution 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 Mylan concentrate for infusion solution.

Dose	Volume withdrawn	Diluent volume	Infusion time	Administration frequency	Total Daily Dose
250 mg	2.5 ml (half a 5 ml vial)	100 ml	15 minutes	Twice daily	500 mg/day
500 mg	5 ml (one 5 ml vial)	100 ml	15 minutes	Twice daily	1000 mg/day
1000 mg	10 ml (two 5 ml vials)	100 ml	15 minutes	Twice daily	2000 mg/day
1500 mg	15 ml (three 5 ml vials)	100 ml	15 minutes	Twice daily	3000 mg/day

This medicinal product is for single use only, and any unused solution must be discarded.
Shelf life after opening: from a microbiological point of view, the product should be used immediately after
dilution. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours between 2 and 8 °C,
unless the dilution has been carried out under controlled and validated aseptic conditions.
Levetiracetam Mylan 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 diluents and stored in polyolefin bags at controlled room temperature of 15–25 °C.
Diluents:

Sodium chloride 9 mg/ml (0.9%) solution for injection
Glucose 50 mg/ml (5%) solution for injection

Any unused product and waste materials must be disposed of in accordance with local regulatory requirements.