Levetiracetam Hospira

Package leaflet: Information for the patient

Levetiracetam Hospira 100 mg/ml concentrate for solution for infusion

levetiracetam
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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, see section 4, and consult your doctor or pharmacist.

Contents of this leaflet:

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

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

Levetiracetam Hospira concentrate is an antiepileptic medicine (a medicine used to treat
epileptic seizures).
Levetiracetam Hospira 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 seizures initially affect only one part of the brain but may subsequently spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed Levetiracetam 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 jerks of a muscle or muscle group) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
• 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 believed to have a genetic cause).

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

2. What you need to know before using Levetiracetam Hospira

Do not use Levetiracetam Hospira

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

Warnings and precautions
Talk to your doctor before using Levetiracetam Hospira

• 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 your child, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Hospira 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 has a heart rhythm disorder (detectable on electrocardiogram) or if you have a disease and/or are taking medicines that may cause irregular heartbeat 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 the appearance of 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. If you experience any of these new symptoms while being treated with Levetiracetam Hospira, consult a doctor as soon as possible. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of acquired skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while being treated with Levetiracetam Hospira,
consult a doctor as soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam Hospira
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking
levetiracetam, as it may cause a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask
your doctor for advice before taking this medicine. Levetiracetam Hospira 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 ruled out. Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Hospira may reduce your ability to drive vehicles 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 machines until you are certain that your ability to perform these activities is not
impaired.
Levetiracetam Hospira contains sodium
A single maximum dose of concentrated Levetiracetam Hospira contains 57 mg of sodium (the main
component of table salt) (19 mg of sodium per vial). This corresponds to 2.85% of the maximum
recommended daily dietary intake for an adult. This should be taken into account in patients on a
low-sodium diet.

3. How to use Levetiracetam Hospira

A doctor or nurse will administer Levetiracetam Hospira to you as an intravenous infusion.
Levetiracetam Hospira 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 adjusting the dose. The total daily dose and frequency of administration remain unchanged.
Adjunctive therapy and monotherapy (from age 16 onwards)
Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
Recommended dose: between 1,000 mg and 3,000 mg per day.
When starting Levetiracetam Hospira 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 per kg of body weight and 60 mg per kg of body weight per day.
Method and route of administration:
Levetiracetam Hospira is for intravenous use.
The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
For doctors and nurses, more detailed instructions on the correct use of Levetiracetam Hospira are provided in section 6.
Duration of treatment:

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

If you stop treatment with Levetiracetam Hospira:
As with any other antiepileptic medicinal product, Levetiracetam Hospira must be discontinued gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with Levetiracetam Hospira, they will provide you with instructions on how to gradually taper off the medication.
If you have any doubts about how to use 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, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• Swelling of the face, lips, tongue, and 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), and swollen lymph nodes (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 present as blisters appearing like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• Widespread rash with blisters and peeling of the skin, especially 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 changes 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 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. 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, restlessness 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;
• 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 in the blood;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (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);
• trauma.

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 face, lips, tongue, and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioral problems), thought disturbances (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;
• uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• alteration of heart rhythm (electrocardiogram changes);
• pancreatitis;
• liver problems, for example liver failure, hepatitis;
• sudden worsening of kidney function;
• skin rash that may present as blisters appearing like 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, especially 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 condition 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 effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Hospira

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.
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6. Package contents and other information

What Levetiracetam Hospira contains

• The active substance is called levetiracetam. One ml contains 100 mg of levetiracetam.
• The other components are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections (see section 2 Levetiracetam Hospira contains sodium).

Description of the appearance of Levetiracetam Hospira and contents of the pack
Levetiracetam Hospira concentrate for solution for infusion (sterile concentrate) is a clear, colourless solution.
Levetiracetam Hospira concentrate for solution for infusion is packaged in a cardboard box containing 10 or 25 vials of 5 ml each.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Service Company BV
Hoge Wei 10
1930 Zaventem
Belgium

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

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

This medicinal product is intended for single use only; any residual product must be discarded.
In-use stability:
The chemical and physical in-use stability of the diluted product stored in PVC bags has been demonstrated for 24 hours at 30°C and at 2-8°C. From a microbiological standpoint, the product should be used immediately unless the dilution method excludes the risk of microbial contamination. If not used immediately, the in-use storage times and conditions are the responsibility of the user.
Levetiracetam Hospira concentrate has been shown to be physically compatible and chemically stable when mixed with the following diluents:

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