LEVETIRACETAM HOSPIRA 100 mg/mL Concentrate for Infusion Solution

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Hospira 100 mg/ml Concentrate for Solution for Infusion EFG

levetiracetam

Read all of 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Levetiracetam Hospira and what is it used for
2. What you need to know before you take Levetiracetam Hospira
3. How to take Levetiracetam Hospira
4. Possible side effects
   1. Storage of Levetiracetam Hospira

1. Contents of the pack and other information

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

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Hospira is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a condition where you have fits (seizures). Levetiracetam is used for a form of epilepsy where the seizures affect only one side of the brain, but may spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of fits.
• in combination with other antiepileptic medicines to treat:
• • partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age.
  • myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
  • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause).

Levetiracetam Hospira concentrate for solution for infusion is an alternative for patients when oral administration of levetiracetam is temporarily not feasible.

2. What you need to know before you take Levetiracetam Hospira

Do not take Levetiracetam Hospira

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

Warnings and precautions

Consult your doctor before taking Levetiracetam Hospira

• If you have kidney problems, follow the instructions of your doctor who will decide if you need to adjust your dose.

• If you notice any decrease in your child’s growth or an unexpected delay in puberty, contact your doctor.
• A small number of people taking antiepileptics such as Levetiracetam Hospira have had thoughts of harming themselves or suicidal thoughts. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

• abnormal thoughts, feeling irritable or aggressive or behaving aggressively or if you, your family or friends notice significant changes in your mood or behaviour.

Children and adolescents

• Monotherapy (single-drug treatment) with Levetiracetam Hospira is not indicated for children and adolescents under 16 years.

Other medicines and Levetiracetam Hospira

Tell 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) for one hour before and one hour after taking levetiracetam as it may reduce its effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam Hospira can only be used during pregnancy if your doctor considers it necessary. Do not stop your treatment without discussing it with your doctor.

The risk of birth defects for your baby cannot be completely ruled out.

Breast-feeding is not recommended during treatment.

Driving and using machines

Levetiracetam Hospira may affect your ability to drive or use tools or machines, as it may cause somnolence (sleepiness). This is more likely at the start of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Hospira contains sodium:

A single maximum dose of Levetiracetam Hospira concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). To be taken into consideration by patients on a controlled sodium diet.

3. How to take Levetiracetam Hospira

Levetiracetam Hospira will be administered to you by a doctor or a nurse through intravenous infusion. Levetiracetam Hospira should be administered twice daily, once in the morning and once in the evening, approximately at the same time every day.

The intravenous formulation is an alternative to oral administration. You can switch from film-coated tablets or oral solution to the intravenous formulation, or vice versa, directly without dose adjustment. Your total daily dose and frequency of administration should be the same.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg and 3,000 mg per day.

When you first start taking Levetiracetam Hospira, your doctor will prescribe you a lower dosefor two weeks before giving you the lowest general dose.

Concomitant therapy

Dose in adults and adolescents (from 12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg per day.

Dose in children (from 4 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg:

General 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 administered by intravenous infusion over 15 minutes.

More detailed information for the correct use of Levetiracetam Hospira is provided in section 6 for healthcare professionals.

Duration of treatment:

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

If you stop taking Levetiracetam Hospira:

As with other antiepileptic medicines, the discontinuation of Levetiracetam Hospira should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Hospira, he/she will tell you how to reduce the dose gradually.

If you have any further questions on 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 everybody gets them.

Tell your doctor immediately or go to the emergency department if you experience:

• weakness, feeling faint or dizzy, or difficulty breathing, as these may be symptoms of a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue and throat (Quincke’s oedema)
• flu-like symptoms and a rash on the face followed by a rash that spreads to other parts of the body, high fever, elevated levels of liver enzymes seen in blood tests and an increased number of a type of white blood cell (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling in legs, ankles or feet, as this may be a sign of sudden kidney failure
• a skin rash which may form blisters and looks like the rash seen with chicken pox (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and 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 signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (memory loss), abnormal behaviour or other neurological signs including involuntary movements or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. Side effects such as sleepiness, fatigue and dizziness are more likely to occur when you first start treatment or when the dose is increased. However, these effects should decrease over time.

Very common(may affect more than 1 in 10 people)

• Nasopharyngitis (infection of the nose or throat);
• somnolence (sleepiness), headache.

Common(may affect up to 1 in 10 people)

• loss of appetite;
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon(may affect up to 1 in 100 people)

• decrease in the number of blood platelets, decrease in the number of white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (lack of coordination), paraesthesia (tingling), attention disturbances (lack of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare(may affect up to 1 in 1,000 people)

• infection;
• decrease in all blood cell types;

• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema);
• decrease in blood sodium levels;

• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the symptoms);
• uncontrolled muscle spasms affecting the head, torso and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver problems, hepatitis
• sudden kidney failure
• skin rash which may form blisters and looks like the rash seen with chicken pox (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis).
• rhabdomyolysis (breakdown of muscle tissue) and associated increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping or difficulty walking.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Hospira

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 on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Levetiracetam Hospira contains

• The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injections.

Appearance and pack contents

Levetiracetam Hospira concentrate for solution for infusion is a clear, colourless sterile concentrate.

Levetiracetam Hospira concentrate for solution for infusion 5 ml vials are packaged in cartons of 10 or 25 vials of 5 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturers

Pfizer Service Company BVBA

Hoge Wei 10

1930 Zaventem

Belgium

Hospira UK Limited

Horizon House,

Honey Lane,

Hurley

Maidenhead

SL6 6RJ

United Kingdom

You can ask for more information about this medicine from the local representative of the Marketing Authorisation Holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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This information is intended only for healthcare professionals:

Instructions for the proper use of Levetiracetam Hospira are provided in section 3.

A vial of Levetiracetam Hospira concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Hospira concentrate to achieve the total daily dose of 500 mg, 1,000 mg, 2,000 mg or 3,000 mg divided into two doses.

Table 1. Preparation and administration of Levetiracetam Hospira concentrate

This medicine is for single use only, and the unused solution should be discarded.

Stability after preparation: the physical and chemical stability of the diluted product stored in PVC bags is 24 hours at 30°C and 2-8°C. From a microbiological point of view, unless the method of dilution prevents the risk of microbial contamination, the product should be used immediately. In case it is not used immediately, the in-use storage times and conditions are the responsibility of the user.

Levetiracetam Hospira concentrate was found to be physically compatible and chemically stable when mixed with the following diluents:

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