Leaflet:information for the patient

Levetiracetam Hikma 100 mg/ml concentrate for infusion solution EFG

levetiracetam

Read this leaflet carefully beforeyou or your child startto use this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.

-This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhavethe same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or nurse, evenifthey are not listed in this leaflet. See section 4.

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

2.What you need to knowbeforestarting touse Levetiracetam Hikma

3.How to use Levetiracetam Hikma

4.Possible side effects

5Storage of Levetiracetam Hikma

6Contents of the pack and additional information

Levetiracetam Hikma is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Hikma is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures;
• in combination with other antiepileptic medications to treat:
• • partial onset seizures with or without generalization in adults, adolescents, and children 4 years of age or older,
  • myoclonic seizures (shock-like, short, muscle or group of muscle seizures) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy,
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Levetiracetam Hikma concentrated solution for infusion is an alternative for patients in whom oral administration is not temporarily viable.

Do not use Levetiracetam Hikma:

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

Warnings and precautions

Consult your doctor before starting to use Levetiracetam Hikma:

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

• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.

• A small number of people taking antiepileptic medications like Levetiracetam Hikma have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

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

• Abnormal thoughts, feeling of irritability, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.

• Worsening of epilepsy

In rare cases, seizures may 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 (SCN8A mutation-associated epilepsy) that causes multiple types of seizures 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, see a doctor as soon as possible.

Children and adolescents

Monotherapy with Levetiracetam Hikma is not indicated in children and adolescents under 16 years old.

Use of Levetiracetam Hikma with other medications

Inform your doctor or nurseif you aretaking, have recently usedor may need to take any other medication.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant orbreastfeeding,believe you may be pregnantor intend to become pregnant,consultyour doctorbefore using this medication.Levetiracetam can only be used during pregnancy if, after a careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor first.

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

Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam Hikma may impair your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not affected.

Levetiracetam Hikma contains sodium

This medication contains 19 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 0.95% of the recommended daily maximum sodium intake for an adult..

A doctor or nurse will administer levetiracetam through intravenous infusion.

Levetiracetam should be taken twice a day, once in the morning and once at night, approximately at the same time each day.

The intravenous formulation is an alternative to oral administration. You can switch from coated tablets or oral solution to the intravenous formulation, or vice versa, directly without adjusting the dose. Your total daily dose and administration frequency must be identical.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) with a weight of 50 kg or more:

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

When starting to take levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the general lowest dose.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) with a weight 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 form of administration:

Levetiracetam is for intravenous administration.

The recommended dose must be diluted to a minimum of 100 ml in a compatible diluent and administered by intravenous infusion over 15 minutes.

Further detailed information for the correct use of levetiracetam is provided in the section 6 for doctors and nurses.

Treatment duration:

No experience is available in the administration of intravenous levetiracetam for a period exceeding 4 days.

If you interrupt treatment with Levetiracetam Hikma

Like with other antiepileptic medications, the discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures.If your doctor decides to stop your treatment with levetiracetam, they will give you instructions for the gradual withdrawal of levetiracetam, if they decide to discontinue your treatment with this medication.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia), and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory decline (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 (drowsiness), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose.However, these side effects should decrease over time.

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

• nasopharyngitis;

• drowsiness (drowsiness), headache.

Common (may affect up to 1 in 10 people):

• anorexia (loss of appetite);

• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability;

• convulsions, balance disorder, dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor);

• vertigo (sensation of rotation);

• cough;

• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;

• skin rash;

• asthenia/fatigue (sensation of weakness).

Rare (may affect up to 1 in 100 people):

• decrease in all types of blood cells;

• severe allergic reactions (DRESS, anaphylactic reaction (severe allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));

• decrease in sodium concentration in blood;

• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);

• delirium;

• encephalopathy (see subsection "Inform your doctor immediately" for a detailed description of symptoms);

• seizures may worsen or occur more frequently;

• uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);

• change in heart rhythm (electrocardiogram);

• pancreatitis (inflammation of the pancreas);

• liver insufficiency, hepatitis (inflammation of the liver);

• sudden decline in kidney function;

• skin rash, which can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).

• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase associated. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

• gait disturbance or difficulty walking.

• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and low level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare (may affect up to 1 in 10,000 people):

• unwanted and repeated thoughts or sensations, or the urge to do something over and over (obsessive-compulsive disorder).

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the vial labeland on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Composition of Levetiracetam Hikma

• The active ingredient is levetiracetam.

Each ml of infusion solution contains 100 mg of levetiracetam.

• The other components are: sodium acetate, glacial acetic acid, sodium chloride, and water for injection preparations.

Appearance of the product and contents of the package

Levetiracetam Hikma concentrate for infusion solution is a sterile, transparent, and colorless liquid.

Levetiracetam Hikma concentrate for infusion solution is packaged in cardboard boxes containing 10 vials of 5 ml.

Marketing authorization holder and responsible manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó nº8, 8A, 8B

Fervença

2705-906 Terrugem SNT

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Levetiracetam Hikma 100 mg/ml, Concentrate for the preparation of an infusion solution

Germany:Levetiracetam Hikma 100 mg/ml, Concentrate for the preparation of an infusion solution

France:Lévétiracétam Hikma 100 mg/ml Solution to be diluted for infusion

Italy:Levetiracetam Hikma, 100 mg/ml, Concentrate for infusion solution

Portugal:Levetiracetam Hikma 100 mg/ml, Concentrate for infusion solution

Spain:Levetiracetam Hikma 100 mg/ml Concentrate for infusion solution

United Kingdom/Northern Ireland: Levetiracetam 100 mg/ml Concentrate for solution for infusion

Date of the last review of this leaflet:August 2024

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This information is intended solely for healthcare professionals:

The instructions for the proper use of Levetiracetam Hikma are provided in section 3.

A vial of concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of Levetiracetam Hikma concentrate for infusion solution 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 Hikma concentrate for infusion solution EFG

This drug is for single use, so the unused solution should be discarded.

Shelf life in use: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the time and storage conditions prior to the next use are the responsibility of the user and should not exceed 24 hours at room temperature (15-25°C), unless the dilution has been made in validated and controlled aseptic conditions.

It was found that Levetiracetam Hikma concentrate for infusion solution was physically compatible and chemically stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at controlled room temperature of 15-25°C.

Diluents:

• Sodium chloride 9 mg/ml (0.9%) injection solution

• Ringer lactate injection solution

• Dextrose 50 mg/ml (5%) injection solution