Patient Information Leaflet

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

levetiracetam

Read this leaflet carefully before you or your child start using this medicine, because it contains important information for you.

−Keep this leaflet as 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 others even if they have the same symptoms as you, as it may harm them.

−If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Levetiracetam Altan

3. How to use Levetiracetam Altan

4. Possible side effects

5. Storage of Levetiracetam Altan

6. Contents of the pack and additional information

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

Levetiracetam Altan 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 to treat 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 muscles) 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 Altan concentrate is an alternative for patients in whom oral administration is not temporarily viable.

No use Levetiracetam Altan

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

Warnings and precautions

Consult your doctor before starting to use Levetiracetam Altan

•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 such as Levetiracetam Altan 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 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-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 Altan, see a doctor as soon as possible.

Children and adolescents

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

Use of Levetiracetam Altan with other medications

Inform your doctor or pharmacistif you are using, have used recently, or may need to use 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Levetiracetam can only be used during pregnancy if, after 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.

It is not recommended to breastfeed naturally during treatment.

Driving and operating machinery

Levetiracetam Altan 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 use machinery until it is confirmed that your ability to perform these activities is not affected.

Levetiracetam Altan contains sodium

A single maximum dose of Levetiracetam Altan 2.5 mmol (57.30 mg) of sodium (0.8 mmol (19 mg) of sodium per vial). This should be taken into account in patients following a low-sodium diet.

A healthcare professional, such as a doctor or nurse, will administer Levetiracetam Altan via intravenous infusion.

Levetiracetam Altan should be administered 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 (from12 to17 years) with a weight of50 kgor more:

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

When starting to takeLevetiracetam Altan, your doctor will prescribe a lower dose for two weeks before administering the lowest daily dose.

Dose in children (from4 to11 years) and adolescents (from12 to17 years) with a weight 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 form of administration:

Levetiracetam Altan is for intravenous administration.

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

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

Treatment duration:

•No experience is available with the administration of levetiracetam intravenously for a period exceeding 4 days.

If treatment with Levetiracetam Altan is interrupted:

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 Altan, they will give you instructions for the gradual withdrawal of Levetiracetam Altan.

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

Like all medications,Levetiracetam Altanmay 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 fever, 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 decreased 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 may 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 (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Veryfrequent:may affect more than 1 in 10 people

•nasopharyngitis;

•drowsiness (feeling sleepy), headache.

Frequent:may affect up to 1 in 10 people

•anorexia (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 rotation);

•cough;

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

•skin rash;

•asthenia/fatigue (feeling weak).

Possible:may affect up to 1 in 100 people

•decreased platelet count, decreased white blood cell count;

•weight loss, weight gain;

•suicidal thoughts and attempts, mental alterations, abnormal behavior, hallucinations, anger, confusion,panic attack,emotional instability/mood changes, agitation;

•amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling),attention alterations (loss of concentration);

•diplopia (double vision), blurred vision;

•elevated/abnormal liver function test results;

•hair loss, eczema, itching;

•muscle weakness, myalgia (muscle pain);

•injury.

Rare:may affect up to 1 in 1000 people

•infection;

•decreased counts of 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));

•decreased sodium concentration in the 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;

?involuntary 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 may lead to blisters that 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);

?myoglobinuria (muscle tissue breakdown) and elevated creatine phosphokinase associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;

?gait disturbance or difficulty walking;

•combinationof fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and low level of consciousness (may be signs of a condition calledneuroleptic 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

again (obsessive-compulsive disorder).

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and on the carton 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 Altan

The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam. Each 5 ml contains 500 mg of levetiracetam.

The other components are: sodium trihydrate acetate, glacial acetic acid, sodium chloride, water for injectable preparations.

Appearance of the product and contents of the package

Levetiracetam Altan concentrated solution for infusion (sterile concentrate) is a clear, colorless liquid.

Colorless glass vial, type I with a capacity of 7 ml. Each vial contains 5 ml of concentrated solution for infusion.

Package sizes: 10 vials.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Altan Pharmaceuticals, S.A.

C/Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F, Edificio Prisma

28230 Las Rozas. Madrid

Spain

Responsible manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

Ó

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198-199, Polígono Industrial Monte Boyal, Casarrubios del Monte, 45950 Toledo Spain

Last review date of this leaflet: June 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely forhealthcare professionals:

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

A vial of Levetiracetam Altan concentrate contains 500 mg of levetiracetam (5 ml of concentrate of 100 mg/ml).

See Table 1 for the recommended preparation and administration of Levetiracetam Altan 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 Altan concentrate

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

Shelf life in use: from a microbiological point of view, the product must 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 between 2 and8°C, unless thedilutionhas been performed in validated and controlled aseptic conditions.

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

Diluents:

•Sodium chloride injection solution (0.9%)

•Ringer lactate injection solution

•Dextrose 5% injection solution