Levetiracetam Altan 100 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam Altan 100 mg/ml concentrate for solution for infusion EFG

levetiracetam

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 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Levetiracetam Altan is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy to treat a specific form of epilepsy. Epilepsy is a condition in which patients experience seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side 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.
• in combination with 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 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 (a type of epilepsy thought to have a genetic cause).

Levetiracetam Altan concentrate is an alternative for patients in whom oral administration is temporarily not feasible.

2. What you need to know before starting Levetiracetam Altan

Do not use Levetiracetam Altan

• 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 starting Levetiracetam Altan

• If you have kidney problems, follow your doctor's instructions, as your doctor will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Altan have had thoughts of harming themselves or of suicide. If you experience symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a personal or family history of irregular heartbeat (visible on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may make you prone to cardiac arrhythmias or electrolyte imbalances.

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

• Abnormal thoughts, feeling irritable, or reacting more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) causing multiple seizure types 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, seek medical advice as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam Altan (treatment with Levetiracetam Altan alone) is not indicated in children and adolescents under 16 years of age.

Taking Levetiracetam Altan with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Levetiracetam may be used during pregnancy only if, after careful assessment, your doctor considers it necessary.

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

The risk of birth defects in the baby 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 infant neurological development are limited.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Altan may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or operate machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Altan contains sodium

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

3. How to use Levetiracetam Altan

A doctor or nurse will administer Levetiracetam Altan by intravenous infusion.

Levetiracetam Altan should be given 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 dose adjustment. Your total daily dose and frequency of administration must remain identical.

Concomitant therapy and monotherapy (from 16 years of age)

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

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

Recommended dose: between 20 mg per kg body weight and 60 mg per kg body weight per day.

Method and route of administration:

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

Duration of treatment:

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

If you interrupt treatment with Levetiracetam Altan:

As with other antiepileptic medicines, 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, he or she will provide instructions for the gradual withdrawal of Levetiracetam Altan.

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

4. Possible adverse effects

Like all medicines, Levetiracetam Altan may produce adverse effects, although not everyone experiences them.

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

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, or throat (angioedema)
• flu-like symptoms and facial rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may be signs of sudden decrease in kidney function
• a skin rash that may blister and may appear as small targets (dark central spots surrounded by a paler 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 causing peeling of the skin 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 (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (feeling sleepy), headache, fatigue, and dizziness. Adverse effects such as feeling sleepy, feeling weak, and dizziness may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (feeling sleepy), headache.

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion, burning and acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results in 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 types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
• decreased concentration of sodium in blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Tell your doctor immediately” for a detailed description of symptoms);

? epileptic seizures may worsen or occur more frequently;

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

? change in heart rhythm (electrocardiogram);

? pancreatitis (inflammation of the pancreas);

? liver failure, hepatitis (inflammation of the liver);

? sudden decrease in kidney function;

? skin rash, which may lead to blisters appearing as small targets (dark central spots surrounded by a paler 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), and a more severe form causing peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis);

? rhabdomyolysis (breakdown of muscle tissue) and elevated blood creatine phosphokinase levels. 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). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Altan

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 carton after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

6. Contents of the package and other information

Composition of Levetiracetam Altan

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

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

Appearance of the product and contents of the container

Levetiracetam Altan concentrate for solution for infusion (sterile concentrate) is a liquid, clear and colourless.

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

Pack sizes: 10 vials.

Marketing Authorization Holder and Manufacturer

Holder:

Altan Pharmaceuticals, S.A.

C/Cólquide No. 6, Portal 2, 1st Floor, Office F, Edificio Prisma

28230 Las Rozas. Madrid

Spain

Manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

Or

Altan Pharmaceuticals, S.A.

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

Date of the most recent revision of this summary: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es

This information is intended exclusively for healthcare professionals:

Instructions for the appropriate use of Levetiracetam Altan are provided in section 3.

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

See Table 1 for the recommended preparation and administration of Levetiracetam Altan concentrate to achieve total daily doses of 500 mg, 1,000 mg, 2,000 mg or 3,000 mg given in two divided doses.

Table 1. Preparation and administration of Levetiracetam Altan concentrate

This medicinal product is for single use; therefore, any unused solution must be discarded.

In-use shelf life: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the time and conditions of storage prior to use are the responsibility of the user and must not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under validated and controlled aseptic conditions.

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

Diluents:

• Sodium chloride 0.9% injection solution
• Lactated Ringer's injection solution
• Dextrose 5% injection solution