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Package Leaflet: Information for the Patient

Levetiracetam Sandoz 250 mg Film-Coated Tablets

Levetiracetam Sandoz 500 mg Film-Coated Tablets

Levetiracetam Sandoz 1.000 mg Film-Coated Tablets

Read this leaflet carefully before you start to take 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.

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

Levetiracetam Sandoz is used:

• alone in adults and adolescents aged 16 years or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease in which 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, children, and infants aged 1 month or older,
  • myoclonic seizures (shock-like, short, muscle or group of muscle seizures) in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy,

• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam Sandoz

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

Warnings and precautions

Consult your doctor before starting to take Levetiracetam Sandoz.

• If you have kidney problems, follow your doctor's instructions. He should decide if you need to adjust your dose,
• if you notice any decrease in your child's growth or an unexpected onset of puberty, please contact your doctor,
• a small number of people taking antiepileptic medications such as levetiracetam 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 irritable, 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 Sandoz, see a doctor as soon as possible.

Children and adolescents

Levetiracetam (monotherapy) treatment is not indicated in children and adolescents under 16 years old.

Other medications and Levetiracetam Sandoz

Inform your doctor or pharmacistif you are taking, have taken recently, or 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 or breastfeeding, or think you may be 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 during treatment.

Driving and operating machinery

Levetiracetam 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 Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

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

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 Sandoz, your doctor will prescribe alower dosefor two weeks before administering the daily dose.

For example: for a planned daily dose of 1,000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg at night, and the dose should be increased gradually to reach 1,000 mg per day after 2 weeks of treatment.

Adults (12 to 17 years) with a weight of 50 kg or less:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam tablets according to weight and dose.

Dose in infants (1 month to 23 months) and children (2 to 11 years) with a weight of less than 50 kg

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Sandoz according to age, weight, and dose.

Levetiracetam Sandoz 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years and for children and adolescents (6 to 17 years) with a weight of less than 50 kg and when tablets do not allow for precise dosing.

Administration form

Swallow Levetiracetam Sandoz tablets with a sufficient amount of liquid (e.g. a glass of water). You can take Levetiracetam Sandoz with or without food.

After oral administration of levetiracetam, its bitter taste may be perceived.

Tablets can be divided into equal doses.

Treatment duration

• Levetiracetam Sandoz is used as a chronic treatment. Continue treatment for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as seizures may increase.

If you take more Levetiracetam Sandoz than you should

The possible adverse effects of a Levetiracetam Sandoz overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

In case of overdose or accidental ingestion, consult immediately, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

Your doctor will establish the best possible treatment for the overdose.

If you forgot to take Levetiracetam Sandoz

Contact your doctor if you have missed one or more doses.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Levetiracetam Sandoz

The end of treatment with levetiracetam should be carried out 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 you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may 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,
• seizures, balance disorder, dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremors (involuntary shaking),
• vertigo (sensation of rotation),
• cough,
• abdominal pain, diarrhea, indigestion, vomiting, nausea,
• rash,
• asthenia / fatigue (fatigue).

Uncommon:may affect up to 1 in 100 people

• decrease in the number of platelets in the blood, decrease in the number of white blood cells,
• weight loss, weight gain,
• suicidal attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability / mood changes, agitation,
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination / ataxia (altered movement coordination), paresthesia (tingling), attention alterations (loss of concentration),
• diplopia (double vision), blurred vision,
• elevated / abnormal liver function test values,
• hair loss, eczema, itching,
• muscle weakness, myalgia (muscle pain),
• injury.

Rare:may affect between 1 in 1,000 people

• infection,
• decrease in all types of blood cells,
• severe allergic reactions (DRESS anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat)),
• decrease in sodium concentration in the blood,
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating),
• delirium,
• encephalopathy (see "Inform your doctor immediately" section for a more 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,
• liver insufficiency, hepatitis,
• skin rash that can form blisters and appears 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. The 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). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

• unwanted thoughts or feelings and repeated 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 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 Medicines for Human Use:https://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 packaging and the blister pack after CAD/EXP.

The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

For bottles, the expiration date after the first opening is 100 days.

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levetiracetam Sandoz

• The active ingredient is levetiracetam.

Levetiracetam Sandoz 250 mg:

• Each film-coated tablet contains 250 mg of levetiracetam.
• The other components are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E-171), talc, and aluminum lake indigo carmine (E-132).

Levetiracetam Sandoz 500 mg:

• Each film-coated tablet contains 500 mg of levetiracetam.
• The other components are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropilcellulose, macrogol type 6000, titanium dioxide (E-171), talc, and yellow iron oxide (E-172).

Levetiracetam Sandoz 1.000 mg:

• Each film-coated tablet contains 1.000 mg of levetiracetam.
• The other components are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E-171), and talc.

Appearance of the product and contents of the package

Levetiracetam Sandoz 250 mg are blue-green colored, oval, biconvex, scored on both sides, and have the mark LVT/250 engraved on one side.

Levetiracetam Sandoz 500 mg are yellow, biconvex, scored on both sides, and have the mark LVT/500 engraved on one side.

Levetiracetam Sandoz 1.000 mg are white, oval, biconvex, scored on both sides, and have the mark LVT/1000 engraved on one side.

The tablets are packaged in OPA/Alu/PVC-Alu blisters or HDPE bottles with a polypropylene screw cap and a silica gel capsule inserted in cardboard containers.

Package sizes:

Levetiracetam Sandoz 250 mg:

Blisters: 10, 20, 28, 30, 50, 50x1, 60, 100, 120, 200 film-coated tablets.

Bottles: 10, 20, 30, 50, 60, 100, 120, 200 film-coated tablets.

Levetiracetam Sandoz 500 mg and Levetiracetam Sandoz 1.000 mg:

Blisters: 10, 28, 30, 50, 50 x 1, 60, 100, 120, and 200 film-coated tablets.

Bottles: 10, 20, 30, 50, 60, 100, 120, and 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Lek Pharmaceuticals d.d

Verovškova 57,

1526 Ljubljana

Slovenia

or

LEK S.A.

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d

Trimlini 2 D,

9220 Lendava,

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-

540472 Targu-Mures

Romania

Last review date of this leaflet:December 2023

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