Prescription Information for the Patient

Levetiracetam Stadafarma 500 mg Film-Coated Tablets

Read this entire leaflet carefully before you or your child start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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).

This medication is used:

• alone (without the need for another antiepileptic medication) in adults and adolescents aged 16 years 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 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:

Do not take Levetiracetam Stadafarma

•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 take levetiracetam.

•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 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:

• Persistent abnormal thoughts, irritability, or increased aggression, 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. If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam (exclusive treatment) is not indicated in children and adolescents under 16 years old.

Other medications and Levetiracetam Stadafarma

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 effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist 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 may impair your ability to drive or operate tools or machinery, as this medication may cause drowsiness. This is more likely to occur 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.

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

Levetiracetam is not available in all the described pharmaceutical forms. For posological recommendations that cannot be achieved with this medication, other medications containing levetiracetam must be used.

Take the number of tablets prescribed by your doctor.

Levetiracetam should be taken twice a day, once in the morning and once in the afternoon, 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:

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

When starting to take levetiracetam, your doctor will prescribe a lower dose for 2 weeks before administering the general lowest dose.

For example: for a 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.

•Adolescents (12 to 17 years) with a weight equal to or less than 50 kg:

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

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

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

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

Administration form

This medication is for oral use.

Swallow the levetiracetam tablets with a sufficient amount of liquid (e.g. a glass of water). You can take levetiracetam with or without food.After oral administration of levetiracetam, its bitter taste may be perceived.

Treatment duration

• Levetiracetam is used as a chronic treatment. Continue treatment with levetiracetam 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 Stadafarma than you should

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

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best possible treatment for the overdose.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service immediately. Telephone 91-562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Levetiracetam Stadafarma

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

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

If you interrupt treatment with Levetiracetam Stadafarma

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

Like all medicines, this medicine 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 (anaphylactic)
• 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 enzyme levels 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 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), tremor (involuntary shaking);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (sensation of weakness).

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

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, 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;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decreased count of 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, or throat);
• hyponatremia (low sodium levels in the blood);
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium
• encephalopathy (see "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;
• hepatic insufficiency, hepatitis;
• 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).
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase levels associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• gait disturbance or difficulty walking.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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 medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Levetiracetam Stadafarma

The active ingredient is levetiracetam.

Each film-coated tablet contains 500 mg of levetiracetam.

The other components are:

Core of the tablet:

Crospovidone (Type B), povidone K30, anhydrous colloidal silica, magnesium stearate.

Film coating:

Hydroxypropyl methylcellulose, macrogol 400, titanium dioxide (E171), talc, iron oxide yellow (E172).

Appearance of the product and contents of the package

Levetiracetam Stadafarma 500 mg film-coated tablets EFG are yellow, oval, scored on one side, with approximate dimensions of 16.5 mm x 7.7 mm. The tablet can be divided into equal doses.

Levetiracetam Stadafarma 500 mg film-coated tablets EFG are available in packages containing 10, 20, 30, 50, 60, 100, 120, or 200 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Stada Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain
[email protected]

Responsible for manufacturing

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area,

Larisa, 41004,

Greece

or

PharOS MT Ltd

HF 62X, Hal-Far Industrial Estate,

Birzebbugia BBG 3000

Malta

or

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

Last review date of this leaflet:October 2021

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