Patient Information Leaflet

Levetiracetam Stada 100 mg/ml Oral Solution

Read this leaflet carefully before you 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, 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. How to take Levetiracetam Stada
2. Possible side effects
3. Storage of Levetiracetam Stada

1. Contents of the pack and additional information

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

Levetiracetam 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 where patients have seizures (crises). Levetiracetam is used for 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.

• concurrently 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 Stada:

• 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 Stada:

• 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.

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.

Children and adolescents

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

Other medications and Levetiracetam Stada

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, 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. Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam may affect 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 the dose is increased. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not impaired.

Levetiracetam Stada contains parahydroxybenzoic acid methyl ester (E218), liquid maltitol (E965), sodium, and benzyl alcohol.

This medication contains parahydroxybenzoic acid methyl ester, which may cause allergic reactions (possibly delayed).

This medication also contains maltitol. If your doctor informs you that you have intolerance to some sugars, contact your doctor before taking this medication.

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

This medication contains 0.0016 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Do not use for more than one week in young children (under 3 years old), unless your doctor or pharmacist indicates otherwise.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney diseases. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

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

Take the oral solution according to your doctor's instructions.

Monotherapy

Dosage in adults and adolescents (16 years of age and older):

Measure the appropriate dose using the 10 ml syringe included in the package for patients 4 years of age and older.

General dosage: Levetiracetam is taken twice a day, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1500 mg).

When starting levetiracetam, your doctor will prescribe alower dosefor two weeks before administering the lowest general dose.

Concomitant therapy

Dosage in adults and adolescents (12 to 17 years):

Measure the appropriate dose using the 10 ml syringe included in the package for patients 4 years of age and older.

General dosage: Levetiracetam is taken twice a day, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1500 mg).

Dosage in children 6 months of age and older:

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

For children 6 months to 4 years, measure the appropriate dose using the3 mlsyringe included in the package.

For children over 4 years, measure the appropriate dose using the10 mlsyringe included in the package.

General dosage: Levetiracetam is taken twice a day, divided into two equal doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kilogram of the child's body weight (see examples of doses in the table below).

Dosage in children 6 months of age and older:

Dosage in infants (1 month to less than 6 months):

For infants 1 month to less than 6 months, measure the appropriate dose using the1 mlsyringe included in the package.

General dosage:Levetiracetam is taken twice a day, divided into two equal doses, each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kilogram of the infant's body weight (see examples of doses in the table below).

Dosage in infants (1 month to less than 6 months):

Administration form

After measuring the correct dose with an appropriate syringe, levetiracetam can be taken by diluting the oral solution in a glass of water or in a bottle. Levetiracetam can be taken with or without food. After oral administration of levetiracetam, its bitter taste may be appreciated.

Instructions for correct administration:

• Open the bottle: press the cap and unscrew in a counterclockwise direction (figure 1).
• Separate the adapter from the syringe (figure 2). Insert the adapter into the neck of the bottle. Make sure it is securely attached.
• Take the syringe and insert it into the opening of the adapter. Place the bottle upside down (figure 3).
• Fill the syringe with a small amount of solution by lowering the plunger (figure 4a) and then raising it to remove any possible bubbles (figure 4b). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 4c).
• Place the bottle upright. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or a bottle by lowering the plunger to the end of the syringe (figure 5).
• Drink the contents of the glass or bottle entirely.
• Close the bottle with a child-resistant cap.
• Wash the syringe only with water (figure 6).

Treatment duration

• Levetiracetam is used as a chronic treatment. You should continue treatment with levetiracetam for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as this may increase your seizures.

If you take more Levetiracetam Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the medication's leaflet to the healthcare professional.

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

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

If you forgot to take Levetiracetam Stada

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 Stada

The discontinuation of treatment with levetiracetam 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 the medication.

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

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 (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 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 (dizziness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• 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 1,000 people):

• infection;

• 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 (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium
• encephalopathy (see subsection "Inform your doctor immediately" for a detailed description of symptoms);
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs,

difficulty controlling movements, hyperkinesia (hyperactivity);

• pancreatitis;

• liver insufficiency, hepatitis
• sudden decline in kidney function
• skin rash, which can 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 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 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 bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After the first opening:Not to store at a temperature above 25°C.

Do not use after 7 months of having opened the bottle.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Levetiracetam Stada

• The active ingredient is levetiracetam.

Each ml of solution contains 100 mg of levetiracetam.

• The other components are: sodium citrate (to adjust the pH), citric acid (to adjust the pH), methyl parahydroxybenzoate (E218), glycerol (E422), potassium acesulfame (E950), liquid maltitol (E965), raspberry liquid (contains benzyl alcohol).

Appearance of the product and contents of the package

Levetiracetam Stada 100 mg/ml oral solution is a transparent liquid.

The 300 ml glass bottle of Levetiracetam Stada (for children from 4 years of age, adolescents, and adults) is packaged in a cardboard box accompanied by a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle of Levetiracetam Stada(for infants and small children from 6 months to less than 4 years of age) is packaged in a cardboard box accompanied by a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

The 150 ml glass bottle of Levetiracetam Stada(for infants from 1 month to less than 6 months of age) is packaged in a cardboard box accompanied by a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

Limassol 3056

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1

190 Vienna

Austria

or

Galenika Pharmaceutical Industry S.A.

3rd Km Old National Road Chalkida Athens,

Chalcis, 341 00

Greece

Last review date of this leaflet:March 2021

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