Leaflet: information for the user

Levetiracetam Normon 100 mg/ml oral solution EFG

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

Levetiracetam Normon is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treata form of epilepsy. Epilepsy is a disease where 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.
• concurrently with other antiepileptic medications to treat:

•partial onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age.

•myoclonic seizures (shock-like, short, muscle or group of muscle seizures) 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.

Do not takeLevetiracetam Normon

• 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 Normon.

• 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 are taking a 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. If you experience any of these new symptoms while taking Levetiracetam Normon, see a doctor as soon as possible.

Children and adolescents

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

Other medications and Levetiracetam Normon

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, breastfeeding, think you may be pregnant, or intend 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.

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

Levetiracetam Normon contains parahydroxybenzoic acid methyl ester (E-218), parahydroxybenzoic acid propyl ester (E-216), and maltitol (E-965)

Levetiracetam Normon 100 mg/ml oral solution may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216).

Levetiracetam Normon contains maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Levetiracetam Normon 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 as instructed by your doctor.

Due to the dosing device of Levetiracetam Normon, this medication cannot be administered to children under 4 years old or with a weight less than10 kg. There are other presentations available in the market suitable for administration in the age range from 1 month to 4 years.

Monotherapy (from 16 years of age)

Adults(≥18 years)and adolescents (from 16 years of age):

For patients 4 years of age or older, measure the appropriate dose using the 5 ml syringe included in the package.

General dose: Levetiracetam Normon is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1,500 mg).

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

Concomitant therapy

Dose in adults and adolescents (from12 to17 years):

For patients 4 years of age or older, measure the appropriate dose using the 5 ml syringe included in the package.

General dose: Levetiracetam Normon is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1,500 mg).

Dose in children 6 months of age and older:

Your doctor will prescribe the most appropriate Levetiracetam Normon formulation based on age, weight, and dose.

For children 6 months to 4 years, measure the appropriate dose using a3 mlsyringe.

For children over 4 years, measure the appropriate dose using the5 mlsyringe included in the package.

General dose: Levetiracetam Normon is taken twice a day, in two equal doses, each individual dose between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kg of body weight of the child (see the following table for dose examples).

Dose in children 6 months of age and older:

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

For infants from 1 month to less than 6 months,measure the appropriate dose using a1 mlsyringe.

General dose: Levetiracetam Normon is taken twice a day, in two equal doses, each individual dose between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of body weight of the infant (see the following table for dose examples).

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

Administration form:

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

Instructions for correct administration

The syringe is inserted into the perforated cap, the bottle is inverted, the plunger is pulled until the liquid reaches the ml mark, the bottle is returned to its initial position, and the syringe is removed.

The syringe must be cleaned and dried after each use.

Treatment duration:

•Levetiracetam Normon is used as a chronic treatment. You should continue treatment with Levetiracetam Normon for the time indicated by your doctor.

•Do not stop treatment without your doctor's recommendation, as this may increase the number of seizures.

If you take moreLevetiracetam Normonthan 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 oral solution than you should. Your doctor will establish the best possible treatment for the overdose.

In case of overdose or accidental ingestion, 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 forget to takeLevetiracetam Normon

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 withLevetiracetam Normon

The discontinuation of Levetiracetam Normon treatment should be done gradually to avoid an increase in seizures.If your doctor decides to stop your treatment with Levetiracetam Normon, they will give you instructions for the gradual withdrawal of Levetiracetam Normon.

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 (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 (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.

Very common:can affect more than 1 in 10 people

• nasopharyngitis;

• drowsiness (feeling sleepy), headache.

Common:can affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorders, dizziness (feeling unstable), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity) vomiting, and nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Rare:can 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 (movement coordination 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.

Very rare:can affect up to 1 in 1,000 people

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (DRESS, anaphylaxis (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 "Inform your doctor immediately" for a detailed description of symptoms);
• epileptic 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);
• decreased kidney function;
• skin rash, which can lead to 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), 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 blood levels associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking.

Reporting ofadverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting adverse reactions, 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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not use after 6 months after opening the packaging.

This medication does not require special storage conditions.

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

Composition ofLevetiracetam Normon

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

-The other components are:monohydrate citric acid, methyl parahydroxybenzoate (E-218), sodium citrate, propyl parahydroxybenzoate (E-216), glycerol (E-422), maltitol (E-965), orange liquid, sodium saccharin, purified water.

Appearance of the product and contents of the packaging

Levetiracetam Normon oral solution is a transparent and colorless liquid.

Levetiracetam Normon 100 mg/ml oral solution is presented in a 300 ml bottle in a cardboard box.

The 300 ml bottle of Levetiracetam Normon is packaged in a cardboard box accompanied by an oral syringe of 5 ml (graduated every 0.5 ml) and a dropper plug for the syringe.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Levetiracetam Normon 250 mg film-coated tablets.

Levetiracetam Normon 500 mg film-coated tablets.

Levetiracetam Normon 1000 mg film-coated tablets.

Levetiracetam Normon 100 mg/ml concentrate for solution for infusion EFG.

Levetiracetam Normon 5 mg/ml infusion solution.

Last review date of this leaflet: April 2021

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76347/P_76347.html