LEVETIRACETAM NORMON 100 MG/ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Levetiracetam Normon 100 mg/ml Oral Solution EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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

Levetiracetam Normon is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a condition where you have attacks (seizures). Levetiracetam is used for a form of epilepsy where the seizures initially only affect one side of the brain but may then spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam for you to reduce the number of seizures.
• with other antiepileptic medicines to treat:

• partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age.
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
• primary generalised tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

2. What you need to know before you take Levetiracetam Normon

Do not takeLevetiracetam Normon

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

Warnings and precautions

Consult your doctor before taking Levetiracetam Normon.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

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

In rare cases, epileptic 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.

Other medicines and Levetiracetam Normon

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

Do not take macrogol (a laxative medicine) for 1 hour before and 1 hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam can only be used during pregnancy if, after a careful evaluation, your doctor considers it necessary.

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

The risk of birth defects for your baby cannot be completely excluded.

Breastfeeding is not recommended during treatment with Levetiracetam Normon.

Driving and using machines

Levetiracetam may affect your ability to drive or use tools or machines, as it may cause you to feel sleepy. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform these activities is not affected.

Levetiracetam Normon contains methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216) and maltitol (E-965)

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

Levetiracetam Normon contains maltitol (E-965). If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Levetiracetam Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Levetiracetam Normon should be taken twice daily, once in the morning and once in the evening, approximately at the same time every day.

Take the oral solution as instructed by your doctor.

In the particular case of Levetiracetam Normon and due to the dosing capacity of the Levetiracetam Normon syringe, this medicine cannot be administered to children under 4 years or weighing less than10 kg. Other presentations suitable for administration in the age range from 1 month to 4 years are available on the market.

Monotherapy (from 16 years of age)

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

For patients from 4 years of age, measure the correct dose using the 5 ml syringe included in the pack.

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

When starting treatment with Levetiracetam Normon, your doctor will prescribe a lower dosefor two weeks before administering the lowest general dose.

Concomitant therapy

Dose in adults and adolescents (from12 to17 years):

For patients from 4 years of age, measure the correct dose using the 5 ml syringe included in the pack.

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

Dose in children from 6 months of age:

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

For children from 6 months to 4 years, measure the correct dose using a 3 mlsyringe.

For children over 4 years, measure the correct dose using the 5 mlsyringe included in the pack.

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

Dose in children from 6 months of age:

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

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

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

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

Method of administration:

After measuring the correct dose with a suitable syringe, Levetiracetam Normon oral solution can be diluted in a glass of water or in a baby bottle. You can take Levetiracetam Normon with or without food. After oral administration of levetiracetam, a bitter taste may be perceived.

Instructions for correct administration

The syringe is inserted into the pierced cap, the bottle is turned upside down, the plunger is pulled until the liquid reaches the ml mark, the bottle is returned to its original position and the syringe is removed.

The syringe must be cleaned and dried after each use.

Duration of treatment:

• 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 your treatment without your doctor's recommendation, as your seizures may increase.

If you take moreLevetiracetam Normonthan you should

The possible side effects of an overdose of levetiracetam 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine 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 make up for forgotten doses.

If you stop takingLevetiracetam Normon

Stopping treatment with Levetiracetam Normon should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Normon, he/she will give you instructions for gradual withdrawal of Levetiracetam Normon.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Tell your doctor immediately, or go to the emergency department 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 rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and 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 output, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as these may be signs of sudden decreased kidney function
• a skin rash that can form blisters and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread 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 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, drowsiness (feeling of sleep), headache, fatigue, and dizziness. Adverse effects such as feeling of sleep, feeling of weakness, and dizziness may be more frequent when treatment is initiated or the dose is increased. However, these adverse effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis;

• drowsiness (feeling of sleep), 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 disorders, dizziness (feeling of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, heartburn, and acidity) vomiting and nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon:may affect up to 1 in 100 people

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal values 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 (important and severe allergic reaction), Quincke's edema (swelling of 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 "Tell your doctor immediately" for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rate (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which can lead to blisters that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread 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 increased creatine phosphokinase in blood. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Levetiracetam Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Levetiracetam Normon

• The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: citric acid monohydrate, 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 Package Contents

Levetiracetam Normon oral solution is a clear 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 with a 5 ml oral syringe (graduated every 0.5 ml) and a dropper plug for the syringe.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Other Presentations

Levetiracetam Normon 250 mg film-coated tablets EFG.

Levetiracetam Normon 500 mg film-coated tablets EFG.

Levetiracetam Normon 1000 mg film-coated tablets EFG.

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

Levetiracetam Normon 5 mg/ml solution for infusion.

Date of the Last Revision of this Leaflet: April 2021

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

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