Levetiracetam Tarbis Farma 100 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Tarbis Farma 100 mg/ml oral solution EFG

levetiracetam

Read this entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Levetiracetam Tarbis Farma is and what it is used for

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

This medicine is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease in which patients have seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may then spread to broader areas on 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 medicines to treat:
  • partial-onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age.
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
  • primary generalized tonic-clonic seizures (grand mal seizures, including loss of
  • consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam Tarbis Farma

Do not take Levetiracetam Tarbis Farma

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

Warnings and precautions

Talk to your doctor before starting this medicine

• If you have kidney problems, follow your doctor's instructions, as your doctor will decide whether your dose needs to be adjusted.
• If you notice any slowing in your child's growth or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as levetiracetam have had thoughts about harming themselves or suicide. If you experience symptoms of depression and/or suicidal thoughts, contact your doctor immediately.
• If you have a personal or family history of irregular heart rhythm (seen on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may make you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

• Abnormal thoughts, feeling irritable, or acting more aggressively than usual, or if you, your family, or friends notice significant changes in mood or behaviour.
• Worsening of epilepsy

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking this medicine, see a doctor as soon as possible.

If you experience any new symptoms while taking this medicine, seek medical advice as soon as possible.

Children and adolescents

• Treatment with Levetiracetam Tarbis Farma alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Tarbis Farma

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

Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Levetiracetam may only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

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

The risk of birth defects in the baby cannot be completely ruled out. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on infant neurological development are limited.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam Tarbis Farma contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and maltitol (E965).

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions.

Maltitol: If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; therefore, it is essentially “sodium-free”.

3. How to take Levetiracetam Tarbis Farma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Levetiracetam should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Take the oral solution as directed by your doctor.

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 appropriate dose using the 10 ml syringe provided in the package.

Recommended dose: levetiracetam is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1500 mg).

When you first start taking Levetiracetam, your doctor will prescribe a lower dose for two weeks before increasing to the lowest daily dose.

Concomitant therapy

Doses in adults and adolescents (12 to 17 years of age):

For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.

Recommended dose: Levetiracetam is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1500 mg).

Doses in children from 6 months of age:

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

For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe provided in the package.

For children over 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.

Recommended dose: Levetiracetam is taken twice daily in two equal doses, with each individual dose ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see examples of dosing in the following table).

Doses in children from 6 months of age:

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

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the 1 ml syringe supplied in the pack.

Recommended dose: Levetiracetam is taken twice daily, in two equal doses, with each individual dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of the infant's body weight (see examples of doses in the table below).

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

Administration method:

This medicine is for oral use. After measuring the correct dose with the appropriate syringe, Levetiracetam oral solution may be diluted in a glass of water or in a feeding bottle. You may take Levetiracetam with or without food. A bitter taste of levetiracetam may be noticed after oral administration.

Instructions on how to use the syringe:

• Open the bottle: press down on the cap and unscrew it counterclockwise (Figure 1)

• Follow these steps the first time you take Levetiracetam:
  • Remove the oral syringe adapter (Figure 2).
  • Insert the adapter into the top of the bottle (Figure 3). Make sure it is properly placed. It is not necessary to remove the adapter after use.

• Follow these steps each time you take Levetiracetam:
  • Insert the oral syringe into the opening of the adapter (Figure 4).
  • Turn the bottle upside down (Figure 5).

• Hold the bottle upside down with one hand and fill the oral syringe with the other.
• Pull the plunger down to fill the oral syringe with a small amount of solution (Figure 5A).
• Then, push the plunger up to remove any possible air bubbles (Figure 5B).
• Pull the plunger down to the dose mark in millilitres (mL) indicated on the oral syringe and prescribed by your doctor (Figure 5C). The plunger may retract into the barrel during the first dose, so you must ensure that you keep the plunger in position until you disconnect the syringe from the bottle.

• Place the bottle upright (Figure 6A). Remove the syringe from the adapter (Figure 6B).

• Empty the contents of the syringe into a glass of water or into a feeding bottle by pushing the plunger all the way down to the end of the syringe (Figure 7).

• Drink the entire contents of the glass or feeding bottle.
• Close the bottle with the plastic screw cap (it is not necessary to remove the adapter).
  • To clean the syringe, rinse it only with cold water, moving the plunger several times up and down to draw in and expel the water, without separating the two components (Figure 8).
  • Store the bottle, the oral syringe, and the package leaflet in the carton.

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You must continue the treatment with levetiracetam for the duration specified by your doctor.
• Do not stop your treatment without consulting your doctor, as your seizures may increase.

If you take more Levetiracetam Tarbis Farma than you should:

Possible adverse effects of a levetiracetam overdose include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more oral solution than you should. Your doctor will determine the most appropriate treatment for the overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount used.

If you forget to take Levetiracetam Tarbis Farma:

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

Do not take a double dose to make up for missed doses.

If you stop treatment with Levetiracetam Tarbis Farma:

Stopping treatment with levetiracetam should be done gradually to avoid an increase in seizures. If your doctor decides to discontinue your treatment with levetiracetam, he or she will give you instructions for the gradual withdrawal of levetiracetam.

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

4. Possible adverse effects

Like all medicines, levetiracetam can cause adverse effects, although not everyone experiences them.

Tell your doctor immediately, or go to the nearest hospital emergency department if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a serious (anaphylactic) allergic reaction
• swelling of the face, lips, tongue or throat (angioedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of legs, arms or feet, as this may be a sign of sudden decrease in kidney function
• a skin rash which may blister 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 peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (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, somnolence (drowsiness), headache, fatigue and dizziness. Adverse effects such as drowsiness, feeling weak and dizziness may be more common when starting treatment or increasing the dose. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (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 (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, burning and acid regurgitation), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results 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 (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue and throat));
• decreased 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;
• uncontrollable muscle spasms affecting the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which may blister 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 peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and increased blood creatine phosphokinase levels. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking.
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, decreased level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Tarbis Farma

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Tarbis Farma

The active substance is levetiracetam.

Each ml contains 100 mg of levetiracetam.

The other components are: maltitol liquid (E965), glycerol (E422), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), monohydrate sodium citrate, citric acid (dihydrate), ammonium glycyrrhizinate, potassium acesulfame (E950), grape flavour, purified water.

Nature of the product and pack contents

Levetiracetam Tarbis Farma 100 mg/ml oral solution EFG is a clear, colourless liquid.

Pack sizes:

Amber glass bottle (type III) of 300 ml (containing 300 ml of oral solution) with a white child-resistant cap (polyethylene), accompanied by a 10 ml graduated oral syringe (polypropylene) and a syringe adapter (polyethylene), all contained in a cardboard box.

Amber glass bottle (type III) of 200 ml (containing 150 ml of oral solution) with a white child-resistant cap (polyethylene), accompanied by a 3 ml graduated oral syringe (polypropylene) and a syringe adapter (polyethylene), all contained in a cardboard box.

Amber glass bottle (type III) of 200 ml (containing 150 ml of oral solution) with a white child-resistant cap (polyethylene), accompanied by a 1 ml graduated oral syringe (polypropylene) and a syringe adapter (polyethylene), all contained in a cardboard box.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:

The Netherlands: Levetiracetam Amarox 100 mg/ml drank

Germany: Levetiracetam Amarox 100 mg/ml Lösung zum Einnehmen

Spain: Levetiracetam Tarbis Farma 100 mg/ml oral solution EFG

Date of the most recent revision of this leaflet: November 2025

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