Prospecto: information for the patient

Levetiracetam Tarbis Farma 250 mg film-coated tablets

Levetiracetam Tarbis Farma 500 mg film-coated tablets

Levetiracetam Tarbis Farma 750 mg film-coated tablets

Levetiracetam Tarbis Farma 1.000 mg film-coated tablets

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What isLevetiracetam TarbisFarmaand what it is used for

2. What you need to know before starting to takeLevetiracetam Tarbis Farma

3. How totakeLevetiracetam Tarbis Farma

4. Possible adverse effects

5. Storage ofLevetiracetam Tarbis Farma

6. Contents of the package and additional information

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

This medication is used:

•alone in adults and adolescents 16 years of age 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 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.

•in combination with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in adults, adolescents, children, and infants 1 month of age or older.
• myoclonic seizures (shock-like, short, muscle or group of muscles) 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 (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam Tarbis Farma

•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 this medication

•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:

•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.

•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 this medication, see a doctor as soon as possible.

Children and adolescents

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

Other medications and Levetiracetam Tarbis Farma

Inform your doctor or pharmacist if 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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. 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 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 impair 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 affected.

Levetiracetam Tarbis Farma contains parahydroxybenzoic acid methyl ester (E218), parahydroxybenzoic acid propyl ester (E216), and maltitol (E965).

Parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216) may cause allergic reactions.

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 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication 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 (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 included in the box.

Recommended dose: Levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

When starting to take Levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the daily dose.

Concomitant therapy

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

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

Recommended dose: Levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children from 6 months of age:

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

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

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

Recommended dose: Levetiracetam 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 from 6 months of age:

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

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

Recommended dose: Levetiracetam 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).

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

Administration form:

This medication is for oral use. After measuring the correct dose with the appropriate syringe, Levetiracetam oral solution can be diluted in a glass of water or in a bottle. You can take Levetiracetam 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 the opposite direction to the clock hands (figure 1)

•Separate the adapter from the syringe (figure 2). Insert the adapter into the neck of the bottle (figure 3). Make sure it is securely attached.

•Take the syringe and insert it into the opening of the adapter (figure 4)

•Turn the bottle upside down (figure 5)

•Fill the syringe with a small amount of solution by lowering the plunger (figure 5A) and then raising it to eliminate any possible bubbles (figure 5B). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 5C).

•Turn the bottle right side up (figure 6A). Remove the syringe from the adapter (figure 6B).

•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 7).

•Drink the contents of the glass or bottle entirely.

•Close the bottle with the plastic screw cap.

•Wash the syringe only with water (figure 8).

Duration of treatment:

•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 Tarbis Farma 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 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 or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount used.

If you forgot to take Levetiracetam Tarbis Farma:

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 Tarbis Farma:

Thetermination 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 levetiracetam.

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

Like all medications, levetiracetam may cause side effects, although not everyone will experience them.

Inform 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 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 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 may 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 deterioration (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 (dizziness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);

•diplopia (double vision);

•cough;

•abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;

•skin rash;

•asthenia/fatigue (weakness).

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

•infection;

•decrease in all types of blood cells;

•severe allergic reactions (DRESS, anaphylaxis (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));

•decreased sodium concentration in blood;

•suicide, personality disorders (behavioral 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 (inflammation of the pancreas);

•liver insufficiency, hepatitis (inflammation of the liver);

•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 associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;

•gait disturbance or difficulty walking.

•combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and low level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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 directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Levetiracetam Tarbis Farma

The active ingredient is levetiracetam.

Each ml contains 100 mg of levetiracetam.

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

Appearance of the product and contents of the package

Levetiracetam Tarbis Farma 100 mg/ml oral solution EFG is a transparent and colorless liquid.

Package sizes:

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

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

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Levetiracetam Amarox 100 mg/ml drank

Germany:Levetiracetam Amarox 100 mg/ml Lösung zum Einnehmen

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

Last review date of this leaflet:November 2022

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