Prospect: 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 prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for 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 prospect. 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 pack and additional information

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

Levetiracetam Tarbis Farma 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 for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later extend 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 from 1 month of age

•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 some 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 unexpected puberty development, contact your doctor.

•A small number of people taking antiepileptic medications like Levetiracetam Tarbis Farma 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 levetiracetam, 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, 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 Tarbis Farma 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 do so is not impaired.

Levetiracetam Tarbis Farma contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; 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.

Take the number of tablets prescribed by your doctor.

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

Concomitant therapy and monotherapy (from 16 years of age)

•Adults(≥18 years) and adolescents (12 to 17 years) with a weight of 50 kg or more:

Recommended dose: between 1,000 mg and 3,000 mg per day.

When starting to take levetiracetam, your doctor will prescribe a lower dose for 2 weeks before administering the lowest daily dose.

For example: for a daily dose of 1,000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg at night, and the dose should be increased gradually to reach 1,000 mg per day after 2 weeks of treatment.

•Adolescents (12 to 17 years) with a weight equal to or less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to weight and dose.

•Dose in infants (1 month to 23 months) and children (2 to 11 years) with a weight less than 50 kg:

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

Levetiracetam 100 mg/ml oral solution is a more suitable formulation for infants and children under 6 years and for children and adolescents (6 to 17 years) with a weight less than 50 kg and when tablets do not allow for precise dosing.

Administration form

Levetiracetam is administered orally. Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water). You can take levetiracetam with or without food. After oral administration of levetiracetam, its bitter taste may be perceived.

Treatment duration

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

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

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 tablets 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 Toxicological 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

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 this medication.

If you have any other doubts 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 nearest hospital emergency department 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 elevated 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 decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as this 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 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 (sensation of instability), 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, 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 in the blood associated with it. 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 communicate directly through the Spanish System for the Vigilance 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.

Medications should not be thrown down the drains or in the 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 of Levetiracetam Tarbis Farma

The active ingredient is levetiracetam.

Each film-coated tablet contains 250 mg of levetiracetam.

Each film-coated tablet contains 500 mg of levetiracetam.

Each film-coated tablet contains 750 mg of levetiracetam.

Each film-coated tablet contains 1,000 mg of levetiracetam.

The other components are:

Core of the tablet:

Maize starch, sodium croscarmellose, povidone (K 30), anhydrous colloidal silica, talc, magnesium stearate.

Coating:

250 mg

Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, aluminum lacquer with indigo carmine (E132).

500 mg

Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172)

750 mg

Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172)

1,000 mg

Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc

Appearance of the product and contents of the package:

Film-coated tablet.

Levetiracetam Tarbis Farma 250 mg film-coated tabletsEFG

Scored, oblong-shaped, blue-colored tablets with a ‘H’ on one face and the number ‘87’ on the other. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Tarbis Farma 500 mg film-coated tablets EFG

Yellow-colored, scored, oblong-shaped tablets with a ‘H’ on one face and the number ‘88’ on the other. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Tarbis Farma 750 mg film-coated tablets EFG

Scored, oblong-shaped tablets with a beige to light orange color, with a ‘H’ on one face and the number ‘90’ on the other. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Tarbis Farma 1,000 mg film-coated tablets EFG

White-colored, scored, oblong-shaped tablets with a ‘H’ on one face and the number ‘91’ on the other. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Tarbis Farma film-coated tablets are packaged in blisters.

Packages containing 1, 30, 50, 60, 100, and 200 film-coated tablets.

Only some package sizes may be marketed.

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:

Germany:Levetiracetam Amarox 250 mg/500 mg/750 mg/1000 mg Filmtabletten

Spain:Levetiracetam Tarbis Farma 250 mg/500 mg/750 mg/1,000 mg film-coated tablets EFG

Last review date of this leaflet:November 2022

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