LEVETIRACETAM TARBIS FARMA 750 mg FILM-COATED TABLETS

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

Do not take Levetiracetam Tarbis Farma

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

Warnings and precautions

Consult your doctor before taking this medicine

• if you have kidney problems, follow the advice of your doctor, who will decide if you need a dose adjustment
• if you notice any decrease in your child’s growth or an unexpected change in puberty, contact your doctor
• a small number of people being treated with antiepileptics such as Levetiracetam Tarbis Farma have had thoughts of harming themselves or ending their lives. If at any time you have these thoughts, contact your doctor
• if you have a history of heart rhythm problems or if you are taking any other medicines that may affect the heart rhythm

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

• abnormal thoughts, feeling irritable or more aggressive than usual or if you or your family and friends notice any significant change in mood or behaviour
• worsening of seizures

In rare cases, seizures may worsen or become more frequent, mainly during the first month after starting treatment or after increasing the dose. If you experience any of these new symptoms while taking levetiracetam, contact your doctor as soon as possible.

Children and adolescents

• Monotherapy (use of only one medicine to treat epilepsy) with Levetiracetam Tarbis Farma is not indicated in children and adolescents below 16 years of age.

Other medicines and Levetiracetam Tarbis Farma

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

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam should only be used during pregnancy if necessary.

Do not stop your treatment without consulting your doctor.

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

Breast-feeding is not recommended during treatment with Levetiracetam Tarbis Farma.

Driving and using machines

Levetiracetam Tarbis Farma may affect your ability to drive or use tools or machines, as it may cause drowsiness. 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 such activities is not affected.

Levetiracetam Tarbis Farma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Levetiracetam Tarbis Farma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the number of tablets that your doctor has prescribed you.

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

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12-17 years) weighing 50 kg or more:

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

When you first start taking levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you 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 in the evening, and the dose should be gradually increased to 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12-17 years) weighing 50 kg or less:

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

• Dose in infants (1-23 months) and children (2-11 years) weighing less than 50 kg:

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

Levetiracetam 100 mg/ml oral solution is a more appropriate formulation for infants and children under 6 years and for children and adolescents (6-17 years) weighing less than 50 kg and when tablets do not allow accurate dosing.

Method of administration

Levetiracetam is taken by mouth. Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water). You may take levetiracetam with or without food. After oral administration, the bitter taste of levetiracetam may be experienced.

Duration of treatment

• Levetiracetam is used as a chronic treatment. You should continue to take it for as long as your doctor has told you.
• Do not stop your treatment without consulting your doctor, as this may cause your seizures to return.

If you take more Levetiracetam Tarbis Farma than you should

The possible side effects of an overdose of levetiracetam are drowsiness, agitation, aggression, decreased alertness, respiratory depression and coma.

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best treatment for the overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, telephone 915 620 420, indicating the medicine 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 a forgotten dose.

If you stop taking Levetiracetam Tarbis Farma

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

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

4. Possible side effects

Like all medicines, levetiracetam can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the casualty 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 oedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests and an increased number of a type of white blood cells (eosinophilia), swollen 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 form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• signs of mental changes such as confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination of movements), paraesthesia (tingling), attention changes (loss of concentration). These may be signs of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as somnolence, fatigue and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis
• somnolence (feeling drowsy), 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 unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (feeling of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommon:may affect up to 1 in 100 people

• decreased number of platelets, decreased number of white blood cells
• weight loss, weight gain
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination of movements), paraesthesia (tingling), attention changes (loss of concentration)
• double vision, blurred vision
• abnormal/elevated liver function tests
• hair loss, eczema, itching
• muscle weakness, 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, Quincke’s oedema)
• decrease in sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating)
• delirium
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the symptoms)
• seizures may worsen or become more frequent
• uncontrolled muscle spasms affecting the head, torso 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 form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping or difficulty walking
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use website: www.notificaRAM.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

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:

Tablet core:

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

Film coating:

250 mg

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

Product Appearance and Package Contents

Film-coated tablet.

Levetiracetam Tarbis Farma 250 mg film-coated tablets EFG

Film-coated tablets, scored, oblong in shape, and blue in color, engraved with an 'H' on one side and with the number '87' on the other. The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Tarbis Farma 500 mg film-coated tablets EFG

Film-coated tablets, yellow in color, oblong in shape, scored, engraved with an 'H' on one side and with the number '88' on the other. The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Tarbis Farma 750 mg film-coated tablets EFG

Film-coated tablets, scored, oblong in shape, beige to light orange in color, engraved with an 'H' on one side and with the number '90' on the other. The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

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

Film-coated tablets, white in color, oblong in shape, scored, engraved with an 'H' on one side and with the number '91' on the other. The score line is only for fracturing 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

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Levetiracetam Amarox 250 mg/500 mg/750 mg/1000 mg film-coated tablets

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

Date of the last revision of this leaflet:March 2024

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