LEVETIRACETAM TARBIS FARMA 500 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 any of the other ingredients of this medicine (listed in section 6), or to other pyrrolidone derivatives

Warnings and precautions

Tell your doctor before you start taking this medicine:

• if you have kidney problems, your doctor may need to adjust your dose
• if you notice any slowing of growth or unexpected pubertal delay in your child during treatment
• a small number of people being treated with anti-epileptics such as Levetiracetam Tarbis Farma have had thoughts of harming or killing themselves. 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 if you experience any of the following: unusual changes in mood or behaviour, depression, anxiety, aggression, or if you become more easily irritable or agitated

• abnormal thoughts, feeling of irritability or being more aggressive than usual, or if you or your family and friends notice changes in your mood or behaviour
• worsening of seizures

In rare cases, anti-epileptic medicines such as Levetiracetam Tarbis Farma may worsen the seizures, especially during the first month of treatment or when the dose is being increased

Children and adolescents

• monotherapy (use of only one medicine to treat epilepsy) with Levetiracetam Tarbis Farma is not indicated for 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 laxative medicine) for one hour before and one hour after taking levetiracetam as it may reduce the absorption of levetiracetam

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 discussing it with your doctor

It is not known whether the use of levetiracetam during pregnancy will affect the baby’s growth or development

Levetiracetam is passed into breast milk. Therefore, you should not breast-feed while taking levetiracetam

Driving and using machines

Levetiracetam Tarbis Farma may cause drowsiness or other symptoms that could affect your ability to drive or operate machinery

Levetiracetam Tarbis Farma contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say 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 as prescribed by your doctor.

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 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 less than 50 kg:

Your doctor will prescribe the most suitable formulation of levetiracetam according to the 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 suitable formulation of levetiracetam according to the 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 (6-17 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 chronic treatment. You should continue to take it for as long as your doctor has told you.
• Do not stop your treatment without discussing it with your doctor as your seizures may return.

If you take more Levetiracetam Tarbis Farma than you should

The possible side effects of an overdose of levetiracetam are sleepiness, agitation, aggression, decrease in alertness, inhibition of breathing, and coma.

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

In case of overdose or accidental intake, contact your doctor or pharmacist or call the National Poison Control Centre on 915 620 420, indicating the medicine and the amount taken.

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

Levetiracetam should be discontinued gradually, under the supervision of your doctor, to reduce the risk of increased seizure frequency.

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

4. Possible side effects

Like all medicines, this medicine 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
• swelling of the face, lips, tongue or throat (Quincke’s oedema)
• symptoms of flu and rash on the face followed by a prolonged rash with high fever, high levels of liver enzymes in the blood tests, and an increased number of a type of white blood cell (eosinophilia), swollen lymph nodes, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)
• symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion, and swelling of the feet, ankles, or hands, as these may be signs of acute kidney injury
• a rash that may form blisters and may look like targets (central red spot surrounded by a paler area, with a red ring around 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 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, sleepiness (lethargy), loss of memory (amnesia), memory impairment (memory loss), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as sleepiness, fatigue, and dizziness are more likely to occur when you first start 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

• loss of appetite (anorexia)
• 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

• decrease in the number of platelets, decrease in the number of white blood cells
• weight loss, weight gain
• suicidal thoughts and behaviour, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attacks, mood swings, agitation
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling), attention deficit/hyperactivity disorder (disorders of attention and activity)
• double vision, blurred vision
• abnormal 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 blood sodium levels
• 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 face, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• abnormal heart rhythm (electrocardiogram)
• pancreatitis (inflammation of the pancreas)
• liver failure, hepatitis (inflammation of the liver)
• sudden decrease in kidney function
• skin rash that may lead to blistering, and may look like targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, particularly 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)
• muscle breakdown (rhabdomyolysis) 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 unstable heart rate, confusion, decreased consciousness (these can 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 get 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 Agency 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

Scored, oblong, blue film-coated tablets 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

Yellow, oblong, scored film-coated tablets 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

Scored, oblong, beige to light orange film-coated tablets 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

White, oblong, scored film-coated tablets 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/