Product Information for the Patient

Levetiracetam Teva 250 mg Film-Coated Tablets

Levetiracetam Teva 500 mg Film-Coated Tablets

Levetiracetam Teva 750 mg Film-Coated Tablets

Levetiracetam Teva 1 000 mg Film-Coated Tablets

Levetiracetam

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

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

Levetiracetam Teva is used:

• alone (monotherapy) in adults and adolescents aged 16 years 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 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.
• concurrently with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in adults, adolescents, children, and infants aged 1 month or older
• myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy
• generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause)

Do not take Levetiracetam Teva

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

Warnings and precautions

Consult your doctor before starting to takeLevetiracetam Teva

• If you have kidney problems, follow your doctor's instructions. They 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 like Levetiracetam Teva 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 or are taking a 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 Teva, see a doctor as soon as possible.

Children and adolescents

Monotherapy with Levetiracetam Teva is not indicated in children and adolescents under 16 years old.

Other medications and Levetiracetam Teva

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take 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.

It is not recommended to breastfeed during treatment.

Driving and operating machinery

Levetiracetam Teva 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 use machinery until it is confirmed that your ability to perform these activities is not impaired.

Levetiracetam Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet EFG; it is essentially "sodium-free".

Levetiracetam Teva 500 mg contains tartrazine

Levetiracetam Teva 500 mg contains the colorant tartrazine (E 102), which may cause allergic reactions.

Levetiracetam Teva 750 mg contains sunset yellow

Levetiracetam Teva 750 mg contains the colorant sunset yellow (E 110), which may cause allergic reactions.

Follow exactly the administration instructions of this medication as 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 Teva 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 Teva, your doctor will prescribe alower dosefor 2 weeks before administering the daily dose of 1,000 mg.

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 based on 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 based on weight and dose.

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

Administration form

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

Treatment duration

• Levetiracetam Teva is used as a chronic treatment. You should continue treatment with Levetiracetam Teva 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 Teva than you should

The possible adverse effects of a Levetiracetam Teva 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.

If you forgot to take Levetiracetam Teva

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 Teva

The discontinuation of treatment with Levetiracetam Teva should be done gradually to avoid an increase in seizures. If your doctor decides to discontinue your treatment with Levetiracetam Teva, they will give you instructions for the gradual withdrawal of Levetiracetam Teva.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• 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 temperature, elevated liver enzyme levels 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, ankles, or feet, as it 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 of rash 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 decline (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 (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, 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 (feeling sleepy), headache.

Common:may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability; convulsions, balance disorder, dizziness, lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• dizziness (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Rare:may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decreased sodium levels in the blood;
• suicide, personality disorders (behavior 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 levels 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 leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister after EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Levetiracetam Teva

• The active ingredient is levetiracetam.

Each coated tablet of Levetiracetam Teva 250, 500, 750, 1 000 mg contains 250, 500, 750, 1000 mg of levetiracetam.

• The other components are:

Core tablet:maize starch, povidone, sodium croscarmellose and magnesium stearate.

Coating:hypromellose 6 cp, titanium dioxide (E 171), macrogol 3350, colorants*.

*The colorants are:

Coated tablets with a 250 mg film coating:brilliant blue FCF (E 133) and indigotin (E 132).

Coated tablets with a 500 mg film coating:indigotin (E 132), tartrazine (E 102) and yellow iron oxide (E 172).

Coated tablets with a 750 mg film coating:yellow iron oxide (E 172), red iron oxide (E 172) and sunset yellow FCF (E 110).

Appearance of the product and contents of the package

Levetiracetam Teva 250 mg coated tablets

Blue-coated tablets, oblong in shape, scored on one side and marked with “9” on one side and “3” on the scored side. Marked with “7285” on the other side of the tablet.

Levetiracetam Teva 500 mg coated tablets

Yellow-coated tablets, oblong in shape, scored on one side and marked with “9” on one side and “3” on the scored side. Marked with “7286” on the other side of the tablet.

Levetiracetam Teva 750 mg coated tablets

Orange-coated tablets, oblong in shape, scored on one side and marked with “9” on one side and “3” on the scored side. Marked with “7287” on the other side of the tablet.

Levetiracetam Teva 1 000 mg coated tablets

White-coated tablets, oblong in shape, scored on one side and marked with “9” on one side and “3” on the scored side. Marked with “7493” on the other side of the tablet.

The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Levetiracetam Teva is supplied in packages of 20, 30, 50, 60, 100, 120 and 200 coated tablets and in single-dose packages of 50 x 1 coated tablets in PVC/PVdC-aluminium perforated.

Only some package sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80. 31-546

Krakow

Poland

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770

Opava-Komarov

Czech Republic

TEVA PHARMA, S.L.U.

C/C, n. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:{MM/AAAA}.

More detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.