Levetiracetam Teva 1000 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Teva 250 mg Film-coated Tablets EFG

Levetiracetam Teva 500 mg Film-coated Tablets EFG

Levetiracetam Teva 750 mg Film-coated Tablets EFG

Levetiracetam Teva 1,000 mg Film-coated Tablets EFG

Levetiracetam

Read the entire leaflet carefully before you or your child starts taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Levetiracetam Teva is and what it is used for
2. What you need to know before taking Levetiracetam Teva
3. How to take Levetiracetam Teva
4. Possible side effects
5. How to store Levetiracetam Teva
6. Contents of the pack and other information

1. What Levetiracetam Teva is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Teva is used:

• as monotherapy (on its own) in adults and adolescents 16 years of age or older with newly diagnosed epilepsy, to treat a specific form of epilepsy. Epilepsy is a condition in which patients experience seizures. Levetiracetam is used for the form of epilepsy in which seizures initially affect only one side of the brain but may then spread to broader areas on 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 medicines to treat:

  • partial-onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy
  • generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).

2. What you need to know before starting Levetiracetam Teva

Do not take Levetiracetam Teva

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

Warnings and precautions

Talk to your doctor before starting Levetiracetam Teva

• If you have kidney problems, follow your doctor's instructions. Your doctor will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Teva have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a personal or family history of irregular heartbeat (visible on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may make you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last longer than a few days:

• Abnormal thoughts, feeling irritable, or reacting more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy
• Rarely, seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking Levetiracetam Teva, see a doctor as soon as possible.

Children and adolescents

Treatment with Levetiracetam Teva alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Teva

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

Do not take macrogol (a laxative medicine) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Levetiracetam may only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without first discussing it with your doctor.

The risk of birth defects in the baby cannot be completely ruled out.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Teva may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. You should not drive or use machinery until you have determined that your ability to perform these activities is not impaired.

Levetiracetam Teva contains sodium

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

Levetiracetam Teva 500 mg contains tartrazine

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

Levetiracetam Teva 750 mg contains sunset yellow

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

3. How to take Levetiracetam Teva

Follow exactly the dosing instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take the number of tablets prescribed by your doctor.

Levetiracetam Teva should be taken twice daily, once in the morning and once in the evening, 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) weighing 50 kg or more:

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

When you start taking Levetiracetam Teva, your doctor will prescribe a lower dose for the first 2 weeks before increasing to the lowest daily dose of 1,000 mg.

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

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

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

• Dosage in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:

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

An oral solution is a more suitable formulation for infants and children under 6 years of age, and for children and adolescents (6 to 17 years) weighing less than 50 kg, or when tablets do not allow precise dosing.

Method of administration

Swallow the Levetiracetam Teva tablets with sufficient liquid (e.g. a glass of water). Levetiracetam Teva may be taken with or without food. After oral administration of levetiracetam, a bitter taste may be noticed.

Duration of treatment

• Levetiracetam Teva is used as a chronic treatment. You must continue taking Levetiracetam Teva for the length of time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as your seizures may increase.

If you take more Levetiracetam Teva than you should

Possible adverse effects of an overdose of Levetiracetam Teva include drowsiness, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

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

If you forget to take Levetiracetam Teva

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for missed doses.

If you stop taking Levetiracetam Teva

Discontinuation of Levetiracetam Teva treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Teva, he or she will provide instructions for the gradual withdrawal of the medicine.

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

4. Possible adverse effects

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

Tell 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 serious allergic (anaphylactic) reaction
• swelling of the face, lips, tongue or throat (angioedema)
• flu-like symptoms and facial rash followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, an increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
• symptoms such as low urine volume, tiredness, nausea, vomiting, confusion, and swelling of legs, ankles or feet, as these may be signs of sudden decrease in kidney function
• a skin rash that may blister and may appear as small target-like lesions (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of rash 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 confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, somnolence (feeling sleepy), headache, fatigue and dizziness. Adverse effects such as feeling sleepy, feeling weak and dizziness may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (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; seizures, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn and acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired coordination of movement), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (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 (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue and throat));
• decreased concentration of sodium in blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Tell your doctor immediately” for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrollable muscle spasms affecting the head, trunk 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 lead to blisters that may appear as small target-like lesions (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially 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);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Teva

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam Teva

• The active substance is levetiracetam.

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

• The other components are:

Tablet core: maize starch, povidone, croscarmellose sodium and magnesium stearate.

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

*The colourants are:

250 mg film-coated tablets: Brilliant Blue FCF (E 133) and indigo carmine (E 132).

500 mg film-coated tablets: indigo carmine (E 132), tartrazine (E 102) and yellow iron oxide (E 172).

750 mg film-coated tablets: yellow iron oxide (E 172), red iron oxide (E 172) and sunset yellow FCF (E 110).

Presentation of the product and contents of the pack

Levetiracetam Teva 250 mg film-coated tablets

Blue, oblong, film-coated tablets, scored on one side, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7285” on the other side of the tablet.

Levetiracetam Teva 500 mg film-coated tablets

Yellow, oblong, film-coated tablets, scored on one side, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7286” on the other side of the tablet.

Levetiracetam Teva 750 mg film-coated tablets

Orange, oblong, film-coated tablets, scored on one side, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7287” on the other side of the tablet.

Levetiracetam Teva 1 000 mg film-coated tablets

White, oblong, film-coated tablets, scored on one side, engraved with “9” on one side and marked with “3” on the scored side. Engraved with “7493” on the other side of the tablet.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer

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

The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.