Levetiracetam Teva 250 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Levetiracetam Teva 250mg film-coated tablets EFG

Levetiracetam Teva 500mg film-coated tablets EFG

Levetiracetam Teva 750mg film-coated tablets EFG

Levetiracetam Teva 1,000mg film-coated tablets EFG

Levetiracetam

Please read all of this leaflet carefully before you or your child starts 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are 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 (single treatment) in adults and adolescents 16 years of age or older with newly diagnosed epilepsy, to treat one type of epilepsy. Epilepsy is a disease in which patients have attacks (seizures). Levetiracetam is used for the type 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 from 12 years of age with juvenile myoclonic epilepsy
  • generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking 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.

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 medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may reduce the effectiveness of levetiracetam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Levetiracetam Teva should not be used during pregnancy unless strictly necessary. The risk of birth defects for the baby cannot be completely ruled out. Animal studies have shown adverse effects on reproduction with Levetiracetam Teva at doses higher than those required to control your seizures.

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 are certain that your ability to perform these activities is not impaired.

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 instructions for using this medicine given by your doctor or pharmacist. If you are unsure, 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.

Monotherapy

• Dosage in adults and adolescents (from 16 years of age):

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

When you first start taking Levetiracetam Teva, your doctor will prescribe a lower dose (500 mg per day) for two weeks before increasing to the lowest usual dose of 1,000 mg.

Concomitant therapy

• Dosage in adults and adolescents (from 12 to 17 years of age) with a body weight of 50 kg or more:

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

For example: if your daily dose is 1,000 mg, you may take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

• Dosage in infants (from 1 month to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) with body weight below 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam based on body 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 (from 6 to 17 years) with body weight below 50 kg, especially 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.

Duration of treatment

• Levetiracetam Teva is used as a chronic treatment. You should continue treatment with Levetiracetam Teva for the duration indicated by your doctor.
• Do not stop your treatment without consulting your doctor, 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, they will provide instructions for gradually withdrawing the medication.

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 everybody gets 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 rash on the face 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 signs of confusion, somnolence (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, 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 (sensation of spinning)
• cough
• abdominal pain, diarrhea, 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 behavior, 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 disturbances (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 (severe and serious allergic reaction), angioedema (swelling of face, lips, tongue, and throat))
• decreased concentration of sodium in blood
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating)
• uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• pancreatitis (inflammation of the pancreas)
• liver failure, hepatitis (inflammation of the liver)
• sudden decrease in kidney function
• skin rash, which may lead to blisters appearing 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.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps 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, 1,000 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 indigotine (E 132).

500 mg film-coated tablets: indigotine (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).

Appearance 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 face and marked with “3” on the scored face. Engraved with “7285” on the other face of the tablet.

Levetiracetam Teva 500 mg film-coated tablets

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

Levetiracetam Teva 750 mg film-coated tablets

Orange, oblong, film-coated tablets, scored on one side, engraved with “9” on one face and marked with “3” on the scored face. Engraved with “7287” on the other face 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 face and marked with “3” on the scored face. Engraved with “7493” on the other face of the tablet.

The score is intended only to facilitate breaking the tablet for ease of swallowing and does not allow division 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 some pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pagalli út 13

Debrecen H-4042

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

United Kingdom

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.