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

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceside effects,consult your doctor or pharmacist, evenifthey are not listed in this leaflet. See section4.

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

5Storage of Levetiracetam Teva

6.Contents of the pack and additional information

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

Levetiracetam Teva is used:

• alone (monotherapy) inadults and adolescents16years of age or older with recently diagnosed epilepsy, to treata form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used to treat the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider 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.

• concurrently with other antiepileptic medications to treat:
• • partial onset seizures with or without generalization inadults, adolescents, children, and infants1 month of age or older
  • myoclonic seizures (shock-like, short, muscle or group of muscles)inadults and adolescents12years of age or older with juvenile myoclonic epilepsygeneralized tonic-clonic seizures (major seizures, including loss of consciousness)inadults and adolescents12years of age 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 take Levetiracetam 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 unexpected puberty development, 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.

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 effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Levetiracetam Teva should not be used during pregnancy unless strictly necessary.The risk of birth defects for the baby cannot be completely ruled out.In animal studies, Levetiracetam Teva has shown unwanted effects on reproduction at doses higher than those you may need to control your seizures.

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 operate machinery until it is confirmed that your ability to perform these activities is not impaired.

Levetiracetam Teva 500 mg contains tartrazine

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

Levetiracetam Teva 750 mg contains sunset yellow

Levetiracetam Teva 750 mg contains sunset yellow (E 110) colorant, 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 that your doctor has prescribed.

Levetiracetam Teva should be taken twice a day, once in the morning and once at night, approximately at the same time each day.

Monotherapy

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

General dosage: between 1,000 mg and 3,000 mg per day.

When starting to take Levetiracetam Teva, your doctor will prescribe a lower dose (500 mg per day) for two weeks before administering the general lowest dose of 1,000 mg.

Concomitant therapy

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

General dosage: between 1,000 mg and 3,000 mg per day.

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

• Dosage in infants (1 month to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) with a weight of less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to weight and dosage.

A oral solution is a more appropriate formulation for infants and children under 6 years old and for children and adolescents (6 to 17 years) with a weight of 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.

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 forget 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 questions 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 (drowsiness), headache, fatigue, and dizziness. The side effects such as drowsiness, 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 10people

• nasopharyngitis;
• drowsiness (drowsiness), headache.

Common:may affect up to 1 in 10people

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

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

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (severe and important allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decrease in sodium concentration in blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which can 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 associated. 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 thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on 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 CAD. The expiration date is the last day of the month indicated.

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

Levetiracetam Teva Composition

• The active ingredient is levetiracetam.

Each coated tablet of Levetiracetam Teva 250, 500, 750, 1.000 mg contains 250, 500, 750, 1.000 mg of levetiracetam.

• The other components are:

Core of the tablet: maize starch, povidone, croscarmellose sodium, 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 pack

Levetiracetam Teva 250 mg coated tablets

Blue coated tablets, oblong in shape, scored on one side and 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 coated tablets

Yellow coated tablets, oblong in shape, scored on one side and 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 coated tablets

Orange coated tablets, oblong in shape, scored on one side and 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 coated tablets

White coated tablets, oblong in shape, scored on one side and 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 only for breaking the tablet and facilitating swallowing, but not for dividing into equal doses.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible Person

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

Netherlands

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:{MM/AAAA}.

Further detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.