Levetiracetam Teva

Patient Information Leaflet: Information for the patient

Levetiracetam Teva 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets

levetiracetam
Read this leaflet carefully before you or your child starts taking this medicine
because it contains important information for you.

• Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 epileptic seizures).
Levetiracetam Teva is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated attacks (seizures). Levetiracetam is used for the type of epilepsy in which the initial seizure affects only one part of the brain, but may subsequently 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.
• as an add-on to other antiepileptic medicines to treat:
  • partial-onset seizures with or without secondary generalization in adults, adolescents, children, and infants from one month of age;
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy;
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed 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 taking Levetiracetam Teva

• If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you notice slowed growth or unexpected onset of puberty in the child, contact your doctor.
• A small number of people being treated with antiepileptic medicines such as Levetiracetam Teva have experienced self-harming thoughts or suicidal ideas. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
• If you or a family member has a heart rhythm disorder (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

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

• Unusual thoughts, feeling irritable, or more aggressive behaviour than usual, or if you or your family and friends notice the onset of significant changes in mood or behaviour.
• Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of existing abilities, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while being treated with Levetiracetam Teva, consult a
doctor as soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 cause loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor before taking this medicine. Levetiracetam may be used during pregnancy only if,
after careful evaluation, your doctor considers it necessary.
Do not stop your treatment without first discussing it with your doctor.
A risk of birth defects in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Teva may reduce your ability to drive vehicles or operate tools or machinery, as it may
cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. Do not
drive or operate machinery until you are certain that your ability to perform these activities is not
affected.
Levetiracetam Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially
'sodium-free'.
Levetiracetam Teva 500 mg contains tartrazine
Levetiracetam Teva 500 mg contains the colouring agent tartrazine (E102), which may cause allergic
reactions.
Levetiracetam Teva 750 mg contains sunset yellow
Levetiracetam Teva 750 mg contains the colouring agent sunset yellow (E110), which may cause
allergic reactions.

3. How to take Levetiracetam Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your
doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Levetiracetam Teva must be taken twice daily, once in the morning and once in the evening, approximately
at the same time each day.
Adjunctive and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When you first start taking Levetiracetam Teva, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.
• Adolescents (12 to 17 years) weighing less than or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on weight and dose.
• Dose for 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 age, weight, and dose.

An oral solution is a more suitable formulation for infants and children under 6 years of age, for children and adolescents (6 to 17 years) weighing less than 50 kg, and when tablets do not allow accurate dosing.
Method of administration
Swallow Levetiracetam Teva tablets with a sufficient amount of liquid (e.g., a glass of water). You may take Levetiracetam Teva with or without food. After oral administration, you may experience a bitter taste of levetiracetam.
Duration of treatment

• Levetiracetam Teva is used as a long-term treatment. Treatment with Levetiracetam Teva should continue for as long as prescribed by your doctor.
• Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures.

If you take more Levetiracetam Teva than you should
Possible adverse effects of an overdose of Levetiracetam Teva include drowsiness, agitation,
aggression, reduced attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for the overdose.
If you forget to take Levetiracetam Teva
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed tablet.
If you stop taking Levetiracetam Teva
If treatment is to be discontinued, Levetiracetam Teva should be gradually withdrawn to avoid an increase in seizures. If your doctor decides to stop treatment with Levetiracetam Teva, they will provide you with instructions on how to gradually discontinue the medication.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately or go to the nearest emergency department if you experience:

• weakness, dizziness or lightheadedness, or have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, and throat (Quincke's oedema)
• flu-like symptoms and a rash on the face followed by widespread rash with high fever, increased liver enzyme levels in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
• symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles, or feet, as these may indicate sudden worsening of kidney function
• a skin rash that may appear as blistering lesions resembling small targets (dark spots in the centre surrounded by a lighter area, with a dark 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 of skin rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behaviour, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most commonly reported side effects are: nasopharyngitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more frequent. However, these effects should decrease over time.
Very common: may affect more than 1 in 10 people

• nasopharyngitis
• drowsiness, headache

Common: may affect up to 1 in 10 people

• loss of appetite (anorexia)
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• seizure, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (sensation of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (feeling weak)

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells in the blood
• weight loss, weight gain
• suicide attempt and suicidal thoughts, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation
• amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paraesthesia (tingling), attention disturbance (loss of concentration)
• diplopia (double vision), blurred vision
• elevated or abnormal liver function test results
• hair loss, eczema, pruritus (itching)
• muscle weakness, myalgia (muscle pain)
• trauma

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

• infection
• decreased number of all types of blood cells
• severe allergic reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], Quincke's oedema [swelling of the face, lips, tongue, and throat])
• decreased concentration of sodium in the blood
• suicide, personality disorder (behavioural problems), thought disturbances (slowed thinking, inability to concentrate)
• delirium
• encephalopathy (see the section “Contact your doctor immediately” for a detailed description of symptoms)
• seizures may worsen or occur more frequently
• uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• changes in heart rhythm (electrocardiogram)
• pancreatitis
• liver failure, hepatitis
• sudden worsening of kidney function
• skin rash that may appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter 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 affecting more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase levels. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping gait 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

Very rare: may affect up to 1 in 10,000 people

• recurrent unwanted thoughts or urges to perform actions repeatedly (obsessive-compulsive disorder)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store 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 that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Teva contains

• The active substance is levetiracetam. Each film-coated tablet of Levetiracetam Teva 250, 500, 750, 1000 mg contains 250, 500, 750, 1000 mg of levetiracetam, respectively.
• The other components are:
  Tablet core: maize starch, povidone, croscarmellose sodium, and magnesium stearate.
  Tablet coating: hypromellose 6 cp, titanium dioxide (E171), macrogol 3350, colourants*

*The colourants are:
Film-coated tablets 250 mg: Brilliant Blue FCF (E133) and indigo carmine (E132).
Film-coated tablets 500 mg: Indigo carmine (E132), tartrazine (E102), and iron oxide yellow (E172).
Film-coated tablets 750 mg: Iron oxide yellow (E172), iron oxide red (E172), and Sunset Yellow FCF (E110).

Description of the appearance of Levetiracetam Teva and pack contents
Levetiracetam Teva 250 mg film-coated tablets
Blue, oblong, film-coated tablets with a breakline on one side, marked with “9” and “3” on either side of the breakline. The other side of the tablet is engraved with “7285”.
Levetiracetam Teva 500 mg film-coated tablets
Yellow, oblong, film-coated tablets with a breakline on one side, marked with “9” and “3” on either side of the breakline. The other side of the tablet is engraved with “7286”.
Levetiracetam Teva 750 mg film-coated tablets
Orange, oblong, film-coated tablets with a breakline on one side, marked with “9” and “3” on either side of the breakline. The other side of the tablet is engraved with “7287”.
Levetiracetam Teva 1000 mg film-coated tablets
White, oblong, film-coated tablets with a breakline on one side, marked with “9” and “3” on either side of the breakline. The other side of the tablet is engraved with “7493”.
The breakline is intended only to facilitate swallowing and is not intended to divide the tablet into equal doses.

Levetiracetam Teva is available in packs containing 20, 30, 50, 60, 100, 120 and 200 film-coated tablets, and in packs of 50 x 1 film-coated tablets in unit dose perforated blisters made of PVC/PVdC–aluminium.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturers
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 Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tel/Tél: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Тел: +359 24899585 Belgien/Belgique
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
Teva GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel.: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel.: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tél: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. Teva Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel. +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

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