Patient leaflet - Levetiracetam Teva
B. PACKAGE LEAFLET
Package Leaflet: 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 all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet :
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1. What Levetiracetam Teva is and what it is used for
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2. What you need to know before you take Levetiracetam Teva
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3. How to take Levetiracetam Teva
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4. Possible side effects
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5. How to store Levetiracetam Teva
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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:
- on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.
- as an add-on to other antiepileptic medicines to treat:
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■ partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age
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■ myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
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■ primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
2. What you need to know before you take Levetiracetam Teva
Do not take Levetiracetam Teva
- If you are allergic to levetiracetam, pyrrolidone derivatives or 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 suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.
- If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
- A small number of people being treated with anti-epileptics such as Levetiracetam Teva have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
- If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
- Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
- Aggravation of epilepsy
Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam Teva, see a doctor as soon as possible.
Children and adolescents
- Levetiracetam Teva is not indicated in children and adolescents below 16 years on its own (monotherapy).
Other medicines and Levetiracetam Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
You should not stop your treatment without discussing this with your doctor.
A risk of birth defects for your unborn child cannot be completely excluded.
Breast-feeding is not recommended during treatment.
Driving and using machines
Levetiracetam Teva may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Levetiracetam Teva contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet that is to say essentially ‚sodium-free ‘.
Levetiracetam Teva 500 mg contains Tartrazine
Levetiracetam Teva 500 mg contains the colouring agent tartrazine (E102) that may cause allergic reactions.
Levetiracetam Teva 750 mg contains Sunset Yellow
Levetiracetam Teva 750 mg contains the colouring agent sunset yellow (E110) that may cause allergic reactions.
3. How to take Levetiracetam Teva
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take the number of tablets following your doctor’s instructions.
Levetiracetam Teva must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Adjunctive Therapy and monotherapy (from 16 years of age)
- Adults (>18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 1,000 mg and 3,000 mg each day.
When you will first start taking Levetiracetam Teva, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Example: if your daily dose is intended to be 1000 mg, your reduced starting 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 incremented to reach 1000 mg daily after 2 weeks.
- Adolescents (12 to 17 years) weighing 50 kg or less:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiractam according to weight and dose.
- Dose 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 according to the age, weight and dose.
An oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when tablets don’t allow accurate dosage.
Method of administration
Swallow Levetiracetam Teva tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Levetiracetam Teva with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
Duration of treatment
- Levetiracetam Teva is used as a chronic treatment. You should continue Levetiracetam Teva treatment for as long as your doctor has told you.
- Do not stop your treatment without your doctor’s advice as this could increase your seizures.
If you take more Levetiracetam Teva than you should
The possible side effects of an overdose of Levetiracetam Teva are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more tablets than you should.Your doctor will establish the best possible treatment of 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 a forgotten tablet.
If you stop taking Levetiracetam Teva
If stopping treatment, Levetiracetam Teva should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam Teva treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Teva.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately, or go to your nearest emergency department, if you experience:
- weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious 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 an extended rash with a high temperature, increased levels of liver enzymes seen 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 low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
- a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
- a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
- a more severe form of rash causing skin peeling in 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 (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.
The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.
Very common: may affect more than 1 in 10 people
- nasopharyngitis;
- somnolence (sleepiness), headache.
Common: may affect up to 1 in 10 people
- anorexia (loss of appetite);
- depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
- convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
- vertigo (sensation of rotation);
- cough;
- abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
- rash;
- asthenia/fatigue (tiredness).
Uncommon: may affect up to 1 in 100 people
- decreased number of blood platelets, decreased number of white blood cells;
- weight decrease, weight increase;
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
diplopia (double vision), vision blurred;
elevated/abnormal values in a liver function test;
hair loss, eczema, pruritus;
muscle weakness, myalgia (muscle pain);
injury.
Rare: may affect up to 1 in 1,000 people
- infection;
- decreased number of all blood cell types;
- severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);
- decreased blood sodium concentration;
- suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
- delirium;
- encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
- seizures may become worse or happen more often;
- uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
- change of the heart rhythm (Electrocardiogram);
- pancreatitis;
- liver failure, hepatitis;
- sudden decrease in kidney function;
- skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis).
- rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
- limp or difficulty walking
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help 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 box and blister after EXP.
The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Levetiracetam Teva contains
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– The active substance is levetiracetam.
Each Levetiracetam Teva 250, 500, 750, 1,000 mg film-coated tablet contains 250, 500, 750, 1,000 mg levetiracetam.
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– The other ingredients are:
What Levetiracetam Teva looks like and contents of the pack
Levetiracetam Teva 250 mg film-coated tablets
Blue, oblong shaped, film-coated tablets, scored on one side and debossed with „9“ on one side of the score and with „3“ on the other side of the score. Debossed with „7285“ on the other side of the tablet.
Levetiracetam Teva 500 mg film-coated tablets
Yellow, oblong shaped, film-coated tablets, scored on one side and debossed with „9“ on one side of the score and with „3“ on the other side of the score. Debossed with „7286“ on the other side of the tablet.
Levetiracetam Teva 750 mg film-coated tablets
Orange, oblong shaped, film-coated tablets, scored on one side and debossed with „9“ on one side of the score and with „3“ on the other side of the score. Debossed with „7287“ on the other side of the tablet.
Levetiracetam Teva 1,000 mg film-coated tablets
White, oblong shaped, film-coated tablets, scored on one side and debossed with „9“ on one side of the score and with „3“ on the other side of the score. Debossed with „7493“ on the other side of the tablet.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Levetiracetam Teva are available in pack sizes of 20, 30, 50, 60, 100, 120 and 200 film-coated tablets and 50 × 1 film-coated tablets in PVC/PVdC – aluminium perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation 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 any information about this medicine, please
Authorisation Holder:
Belgie/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 38207373
Etnrapua
TeBa OapMa EAfl
Ten: +359 24899585
Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111
Danmark
Teva Denmark A/S
Tlf: +45 44985511
Deutschland
Teva GmbH
Tel: +49 73140208
Eesti
UAB Teva Baltics Eesti filiaal
Tel.: +372 6610801
EZZaöa
Specifar A.B.E.E.
Tql: +30 2118805000
España
Teva Pharma, S.L.U.
Tél: +34 913873280
contact the local representative of the Marketing
Lietuva
UAB Teva Baltics
Tel: +370 52660203
Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgien/Belgique
Tel/Tel: +32 38207373
Magyarorszag
Teva Gyogyszergyar Zrt
Tel.: +36 12886400
Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117
Nederland
Teva Nederland B.V.
Tel: +31 8000228400
Norge
Teva Norway AS
Tlf: +47 66775590
Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel.: +43 1970070
Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300
| France Teva Santé Tél: +33 155917800 | Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o. Tel: + 385 13720000 | Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524 |
| Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
| Island Teva Pharma Iceland ehf. Simi: + 354 5503300 | Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel. + 358 201805900 |
| Knnpoç Specifar A.B.E.E. EXXaSa | Sverige Teva Sweden AB Tel: +46 42121100 |
Tql: +302118805000
| Latvija UAB Teva Baltics filiale Latvijä Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
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