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Levetiracetam Teva (levetiracetam) – Package leaflet - N03AX14

Updated on site: 08-Oct-2017

Medication nameLevetiracetam Teva
ATC CodeN03AX14
Substancelevetiracetam
ManufacturerTeva B.V.

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.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-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:

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

2.What you need to know before you take 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:

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:

partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

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

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.

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 breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam Teva should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetiracetam Teva has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

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 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.

Monotherapy

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

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 (500 mg each day) during 2 weeks before giving you the lowest general dose of 1,000 mg.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more: General dose: between 1,000 mg and 3,000 mg each day.

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

Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 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.

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);

uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

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.

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

-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.

-The other ingredients 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:

250 mg film-coated tablets: brilliant blue FCF (E133) and indigotine (E132).

500 mg film-coated tablets: indigotine (E132), tartrazine (E102) and iron oxide yellow (E172). 750 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172) and sunset yellow FCF (E110).

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 x 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 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./A.G.

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Tel: +370 5 266 02 03

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

Teva Pharma Belgium S.A./A.G.

Teл: +359 2 489 95 82

Belgien/Belgique

 

Tél/Tel: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: +49 731 402 08

Tel: +31 (0) 800 0228400

Eesti

Norge

Teva Eesti esindus

Teva Norway AS

UAB Sicor Biotech Eesti filiaal

Tlf: +47 66 77 55 90

Tel.: +372 6610801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

España

Polska

Teva Pharma, S.L.U

Teva Pharmaceuticals Polska Sp. z o.o.

Tél: +(34) 91 387 32 80

Tel.: +(48) 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +(33) 1 55 91 7800

Tel: (351) 214 235 910

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 (0)51 321740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

ratiopharm Oy

Teva Pharmaceuticals Slovakia s.r.o.

Finnland

Tel: +(421) 2 5726 7911

Sími: + 358 20 180 5900

 

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +39 028917981

puh./tel. + 358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

Ελλάδα

Tel: +(46) 42 12 11 00

Τηλ: +30 210 72 79 099

 

Latvija

United Kingdom

UAB Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67 323 666

Tel: +(44) 1977 628 500

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

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