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LEVETIRACETAM RIVOPHARM 1000 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM / LEVETIRACETAM

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Levetiracetam Rivopharm 1000 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 tablets are and what they are used for
2. What you need to know before you take Levetiracetam tablets
3. How to take Levetiracetam tablets
4. Possible side effects
5. How to store Levetiracetam tablets
6. Contents of the pack and other information

1. What Levetiracetam tablets are and what they are used for
Levetiracetam tablets (as they will be called in the rest of this leaflet) contain 1000 mg of Levetiracetam in a
film coated tablet.
Levetiracetam tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
They may be used:
• on their 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 tablets
Do not take Levetiracetam
• If you are allergic to levetiracetam, pyrrolidone derivates or any of the other ingredients of this medicine
(listed in Section 6).
Warnings and precautions
Talk to your doctor before taking Levetiracetam tablets
• 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 tablets 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 tablets are not indicated in children and adolescents below 16 years on its own
(monotherapy).
Other medicines and Levetiracetam tablets
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 tablets should not be used during pregnancy unless clearly necessary. A risk of birth defects
for your unborn child cannot be completely excluded. Levetiracetam 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 tablets may impair your ability to drive or operate any tools or machinery, as they 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.

3. How to take Levetiracetam tablets
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 tablets 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 1000 mg and 3000 mg each day.
When you will first start taking Levetiracetam tablets , your doctor will prescribe you a lower dose (500 mg
each day) during 2 weeks before giving you the lowest general dose of 1000mg.
Add-on therapy
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 1000 mg and 3000 mg each day.
Example: if your daily dose is 1000 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 tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take
Levetiracetam tablets with or without food.
Duration of treatment
• Levetiracetam tablets are used as a chronic treatment. You should continue Levetiracetam tablets
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 tablets than you should
The possible side effects of an overdose of Levetiracetam tablets 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 tablets
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 tablets
If stopping treatment, Levetiracetam tablets should be discontinued gradually to avoid an increase of
seizures. Should your doctor decide to stop your Levetiracetam tablets treatment, he/she will instruct you
about the gradual withdrawal of Levetiracetam tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Levetiracetam Rivopharm 1000 mg_Bozza 8_01-06-2017

Package Leaflet: Information for the patient

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 user in 10 people
• nasopharyngitis (inflammation of the nose and throat area)
• somnolence (sleepiness), headache
Common: may affect 1 to 10 users in 100 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, diarrhea, dyspepsia (indigestion), vomiting, nausea
• rash
• asthenia/fatigue (tiredness)
Uncommon: may affect 1 to 10 users in 1,000 people
• decreased number of blood platelets, decreased number of white blood cells
• weight decrease, weight increase
• suicide attempt and suicidal ideation, mental disorder, abnormalbehaviour, 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 (itching)
• muscle weakness, myalgia (muscle pain)
• injury
Rare: may affect 1 to 10 users in 10,000 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 abnormally (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, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam tablets
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 that month.
This medicine does not require any special storage conditions.
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 tablets contain
The active substance is called levetiracetam.
Each tablet contains 1000 mg of levetiracetam.
The other ingredients are:
Tablet core: Maize starch, Colloidal anhydrous silica, Magnesium stearate, Talc, Povidone K 30.
Film-coating: Opadry 85F18422: Macrogol 3350, Polyvinyl alcohol, Titanium dioxide (E171), Talc.
Levetiracetam tablets are packed in blisters in cardboard boxes.
Each blister contains 10 tablets.
What Levetiracetam tablets look like and contents of the pack
Levetiracetam 1000 mg film-coated tablets are white, oblong, scored and marked with the code “1000” on
the same side.
The tablet can be divided into equal halves.
The cardboard boxes contain 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10) and 200
(20x10) film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Rivopharm UK Ltd.
30th Floor, 40 Bank Street
Canary Wharf
London E14 5NR, UK
Manufacturers:
Laboratoires BTT
ZI de Krafft,
67150 Erstein,
France
Rivopharm UK Ltd.
30th Floor, 40 Bank Street
Canary Wharf
London E14 5NR, UK

This leaflet was last revised in 05/2017

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Levetiracetam Rivopharm 1000 mg_Bozza 8_01-06-2017

4. Possible side effects

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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