Leracet tablets contain 250 mg or 500 mg of Levetiracetam film coated tablet.
Leracet 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). Leracet 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).
 

Do not take Leracet
• 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 Leracet 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 slowdown 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 Leracet tablets 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.
In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that
causes multiple types of seizures and loss of skills you may notice that the seizures remain
present or are becoming worse during your treatment.
If you experience any of these new symptoms while taking Leracet, see a doctor as soon as
possible.
 

Children and adolescents
• Leracet tablets are not indicated in children and adolescents below 16 years on its own
(monotherapy).
 

Other medicines and Leracet 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. Leracet 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 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.
 

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.
Leracet tablets 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
Recommended dose: between 1 000 mg and 3 000 mg each day. When you will first start taking
Levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the
lowest daily dose.
Example: if your daily dose is intended to be 1 000 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 1 000 mg daily after 2 weeks.
 

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more
Your doctor will prescribe the most appropriate pharmaceutical form of Leracet according to
weight and dose.
 

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 Leracet tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take
Leracet tablets with or without food. After oral administration the bitter taste of levetiracetam
may be experienced.
 

Duration of treatment
• Leracet tablets are used as a chronic treatment. You should continue Leracet 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 Leracet 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 Leracet 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 Leracet tablets
If stopping treatment, Leracet tablets should be discontinued gradually to avoid an increase of
seizures. Should your doctor decide to stop your Leracet tablets treatment, he/she will instruct
you about the gradual withdrawal of Leracet tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
 

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 (itching)
• 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 of skin rash 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.
Evidence also suggests a possible predisposition of the Japanese population to neuroleptic
malignant syndrome (NMS).
 

Very rare: may affect up to 1 in 10000 people
• repeated unwanted thoughts or sensations or the urge to do something over and over again
(Obsessive Compulsive Disorder).
Reporting of side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
 

- Keep this medicine out of the sight and reach of children.
- Keep this medicine in the original package.
- Store below 30°C.
- Do not use this medicine after the expiry date which is stated on the blister and carton.
- 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.