LETIREM film-coated tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

LETIREM is used:

As monotherapy:

·       In adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalization (a secondary generalization is when the seizure spreads within the brain).

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 in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.

·       Primary generalised tonic-clonic seizures 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 LETIREM

·       If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of this medicine (listed in Section 6).

Take special care with LETIREM

Talk to your doctor before taking LETIREM

·       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.

·       If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.

·       A small number of people being treated with anti-epileptics such as LETIREM have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking LETIREM with food, drink and alcohol

You may take LETIREM with or without food. As a safety precaution, do not take LETIREM with alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or if you think you may be pregnant, please inform your doctor.

LETIREM should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. 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

LETIREM may impair your ability to drive or operate any tools or machinery, as LETIREM 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.

LETIREM must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Take the number of tablets following your doctor´s instructions.

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 LETIREM, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

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.

Dose in infants (6 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 presentation more appropriate to infants and children under the age of 6 years.

General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.

Example: a general dose of 20 mg per kg bodyweight each day, you must give your 25 kg child 1 tablet of LETIREM 250 mg in the morning and 1 tablet in the evening.

Dose in infants (1 month to less than 6 months):

An oral solution of levetiracetam (100 mg/ml) is a presentation more appropriate to infants.

Method of administration

Swallow LETIREM tablets with a sufficient quantity of liquid (e.g. a glass of water).

Duration of treatment

·       LETIREM is used as a chronic treatment. You should continue LETIREM 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. Should your doctor decide to stop your LETIREM treatment, he/she will instruct you about the gradual withdrawal of LETIREM.

If you take more LETIREM than you should

The possible side effects of an overdose of levetiracetam 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 LETIREM

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 LETIREM

If stopping treatment, as with other antiepileptic medicines, LETIREM should be discontinued gradually to avoid an increase of seizures.

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.

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.

Very common: may affect more than 1 user in 10

·       Nasopharyngitis;

·       Somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100

·       Anorexia (loss of appetite);

·       Depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

·       Convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary trembling);

·       Vertigo (sensation of rotation);

·       Cough;

·       Abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

·       Rash;

·       Asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000

·       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;

·       Liver function test abnormal;

·       Hair loss, eczema, pruritus;

·       Muscle weakness, myalgia (muscle pain);

·       Injury.

Rare: may affect 1 to 10 users in 10,000

·       Infection;

·       Decreased number of all blood cell types;

·       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;

·       Hepatic failure, hepatitis;

·       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).

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

-       Keep this medicine out of the sight and reach of children.

-       Do not store above 30ºC.

-       Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.

-       Do not use LETIREM if you notice any visible signs of deterioration.

-       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.