Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Epitam 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).

Do not take Epitam

• 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 Epitam

• 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 Epitam 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

• Epitam is not indicated in children and adolescents below 16 years on its own (monotherapy).

Taking other medicines, herbal or dietary supplements
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.

Epitam should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Epitam 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
Epitam 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.

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.

Epitam 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 3,000 mg each day.

When you will first start taking Epitam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

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 Epitam according to the age, weight and dose.

Epitam 100 mg/ml 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 Epitam tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Epitam with or without food.

Duration of treatment

• Epitam is used as a chronic treatment. You should continue Epitam 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 Epitam® than you should
The possible side effects of an overdose of Epitam 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 Epitam®
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 Epitam®
If stopping treatment, Epitam should be discontinued gradually to avoid an increase of seizures.

Should your doctor decide to stop your Epitam treatment, he/she will instruct you about the gradual withdrawal of Epitam.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Epitam 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 behavior 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;
• 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, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• Rash;
• Asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000 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 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 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.

Keep out of the sight and reach of children.
Store below 30°C.
Do not use Epitam® after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of that 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.