Each film coated tablet of  Leepra® 500 mg contains:

• Levetiracetam                            500 mg   

Each film coated tablet of  Leepra® 250 mg contains:

• Levetiracetam                            250 mg 

Each 1ml  of  Leepra® Solution contains:

• Levetiracetam                            100 mg   

As Monotherapy: 

• In the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.

As Adjunctive therapy: 

• In the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
• In the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults and
  adolescents from 12 years of age with Idiopathic Generalised Epilepsy.

• If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine.

Probenecid:

• Probenecid, a renal tubular secretion blocking agent, has been shown to inhibit the renal clearance of the primary metabolite, but not of levetiracetam. Nevertheless, the concentration of this metabolite remains low.

Methotrexate:

• Concomitant administration of levetiracetam and methotrexate has been reported to decrease methotrexate clearance,resulting in increased/prolonged blood methotrexate concentration to potentially toxic levels. Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs.

Laxatives:

• There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.

Food and alcohol:

• The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced.

• 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. Leepra® 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.

¤ Although it may be rare, some patients may experience undesirable side effects when taking a medication. Tell your doctor or get medical help if you have any of the following signs or symptoms:

• The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness.
• At the beginning of the treatment or at increased dose side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common:

• Nasopharyngitis.
• Sleepiness, headache.

Common:

• 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:

• 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.

Overdosage:

• If you take a lot of Leepra®, you should contact your doctor directly or go to the nearest Hospital even if there are no signs of discomfort.

¤ Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

• General dose: between 1000 mg and 3000 mg each day.
• When you will first start taking Leepra®, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

¤ Adolescents (12 to 17 years) weighing 50 kg or less:

• Your doctor will prescribe the most appropriate pharmaceutical form of Leepra® according to weight and dose.

¤ Dose in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:

• Your doctor will prescribe the most appropriate pharmaceutical form of Leepra® according to the age, weight and dose.
• Leepra® 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets don’t allow accurate dosage.

¤ If you forget to take Leepra® Take the missed dose as soon as you remember. If it is already close to the next dose, just skip the missed dose and continue with your regular regimen. Do not double the dose.

¤ If you were prescribed the oral solution, make sure to ask your pharmacist for a medicine dropper to help you measure your dose. Do not use a household teaspoon.

¤ Recommended dose is individualized based on age and indication. The medication is usually taken twice a day. Take as directed by your doctor.

¤ Take tablets with or without food.

¤ Take tablet with a full glass of water.

¤ Do not chew or crush tablets.

¤ Take Leepra® at the same time every day.

¤ Do not stop taking your medication without consulting your doctor.

• Talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness.
• Contact your doctor if you experience unusual changes in behavior or mood, appearance or worsening of depression, suicidal thoughts, excessive drowsiness or fatigue and weakness.
• Contact your doctor if you experience liver problems like dark urine, feeling tired, not hungry, stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• This medication may cause blood problems such as neutropenia (Low number of neutrophils, neutrophils are responsible for fighting infections caused by bacteria), a decrease in red blood cells and in heamoglobin.
• 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 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.
• If stopping treatment, Leepra® should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Leepra® treatment, he/she will instruct you about the gradual withdrawal of Leepra®.

Effects on ability to drive and use machines:

• Leepra® 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.

• Bottle of 100 ml Oral solution.
• Blister of 10 tablets, pack of 3 blisters.  

• Store in a dry place, at temperature below 25º C.