- Levetiracetam is a medication that belongs to a class of medicines called
“antiepilepticts”. It is usually used as adjuvant therapy to treat multiple types of
seizures (abnormal electrical conductions in the brain) in children and adults.
-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.
- 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 Kepalev®, 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 Kepalev®
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 Kepalev® according to the age, weight and dose.
- Kepalev® 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 Kepalev® 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.
- 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.
- 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.
- Take Kepalev® at the same time every day.
- Do not stop taking your medication without consulting your doctor.
Each film coated tablet of Kepalev® 500 mg contains:
Levetiracetam 500 mg
- Each film coated tablet of Kepalev® 250 mg contains:
Levetiracetam 250 mg
- Each 1ml of Kepalev® Solution contains:
Levetiracetam 100 mg
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. Kepalev® 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.
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.
- Do not stop your medication without consulting your doctor. Abrupt discontinuation of this medication may worsen your convulsions. Dose should be gradually decreased.
- 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, Kepalev® should be discontinued gradually to avoid an increase of
seizures. Should your doctor decide to stop your Kepalev® treatment, he/she will instruct
you about the gradual withdrawal of Kepalev®.
- Bottle of 100 ml Oral solution.
- Blister of 10 tablets, pack of 3 blisters.
- Store in a dry place, at temperature below 25º C.
