Levetiracetam S Kant

Levetiracetam.

The active substance is levetiracetam.
Each ml of oral solution contains 100mg levetiracetam.
Excipients/Inactive Ingredients: The other ingredients are: sodium citrate (E331) (for pH-adjustment), citric acid monohydrate (for pH-adjustment), methyl parahydroxybenzoate (E218), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), grape flavour (contains propylene glycol (E1520)) and purified water.

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

Patient should always take this medicine exactly as prescribed, and to check with a doctor or pharmacist if not sure.
Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Patient must take the oral solution following the doctor's instructions.
Monotherapy (from 16 years of age): Adults (≥18 years) and adolescents (from 16 years of age): Measure the appropriate dosage using the 10ml syringe for patients 4 years and above.
Recommended dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 5ml (500mg) and 15ml (1500mg).
When first starting Levetiracetam, prescribe a lower dose during 2 weeks before giving the lowest daily dose.
Add-on therapy: Dose in adults and adolescents (12 to 17 years): Measure the appropriate dosage using the 10ml syringe for patients of 4 years and above.
Recommended dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 5ml (500mg) and 15ml (1500mg).
Dose in children 6 months and older: Prescribe the most appropriate pharmaceutical form of Levetiracetam according to the age, weight and dose.
For children 6 months to 4 years: Measure the appropriate dosage using the 3ml syringe.
For children above 4 years: Measure the appropriate dosage using the 10ml syringe.
Recommended dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1ml (10mg) and 0.3ml (30mg), per kg bodyweight of the child. (See Table 1 for dose examples).

Click on icon to see table/diagram/image

Dose in infants (1 month to less than 6 months): For infants 1 month to less than 6 months: Measure the appropriate dosage using the 1ml syringe.
Recommended dose: Levetiracetam is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07ml (7mg) and 0.21ml (21mg), per kg bodyweight of the infant. (See Table 2 for dose examples).

Click on icon to see table/diagram/image

Method of administration: After measuring the correct dosage with an appropriate syringe, Levetiracetam oral solution may be diluted in a glass of water or baby's bottle. Levetiracetam may be taken with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
Duration of treatment: Levetiracetam is used as a chronic treatment. Levetiracetam treatment should be continued for as long as prescribed.
Do not stop treatment without the doctor's advice as this could increase the seizures.
If patient forgets to take Levetiracetam: Patient should contact the doctor if he/she has missed one or more doses. Do not take a double dose to make up for a forgotten dose.
If patient stops taking Levetiracetam: If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase of seizures. Should it be decided to stop Levetiracetam treatment, instruct patient about the gradual withdrawal of Levetiracetam.
In case of any further questions on the use of this medicine, patient should ask the doctor or pharmacist.

The possible side effects of an overdose of Levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Patient should contact the doctor if he/she took more Levetiracetam than prescribed. Establish the best possible treatment of overdose.

Patient should not take Levetiracetam if he/she is allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (see Description).

Before using Levetiracetam, be advised: If patient suffers from kidney problems, he/she should follow the doctor's instructions. The dose may be adjusted.
If patient notices any slowdown in the growth or unexpected puberty development of the child, advise patient to contact the doctor.
A small number of people being treated with anti-epileptics such as Levetiracetam have had thoughts of harming or killing themselves. In case of any symptoms of depression and/or suicidal ideation, advise patient to contact the doctor.
If patient has a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or has a disease and/or takes treatment that make(s) him/her prone to heartbeat irregularities or salt imbalances.
Advise patient to tell the 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 the patient or his/her family and friends notice important changes in mood or behaviour; aggravation of epilepsy.
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. If patient experiences any of these new symptoms while taking Levetiracetam, he/she should see a doctor as soon as possible.
Driving and using machines: Levetiracetam may impair the ability to drive or operate any tools or machinery, as it may make the patient feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. Patient should not drive or use machines until it is established that his/her ability to perform such activities is not affected.
Levetiracetam contains: Methyl parahydroxybenzoate (E218): May cause allergic reactions (possibly delayed).
Liquid Maltitol (E965): If patient has been told that he/she has an intolerance to some sugars, advise patient to contact the doctor before taking this medicine.
Sodium: This medicine contains 82.2mg sodium (main component of cooking/table salt) per maximum dose of 30ml. This is equivalent to 4.11% of the recommended maximum daily dietary intake of sodium for an adult.
Propylene glycol (E1520): This medicine contains 9.61mg propylene glycol in each ml. Be advised if the baby is less than 4 weeks old, before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Use in children and adolescents: Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy).

If patient is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, she must ask the doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary.
Patient should not stop the treatment without discussing this with the doctor. A risk of birth defects for the unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patient should tell the doctor immediately, or go to the nearest emergency department, if he/she experiences: Weakness, feels light-headed or dizzy or has 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 the patient 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 adverse reactions were 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.
Muscle weakness, myalgia (muscle pain).
Injury.
Rare: may affect up to 1 in 1000 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 previously mentioned 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 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.
Combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Reporting of side effects: Be advised if patient gets any side effects. This includes any possible side effects not listed in this monograph. Reporting of side effects can also be directly via the local reporting system. By reporting side effects, more information on the safety of this medicine can be provided.

Be advised if patient is taking or has recently taken or might take any other medicines.
Patient should not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may result in a reduction of its effect.

Store below 30°C.
Discard 7 months after first opening.
Store in the original bottle, in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.

Anticonvulsants

N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.

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