Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Levetiracetam Thame 100mg/ml Oral Solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Levetiracetam may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 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 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).
What you need to know before you take it
e Levetiracetam Do not take Levetiracetam 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 Levetiracetam 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. VAR/IB-025
A small number of people being treated with anti-epileptics such as Levetiracetam have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, 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.
Tell your 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 you or your family and friends notice important changes in mood or behaviour. Aggravation of epilepsy Your 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. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills you may notice that the seizures remain present or are becoming worse during your treatment. If you experience any of these new symptoms while taking Levetiracetam, see a doctor as soon as possible. Children and adolescents Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy). Other medicines and Levetiracetam Tell your doctor or pharmacist if you are taking or 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 reduction 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. Levetiracetam 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. Driving and using machines Levetiracetam 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. Levetiracetam contains: Methyl parahydroxybenzoate (E218): May cause allergic reactions (possibly delayed). Liquid Maltitol (E965): If you have been told by your doctor that you have an intolerance to some sugars, contact your 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. VAR/IB-025
Propylene glycol (E1520): This medicine contains 9.61mg propylene glycol in each ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
How to take it
Levetiracetam Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are 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. Take the oral solution following your 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 included in the package 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 you will first start taking Levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest daily dose. Add-on therapy Dose in adults and adolescents (12 to 17 years): Measure the appropriate dosage using the 10ml syringe included in the package 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: Your doctor will 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 included in the package. For children above 4 years, measure the appropriate dosage using the 10ml syringe included in the package. 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 below for dose examples). Dose in children 6 months and older: Weight Starting dose: 0.1ml/kg twice daily 6kg 0.6ml twice daily 8kg 0.8ml twice daily 10kg 1ml twice daily 15kg 1.5ml twice daily 20kg 2ml twice daily 25kg 2.5ml twice daily From 50kg 5ml twice daily
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Maximum dose: 0.3ml/kg twice daily 1.8ml twice daily 2.4ml twice daily 3ml twice daily 4.5ml twice daily 6ml twice daily 7.5ml twice daily 15ml twice daily
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 included in the package. 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 below for dose examples). Dose in infants (1 month to less than 6 months): Weight 4kg 5kg 6kg 7kg
Starting dose: 0.07ml/kg twice daily 0.3ml twice daily 0.35ml twice daily 0.45ml twice daily 0.5ml twice daily
Maximum dose: 0.21ml/kg twice daily 0.85ml twice daily 1.05ml twice daily 1.25ml twice daily 1.5ml twice daily
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. You may take Levetiracetam with or without food. After oral administration the bitter taste of levetiracetam may be experienced. Instructions for use: 1. Open the bottle: press the cap and turn it anticlockwise (figure 1) 2. Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).
3. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble(figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).
4. Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B). VAR/IB-025
Empty the contents of the syringe in a glass of water or baby's bottle by pushing the piston to the bottom of the syringe (figure 7).
5. Drink the whole contents of the glass/baby's bottle. 6. Close the bottle with the plastic screw cap. Wash the syringe with water only (figure 8).
Duration of treatment: Levetiracetam is used as a chronic treatment. You should continue Levetiracetam 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 Levetiracetam 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 Levetiracetam than you should. Your doctor will establish the best possible treatment of overdose. If you forget to take Levetiracetam: Contact your doctor if you have missed one or more doses. Do not take a double dose to make up for a forgotten dose. If you stop taking Levetiracetam: If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine 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 and the involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
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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 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; VAR/IB-025
encephalopathy (see sub-section "Tell your doctor immediately" 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.
Very rare: may affect up to 1 in 10000 people repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder). Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Levetiracetam
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle after 'EXP:'. The expiry date refers to the last day of the month. This medicinal product does not require any special storage conditions. 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 your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Levetiracetam contains The active substance is levetiracetam. Each ml of oral solution contains 100mg levetiracetam. The other ingredients are: sodium citrate (E331) (for pH-adjustment), citric acid monohydrate (for pHadjustment), methyl parahydroxybenzoate (E218), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), grape flavour (contains propylene glycol (E1520)) and purified water.
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What Levetiracetam looks like and contents of the pack Levetiracetam oral solution is a clear, colourless or pale yellow to pale brown colour solution with grape flavour supplied in amber glass bottles with tamper evident child resistant plastic cap. The 300ml glass bottle is packed in a cardboard box containing a 10ml oral syringe with 0.25ml graduation mark and an adaptor for the syringe. The 150ml glass bottle is packed in a cardboard box containing a 3ml oral syringe with 0.1ml graduation mark and an adaptor for the syringe. The 150ml glass bottle is packed in a cardboard box containing a 1ml oral syringe with 0.05ml graduation mark and an adaptor for the syringe. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Thame Laboratories Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help. This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: UK (NI) and IE: Levetiracetam Thame 100mg/ml Oral Solution This leaflet was last revised in 11/2025.
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Frequently asked questions about Levetiracetam Thame 100mg/ml Oral Solution
How do I take Levetiracetam Thame 100mg/ml Oral Solution?
Levetiracetam Thame 100mg/ml Oral Solution comes as oral solution containing 100mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Levetiracetam Thame 100mg/ml Oral Solution?
The active substance in Levetiracetam Thame 100mg/ml Oral Solution is levetiracetam.
Are there equivalent medicines to Levetiracetam Thame 100mg/ml Oral Solution?
Medicines with the same active substance, strength and form include: Desitrend 100 mg/ml Oral Solution, Keppra 100 mg/ml oral solution, Levetiracetam Amarox 100 mg/ml oral solution. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Levetiracetam Thame 100mg/ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Levetiracetam Thame 100mg/ml Oral Solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: levetiracetam
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Levetiracetam is indicated 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.
Levetiracetam is indicated 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.
4.2. Posology and method of administration
Posology
Partial onset seizures
The recommended dosing for monotherapy (from 16 years of age) and adjunctive therapy is the same; as outlined below.
All indications
Adults (≥18 years) and adolescents (12 to 17 years) weighing 50kg or more
The initial therapeutic dose is 500mg (5ml) twice daily. This dose can be started on the first day of treatment. However, a lower initial dose of 250mg (2.5ml) twice daily may be given based on physician assessment of seizure reduction versus potential side effects. This can be increased to 500mg (5ml) twice daily after two weeks.
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1500mg (15ml) twice daily. Dose changes can be made in 250mg or 500mg (2.5ml or 5ml) twice daily increases or decreases every two to four weeks.
Adolescents (12 to 17 years) weighing below 50 kg and children from 1 month of age
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to weight, age and dose. Refer to Paediatric population section for dosing adjustments based on weight.
Discontinuation
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50kg: 500mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighing less than 50kg: dose decrease should not exceed 10mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7mg/kg twice daily every two weeks).
Special populations
Elderly (65 years and older)
Adjustment of the dose is recommended in elderly patients with compromised renal function (see “Renal impairment” below).
Renal impairment
The daily dose must be individualised according to renal function.
For adult patients, refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighing 50kg or more, the following formula:
Then CLcr is adjusted for body surface area (BSA) as follows:
Dosing adjustment for adult and adolescent patients weighing more than 50kg with impaired renal function:
Group
Creatinine clearance (ml/min/1.73m2)
Dose and frequency
Normal
≥ 80
500 to 1500mg (5ml to 15ml) twice daily
Mild
50-79
500 to 1000mg (5ml to 10ml) twice daily
Moderate
30-49
250 to 750mg (2.5ml to 7.5ml) twice daily
Severe
< 30
250 to 500mg (2.5ml to 5ml) twice daily
End-stage renal disease patients undergoing dialysis (1)
-
500 to 1000mg (5ml to 10ml) once daily (2)
(1) A 750mg (7.5ml) loading dose is recommended on the first day of treatment with levetiracetam.
(2) Following dialysis, a 250 to 500mg (2.5 to 5ml) supplemental dose is recommended.
For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function. This recommendation is based on a study in adult renally impaired patients.
The CLcr in ml/min/1.73m2 may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13years and in adolescent female; ks= 0.7 in adolescent male
Dosing adjustment for infants, children and adolescent patients weighing less than 50 kg with impaired renal function:
Group
Creatinine clearance (ml/min/ 1.73m2)
Dose and frequency (1)
Infants 1 to less than 6 months
Infants 6 to 23 months, children and adolescents weighing less than 50kg
Normal
≥80
7 to 21mg/kg (0.07 to 0.21ml/kg) twice daily
10 to 30mg/kg (0.10 to 0.30ml/kg) twice daily
Mild
50-79
7 to 14mg/kg (0.07 to 0.14ml/kg) twice daily
10 to 20mg/kg (0.10 to 0.20ml/kg) twice daily
Moderate
30-49
3.5 to 10.5mg/kg (0.035 to 0.105ml/kg) twice daily
5 to 15mg/kg (0.05 to 0.15ml/kg) twice daily
Severe
< 30
3.5 to 7mg/kg (0.035 to 0.07ml/kg) twice daily
5 to 10mg/kg (0.05 to 0.10ml/kg) twice daily
End-stage renal disease patients undergoing dialysis
--
7 to 14mg/kg (0.07 to 0.14ml/kg) once daily (2) (4)
10 to 20mg/kg (0.10 to 0.20ml/kg) once daily (3) (5)
(1) Levetiracetam oral solution should be used for doses under 250mg, for doses not multiple of 250mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
(2)A 10.5mg/kg (0.105ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(3) A 15mg/kg (0.15ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(4) Following dialysis, a 3.5 to 7mg/kg (0.035 to 0.07ml/kg) supplemental dose is recommended.
(5) Following dialysis, a 5 to 10mg/kg (0.05 to 0.10ml/kg) supplemental dose is recommended.
Hepatic impairment
No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60ml/min/1.73m2.
Paediatric population
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Levetiracetam Thame oral solution is the preferred formulation for use in infants and children under the age of 6 years. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25kg, for patients unable to swallow tablets or for the administration of doses below 250mg. In all of the above cases Levetiracetam Thame oral solution should be used.
Monotherapy
The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.
No data are available.
Adolescents (16 and 17 years of age) weighing 50 kg or more with partial onset seizures with or without secondary generalisation with newly diagnosed epilepsy
Please refer to the above section on Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more.
Add-on therapy for infants aged 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50kg
The initial therapeutic dose is 10mg/kg (0.1ml/kg) twice daily.
Depending upon the clinical response and tolerability, the dose can be increased by 10mg/kg (0.1ml/kg) twice daily every 2 weeks up to 30mg/kg (0.3ml/kg) twice daily. Dose changes should not exceed increases or decreases of 10mg/kg (0.1ml/kg) twice daily every two weeks. The lowest effective dose should be used for all indications.
Dose in children 50kg or greater is the same as in adults for all indications.
Please refer to the above section on Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more for all indications.
Dose recommendations for infants from 6 months of age, children and adolescents:
Weight
Starting dose: 10mg/kg twice daily
Maximum dose 30mg/kg twice daily
6kg (1)
60mg (0.6ml twice daily)
180mg (1.8ml) twice daily
10kg (1)
100mg (1ml) twice daily
300mg (3ml) twice daily
15kg (1)
150mg (1.5ml) twice daily
450mg (4.5ml) twice daily
20kg (1)
200mg (2ml) twice daily
600mg (6ml) twice daily
25kg
250mg (2.5ml) twice daily
750mg (7.5ml) twice daily
From 50kg (2)
500mg (5ml) twice daily
1500mg (15ml) twice daily
(1) Children 25kg or less should preferably start the treatment with Levetiracetam Thame 100mg/ml oral solution.
(2) Dose in children and adolescents 50kg or more is the same as in adults.
Add-on therapy for infants aged from 1 month to less than 6 months
The initial therapeutic dose is 7mg/kg (0.07ml/kg) twice daily.
Depending upon the clinical response and tolerability, the dose can be increased by 7mg/kg (0.07ml/kg) twice daily every 2 weeks up to recommended dose of 21mg/kg (0.21ml/kg) twice daily. Dose changes should not exceed increases or decreases of 7mg/kg (0.07ml/kg) twice daily every two weeks. The lowest effective dose should be used.
Infants should start the treatment with Levetiracetam 100mg/ml oral solution. Dose recommendations for infants aged from 1 month to less than 6 months:
Weight
Starting dose: 7mg/kg (0.07ml/kg) twice daily
Maximum dose: 21mg/kg (0.21ml/kg) twice daily
4kg
28mg (0.3ml) twice daily
84mg (0.85ml) twice daily
5kg
35mg (0.35ml) twice daily
105mg (1.05ml) twice daily
7kg
49mg (0.5ml)twice daily
147mg (1.5ml) twice daily
Three presentations are available:
- A 300ml bottle with a 10ml oral syringe (delivering up to 1000mg levetiracetam) graduated every 0.25ml (corresponding to 25mg).
This presentation should be prescribed for children aged 4 years and older, adolescents and adults.
- A 150ml bottle with a 3ml oral syringe (delivering up to 300mg levetiracetam) graduated every 0.1ml (corresponding to 10mg)
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants and young children aged from 6 months to less than 4 years.
- A 150ml bottle with a 1ml oral syringe (delivering up to 100mg levetiracetam) graduated every 0.05ml (corresponding to 5mg)
In order to ensure the accuracy of the dosing, this presentation should be prescribed for infants aged 1 month to less than 6 months.
Method of administration
The oral solution may be diluted in a glass of water or baby's bottle and may be taken with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
4.3. Contraindications
Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Renal impairment
The administration of levetiracetam to patients with renal impairment may require dose adjustment. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection (see section 4.2).
Acute Kidney injury
The use of levetiracetam has been very rarely associated with acute kidney injury, with a time to onset ranging from a few days to several months.
Blood cell counts
Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment. Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (section 4.8).
Suicide
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam). A meta-analysis of randomized placebo-controlled trials of anti-epileptic medicinal products has shown a small increased risk of suicidal thoughts and behaviour. The mechanism of this risk is not known.
Therefore, patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Abnormal and aggressive behaviours
Levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and aggressiveness. Patients treated with levetiracetam should be monitored for developing psychiatric signs suggesting important mood and/or personality changes. If such behaviours are noticed, treatment adaptation or gradual discontinuation should be considered. If discontinuation is considered, please refer to section 4.2.
Worsening of seizures
As with other types of antiepileptic drugs, levetiracetam may rarely exacerbate seizure frequency or severity. This paradoxical effect was mostly reported within the first month after levetiracetam initiation or increase of the dose, and was reversible upon drug discontinuation or dose decrease.
Patients should be advised to consult their physician immediately in case of aggravation of epilepsy.
Lack of efficacy or seizure worsening has for example been reported in patients with epilepsy associated with sodium voltage-gated channel alpha subunit 8 (SCN8A) mutations
Electrocardiogram QT interval prolongation
Rare cases of ECG QT interval prolongation have been observed during the post-marketing surveillance. Levetiracetam should be used with caution in patients with QTc-interval prolongation, in patients concomitantly treated with drugs affecting the QTc-interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances.
Paediatric population
Available data in children did not suggest impact on growth and puberty. However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Excipients
This medicinal product contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
This medicinal product also contains liquid maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Sodium content
This medicinal product also contains 82.2mg sodium per dose (maximum dose of 3000mg), equivalent to 4.11% of the WHO recommended maximum daily intake of 2g sodium for an adult.
4.5. Interaction with other medicinal products and other forms of interaction
Antiepileptic medicinal products
Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60mg/kg/day levetiracetam.
A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate. However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme-inducing antiepileptic medicinal products. Dose adjustment is not required.
Probenecid
Probenecid (500mg four times daily), 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.
Oral contraceptives and other pharmacokinetics interactions
Levetiracetam 1000mg daily did not influence the pharmacokinetics of oral contraceptives (ethinyl-estradiol and levonorgestrel); endocrine parameters (luteinizing hormone and progesterone) were not modified. Levetiracetam 2000mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified. Co-administration with digoxin, oral contraceptives and warfarin did not influence the pharmacokinetics of levetiracetam.
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.
No data on the interaction of levetiracetam with alcohol are available.
4.6. Fertility, pregnancy and lactation
Women of child bearing potential
Specialist advice should be given to women who are of childbearing potential. Treatment with levetiracetam should be reviewed when a woman is planning to become pregnant. As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible because therapy with multiple antiepileptic medicines AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.
Pregnancy
A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations. Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero. However, current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays.
Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically needed. In such case, the lowest effective dose is recommended.
Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy). Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Breast-feeding
Levetiracetam is excreted in human breast milk. Therefore, breast-feeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Fertility
No impact on fertility was detected in animal studies (see section 5.3). No clinical data are available, potential risk for human is unknown.
4.7. Effects on ability to drive and use machines
Levetiracetam has minor or moderate influence on the ability to drive and use machines. Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase. Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery. Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness. The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3416 patients treated with levetiracetam. These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Tabulated list of adverse reactions
Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency. Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
MedDRA SOC
Frequency category
Very common
Common
Uncommon
Rare
Very Rare
Infections and infestations
Nasopharyngitis
Infection
Blood and lymphatic system disorders
Thrombocytopenia, leukopenia
Pancytopenia, neutropenia, agranulocytosis
Immune system disorders
Drug reaction with eosinophilia and systemic symptoms (DRESS)(1), Hypersensitivity (including angioedema and anaphylaxis)
Metabolism and nutrition disorders
Anorexia
Weight decreased, weight increase
Hyponatraemia
Psychiatric disorders
Depression, hostility/ aggression, anxiety, insomnia, nervousness/ irritability
Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation
Completed suicide, personality disorder, thinking abnormal, delirium
Obsessive compulsive disorder (2)
Nervous system disorders
Somnolence, headache
Convulsion, balance disorder, dizziness, lethargy, tremor
Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention
Choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy, seizures aggravated, Neuroleptic malignant syndrome(3)*
Eye disorders
Diplopia, vision blurred
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Electrocardiogram QT prolonged
Respiratory, thoracic and mediastinal disorders
Cough
Gastrointestinal disorders
Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Pancreatitis
Hepatobiliary disorders
Liver function test abnormal
Hepatic failure, hepatitis
Renal and urinary disorders
Acute Kidney injury
Skin and subcutaneous tissue disorders
Rash
Alopecia, eczema, pruritus
Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Musculoskeletal and connective tissue disorders
Muscular weakness, myalgia
Rhabdomyolysis and blood creatine phosphokinase increased(3)*
General disorders and administration site conditions
Asthenia/ fatigue
Injury, poisoning and procedural complications
Injury
(1) See Description of selected adverse reactions.
(2) Very rare cases of development of obsessive-compulsive disorders (OCD) in patients with underlying history of OCD or psychiatric disorders have been observed in post-marketing surveillance.
(3) Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Description of selected adverse reactions
Multiorgan hypersensitivity reactions
Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported rarely in patients treated with levetiracetam. Clinical manifestations may develop 2 to 8 weeks after starting treatment. These reactions are variable in expression, but typically present with fever, rash, facial oedema, lymphadenopathies, haematologic abnormalities and can be associated with involvement of different organ systems, mostly the liver. If multiorgan hypersensitivity reaction is suspected, levetiracetam should be discontinued.
The risk of anorexia is higher when levetiracetam is coadministered with topiramate.
In several cases of alopecia, recovery was observed when levetiracetam was discontinued. Bone marrow suppression was identified in some of the cases of pancytopenia.
Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Paediatric population
In patients aged 1 month to less than 4 years, a total of 190 patients have been treated with levetiracetam in placebo-controlled and open label extension studies. Sixty of these patients were treated with levetiracetam in placebo-controlled studies. In patients aged 4-16 years, a total of 645 patients have been treated with levetiracetam in placebo-controlled and open label extension studies. 233 of these patients were treated with levetiracetam in placebo-controlled studies. In both these paediatric age ranges, these data are supplemented with the post-marketing experience of the use of levetiracetam.
In addition, 101 infants aged less than 12 months have been exposed in a post authorization safety study. No new safety concerns for levetiracetam were identified for infants less than 12 months of age with epilepsy.
The adverse reaction profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications. Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults. In children and adolescents aged 4 to 16 years, vomiting (very common, 11.2%), agitation (common, 3.4%), mood swings (common, 2.1%), affect lability (common, 1.7%), aggression (common, 8.2%), abnormal behaviour (common, 5.6%), and lethargy (common, 3.9%) were reported more frequently than in other age ranges or in the overall safety profile. In infants and children aged 1 month to less than 4 years, irritability (very common, 11.7%) and coordination abnormal (common, 3.3%) were reported more frequently than in other age groups or in the overall safety profile.
A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures. It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population. Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL – Achenbach Child Behavior Checklist). However, subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses.
Management of overdose
After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specific antidote for levetiracetam. Treatment of an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
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Medicines containing Levetiracetam
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- Desitrend 250 mg coated granules in sachet
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