Patient leaflet - Levetiracetam Tillomed 100 mg/ml oral solution
1. What Levetiracetam is and what it is used for
Levetiracetam Tillomed 100 mg/ml oral solution (hereinafter referred to as 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:
o partial onset seizures with or without generalisation in adults,
adolescents, children and infants from one month of age
o 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
o 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).
2. What you need to know before you take 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. They 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
- 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.
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, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Do not take macrogol (a medicine used as a laxative) for one hour before and one hour after taking levetiracetam as this may result in a reduction of its effect.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
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. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, the available data regarding the impact of levetiracetam on neurodevelopment in children is limited.
Breast-feeding
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 (E128), propyl parahydroxybenzoate (E216) and maltitol
Levetiracetam oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Levetiracetam oral solution also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take 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 10 ml syringe included in the package for patients 4 years and above.
Recommended dose: Levetiracetam should be taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
When you will first start taking Levetiracetam, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.
Add-on therapy
Dose in adults and adolescents (12 to 17 years):
Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
Recommended dose: Levetiracetam should be taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
Dose in children aged 6 months and older:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to the age, weight and dose. For children aged 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package. For children above 4 years of age, measure the appropriate dosage using the 10 ml syringe included in the package.
Recommended dose: Levetiracetam should be taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child (see table below for dose examples).
Dose in children 6 months and older:
Weight Starting dose:
0.1 ml/kg twice daily
Maximum dose:
0.3 ml/kg twice daily 6 kg 0.6 ml twice daily 1.8 ml twice daily 8 kg 0.8 ml twice daily 2.4 ml twice daily 10 kg 1 ml twice daily 3 ml twice daily 15 kg 1.5 ml twice daily 4.5 ml twice daily 20 kg 2 ml twice daily 6 ml twice daily 25 kg 2.5 ml twice daily 7.5 ml twice daily From 50 kg 5 ml twice daily 15 ml 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 1 ml syringe included in the package. Recommended dose: Levetiracetam should be taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg bodyweight of the infant (see table below for dose examples).
Dose in infants (1 month to less than 6 months):
Weight Starting dose:
0.07 ml/kg twice daily
Maximum dose: 0.21 ml/kg twice daily 4 kg 0.3 ml twice daily 0.85 ml twice daily 5 kg 0.35 ml twice daily 1.05 ml twice daily 6 kg 0.45 ml twice daily 1.25 ml twice daily 7 kg 0.5 ml twice daily 1.5 ml 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 a bitter taste (of levetiracetam) may be experienced.
Instructions for use:
Open the bottle: press the cap and turn it
anti-clockwise (see figure 1)
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).
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
millilitres (ml) prescribed by your doctor
(figure 5C).
5 A 5 B
5 C
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Levetiracetam Tillomed 100 mg/ml
oral solution
1
2 3
4 5
As stated in design
Package leaflet
TBA
TW228427 (design)
UK
All
NA
TBA
9 points (Reg text)
Black C
Also TW236660 & 252508 (PRAC & SmPC)
Turn the bottle the right way up (figure 6A).
Remove the syringe from the adaptor (figure 6B).
Empty the contents of the syringe in a
glass of water or baby’s bottle by pushing
the piston to the bottom on the syringe
(figure 7).
Drink the whole contents of the glass/baby’s
bottle. 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 to.
- Do not stop your treatment without your doctor’s advice as this could increase your seizures.
If you take more Levetiracetam than you should
If you accidentally take too much solution, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining solution with you. Symptoms of overdose include: sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
If you forget to take Levetiracetam
Take it as soon as you remember, unless it is time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose. Contact your doctor if you have missed one or more doses.
If you stop taking Levetiracetam
It is important that you keep taking Levetiracetam for as long as your doctor has told you to. If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase in seizures. Should your doctor decide to stop your Levetiracetam treatment, they 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.
4. 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 (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 behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of 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, irritability
- anxiety, nervousness
- convulsion, tremor (involuntary trembling)
- balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), vertigo (sensation of rotation)
- cough
- abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
- rash
- lethargy (lack of energy and enthusiasm), asthenia/fatigue (tiredness), insomnia
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 co-ordination/ataxia (impaired co-ordinated 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 1,000 people
- infection
- decreased number of all blood cell types
- decreased blood sodium concentration
- suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate)
- delirium
- 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
- 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
Evidence also suggests a possible predisposition of the Japanese population to neuroleptic malignant syndrome (NMS).
Very Rare: may affect up to 1 in 10,000 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 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.
5. How to store Levetiracetam
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month.
- Do not use after 4 months of first opening the bottle.
- 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.
6. Contents of the pack and other information
What Levetiracetam oral solution contains
The active substance is called levetiracetam.
Each ml contains 100 mg of levetiracetam.
- The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.
What Levetiracetam looks like and contents of the pack
Levetiracetam 100 mg/ml oral solution is a clear liquid. The 300 ml glass bottle (containing 300 ml oral solution) of Levetiracetam (for children aged 4 years and above, adolescents and adults) is packed in a carton containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.
The 200 ml glass bottle (containing 150 ml oral solution) of Levetiracetam (for infants and young children aged from 6 months to less than 4 years) is packed in a carton containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe. The 200 ml glass bottle (containing 150 ml oral solution) of Levetiracetam (for infants aged 1 month to less than 6 months) is packed in a carton containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Manufacturer
Manx Healthcare Ltd
Unit 2, Bosworth Avenue, Tournament Fields
Warwick, CV34 6UQ, United Kingdom
This leaflet was last revised in July 2026
Placeholder code 6 A 6 B
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