Patient leaflet - Levetiracetam Bristol Lab 1000 mg film-coated tablets
1. What Levetiracetam is and what it is used for
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 Levetiracetam according to the age, weight and dose.
Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy). Other medicines and Levetiracetam
2. What you need to know before you take Levetiracetam
3. How to take Levetiracetam
Tell your doctor or pharmacist if you are taking, 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 loss of its effect.
4. Possible side effects
Levetiracetam 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when tablets don't allow accurate dosage.
5. How to store Levetiracetam
6. Contents of the pack and other information
- 1.
What Levetiracetam is and what it is used for
Pregnancy and breast-feeding
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
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.
Method of administration tablets:
Swallow Levetiracetam with a sufficient quantity of liquid (e.g. a glass of water). You may take levetiracetam with or without food.
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.
Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
After oral administration the bitter taste of levetiracetam may be experienced.
You should not stop your treatment without discussing this with your doctor.
Duration of treatment:
- Levetiracetam is used as a chronic treatment. You should continue levetiracetam treatment for as long as your doctor has told you.
Levetiracetam should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment. Driving and using machines
- Do not stop your treatment without your doctor's advice as this could increase your seizures. If you take more Levetiracetam than you should:
- 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;
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.
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 tablets than you should. Your doctor will establish the best possible treatment of overdose.
- 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).
Levetiracetam 750mg contains Sunset Yellow FCF (E110)
If you forget to take Levetiracetam:
Contact your doctor if you have missed one or more doses.
Sunset yellow FCF (E110 colouring agent), which may cause allergic reactions.
Do not take a double dose to make up for a forgotten dose.
Information on sodium content
What you need to know before you take
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
If you stop taking Levetiracetam:
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.
Do not take Levetiracetam:
- 3. How to take Levetiracetam
- •
if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6)
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Warnings and precautions
Take the number of tablets following your doctor's instructions.
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.
Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
- 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor
250mg and 750mg tablets: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Tell your doctor immediately, or go to your nearest emergency department, if you experience:
A small number of people being treated with anti-
500mg and 1000mg tablets: The tablets can be divided
Each 250 mg tablet contains 250 mg Levetiracetam. Each 500 mg tablet contains 500 mg Levetiracetam. Each 750 mg tablet contains 750 mg Levetiracetam. Each 1000 mg tablet contains 1000 mg Levetiracetam. breathing, as these may be signs of a serious allergic (anaphylactic) reaction
- muscle weakness, myalgia (muscle pain)
- injury.
swelling of the face, lips, tongue and throat (Quincke's oedema)
Rare: may affect up to 1 in 1,000 people
- infection
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])
- 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])
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
- decreased blood sodium concentration
- suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate)
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)
- delirium;
- encephalopathy (see sub-section "Tell your doctor immediately" for a detailed description of symptoms);
a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
- uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)
a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
- pancreatitis
- liver failure, hepatitis
- sudden decrease in kidney function
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.
- 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).
The most frequently reported side effects are 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.
- rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Very common: may affect more than 1 in 10 people
- seizures may become worse or happen more often;
- nasopharyngitis
- somnolence (sleepiness); headache
- change of the heart rhythm (Electrocardiogram);
- limp or difficulty walking.
Common: may affect up to 1 in 10 people
Reporting of side effects
anorexia (loss of appetite)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website
- 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)
'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.
- vertigo (sensation of rotation)
cough
- 5. How to store Levetiracetam
abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
- Keep this medicine out of the sight and reach of children.
rash
- This medicinal product does not require any special storage conditions.
- asthenia/fatigue (tiredness).
Uncommon: may affect up to 1 in 100 people
- Do not use this medicine after the expiry date stated on the carton box and blister after “EXP.” The expiry date refers to the last day of that month.
- decreased number of blood platelets, decreased number of white blood cells
- weight decrease, weight increase
- 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 to protect the environment
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation
- 6. Contents of the pack and other information What Levetiracetam contains
amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration)
The active substance is Levetiracetam.
- diplopia (double vision), vision blurred;
- elevated/abnormal values in a liver function test
hair loss, eczema, pruritus
The other ingredients are:
Tablet core:
Maize starch, Croscarmellose sodium, Povidone (kollidon 30), Silica colloidal anhydrous, Talc and Magnesium Stearate.
Tablet coating:
Levetiracetam Bristol Lab 250 mg film-coated tablets: Talc, Polyvinyl alcohol, Indigo carmine (E132), Macrogol (3350) and Titanium dioxide (E171). Levetiracetam Bristol Lab 500 mg film-coated tablets: Talc, Polyvinyl alcohol, Yellow Iron Oxide (E172), Macrogol 3350 and Titanium dioxide (E171). Levetiracetam Bristol Lab 750 mg film-coated tablets: Talc, Polyvinyl alcohol, Sunset yellow FCF (E110), Macrogol (3350) and Titanium dioxide (E171), Iron oxide red (E172).
Levetiracetam Bristol Lab 1000 mg film-coated tablets: Talc, Polyvinyl alcohol, Macrogol (3350) and Titanium dioxide (E171).
What Levetiracetam tablets look like and contents of the pack
Levetiracetam Bristol Lab 250 mg film-coated tablets are blue coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and "87" on other side.
Levetiracetam Bristol Lab 500 mg film-coated tablets are yellow coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “88” on the other side.
Levetiracetam Bristol Lab 750 mg film-coated tablets are orange coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “90” on the other side.
Levetiracetam Bristol Lab 1000 mg film-coated tablets are white coloured, oblong shaped, film-coated tablets scored on one side, debossed with “H” on one side and “91” on the other side.
Levetiracetam is available in the cardboard boxes containing 10, 20, 30, 50, 60, 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road Berkhamsted, Hertfordshire, HP4 1EG, UK
Telephone: 0044 (0) 1442 200922, Fax: 0044 (0) 1442 873717 Email : info@bristol-labs.co.uk
Manufacturer
Bristol Laboratories Limited
Laporte Way,
Luton,
LU4 8WL,
United Kingdom
Levetiracetam Bristol Lab 250 mg film-coated tablets; PL 17907/0388
Levetiracetam Bristol Lab 500 mg film-coated tablets; PL 17907/0389
Levetiracetam Bristol Lab 750 mg film-coated tablets; PL 17907/0390
Levetiracetam Bristol Lab 1000 mg film-coated tablets; PL 17907/0391
This leaflet was last revised in November 2021.
To request a copy of this leaflet in a braille, large print or audio format, please contact the marketing authorisation holder at the address above (or telephone, fax, email).
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