Patient Leaflet Updated 29-Nov-2019 | Zentiva
Levetiracetam 250mg, 500mg, 750mg & 1000mg Film-Coated Tablets
Package leaflet: Information for the patient
Levetiracetam Zentiva 250 mg, 500 mg, 750 mg and 1000 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Levetiracetam is and what it is used for
2. What you need to know before you take Levetiracetam
3. How to take Levetiracetam
4. Possible side effects
5. How to store Levetiracetam
6. Contents of the pack and other information
1. WHAT LEVETIRACETAM IS AND WHAT IT IS USED FOR
Levetiracetam Zentiva 250 mg, 500 mg, 750 mg and 1000 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam is used:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM
Do not take Levetiracetam:
Warnings and precautions
Talk to your doctor before taking Levetiracetam:
Children and adolescents
Other medicines and Levetiracetam:
Please 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 a laxative) for one hour before and one hour after taking levetiracetam as this may result in a loss of its effect.
Taking Levetiracetam with food, drink and alcohol
You may take levetiracetam with or without food. You may feel a bitter taste of levetiracetam after oral use. As a safety precaution, do not take levetiracetam with alcohol.
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 or pharmacist 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 levetiracetam 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 sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE LEVETIRACETAM
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Levetiracetam must be taken twice a day, half of the daily dose in the morning and half of the daily dose in the evening, at about the same time each day.
Take the number of tablets following your doctor’s instructions.
Dose in adults and adolescents (from 16 years of age):
General dose: between 1,000 mg and 3,000 mg each day.
When you first start taking levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 1,000 mg and 3,000 mg each day.
Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Dose in infants (1 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
Oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50kg and when tablets don’t allow accurate dosage.
Method of administration
Swallow Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water).
Duration of treatment:
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
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 tablets 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 tablet.
If you stop taking Levetiracetam
If stopping treatment, as with other antiepileptic medicines, 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.
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:
The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or 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 user in 10 people):
Common (may affect 1 to 10 users in 100 people):
Uncommon (may affect 1 to 10 users in 1,000 people):
Rare (may affect 1 to 10 users in 10,000 people):
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 which is stated on the carton box and blister after EXP:. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions
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 contains
The active substance is levetiracetam.
Levetiracetam Zentiva 250 mg: each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Zentiva 500 mg: each film-coated tablet contains 500 mg levetiracetam.
Levetiracetam Zentiva 750 mg: each film-coated tablet contains 750 mg levetiracetam.
Levetiracetam Zentiva 1000 mg: each film-coated tablet contains 1000 mg levetiracetam.
The other ingredients are:
Povidone 30, Croscarmellose sodium, Silica, colloidal anhydrous, Sodium stearyl fumarate
Hypromellose 2910/5, Macrogol 6000, Talc, Titanium dioxide (E-171), Simeticone emulsion (water, purified 67.4 %, simeticone 30.0 %, methylcellulose 2.5 %, sorbic acid 0.1 %)
Levetiracetam Zentiva 250 mg also contains Indigo carmine aluminium lake (E-132).
Levetiracetam Zentiva 500 mg also contains Iron oxide yellow (E-172).
Levetiracetam Zentiva 750 mg also contains Iron oxide red (E-172), Iron oxide yellow (E-172).
What Levetiracetam looks like and contents of the pack
Levetiracetam Zentiva 250 mg: Blue oblong film-coated tablet, with length approx. 12.6 mm and width approx. 6.1 mm, scored on both sides.
Levetiracetam Zentiva 500 mg: Yellow oblong film-coated tablet, with length approx. 16.1 mm and width approx. 7.6 mm, scored on both sides.
Levetiracetam Zentiva 750 mg: Orange oblong film-coated tablet, with length approx. 18.6 mm and width approx. 8.6 mm, scored on both sides.
Levetiracetam Zentiva 1000 mg: White to off -white oblong, film-coated tablet, with length approx. 19.1 mm and width approx. 10.1 mm, scored on both sides.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole. Levetiracetam Zentiva 250, 500, 750, 1000 mg is packed in PVC/Al blisters with 20, 30, 60, 100, 200 tablets.
It means 2, 3, 6, 10, 20 blisters, each containing 10 tablets in one folding box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was updated in October 2019.