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The product code(s) for this leaflet is: PL25258/0192 .
Levetiracetam Glenmark 250 mg, 500 mg, 750 mg, 1000mg film-coated tablets
Levetiracetam Glenmark 250 mg film-coated tablets
Levetiracetam Glenmark 500 mg film-coated tablets
Levetiracetam Glenmark 750 mg film-coated tablets
Levetiracetam Glenmark 1000 mg film-coated tablets
Levetiracetam
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
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam is used:
Talk to your doctor before taking Levetiracetam.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
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 loss of its effect.
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.
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.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ҅ sodium-free ҆.
Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
The other strengths of Levetiracetam tablets do not contain this ingredient.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take the number of tablets following your doctor’s instructions.
Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Dose in adults and adolescents (from 16 years of age):
General dose: between 1000 mg and 3000 mg each day.
When you will first start taking Levetiracetam, you doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
250 mg:
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.
500 mg:
Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of 250mg in the morning and 2 tablets of 250 mg in the evening.
750 mg:
Example: if your daily dose is 3000 mg, your reduced starting dose is 2 tablets of 750 mg in the morning and 2 tablets of 750 mg in the evening.
1000 mg:
Example: if your daily dose is 2000 mg, your reduced starting dose is 1 tablet of 1000 mg in the morning and 1 tablet of 1000 mg in the evening.
Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:
General dose: between 1000 mg and 3000 mg each day.
250 mg:
Example: if your daily dose is 1000 mg, you must take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
500 mg:
Example: if your daily dose is 1000 mg, you might take 1 tablet of 500 mg in the morning and 1 tablet of 500 mg in the evening.
750 mg:
Example: if your daily dose is 1500 mg, you might take 1 tablet in the morning and 1 tablet in the evening.
1000 mg:
Example: if your daily dose is 2000 mg, you might take 1 tablet in the morning and 1 tablet in the evening.
Dose in infants (1 month 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.
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 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). You may take Levetiracetam with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
250 mg:
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
500 mg:
The tablet can be divided into equal doses.
750 mg:
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
1000 mg:
The tablet can be divided into equal doses.
Duration of treatment:
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.
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 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people
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: 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.
Keep this medicine out of the sight and reach of children.
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 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.
The active substance is levetiracetam.
Each film-coated tablet contains 250 mg of levetiracetam.
Each film-coated tablet contains 500 mg of levetiracetam.
Each film-coated tablet contains 750 mg of levetiracetam.
Each film-coated tablet contains 1000 mg of levetiracetam.
The other ingredients are:
Tablet core:
Maize starch, Croscarmellose sodium, Povidone (K 30), Silica colloidal anhydrous, Talc and Magnesium Stearate.
Tablet coating:
Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc and colourants*.
The colourants are:
250 mg: Indigo carmine (E132).
500 mg: Iron oxide yellow (E172)
750 mg: Sunset yellow FCF (E110), Iron oxide red (E172).
1000 mg: no additional colourant.
Levetiracetam 250 mg film-coated tablets are blue coloured, oblong shaped, scored on one side film-coated tablets debossed with “H” on one side and “87” on other side.
Levetiracetam 500 mg film-coated tablets are yellow coloured, oblong shaped, scored on one side, film-coated tablets debossed with “H” on one side and “88” on the other.
Levetiracetam 750 mg film-coated tablets are orange coloured, oblong shaped, scored on one side, film-coated tablets debossed with “H” on one side and “90” on the other side.
Levetiracetam 1000 mg film-coated tablets are white coloured, oblong shaped, scored on one side, film-coated tablets debossed with “H” on one side and “91” on the other side.
Levetiracetam is supplied in the following pack sizes:
Levetiracetam 250 mg are available in blister packs containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Levetiracetam 500 mg are available in blister packs containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Levetiracetam 750 mg are available in blister packs containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Levetiracetam 1000 mg are available in blister packs containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 01/2021.