Consumer medicine information

Levi 250 mg Tablets

Levetiracetam

BRAND INFORMATION

Brand name

Levi

Active ingredient

Levetiracetam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Levi 250 mg Tablets.

1. Why am I using LEVI?


LEVI tablet contains the active ingredient Levetiracetam. LEVI is used to in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation.
Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.
For more information, see Section 1. Why am I using LEVI? in the full CMI.

2. What should I know before I use LEVI?


Do not use if you have ever had an allergic reaction to LEVI or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use LEVI? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with LEVI and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use LEVI?

  • The film coated tablets must be taken orally, swallowed with liquid and may be taken with or without food.
  • The daily dose is administered in two equally divided doses.

More instructions can be found in Section 4. How do I use LEVI? in the full CMI.

5. What should I know while using LEVI?

Things you should do
  • Remind any doctor, dentist or pharmacist.
Things you should not do
  • Do not stop using this medicine suddenly (if relevant).
Driving or using machines
  • Be careful driving or operating machinery until you know how this medicine affects you. Children should be careful doing things like riding bicycles or climbing trees.
Drinking alcohol
  • Be careful when drinking alcohol while taking this medicine.
  • Combining LEVI tablets and alcohol can make you more drowsy. Your doctor may suggest you avoid alcohol while you are being treated with LEVI.
Looking after your medicine
  • Keep your tablets in the pack until it is time to take them.
  • If you take the tablets out of the pack they will not keep well.
  • Keep your tablets in a cool dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using LEVI? in the full CMI.

6. Are there any side effects?


Most common side effects are: dizziness, feeling weak, headache, common cold, upset stomach, diarrhoea, feeling tired, drowsy or sleepy.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Levi

Active ingredient

Levetiracetam

Schedule

S4

 

1 Name of Medicine

Levetiracetam.

2 Qualitative and Quantitative Composition

Levetiracetam tablets are available in strengths of 250 mg, 500 mg and 1000 mg.
Levetiracetam is a white to off-white powder with a faint odour and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Levi 250 are white to off-white, oval biconvex, film coated tablets, debossed 'L 64' and breakline on one side and plain on the other side.
Levi 500 are yellow coloured, oval biconvex, film coated tablets, debossed 'L 65' and breakline on one side and plain on the other side.
Levi 1000 are white to off-white, oval biconvex, film coated tablets, debossed 'L 67' and breakline on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

The highest known dose of levetiracetam tablets received in the clinical development program was 6000 mg/day. Other than drowsiness, there were no adverse events in the few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam tablets overdoses in postmarketing use.
There is no specific antidote for levetiracetam. Treatment for an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60% for levetiracetam and 74% for the major metabolite (ucb L057).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Levetiracetam was negative in gene mutation assays (bacterial, Chinese hamster ovary/ HGPRT locus) and in assays for chromosomal damage in vitro and in vivo (Chinese hamster ovary cells, mouse micronucleus assay). The hydrolysis product and major human metabolite (ucb L057) was not mutagenic in bacterial reverse mutation assays or the in vitro mouse lymphoma assay.
Carcinogenicity. There was no evidence of carcinogenicity following administration of levetiracetam in the diet to rats or orally to mice for 104 weeks, associated with respective systemic exposures (plasma AUC) up to fourfold and eightfold that in humans at the maximal recommended clinical dose of 3000 mg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Chemical name: - (S)-alpha-ethyl-2-oxo-1-pyrrolidine acetamide.
Molecular formula of C8H14N2O2.
Molecular weight of 170.21.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLEVETI.gif CAS number. CAS No.: 102767-28-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/LEVTABST.gif