Consumer medicine information

1. Why am I using Levetiracetam SZ?

Levetiracetam SZ contains the active ingredient levetiracetam. Levetiracetam SZ is used to control epilepsy. For more information, see Section 1. Why am I using Levetiracetam SZ? in the full CMI.

2. What should I know before I use Levetiracetam SZ?

Do not use if you have ever had an allergic reaction to levetiracetam 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 Levetiracetam SZ? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Levetiracetam SZ 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 Levetiracetam SZ?

• For patients 12 years of age and older, the dosage is generally between 1000 mg and 3000 mg each day, taken in two doses.

• For children 4 to 11 years of age the doctor will calculate the dosage based on the child's weight and tell you how much to give. The medicine is to be given twice daily.

5. What should I know while using Levetiracetam SZ?

6. Are there any side effects?

Common side effects include: dizziness, feeling weak, headache, common cold, upset stomach, diarrhoea, feeling tired, drowsy or sleepy.
Serious side effects include: mood changes such as depression, nervousness, aggression, anger, anxiety, confusion, hallucination, irritability, feelings of depression, upper respiratory tract infections, weight loss.
Very serious side effects include: thoughts of harming yourself, more frequent or more severe seizures, shortness of breath, wheezing or difficulty breathing, swelling, blistering or peeling skin around the face, lips, mouth, throat, tongue, genitals or other parts of the body, rash, itching or hives on the skin.
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.

Notes

Distributed by Sandoz Pty Ltd

1 Name of Medicine

Levetiracetam.

2 Qualitative and Quantitative Composition

The product, Levetiracetam SZ tablets, contains levetiracetam as the active ingredient, available in strengths of 250 mg, 500 mg and 1000 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets - oblong, film coated.
250 mg. Blue, marked Lev 250 on one side with central score on both faces.
500 mg. Yellow, marked Lev 500 on one side with central score on both faces.
1,000 mg. White, marked Lev 1000 on one side with central score on both faces.

4 Clinical Particulars

4.9 Overdose

Symptoms. The highest known dose of levetiracetam received in the clinical development program was 6,000 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 overdoses in postmarketing use.
Treatment. 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 Poison Information Centre on 131126 (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 3,000 mg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Levetiracetam is the pure S-enantiomer of the racemate etiracetam. It 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 mg/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.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLEVETR.gif Chemical Name: (S)-2-(2-oxopyrrolidin-1-yl)butanamide.
Molecular Formula: C₈H₁₄N₂O₂.
Molecular Weight: 170.2.
CAS number. 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/LEVETIST.gif