Consumer medicine information

Keppra tablets

Levetiracetam

BRAND INFORMATION

Brand name

Keppra Oral

Active ingredient

Levetiracetam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Keppra tablets.

What is in this leaflet

This leaflet answers some common questions about Keppra.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Keppra against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Keppra is used for

Keppra is used to control epilepsy.

Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe.

This medicine belongs to a group of medicines called antiepileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen.

Keppra may be used alone, or in combination with other medicines, to treat your condition.

Your doctor may have prescribed this medicine in addition to your current therapy.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

There is no evidence that this medicine is addictive.

This medicine is available only with a doctor’s prescription.

The safety and effectiveness of Keppra has not been established in patients less than 4 years of age.

Before you take Keppra

When you must not take it

Do not take Keppra if you have an allergy to:

  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take this medicine after the expiry date (EXP) printed on the pack.

Do not take this medicine if the packaging is torn or shows signs of tampering or if the tablets do not look quite right. If this medicine has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines, especially barbiturates (such as phenobarbitone) or any other antiepileptic medicines (such as carbamazepine, lamotrigine or valproate)
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • kidney problems
  • liver problems.

Tell your doctor if you are pregnant or intend to become pregnant. Keppra may affect your developing baby if you take it during pregnancy. However, it is very important to control your seizures while you are pregnant. Your doctor will outline and weigh up all the risks and benefits of taking Keppra during pregnancy to help decide whether or not you should take it.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in Keppra passes into breast milk and there is a possibility that your baby may be affected. Your doctor will discuss the risks and benefits of using Keppra if you are breastfeeding.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Keppra.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Keppra does not interact with the oral contraceptive pill.

However, you may be given Keppra together with other antiepileptic medicines that do interact and may affect the effectiveness of your contraceptive. Your doctor may advise you to use an additional method of contraception if you take Keppra with other antiepileptic medicines.

How to take Keppra

How much to take

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Your doctor will tell you how much Keppra you will need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.

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.

Your doctor may start you on a low dose of Keppra first. Your doctor will slowly increase the amount of medicine until you are taking enough to control your epilepsy and you are not having seizures.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How to take it

Swallow the tablets whole with a glass of water.

When to take it

Take Keppra twice a day, once in the morning and once at night. Take it at about the same time each day. Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you take this medicine before or after food.

If you forget to take it

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

How long to take it

Most antiepileptic medicines take time to work, so do not be discouraged if you do not feel better straight away.

Continue taking your medicine for as long as your doctor tells you to. This medicine helps control your condition, but does not cure it. Therefore you must take your medicine every day, even if you feel well.

Do not stop taking Keppra, or change the dosage, without checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays. Stopping Keppra suddenly may cause unwanted side effects or make your condition worse. Your doctor will slowly reduce your dose before you can stop taking it completely.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Keppra. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include feeling drowsy.

While you are using Keppra

Things you must do

Tell your doctor immediately if you notice an increase in seizures.

Tell your doctor immediately if you have symptoms of depression or thoughts of harming yourself.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking this medicine.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Keppra.

Before you have any surgery or emergency treatment, tell your doctor or dentist that you are taking Keppra.

Tell your doctor if you feel Keppra is not helping your condition. Your doctor may need to change your medicine.

Tell your doctor if, for any reason, you have not taken this medicine exactly as prescribed. Otherwise, your doctor may change your treatment unnecessarily.

If you become pregnant while taking this medicine, tell your doctor.

Be sure to keep all of your doctor’s appointments so that your progress can be checked. Your doctor will check your progress and may want to take some tests from time to time. This helps to prevent unwanted side effects.

Things you must not do

Do not give Keppra to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.

Do not take Keppra to treat any other complaints unless your doctor tells you to.

Things to be careful of

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.

As with other antiepileptic medicines, Keppra may cause dizziness or drowsiness in some people. This is more frequent at the beginning of treatment or after an increase in the dose.

If you are feeling dizzy or drowsy do not drive, operate machinery, or do anything else that could be dangerous. Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling dizzy or drowsy.

Be careful when drinking alcohol while taking this medicine. Combining Keppra and alcohol can make you more drowsy. Your doctor may suggest you avoid alcohol while you are being treated with Keppra.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Keppra. This medicine helps most people with epilepsy, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

If you get any side effects, do not stop taking Keppra without first talking to your doctor or pharmacist.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • dizziness
  • feeling weak
  • headache
  • common cold
  • upset stomach
  • diarrhoea
  • feeling tired, drowsy or sleepy.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

  • mood changes such as depression, nervousness, aggression, anger, anxiety, confusion, hallucination, irritability
  • feelings of depression
  • upper respiratory tract infections
  • weight loss.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • 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.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may happen in some people.

After using Keppra

Storage

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.

Do not store Keppra or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car on hot days. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Keppra tablets are available in three strengths:

  • 250mg – blue, oblong, scored tablet with ucb and 250 stamped on one side
  • 500mg - yellow, oblong, scored tablet with ucb and 500 stamped on one side
  • 1000mg - white, oblong, scored, tablet with ucb and 1000 stamped on one side.

Ingredients

Each Keppra tablet contains either 250 mg, 500mg, or 1000mg of levetiracetam as the active ingredient.

Other ingredients in Keppra tablets include:

  • croscarmellose sodium
  • macrogol
  • magnesium stearate
  • silica colloidal anhydrous.

Keppra tablets are film-coated. The coating for each tablet strength contains polyvinyl alcohol, macrogol, talc and titanium dioxide. The following strengths also contain:

  • 250mg – indigo carmine
  • 500mg –iron oxide yellow.

Keppra tablets do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

UCB Pharma
A division of UCB Australia Pty Ltd
Level 1, 1155 Malvern Road
Malvern Vic 3144, Australia

Keppra 250mg - AUST R 120508

Keppra 500mg - AUST R 120509

Keppra 1000mg - AUST R 120513

Date of preparation:
January 2016

Keppra is a registered trademark of UCB Biopharma SPRL

Published by MIMS December 2019

BRAND INFORMATION

Brand name

Keppra Oral

Active ingredient

Levetiracetam

Schedule

S4

 

1 Name of Medicine

Levetiracetam.

2 Qualitative and Quantitative Composition

Keppra film-coated tablets are available in strengths of 250 mg, 500 mg, 750 mg and 1000 mg levetiracetam. Keppra oral solution is available as 100 mg/mL strength.
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.
Keppra oral solution contains the following excipients: Methylhydroxybenzoate, propylhydroxybenzoate, and maltitol solution. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Keppra film-coated tablets:
250 mg. Blue, oblong, scored film-coated tablet debossed with the code ucb and 250 on one side.
500 mg. Yellow, oblong, scored film-coated tablet debossed with the code ucb and 500 on one side.
750 mg*. Orange, oblong, scored film-coated tablet debossed with the code ucb and 750 on one side.
1000 mg. White, oblong, scored film-coated tablet debossed with the code ucb and 1000 on one side.
*Not currently distributed in Australia.

4 Clinical Particulars

4.9 Overdose

The highest known dose of Keppra 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 Keppra 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 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 4-fold and 8-fold that in humans at the maximal recommended clinical dose of 3000 mg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide.
Molecular formula: C8H14N2O2.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLEVETI.gif CAS number. 102767-28-2.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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