Keppra Tablets 1000mg 60 SPX Authority

  Information General Information Consumer Medicine InformationWhat is in this leafletThis 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 forKeppra is used to control epilepsy.Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe.Keppra 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 prescribe Keppra in addition to your current therapy.Ask your doctor if you have any questions about why Keppra has been prescribed for you.There is no evidence that Keppra 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 KeppraWhen you must not take itDo not take Keppra if you have an allergy to:any of the ingredients listed at the end of this leafletSymptoms of an allergic reaction to Keppra 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 skinIf you are unsure whether any of the above conditions apply to you, ask your doctor.Keppra oral solution contains maltitol. Do not use Keppra oral solution if you have hereditary problems of fructose intolerance.Do not take Keppra if you are pregnant or intend to become pregnant, without talking to your doctor first. Like most antiepileptic medicines, Keppra is not recommended for use during pregnancy. However, it is very important to control your fits while you are pregnant. If it is necessary for you to take Keppra, your doctor can help you decide whether or not to take it during pregnancy.Do not breastfeed while taking Keppra. Keppra passes into breast milk.Do not take Keppra after the expiry date (EXP) printed on the pack.Do not take Keppra tablets if the packaging is torn or shows signs of tampering or if the tablets do not look quite right.Do not take Keppra oral solution if the solution is not clear or the bottle shows signs of tamperingIf Keppra has expired or is damaged, return to your pharmacist for disposal.If you are not sure whether you should start taking Keppra, talk to your doctor or pharmacist.Before you start to take itTell your doctor or pharmacist if you have allergies to:any other medicines, especially barbiturates or any other anticonvulsant medicines any other substances, such as foods, preservatives or dyesTell your doctor if you have or have had any medical conditions, especially the following:kidney problems (renal damage, renal insufficiency, impaired renal function) liver problemsTell 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 fits while you are pregnant. If it is necessary for you to take Keppra, your doctor can help you decide whether or not to take it during pregnancy.Tell your doctor if you are breast-feeding or plan to breast-feed. It is recommended that you do not breastfeed while taking Keppra.If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Keppra.Taking other medicinesTell 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 drugs that do interact and they may compromise contraceptive efficacy.Your doctor may advise you to use an additional method of contraception if you take Keppra with other antiepileptic drugs.How to take KeppraHow much to takeFor patients 12 years of age and older, the dosage is generally between 1000mg and 3000mg each day.For children 4 to 11 years of age the dose is 20 mg/kg to 60 mg/kg each day.There is no data to support the use of Keppra for patients less than 4 years of age.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.Your doctor may recommend that you start with a low dose of Keppra and slowly increase the dose to the lowest amount needed to control your epilepsy/seizures (fits).Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.If you believe that the effect of Keppra is too weak, talk to your doctor.If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.How to take itKeppra TabletsSwallow Keppra tablets whole with a glass of water.Keppra Oral SolutionSwallow Keppra oral solution undiluted or diluted in a glass of water.To take a dose of the oral solution, open the bottle by pressing the cap and turning it anticlockwise.Take the syringe and place it in the bottle. Fill the syringe with the liquid by pulling the piston up to the graduation mark corresponding to the dose in milligrams (mg) prescribed by your doctor Remove the syringe from the bottle and take the dose (undiluted or diluted in a glass of water). When to take itKeppra must be taken two times a day, once in the morning and once in the evening, at about the same time each day. Taking Keppra at the same time each day will have the best effect. It will also help you remember when to take the tablets/oral solution.It does not matter if you take Keppra before or after food.If you forget to take itContact 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 itMost anticonvulsant medicines take time to work, so do not be discouraged if you do not feel better straight away.Continue taking Keppra for as long as your doctor tells you to. Keppra 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 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 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. If you take too much Keppra you may feel drowsy.While you are using KeppraThings you must doTell your doctor immediately if you notice an increase in seizures (fits).Tell your doctor immediately if you have symptoms of depression or thoughts of self harm.Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Keppra.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 Keppra exactly as prescribed. Otherwise, your doctor may change your treatment unnecessarily.If you become pregnant while taking Keppra, 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 doDo 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.Do not stop using it unless your doctor tells you to.Things to be careful ofBe careful driving or operating machinery until you know how Keppra affects you. As with other anticonvulsant medicines, Keppra may cause drowsiness in some people.This is more frequent at the beginning of treatment or at dosage increase.Make sure you know how you react to Keppra before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy. Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling drowsy or sleepy.Keppra may cause drowsiness and affect alertness.Be careful when drinking alcohol while taking Keppra. Combining Keppra and alcohol can make you more drowsy.Your doctor may suggest you avoid alcohol while you are being treated with Keppra.Side effectsTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Keppra. Keppra 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 treatment if you get some of the side effects.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 common cold and upper respiratory tract infections feeling tired, drowsy or sleepyThese are the more common side effects of Keppra. Mostly these are mild and short-lived.Other side-effects reported include:mood changes such as depression, nervousness, aggression, anger, anxiety, confusion, hallucination, irritabilityKeppra oral solution includes methylhydroxybenzoate and parahydroxybenzoate which may cause allergic reactions, and maltitol which may have a mild laxative effect. Patients with rare hereditary problems of fructose intolerance should not take the oral solution.Keppra oral solution also contains glycerol which can cause headache, stomach upset and diarrhoea when ingested in doses greater than 10g. However, recommended doses of Keppra oral solution for children of 20kg or less contains less than 1.5g glycerol.You may not experience any of these side-effects.If you experience any other side-effects, tell your doctor immediately.If you experience more frequent or more severe seizures (fits), or thoughts of self harm tell your doctor immediately or go to Accident and Emergency at your nearest hospital.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.Some of these side effects can only be found when your doctor does tests from time to time to check your progress.After using KeppraStorageKeep your tablets in the pack or your solution in its original bottle until it is time to take it. If you take the tablets or solution out of their packs they will not keep well.Keep your tablets in a cool dry place where the temperature stays below 25°C.Keep your oral solution in a cool place where the temperature stays below 25°C and protect from light.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.DisposalIf your doctor or pharmacist tells you to stop taking Keppra or they have passed their expiry date, ask your pharmacist what to do with any that is left over.Product descriptionWhat it looks likeKeppra 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 sideKeppra oral solution is available in a 100 mg/mL strength and is supplied in an amber bottle with a child resistant cap. It is also supplied with a measuring syringe for dosing.IngredientsEach 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 anhydrousKeppra 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 yellowKeppra tablets do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.Keppra oral solution contains 100 mg/mL levetiractam as the active ingredient.Other ingredients in Keppra oral solution include:sodium citrate citric acid monohydrate methylhyroxybenzoate parahydroxybenzoate ammonium glycyrrhizate glycerol maltitol solution acesulfame potassium grape flavourSponsor:UCB PharmaA division of UCB Australia Pty LtdLevel 1, 1155 Malvern RoadMalvern Vic 3144, AustraliaKeppra 250mg - AUST R 120508Keppra 500mg - AUST R 120509Keppra 1000mg - AUST R 120513Keppra oral solution - AUST R 120499 (not available in New Zealand)Date of preparation:23rd May 2008 Miscellaneous Drug Interactions Warnings Common Uses Ingredients Directions Indications