Exelon 2mg/mL Oral Solution 120mL

  Information General Information Consumer Medicine InformationWhat is in this leafletThis leaflet answers some common questions about Exelon. 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 it against the benefits they expect it will provide. 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 Exelon is used for Exelon is used to treat a condition called Alzheimer's disease. Alzheimer's disease is a condition in which changes in the brain cause problems with memory, thinking and behaviour. These problems gradually become worse with time. Exelon works by preventing the breakdown of a chemical in the brain called acetylcholine. This chemical is needed to help keep the brain working properly. Exelon helps to slow down the mental decline that happens in people with Alzheimer's disease and it helps to improve the ability to cope with everyday activities. It does not cure the condition. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. Exelon is only available with a doctor's prescription. It is not addictive. There is not enough information to recommend this medicine for children. Before you take Exelon When you must not take itDo not take Exelon if you have had an allergic reaction to any of the following:rivastigmine, the active ingredient in Exelon any of the other ingredients of Exelon listed at the end of this leaflet. other related "carbamate" medicines (if you are unsure about these, ask your doctor or pharmacist) Symptoms of an allergic reaction may include wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash or hives on the skin. Do not take Exelon if you have a severe liver disorder. There is no information on the use of this medicine in people with severe liver problems. Do not take Exelon after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist. Before you start to take itTell your doctor if you have any of the following conditions:a problem with your heart a history of stomach ulcer problems with your lungs such as asthma or emphysema difficulty passing urine (water) seizures (fits) problems with your kidneys or liverIf you have any of the above conditions your doctor may want to take special precautions while you are taking this medicine. Tell your doctor if you are pregnant or breast-feeding. It is not known whether taking Exelon during pregnancy or while breast-feeding could affect your baby. Breast-feeding is not recommended while you are taking this medicine. Tell your doctor if you smoke. Nicotine can affect the amount of Exelon that is in your body. A sudden change in your usual smoking habit can also change the effects of Exelon. Taking other medicinesTell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines and Exelon may interfere with each other. These include: cholinergic medicines (e.g. bethanecol, medicines used during surgery) anticholinergic medicines (e.g. medicines for stomach cramps, medicines for travel sickness, many medicines used to treat mental illness) non-steroidal anti-inflammatory drugs (NSAIDs), which are medicines used to treat arthritis and other painful conditions such as muscle strains, back pain, menstrual cramps and migraine You may need to take different amounts of your medicines or to take different medicines while you are taking Exelon. Your doctor and pharmacist have more information. If you have not told your doctor about any of these things, tell him/her before you start taking this medicine. How to take Exelon Follow all directions given to you by your doctor and pharmacist carefully. These instructions may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help. How much to takeThe usual starting dose is 1.5 mg twice a day. After two weeks, if you don't have any problems with the medicine, the dose may be gradually increased up to a maximum of 6 mg twice a day. If for any reason you stop taking Exelon for more than several days, tell your doctor before you start taking Exelon again. Your doctor will restart you at the lowest dose to help prevent side effects such as nausea and vomiting. How to take itExelon is available in capsules or in a liquid form called an oral solution. If you are taking the capsules, swallow them whole with a full glass of water or other liquid, with your morning and evening meals. Do not open or crush the capsules. If you are taking the oral solution, use the oral dosing syringe supplied in the pack to measure the correct dose.Using the syringe, withdraw the prescribed amount of Exelon oral solution from the container. Pictures and instructions in the pack will explain exactly what you must do. Swallow the dose of Exelon directly from the syringe or, if you prefer, first add the solution to a small glass of water, cold orange or apple juice or Coca-Cola. Stir and drink the entire mixture right away.Take Exelon 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. How long to take itContinue taking Exelon for as long as your doctor tells you to. This medicine helps to slow the progression of Alzheimer's disease but does not cure it. Your treatment can be continued for as long as it benefits your condition. Your doctor can give you more information. If you forget to take itIf it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally. Do not take a double dose to make up for the one that you missed. This may increase the chance of you getting an unwanted side effect. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints. If you take too much (overdose) Immediately telephone your doctor or the Poisons Information Centre (telephone number 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Exelon. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.Some of the symptoms of an overdose may include severe nausea (feeling sick), vomiting, diarrhoea, slow heartbeat and breathing, excess saliva, sweating, muscle weakness, fainting and seizures (fits). While you are taking Exelon Things you must doBe sure to keep all of your doctor's appointments so your progress can be checked. You and your caregiver can help to produce the maximum benefit from your treatment by keeping in close contact with your doctor. Make sure you or your caregiver tells your doctor if you experience considerable nausea and vomiting with loss of appetite and weight loss. If you become pregnant while taking Exelon, tell your doctor.If you are going to have surgery, tell your doctor and anaesthetist that your are taking Exelon. Exelon may affect some medicines you receive during surgery. If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Exelon. Tell any other doctor, dentist or pharmacist who treats you that you are taking Exelon. Things you must not doDo not give this medicine to anyone else even if their condition seems similar to yours. Do not use Exelon to treat any other complaints unless your doctor tells you to. Side effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Exelon, even if you do not think it is connected with the medicine. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by these lists of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you: nausea (feeling sick) or vomiting diarrhoea loss of appetite indigestion, abdominal discomfort weight loss dizziness headache unusual tiredness, weakness or sleepiness, feeling generally unwell trembling or shakiness increased sweating difficulty sleeping confusion feeling anxious or depressed hallucinations (hearing or seeing things that are not there) The above side effects usually happen at the start of treatment when the dose is being increased. They are not usually serious and may gradually disappear as your body gets used to the medicine. Women are more likely than men to get some side effects (e.g. nausea, vomiting, loss of appetite, weight loss). Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:signs of allergy such as rash or hives on the skin; swelling of the face, lips, tongue or other parts of the body; wheezing or difficulty breathing chest pain unusually fast, slow or irregular heart beat severe dizziness, fainting or fits (seizures) vomiting blood or material that looks like coffee grounds bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea severe pain in the abdomen, often with nausea and vomiting signs of a urinary tract infection such as frequent urge to urinate or pain on urinationTell your doctor if you notice anything else that is making you feel unwell. Some people may have other side effects not yet known or mentioned in this leaflet. Some of the side effects (for example, changes in liver function) can only be found when your doctor does tests from time to time to check your progress. Exelon oral solution contains sodium benzoate, which may be mildly irritating to the skin, eyes or mucous membranes. After using Exelon StorageKeep your medicine in the original container until it is time to take it. Store the medicine at room temperature. Do not refrigerate or freeze Exelon oral solution. Do not store Exelon or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Keep the medicine 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 tells you to stop taking Exelon or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over. Product description What it looks likeExelon capsules are available in four strengths, in packs of 56 capsules.Exelon 1.5 mg: yellow capsules printed with "EXELON" and "1.5 mg" in red. Exelon 3.0 mg: orange capsules printed with "EXELON" and "3 mg" in red. Exelon 4.5 mg: red capsules printed with "EXELON" and "4.5 mg" in white. Exelon 6.0 mg: orange and red capsules printed with "EXELON" and "6 mg" in red.Exelon oral solution is a clear yellow solution in a 120 mL glass bottle. The pack also contains an oral syringe for use in measuring the dose.IngredientsExelon capsules contain 1.5, 3.0, 4.5 or 6.0 mg of the active ingredient, rivastigmine (as the hydrogen tartrate salt). They also contain:magnesium stearate hypromellose colloidal anhydrous silica microcrystalline cellulose gelatin red iron oxide (CI77491) yellow iron oxide (CI77492) titanium dioxideExelon oral solution contains 2 mg of the active ingredient, rivastigmine (as the hydrogen tartrate salt) per mL of solution. It also contains: sodium benzoate citric acid sodium citrate quinoline yellow CI47005 purified waterSponsorExelon is supplied in Australia by:NOVARTIS Pharmaceuticals Australia Pty LimitedABN 18 004 244 16054 Waterloo RoadNorth Ryde NSW 2113Telephone 1 800 671 203® = Registered TrademarkThis leaflet was prepared in April 2006(exe270406c.doc) based on PI (exe270406i.doc) Australian Registration Number1.5 mg capsule AUST R 714453.0 mg capsule AUST R 714464.5 mg capsule AUST R 714476.0 mg capsule AUST R 714482 mg/mL solution AUST R 78269 Miscellaneous Drug Interactions Warnings Common Uses Ingredients Directions Indications