Sumagran 50mg Tablets 4

  Information General Information SUMAGRANcontains the active ingredient sumatriptan succinate--------------------------------------------------------------------------------Consumer Medicine InformationWhat is in this leafletPlease read this leaflet carefully before you start taking SUMAGRAN tablets.This leaflet answers some common questions about SUMAGRAN tablets. It does not contain all of 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 expected benefits of you taking SUMAGRAN against the risks this medicine could 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 SUMAGRAN is used forSUMAGRAN contain the active ingredient sumatriptan succinate. This medicine belongs to a group of drugs called serotonin agonists.SUMAGRAN are used to relieve a migraine attack. They should not be used to prevent migraine attacks from occurring. SUMAGRAN may be used for migraine headaches with or without what is known as 'aura'.It is thought that migraine headache is due to widening of certain blood vessels in the head.SUMAGRAN works by making those vessels normal again and eases the symptoms of migraine.SUMAGRAN does not work in other types of headache that are not a migraine.Your doctor may have prescribed SUMAGRAN for another reason. Ask your doctor if you have any questions about why SUMAGRAN has been prescribed for you.SUMAGRAN are not addictive.SUMAGRAN is available only with a doctor's prescription.Use in children and adolescents SUMAGRAN is not recommended for use in children and adolescents under 12 years of age, as the safety and efficacy in this age group has not been established.Use in elderly SUMAGRAN is not recommended for use in elderly patients aged over 65, as experience of its use in this age group is limited.Before you take SUMAGRANWhen you must not take itDo not take SUMAGRAN if you are allergic to sumatriptan succinate or 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 SUMAGRAN if you have or have had:heart disease or heart attackshortness of breath, pain or tightness in the chest, jaw or upper armperipheral vascular disease (pain in the back of the legs) or are prone to cold, tingling or numb hands and feetPrinzmetal's angina (uncommon form of angina where pain is experienced at rest rather than during activity)anginahigh blood pressurestrokesevere liver disease.Do not take SUMAGRAN if you have taken any of these medicines in the last 24 hours:ergotamine (eg Cafergot)dihydroergotamine (eg Dihydergot)methysergide (eg Deseril)naratriptan (eg Naramig)zolmitriptan (eg Zomig).Do not take SUMAGRAN if you have taken monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression, in the last two weeks.Do not take SUMAGRAN if the expiry date (EXP) printed on the pack has passed.Do not take SUMAGRAN if the packaging is torn or shows signs of tampering.Before you start to take itTell your doctor if you are allergic to foods, dyes, preservatives or any other medicines including those containing sulphur (eg sulphonamide antibiotics) or lactose (SUMAGRAN tablets contain lactose).Tell your doctor if you are taking or have taken any other medicines in the last two weeks, including those you buy without a prescription, particularly herbal preparations containing St John's wort.Tell your doctor if you are breastfeeding, pregnant or trying to become pregnant.Tell your doctor if you have or have had medical conditions like:liver or kidney problemsheart problems; risk factors including high blood pressure (even it is under control), high blood cholesterol levels, a family history of heart problem, obesity, diabetes, smoking, male and over 40 years of age, female and have undergone menopauseepilepsy, seizures or fits or been told that you are prone to this problemstroke.Tell your doctor if you:have not had your headache diagnosed as migraine by a doctorthink that this headache is different and worse than your usual migrainehave difficulty moving one side of your body when you have the "migraine" headachehave not responded to your first dose of SUMAGRAN.If you have not told your doctor about any of the above, tell them before you start taking SUMAGRAN.Taking other medicinesTell your doctor if you are taking any other medicines, including those you buy without a prescription from a pharmacy, supermarket or health food shop.Some medicines may be affected by SUMAGRAN, or may affect how well it works. These include:ergotamine dihydroergotaminemethysergide triptans such as naratriptan, zolmitriptanmonoamine oxidase inhibitorsSt John's wortother medicines for depression.Your doctor can tell you what to do if you are taking any of these medicines.If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking SUMAGRAN.How to take SUMAGRANFollow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.If you do not understand what you should do, ask your doctor or pharmacist.How much to takeThe recommended starting dose for adults is 50 mg. However, you may need to have your dose increased to 100 mg. Your doctor will tell you which dose is right for you.If the first SUMAGRAN tablet helps your migraine, but the migraine comes back later, you may take another SUMAGRAN tablet. Do not take more than 300 mg of SUMAGRAN tablets in any 24-hour period. Six 50 mg or three 100 mg tablets contain 300 mg.Do not take more SUMAGRAN tablets, or any other form of medications containing sumatriptan, if the first dose has not provided any relief from your symptoms. You may take your usual headache relief medication provided it does not contain ergotamine, dihydroergotamine or methysergide. If you are not sure what to do, ask your doctor or pharmacist.If your migraine is not relieved by SUMAGRAN, you may use it on another occasion to treat another migraine attack.Provided there are no side effects, you can use SUMAGRAN to treat at least three separate migraine attacks before you and your doctor decide this medicine is ineffective for you.How to take SUMAGRANSwallow the tablets with a drink of water. Do not crush or chew the tablet as it has a bitter taste.When to take SUMAGRAN It is best to take your SUMAGRAN:when the migraine headache begins, orwhen other symptoms of the migraine begin, such as nausea (feeling sick), vomiting or your eyes becoming sensitive to light.If you take your tablet later during the migraine attack, it will still work for you.Do not take SUMAGRAN before the above symptoms occur.If you take too much SUMAGRAN (overdose)Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much SUMAGRAN.Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.While you are taking SUMAGRANThings you must doTell any other doctors, dentists and pharmacists who treat you that you are taking SUMAGRAN.If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking SUMAGRAN.Tell your doctor if you become pregnant or are trying to become pregnant while taking SUMAGRAN.Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise, your doctor may think that it is not working and change your treatment unnecessarily.Things you must not doDo not give your medicine to anyone else, even if they have the same condition as you.Do not use SUMAGRAN to treat any other medical complaints unless your doctor tells you to.Do not change the dosage, without checking with your doctor.Things to be careful ofBe careful driving or operating machinery until you know how SUMAGRAN affect you. As with many other medicines, SUMAGRAN may cause drowsiness in some people.Side effectsTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SUMAGRAN. Like all other medicines, SUMAGRAN may have unwanted side effects in some people. 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 this list 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 experience any of the following after taking SUMAGRAN:pain, tingling, heat or flushing in any part of the bodyfeeling of sleepiness, dizziness or tirednessnausea (feeling sick) or vomitinga change in blood pressurefeeling of faintnessproblems with your eyesightpain in the lower tummy and bloody diarrhoea (ischaemic colitis)shaking or tremorsuncontrolled movements.If you notice any of the following while taking SUMAGRAN, stop taking it and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:feel heaviness, pressure or tightness in any part of the body including the chest or throatfeel irregular heartbeathave a fit or convulsionhave persistent purple discolouration and/or pain in the fingers, toes, ears, nose or jaw in response to coldhave wheezing, swelling of the lips or mouth, difficulty in breathing, hay fever, lumpy rash ("hives") or fainting. These could be a symptom of an allergic reaction.These side effects are likely to be serious. You may need urgent medical attention or hospitalisation.Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.After using SUMAGRANStorageKeep SUMAGRAN 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.Keep the tablets in a cool, dry place where the temperature stays below 25°C.Keep the tablets in their pack until time to take. If you take it out of the pack, it may not keep well.Do not store SUMAGRAN in the bathroom or near a sink.Do not leave SUMAGRAN in the car or on window sills. Heat and dampness can destroy some medicines.DisposalIf your doctor tells you to stop taking SUMAGRAN, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.Product descriptionWhat it looks likeSUMAGRAN tablets come in two strengths:SUMAGRAN 50 - white to off-white, round biconvex tablet, embossed with 'SA' over '50' on one side and '>' on the other side. Each pack contains 2 or 4 tablets.SUMAGRAN 100 - white to off-white, round, biconvex tablet, embossed with 'SA' over '100' on one side and '>' on the other side. Each pack contains 2 tablets.IngredientsThe active ingredient in SUMAGRAN is sumatriptan (as succinate).each SUMAGRAN 50 contains 50 mg of sumatriptaneach SUMAGRAN 100 contains 100 mg of sumatriptan.The tablets also contain:microcrystalline cellulosecroscarmellose sodiummagnesium stearateanhydrous lactose.The tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.ManufacturerArrow Pharmaceuticals Pty Ltd (a member of the Sigma group of companies) 96 Merrindale Drive Croydon Vic 3136Tel: 03 - 9839 2800 03 - 9839 2800Australian registration numbers:SUMAGRAN 50- AUST R 117670SUMAGRAN 100- AUST R 117727Date of preparation: May 2007.Published by MIMS/myDr May 2008Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from Miscellaneous Drug Interactions Warnings Common Uses Ingredients Directions Indications