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Microsoft word - arrow sumatriptan inj_nov 2010_cmi.doc

Arrow – Sumatriptan Injection
Sumatriptan Injection 6mg/0.5mL

What is in this leaflet
Please read this leaflet carefully before you start using ARROW - SUMATRIPTAN Injection. This leaflet answers some common questions about ARROW - SUMATRIPTAN Injection. 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 risks of you taking ARROW - SUMATRIPTAN Injection against the benefits this medicine is expected to 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 ARROW - SUMATRIPTAN Injection is used for
ARROW - SUMATRIPTAN Injection contains the active ingredient sumatriptan succinate. This medicine belongs to a group of drugs called serotonin agonists. ARROW - SUMATRIPTAN Injection is used to relieve headache and other symptoms of a migraine attack. It should not be used to prevent migraine attacks from occurring. ARROW – SUMATRIPTAN Injection may be used for migraine headaches with or without what is known as 'aura'. There is no information on the use of ARROW - SUMATRIPTAN Injection in special kinds of migraine known as 'basilar migraine' or 'hemiplegic migraine'. It is thought that migraine headache is due to widening of certain blood vessels in the head. ARROW - SUMATRIPTAN Injection works by making those vessels normal again and easing the symptoms of migraine. ARROW - SUMATRIPTAN Injection is also used for treatment of cluster headache. Before you take ARROW – SUMATRIPTAN Injection
When you must not take it
Do not use ARROW - SUMATRIPTAN Injection if you have ever had an allergic reaction to sumatriptan succinate or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting. Do not take ARROW - SUMATRIPTAN Injection if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should. Your doctor will discuss the risks and benefits of taking ARROW - SUMATRIPTAN Injection if you are pregnant or breastfeeding. Do not take ARROW - SUMATRIPTAN Injection if you have or have had: • heart disease, or previous heart attack. • shortness of breath, pain or tightness in the chest, jaw or upper arm. • Prinzmetal's angina. • angina, or severe chest pain or tightness. • high blood pressure that isn't under control • severe liver disease. • a stroke • temporary loss of oxygen to the brain - also called TIAs or mini-strokes Do not use ARROW - SUMATRIPTAN Injection if you have taken any of these medicines in the last 24 hours: • Ergotamine containing preparations (for example, Cafergot™) • Methysergide (for example, Deseril™) Do not use ARROW - SUMATRIPTAN Injection if you have taken Monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression in the last two weeks, e.g. tranylcypromine (Parnate™). Do not use ARROW - SUMATRIPTAN Injection after the expiry date printed on the pack. If you use it after the expiry date has passed, it may not work as well. Do not use ARROW - SUMATRIPTAN Injection if the packaging is torn or shows signs of tampering. If you're not sure whether you should be taking ARROW - SUMATRIPTAN Injection, talk
to your doctor.

What you must do
You must tell your doctor if you are allergic to: • food, dyes or preservatives. • any medicine, including any that contain sulphur (for example, sulphonamide antibiotics). • if you are allergic to an antibiotic but you are unsure if it belongs to this group, ask your You must tell your doctor if you have or have had any of the following medical conditions: • liver or kidney disease. • epilepsy or fits. • brain tumour, or any other condition affecting the brain. • irregular heart beats. • high blood pressure - even if it is under control. • high blood cholesterol levels. • a family history of heart problems. Your doctor may check if your heart is healthy before prescribing ARROW - SUMATRIPTAN Injection. Your doctor may also decide to do tests if you get certain symptoms with ARROW - SUMATRIPTAN Injection. This is because ARROW - SUMATRIPTAN Injection can make certain types of heart disease worse. • are over 65 years of age or under 18 years of age. • are taking a selective serotonin reuptake inhibitor (SSRI), a type of medicine used to treat depression, e.g. paroxetine (Aropax™), fluoxetine (Prozac™, Fluox™), citalopram (Cipramil™, Celapram™), nefazodone (Serzone™), sertraline (Zoloft™), venlafaxine (Efexor™). • have not had your headache diagnosed as migraine by a doctor.
• think that this headache is different and worse than your usual migraine.
• have difficulty moving one side of your body when you have the "migraine" headache.
• have not responded to your first dose of ARROW - SUMATRIPTAN Injection.
Use in children
There is no information on the use of ARROW - SUMATRIPTAN Injection in children under 18 years of age. Taking other medicines
Tell your doctor if you are taking or have taken any other medicines in the last two weeks, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when taking ARROW - SUMATRIPTAN Injection with other medicines. How to use your ARROW – SUMATRIPTAN Injection
Take your medicine as your doctor has told you. The label on the pack will tell you how often you can use them. If you do not understand what you should do, ask your doctor or pharmacist. How much to use
Migraine
The recommended dose for adults is a single 6mg (0.5mL) injection. If the injection doesn't help the migraine, you CANNOT use another ARROW - SUMATRIPTAN for that attack. However, if the injection does help the migraine but the migraine comes back you can use a second injection. See below for more information. If the migraine does not get better DO NOT use another injection for the same migraine.
You may take something else for the pain but do not take medicine containing ergotamine or
dihydroergotamine or methysergide. If you are not sure what to do, ask your doctor or
pharmacist. He or she can tell you what you may take. If the first ARROW - SUMATRIPTAN
Injection did not relieve your migraine, you may use ARROW - SUMATRIPTAN Injection on
another occasion to treat another migraine attack.
If the migraine improves after the injection but the headache comes back, a second injection can be used, but it must be at least an hour after the first injection. The maximum dose is two injections in 24 hours. Cluster headache
The recommended dose for adults is a single 6mg (0.5mL) injection for each cluster attack. The maximum dose in 24 hours is two 6mg injections with at least one hour between injections. How to use it
ARROW - SUMATRIPTAN Injection is injected under the skin. When to use it
It is best to use your ARROW - SUMATRIPTAN Injection at the first sign of a migraine headache or associated symptoms: • when the migraine headache begins; or • when other symptoms of the migraine headache begin. These symptoms may be nausea (feeling sick), vomiting or your eyes becoming sensitive to light. If you use your injection later during the migraine attack it will still work for you. Do not use your ARROW - SUMATRIPTAN Injection before the above symptoms occur. If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (0800 POISON or 0800 764 766) for advice, if you think you or anyone else may have used too many ARROW - SUMATRIPTAN Injections, even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy. If you are not sure what to do, contact your doctor or pharmacist. While you are using ARROW – SUMATRIPTAN Injection
Things you must do
Tell your doctor or pharmacist that you are using ARROW - SUMATRIPTAN Injection if you are about to be started on any new medicines. Tell your doctor if you become pregnant or are trying to become pregnant. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think it was not effective and change your treatment unnecessarily. Things you must not do
Do not change the dose of your ARROW - SUMATRIPTAN Injection without first checking with your doctor. Do not give this medicine to anyone else, even if their symptoms seem similar to yours. Things to be careful of
Be careful driving or operating machinery until you know how ARROW - SUMATRIPTAN Injection affects you. ARROW - SUMATRIPTAN Injection generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, ARROW - SUMATRIPTAN Injection may cause drowsiness in some people. If you use ARROW - SUMATRIPTAN Injection too often, it may make your headache worse. If this happens, your doctor may tell you to stop taking ARROW - SUMATRIPTAN Injection. Side effects
Check with your doctor as soon as possible if you have any problems while using ARROW - SUMATRIPTAN Injection, even if you do not think the problems are connected with the medicine or are not listed in this leaflet. Like other medicines, ARROW - SUMATRIPTAN Injection can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention. Tell your doctor at your next visit if you notice any of the following after taking ARROW - SUMATRIPTAN Injection: • pain, tingling, heat, or flushing in any part of the body. • feeling of sleepiness, dizziness or tiredness. • nausea (feeling sick) or vomiting. • a change in blood pressure. • feeling of faintness or weakness • visual disturbances. • shaking or tremors. • temporary pain where the injection is given. • shortness of breath. These are more common side effects of ARROW - SUMATRIPTAN Injection and are usually only temporary. If they continue or trouble you, check with your doctor. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor immediately and do not take any more ARROW - SUMATRIPTAN
Injection if you:
• feel heaviness, pressure or tightness in any part of the body, including the chest or throat. This can be a common side effect, but it is wise to check it with your doctor as it can also be a sign of something more serious. • feel abnormal heart beats - too fast, too slow, or irregular heart beats, palpitations. • have a fit or convulsion. • have severe pain in the stomach or abdomen These side effects may be serious. If you have them stop taking ARROW-SUMATRIPTAN Injection and seek medical attention straight away. If you think you are having an allergic reaction to ARROW - SUMATRIPTAN Injection,
tell your doctor immediately or go to your casualty department at your nearest
hospital.

Symptoms of an allergic reaction usually include some or all of the following:
• wheezing. • swelling of the lips/mouth. • difficulty in breathing. • hay fever. • lumpy rash ("hives"). • fainting. This is not the complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known. Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side-effects. You may not experience any of
them.

After using ARROW – SUMATRIPTAN Injection
Storage
Keep this medicine where young 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 ARROW – SUMATRIPTAN Injection in a cool, dry place where it stays below 25°C, protect from light. Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat, light and dampness can destroy some medicines. Disposal
If your doctor tells you to stop taking ARROW - SUMATRIPTAN Injection, or the injection has passed the expiry date, ask your pharmacist what to do with any injection left over. Needles and syringes may be hazardous and should be disposed of safely and hygienically. Product Description
What ARROW - SUMATRIPTAN injection looks like
ARROW - SUMATRIPTAN Injection is a syringe containing a clear, colourless to pale yellow solution. Each pack contains two prefilled syringes. Ingredients
ARROW - SUMATRIPTAN Injection contains sumatriptan succinate, sodium chloride, water for injections. ARROW - SUMATRIPTAN Injection does not contain lactose, sucrose or gluten. Supplier
ARROW – SUMATRIPTAN Injection is distributed in New Zealand by: Arrow Pharmaceuticals (NZ) Limited Mount Eden Central Business Park 33a Normanby Road, Mt Eden Auckland, New Zealand. Date of information

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Veuillez lire attentivement cette notice avant de prendre ce médicament. Elle contient des informations importantes pour votre • Ce médicament peut être utilisé en automédication, c’est-à-dire utilisé sans consultation ni prescription d’un médecin. • Si les symptômes persistent, s’ils s’aggravent après 2 jours de traitement ou si de nouveaux symptômes apparaissen

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