Imigran 10mg Nasal Spray
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By keddies at 1:47 pm, 5/19/06
SUMATRIPTAN 10MG NASAL SPRAY
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully before you start to use your medicine.
The name of your medicine is Sumatriptan 10mg Nasal Spray but will be referred to as Sumatriptan Nasal Spray throughout the remainder of this leaflet.
What your medicine contains
Each pre-filled nasal spray device contains 10mg of the active ingredient sumatriptan.
Also contains the following inactive ingredients: potassium dihydrogen phosphate, anhydrous dibasic sodium phosphate, sulphuric acid, sodium hydroxide and purified water.
Each pack contains 2 single dose pre-filled nasal sprays in grey plastic containers with blue pumps containing solution for nasal inhalation.
Who has made your medicine?
Sumatriptan Nasal Spray is manufactured by: Glaxo Wellcome Farmaceutica, Lda, R. Dr. Antonio Loureiro Borges, 3, Arqu iparque, Miraflores, 1495-131, Alges, Portugal.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 7, Crystal Way, Elmgrove Road, Harrow, Middlesex HA1 2HP.
Sumatriptan 10mg Nasal Spray PL No: 18799/1365
What your Nasal Spray does
Sumatriptan Nasal Spray contains sumatriptan, a medicine developed for the treatment of migraine. The symptoms of migraine may be due to swollen blood vessels around the brain. Medicines like Sumatriptan Nasal Spray probably work by reducing the size of the blood vessels and are called 5HTi receptor agonists.
IF YOU ARE NOT SURE WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ASK YOUR DOCTOR
Before using Sumatriptan Nasal Spray tell your doctor if:
• If you are allergic to Sumatriptan Nasal spray, sumatriptan or to
any of the ingredients in the nasal spray listed above or to medicines called sulphonamides
• You suffer from unexpected shortness of breath, or from pain or
tightness in the chest (which may or may not spread to your jaw or upper arms)
• You have any of the following medical conditions: heart disease
such as heart failure, angina or coronary thrombosis (heart attack), high blood pressure, disease of the liver or kidneys
• You are taking any medicines for your migraine which contain
ergotamine, (if so you should stop taking them at least 24 hours before using Sumatriptan Nasal Spray)
• You are taking any medicines on a doctor's prescription for the
treatment of depression such as MAOI's or SSRI's (including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline)
• You are taking any medicines on a doctor's prescription to help
you lose weight, or for the treatment of epilepsy
• You are taking anything containing the herbal remedy St John's
Wort (Hypericum perforatum). Taking this with Sumatriptan Nasal Spray may increase the likelihood of you suffering side effects
Assessed against UK PIL dated March 2006
• You are pregnant, or likely to become pregnant, or have stopped
having periods altogether,
• You are breastfeeding. Your doctor may still advise you to take
sumatriptan but breastfeeding should be avoided for 12 hours after a dose and during this time any breast milk expressed should be discarded
• You are a man over 40 years of age
• You have a family history of heart disease
• You have had a stroke or transient ischaemic attack (TIA).
Even so your doctor may still want you to use it.
You should also talk to your doctor before using this nasal spray if:
• You have been told you have sugar diabetes or a high blood
cholesterol
• You are a regular cigarette smoker or if you are very overweight. As with other migraine treatments, overuse could make your migraines worse and make them occur more often.
Driving and using machines
Sumatriptan Nasal Spray may cause drowsiness. If you are affected do not drive or operate machinery.
How to use your Sumatriptan Nasal Spray
Look at the label - it should say WHO should use it, WHAT DOSE and WHEN. If it does not, or you are not sure, ask your doctor or pharmacist or follow this advice. Instructions on how to use Sumatriptan Nasal Spray are given later on in this leaflet.
For adults (over 18 years of age)
You should use two Sumatriptan Nasal Sprays in one nostril as soon as you feel a migraine coming on, although it can be used at any time during an attack. Do not use more than four Nasal sprays in 24 hours. For young(er) people (12 -17 years of age)
You/your child should use one Sumatriptan 10mg Nasal spray in one nostril as soon as you/your child feel a migraine coming on, although it can be used at any time during an attack.
DO NOT use more than two 10mg Nasal Sprays in 24 hours.
If your migraine does not go, do not use a second spray or any other preparation for the same attack. It will not help you.
If your migraine goes, then comes back, you can use a second nasal spray provided it is at least two hours since you used the first spray. There is little experience of Sumatriptan Nasal Spray in children or those over 65 years of age so it is not usually prescribed for these age groups.
If you accidentally spray Sumatriptan Nasal Spray in your eye(s) wash with plenty of water. If there is any irritation consult your doctor.
After starting to use your nasal spray
Within an hour or two of using Sumatriptan Nasal Spray, most people find their migraine is much better. If the nasal spray does not ease your migraine, you may then take your usual “pain killers”, provided they do not contain ergotamine. Wait at least six hours after one nasal spray before taking any medicines containing ergotamine.
What to do if too many Sumatriptan Nasal Sprays are used?
It is important to keep to the dose on the label. Using more than this could make you ill. If an overdose is taken, DO NOT DELAY, ask your doctor what to do or contact your nearest hospital emergency department.
Possible side effects
Most people find taking this medicine causes no problems. As with most medicines, a few people may find they have side-effects to it. The most common side effect of Sumatriptan Nasal Spray is that you may notice an unusual taste from the medicine. This soon passes.
Final Draft Mock up
Common side effects (could happen to between 1 in 10 and 1 in 100 people taking it):
• Short lasting mild irritation or burning your nose and throat and you might get nosebleeds
• Flushing (redness of the face lasting a few minutes), dizziness, feelings of weakness, tiredness and drowsiness (IMPORTANT if you are driving or working a machine)
• Short lasting increases in blood pressure soon after taking the medicine
• Feeling sick or (nausea) or being sick (vomiting) - when not part of a migraine attack.
• Pain, sensations of tingling, heat, heaviness and pressure or tightness. If they continue or are particularly severe (especially chest or heart pain which spreads to the arms) tell your doctor immediately as there have been rare reports of such problems being caused by a heart attack.
Very rare side effects (could happen to less than 1 in 10,000 people taking it):
• Visual disturbances including flickering, double vision and reduced vision. There have been cases where permanent vision defects have occurred.
• Lowering of blood pressure that can lead to felling of faintness especially on standing up
• Slowing or quickening in the speed of your heart beat, palpitations (feeling of fast heart beat), changes in heart rhythm
• Shaking, tremors or uncontrolled movements
• Stiffness in the neck
• If you have a blood test to check how your liver is working and have used Sumatriptan Nasal Spray, tell your doctor as it may affect the results.
If you have any of these effects mentioned above, you do not have to stop using Sumatriptan Nasal Spray unless they persist or you find them too unpleasant, but you should contact your doctor immediately and do not use any more Sumatriptan Nasal Spray unless your doctor tells you to do so.
• Sudden wheeziness, fluttering or tightness in the chest, swelling of
the eyelids, face or lips, skin rash-red spots or hives (skin lumps), which may be signs of an allergic reaction
• Fits (usually in people with a history of epilepsy)
• Inflammation of the colon (part of the intestine), which may present
as lower left-sided tummy pain and/or bloody diarrhoea
• Raynaud's phenomenon, which might appear as paleness or a blue
tinge to the skin and/or pain of the fingers, toes, ears, nose or jaw in response to cold or stress.
If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
If you do not feel better
If you do not get satisfactory relief of your migraine by using Sumatriptan Nasal Spray then tell your doctor at your next visit.
Looking after your Sumatriptan Nasal Spray
You may wish to carry the Sumatriptan Nasal Spray with you in case of a migraine attack.
Keep your nasal sprays away from heat and out of the light, which could spoil them.
Always keep your nasal spray in the sealed blister pack provided.
Do not freeze. Do not store above 30°C. If they are keep warmer than this for more than 24 hours it could spoil them. Store in the original container.
Assessed against UK PIL dated March 2006
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. A child may be harmed by medicine prescribed to someone else.
Remember - This Sumatriptan Nasal Spray is for YOU. Only a doctor can prescribe it for you. Never let someone else use it. There may be reasons why it could harm that person.
Further information
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has the information you need and will advise you. Pharmaceutical companies are not allowed to answer questions from patients about their diseases. There are two national organisations that offer both help and advice on migraine:
Migraine Action Association, Unit 6, Oakley Hay Lodge Business Park, Great Folds Road, Great Oakley, Northants NN18 9AS. Tel: 01536 461333.
The Migraine Trust, 55-56 Russell Square, London, WC1B 4HP. Telephone: 020 7436 1336
You may well be able to find out more about prescribed medicines from books in public libraries.
ABOUT YOUR NASAL SPRAY
Your Sumatriptan Nasal Spray is packed in a box containing the nasal sprays individually sealed in plastic containers. Each Sumatriptan Nasal Spray contains one dose of Sumatriptan Nasal Spray 10mg.
Do not open a packet until you are ready to use a spray. Each spray is sealed in a plastic container to help keep it clean and safe. If you carry a spray around out of the plastic, or in an open blister, it may not work properly when you need it.
Keep your Sumatriptan Nasal Spray in the box. The box is for you to
keep the blister pack in and to help protect it from light and damage. It is best to keep the sprays in the box but if you want to carry only one spray around with you, you may split the blister pack.
• Keep this information leaflet in a safe place. This leaflet tells you how to use your sprays and other useful information about your medicine. Keep the leaflet with Sumatriptan Nasal Spray so that you can read it again when you need to.
HOW TO USE SUMATRIPTAN NASAL SPRAY
Sumatriptan Nasal Spray must only be removed from the blister packaging immediately before use.
• First get into a comfortable position. You may like to sit down if there is a sit close by.
• Blow your nose first if it feels blocked, or if you have a cold.
• Peel open a blister pack and take out a nasal spray.
• Hold Sumatriptan Nasal Spray gently with your fingers and thumb as shown in the picture below.
• Do not press the blue plunger yet.
• Block one nostril by pressing a finger firmly on the side of your nose. It does not matter which nostril is used.
• Keep your head upright for 10-20 seconds and breathe gently in through your nose and out through your mouth. This helps the medicine stay in your nose. You can remove Sumatriptan Nasal Spray and your finger from the other side of your nose whilst you do this.
• Your nose may feel wet inside and you may notice a slight taste after using Sumatriptan Nasal Spray - this is normal and will soon pass.
• Your Sumatriptan Nasal Spray is now empty. It should be disposed of safely and hygienically.
YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NOT THROW IT AWAY UNTIL YOU HAVE FINISHED YOUR MEDICINE.
The information provided applies only to Sumatriptan 20mg Nasal Spray.
Leaflet revised: 19.05.2006
The Blue plunger: When you press the plunger the whole dose sprays into your nostril in one go. The plunger only works once so do not press it until you have put the nozzle into your nostril or you will have lost the dose.
Sumatriptan Nasal Spray consists of the following parts:
The Nozzle: This is the part that you put into your nostril. The spray comes out of a tiny hole in the top.
The finger grip:
This is the part that you hold when you use the spray.
Breathe out gently through your mouth
Put the nozzle of Sumatriptan Nasal Spray into the other nostril, as far as feels comfortable (about 1cm or A inch).
Keep your head upright as shown in the picture below and close your mouth.
Start to breathe in gently through your nose and at the same time press the blue plunger firmly with your thumb. Keep breathing in while spraying.
The plunger may feel a bit stiff and you may hear it click.