drug-medicine: imigran nasal spray

Patient Information Leaflet

IMIGRAN ® NASAL SPRAY

sumatriptan

What you should know about IMIGRAN NASAL SPRAY

Please read this carefully before starting to use your medicine.

What your nasal spray contains

Each pre-filled nasal spray device contains the active ingredient 10 mg or 20 mg sumatriptan in 0.1 ml of yellow-coloured aqueous solution.

The other ingredients are potassium phosphate, sodium phosphate, sulphuric acid, sodium hydroxide and purified water.

Each 20 mg pack contains either 2 or 6 pre-filled nasal spray devices and each 10 mg pack contains 2 pre-filled nasal spray devices.

What IMIGRAN NASAL SPRAY does

IMIGRAN 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 Imigran probably work by reducing the size of these blood vessels and are called 5HT1 receptor agonists.

If you are not sure why IMIGRAN has been prescribed for you ask your doctor.

Before you use IMIGRAN NASAL SPRAY

Before using your nasal spray tell your doctor if:

you are allergic to Imigran, sumatriptan or to any of the other 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 IMIGRAN NASAL SPRAY)
you are taking any medicines on a doctor’s prescription for the treatment of depression such as MAOIs or SSRIs (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 together with IMIGRAN NASAL SPRAY may increase the likelihood of you suffering side effects
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 are very overweight.

As with other migraine treatments, overuse could make your migraines worse and make them occur more often.

Driving and using machines

IMIGRAN may cause drowsiness. If you are affected do not drive or operate machinery.

How to use IMIGRAN 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 your IMIGRAN NASAL SPRAY are given later on in this leaflet.

For adults (over 18 years of age)

You should use one Imigran 20 mg Nasal Spray 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 two 20 mg Nasal Sprays in 24 hours.

For young(er) people (12 to 17 years of age)

You/your child should use one Imigran 10 mg 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 10 mg Nasal Sprays in 24 hours.

If your migraine does not go, do not use a second spray or any other Imigran 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 Imigran in children or those over 65 years of age so it is not usually prescribed for these age groups.

If you accidentally spray Imigran 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 a 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.

If you use too much IMIGRAN NASAL SPRAY

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, however a few people may find they have side effects to it.

The most common side effect of IMIGRAN NASAL SPRAY is that you may notice an unusual taste from the medicine. This soon passes.

Common side effects (could happen to between 1 in 10 and 1 in 100 people taking it):

Short lasting mild irritation or burning in 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 (nausea) or being sick (vomiting) - when not part of 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 feeling 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 IMIGRAN NASAL SPRAY, tell your doctor as it may affect the results.

If you have any of these side effects mentioned above, you do not have to stop using your IMIGRAN NASAL SPRAY unless they persist or you find them too unpleasant, but you should contact your doctor as soon as possible.

The following side effects are very rare but you should contact your doctor immediately and do not use any more IMIGRAN NASAL SPRAY unless your doctor tells you to do so.

Sudden wheeziness, fluttering or tightness in the chest, swelling of 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 IMIGRAN NASAL SPRAY then tell your doctor at your next visit.

Looking after your IMIGRAN NASAL SPRAY

You may wish to carry the IMIGRAN 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 kept warmer than this for more than 24 hours it could spoil them
As with all medicines, keep them safely out of the reach and sight of children. A child may be harmed by medicine prescribed for someone else.

What to do with any unused nasal spray

If your doctor stops your treatment do not keep any left over nasal spray unless your doctor tells you to.

Return any unused nasal spray to your pharmacist for safe disposal.

Do not use IMIGRAN NASAL SPRAY after the expiry date printed on the pack but return it to your pharmacist.

Remember

This 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.

ABOUT YOUR NASAL SPRAY

- Your IMIGRAN NASAL SPRAY is packed in a box containing the nasal sprays individually sealed in blisters. Each nasal spray contains one dose of Imigran.
	- Do not open a blister until you are ready to use a spray. Each spray is sealed in a blister to help keep it clean and safe. If you carry a spray around out of the blister, or in an open blister, it may not work properly when you need it.
	- Keep your IMIGRAN NASAL SPRAYs 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 in the box with the sprays so that you can read it again when you need to.

The 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.
	- 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.

HOW TO USE THE NASAL SPRAY

The 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 seat close by
- Blow your nose if it feels blocked, or if you have a cold
- Peel open a blister pack and take out a nasal spray
- Hold the nasal spray gently with your fingers and thumb as shown in the picture
- 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
- Breathe out gently through your mouth
- Put the nozzle of the nasal spray into the other nostril, as far as feels comfortable (about 1 cm or half an inch)
- Keep your head upright as shown in the picture 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
- 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 the 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 the spray - this is normal and will soon pass
- Your 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 IMIGRAN NASAL SPRAY.

Medicine: imigran nasal spray