Skip to Content

IMIGRAN NASAL SPRAY 20MG/0.1ML

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

FRONT PAGE
Imigran® Nasal Spray 20mg/0.1ml
(sumatriptan)

T04354

The name of your product is Imigran Nasal Spray 20 mg/0.1 ml but will be referred to as Imigran nasal
spray throughout the patient information leaflet.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist (chemist).
• This medicine has been prescribed for you only. Do not pass it on to others - it may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1 What Imigran is and what it is used for
2 Before you use Imigran nasal spray
3 How to use Imigran nasal spray
4 Possible side effects
5 How to store Imigran nasal spray
6 Contents of the pack and other information

1. What Imigran is and what it is used for
Each Imigran nasal spray contains a single dose of sumatriptan, which belongs to a group of
medicines called triptans (also known as 5-HT1 receptor agonists).
Imigran nasal spray is used to treat migraine headache.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Imigran
nasal spray is believed to reduce the widening of these blood vessels. This in turn helps to take away
the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or
vomiting) and sensitivity to light and sound.

2. Before you use Imigran Nasal Spray
Don’t use Imigran:
• If you’re allergic to sumatriptan, or any of the other ingredients (listed in Section 6).
• If you have a heart problem such as narrowing of the arteries (Ischaemic heart disease) or chest
pains (angina), or have already had a heart attack.
• If you have circulation problems in your legs that cause cramp-like pains when you walk
(peripheral vascular disease).
• If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA).
• If you have high blood pressure. You may be able to use Imigran if your high blood pressure is
mild and is being treated.
• If you have serious liver disease.
• With other migraine medicines, including those which contain ergotamine, or similar medicines
such as methysergide or any triptan/5-HT1 receptor agonist (medicines which are also used for
treating migraine).
• With anti-depressants called MAOIs (monoamine oxidase inhibitors), or if you have taken these
medicines in the last 2 weeks.
If any of these apply to you:
� Tell your doctor, and don’t use Imigran nasal spray.
Take special care with Imigran
Your doctor needs to know certain information before you use Imigran:
If you have any extra risk factors
• If you are a heavy smoker, or are using nicotine replacement therapy, and especially
• If you are a man aged over 40, or
• If you are a woman who has been through the menopause.
In very rare cases, people have developed serious heart conditions after using Imigran, even though
they had no signs of heart disease before. If any of the points above applies to you it could mean you
have a greater risk of developing heart disease - so:
� Tell your doctor so that your heart function can be checked before Imigran is prescribed for you.
If you have a history of fits (seizures)
Or if you have other conditions which might make it more likely that you’ll have a fit – for example, a
head injury or alcoholism:
� Tell your doctor so that you can be supervised more closely.
If you have liver or kidney disease
� Tell your doctor so that you can be supervised more closely.
If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Imigran. If you know you are allergic to an antibiotic but you are not
sure whether it is a sulphonamide:
�Tell your doctor or pharmacist before using Imigran.

If you are taking anti-depressants called SSRIs
(Selective Serotonin Reuptake Inhibitors) or SNRIs(Serotonin Noradrenaline Reuptake Inhibitors)
� Tell your doctor or pharmacist before you use Imigran.Also see Other medicines and Imigran,
below.
If you use Imigran frequently
Using Imigran too often may make your headaches worse.
�Tell your doctor if this applies to you. He or she may recommend you stop using Imigran.
If you feel pain or tightness in your chest after you use Imigran
These effects may be intense but they usually pass quickly. If they don’t pass quickly, or they become
severe:
� Get medical help immediately. Section 4 of this leaflet has more information about these possible
side effects.
Other medicines and Imigran
Tell your doctor or pharmacist if you’re taking, have recently taken or might take any other
medicines. This includes any herbal products or medicines you’ve bought without a prescription.
Some medicines must not be taken with Imigran and others may cause adverse effects if they’re taken
with Imigran. You must tell your doctor if you are taking:
• ergotamine also used to treat migraine, or similar medicines such as methysergide (see Section
2). Don’t use Imigran at the same time as these medicines. Stop taking these medicines at least 24
hours before using Imigran. Don’t take any medicines which contain ergotamine or compounds
similar to ergotamine again for at least 6 hours after using Imigran.
• other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used
to treat migraine, (see Section 2). Don’t use Imigran at the same time as these medicines. Stop
taking these medicines at least 24 hours before using Imigran. Don’t take another triptan/5-HT1
receptor agonist again for at least 24 hours after using Imigran.
• SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake
Inhibitors) used to treat depression. Using Imigran with these medicines can cause serotonin
syndrome (a collection of symptoms which can include restlessness, confusion, sweating,
hallucinations, increased reflexes, muscle spasms, shivering, increased heartbeat and shaking).
Tell your doctor immediately if you are affected in this way.
• MAOIs (monoamine oxidase inhibitors) used to treat depression. Don’t use Imigran if you have
taken these in the last 2 weeks.
• St John’s Wort (Hypericum perforatum). Taking herbal remedies that contain St John’s Wort while
you are using Imigran may make side effects more likely.
Pregnancy and breast-feeding
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine. There is only limited information about the safety
of Imigran for pregnant women, though up till now there is no evidence of any increased risk of birth
defects. Your doctor will discuss with you whether or not you should use Imigran while you are
pregnant.
• Don’t breast-feed your baby for 12 hours after using Imigran. If you express any breast milk
during this time, discard the milk and don’t give it to your baby.
Driving and using machines
Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, don’t
drive or operate machinery.

3. How to use Imigran Nasal Spray
Only use Imigran after your migraine headache begins
Don’t use Imigran to try to prevent an attack.
Always use Imigran nasal spray exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
There’s a step-by-step guide to using the spray at the end of this section.
How much to use
Adults aged 18 to 65
• The usual dose for adults aged 18 to 65 is one Imigran 20 mg spray into just one nostril. But one
Imigran 10 mg spray into one nostril is enough for some people.
Don’t use more than two sprays in 24 hours.
Adolescents aged 12 to 17
• The usual dose for adolescents aged 12 to 17 is one Imigran 10 mg spray into one nostril.
Children under 12
• Imigran nasal spray is not recommended for children under 12 years old.
Older people (aged over 65)
• Imigran nasal spray is not recommended for people aged over 65.
When to use Imigran
• It’s best to use Imigran as soon as you feel a migraine coming on, although it can be used at
any time during an attack.
If your symptoms start to come back
• You can use a second Imigran nasal spray after 2 hours, but don’t use more than two sprays in
24 hours.
If the first spray has no effect
• Don’t use a second spray or any other Imigran preparation for the same attack. If Imigran doesn’t
give you any relief:

BACK PAGE
� Ask your doctor or pharmacist for advice.
If you use more Imigran than you should
• Don’t use more than two Imigran nasal sprays in 24 hours.
Using too much Imigran could make you ill. If you have used more than two sprays in 24 hours:
� Contact your doctor for advice.
If you have any further question on the use of this medicine, ask your doctor or pharmacist.
Step-by-step guide to using your Imigran nasal spray
Don’t open a blister until you are ready to use a spray. Each spray is sealed in a blister to keep it
clean and safe. If you carry a spray without a blister, or in an open blister, it may not work properly when
you need it.
Each spray contains just one dose of Imigran.
Don’t press the plunger too soon or you will lose the dose.
Imigran nasal spray has three parts:
The nozzle
The part that you put into your nostril. The spray comes out of a tiny hole in
the top.
The finger-grip
Hold this when you use the spray.
The blue plunger
Press this to spray the whole dose into your nostril in one go. This only
works once - don’t press the plunger until you have put the nozzle into
your nostril or you will lose the dose.
How to use the nasal spray
1. Remove the nasal spray from the blister packaging just before you
want to use it.
2. Get into a comfortable position. You may prefer to sit down.
3. Blow your nose if it feels blocked, or if you have a cold.
4. Hold the nasal spray gently with your fingers and thumb, as shown in
picture A.
Don’t press the blue plunger yet.
5. Block one nostril by pressing a finger firmly on the side of your nose.
It doesn’t matter which nostril you choose.
6. Put the nozzle of the nasal spray into the other nostril, as far as feels
1
comfortable - about 1 cm or /2 inch (picture B).
Breathe out gently through your mouth.
Hold your head upright and close your mouth.

7. Start to breathe in gently through your nose.
As you breathe in:
Press the blue plunger firmly with your thumb.
The plunger may feel a bit stiff and you may hear it click. Keep breathing
in while spraying (picture C).
8. Remove the spray and remove your finger from the side of your
nose.
Keep your head upright for 10-20 seconds, breathing gently in
through your nose and out through your mouth. This helps the medicine
stay in your nose.
Your nose may feel wet inside and you may notice a slight taste after
using the spray - this is normal and will soon pass.
9. Your nasal spray is now empty. Throw it away safely and hygienically.

4. Possible side effects
Like all medicines, Imigran nasal spray can cause side effects, but not everybody gets them.
Some symptoms may be caused by the migraine itself.
Adverse events reported in adults have also been observed in adolescents. These include very rare
reports of heart attacks.
Allergic reaction: get doctor’s help straight away
The following side effects have occurred but their exact frequency is not known.
• The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips;
complete collapse.

Very common side effects
(affecting more than 1 in 10 people)
• Unpleasant taste.
Common side effects
(affect up to 1 in 10 people)
• Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, or feelings
of unusual sensations, including numbness, tingling and warmth or cold. These effects may be
intense but generally pass quickly.
If these effects continue or become severe (especially the chest pain):
� Get medical help urgently. In a very small number of people these symptoms can be caused by a
heart attack.
Other common side effects include:
• Irritation or burning sensation in the nose or throat; nose bleeds.
• Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself.
• Tiredness or drowsiness.
• Dizziness, feeling weak, or getting hot flushes.
• Temporary increase in blood pressure.
• Shortness of breath.
• Aching muscles.
Very rare side effects
(affect up to 1 in 10,000 people)
• Liver function changes. If you have a blood test to check your liver function, tell your doctor or
nurse that you are using Imigran.
Some people may have the following side effects but it is not known how often they occur
• Seizures/fits, tremors, muscle spasm, neck stiffness.
• Visual disturbances such as flickering, reduced vision, double vision, loss of vision, and in some
cases even permanent defects (although these may be due to the migraine attack itself).
• Heart problems, where your heartbeat may go faster, slower or change rhythm, chest pains
(angina) or heart attack.
• Pale, blue-tinged skin and/or pain in your fingers, toes, ears, nose or jaw in response to cold or
stress (Raynaud’s phenomenon).
• Feeling faint (blood pressure may go down).
• Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• Pain in the joints.
• Feeling anxious.
• Excessive sweating.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Imigran Nasal Spray
• Keep out of the sight and reach of children.
• Keep Imigran nasal spray in the sealed blister in the box to protect it from light.
• Don’t store above 30°C and don’t freeze.
• Don’t use Imigran nasal spray after the expiry date shown on the carton. The expiry date refers to
the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Imigran nasal spray contains
• Each pre-filled nasal spray device contains the active ingredient - 20mg sumatriptan in 0.1ml
yellow-coloured aqueous solution.
• The other ingredients are sodium hydroxide, purified water, sulphuric acid, potassium dihydrogen
phosphate and sodium phosphate dibasic.
What Imigran nasal spray looks like and contents of the pack
• Each pack contains either 2 or 6 pre-filled, single use nasal spray devices containing a yellow
aqueous solution.
Manufacturer and Product Licence Holder
This product is manufactured by Manufactured by Glaxo Wellcome Spa, Strada Asolana Km 11 - 43056
San Polo Di Torrile, Parma, Italy. It is procured from within the EU by the Product Licence Holder:
Swinghope Limited, Brandon House, Marlowe Way, Croydon, CR0 4XS and repackaged by Interport
Limited, Brandon House, Marlowe Way, Croydon, CR0 4XS.
POM

PL No: 10380/1026

Leaflet revision date: 22/08/2013

If you get any of these symptoms soon after using Imigran:
� Don’t use any more. Contact a doctor straight away.
T04354

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide