PACKAGE LEAFLET: INFORMATION FOR THE USER

Imigran® 20mg/0.1ml Nasal Spray / Imigrane 20mg/0.1ml Nasal Spray

(sumatriptan)

This product is available using either of the above names but will be referred to as Imigran Nasal Spray throughout the following leaflet. Please note that the leaflet also contains information about other strength (Imigran 10mg/0.1ml Nasal Spray).

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.

•    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. See section 4.

What is in this leaflet

1.    What Imigran Nasal Spray is and what it is used for

2.    What you need to know 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 Nasal Spray is and what it is used foi

Each Imigran Nasal Spray contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HTi 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. What you need to know before you use Imigran Nasal Spray|

Don't use Imigran Nasal Spray:

■    If you're allergic to sumatriptan, or any of the other ingredients of this medicine (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 Nasal Spray 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-HT 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 Nasal Spray

Talk to your doctor or pharmacist before using Imigran Nasal Spray:

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 Nasal Spray, 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 Nasal Spray 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 Nasal Spray. 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 Nasal Spray.

If you are taking anti-depressants called SSRIs

(Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)

^ Tell your doctor or pharmacist before using Imigran Nasal Spray.

Also see Other medicines and Imigran Nasal Spray, below.

If you use Imigran Nasal Spray frequently

Using Imigran Nasal Spray too often may make your headaches worse.

^ Tell your doctor if this applies to you. He or she may recommend you stop using Imigran Nasal Spray.

If you feel pain or tightness in your chest after you use Imigran Nasal Spray

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 Nasal Spray

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 Nasal Spray and others may cause adverse effects if they're taken with Imigran Nasal Spray. 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 Nasal Spray at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran Nasal Spray. Don't take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using Imigran Nasal Spray.

■    other triptans/5-HT receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see Section 2). Don't use Imigran Nasal Spray at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran Nasal Spray.

Don't take another triptan/5-HT receptor agonist again for at least 24 hours after using Imigran Nasal Spray.

■    SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors) used to treat depression. Using Imigran Nasal Spray 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 Nasal Spray 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 Nasal Spray 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 Nasal Spray 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 Nasal Spray while you are pregnant.

■    Don't breast-feed your baby for 12 hours after using Imigran Nasal Spray. 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 Spra;

Only use Imigran Nasal Spray after your migraine headache begins Don't use Imigran Nasal Spray to try to prevent an attack.

Always use this medicine 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 20mg 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 Nasal Spray

■    It's best to use Imigran Nasal Spray 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:

^ Ask your doctor or pharmacist for advice.

If you use more Imigran Nasal Spray than you should

■    Don't use more than two Imigran Nasal Sprays in 24 hours.

Using too much Imigran Nasal Spray could make you ill. If you have used more than two sprays in 24 hours:

^ Contact your doctor for advice.

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 Nasal Spray.

Don't press the plunger too soon or you will lose the dose.

Imigran Nasal Spray has three parts:

The nozzle

yThe 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 comfortable - about 1 cm or 1/2 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, this medicine 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 frequency is not known.

■    The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after using Imigran Nasal Spray:

^ Don't use any more. Contact a doctor straight away.

Very common side effects

(affect 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.

■    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 Nasal Spray.

Some patients 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 heart beat 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

|5. How to store Imigran Nasal Spra;

■    Keep out of the sight and reach of children.

■    You may wish to carry the Imigran Nasal Spray with you in case of a migraine attack.

■    Do not store above 30°C. Do not freeze.

■ Store in the sealed blister, preferably in the carton to protect from light.

■ Do not use Imigran Nasal Spray after the expiry date printed on the pack. The expiry date refers to the last day of that month.

■    If your medicine become discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.

If your doctor stops your treatment do not keep any leftover nasal spray unless your doctor tells you to. Return any unused nasal spray to your pharmacist for safe disposal.

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.

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.

6. Contents of the pack and other information

What Imigran Nasal Spray contains

The active substance is sumatriptan 20mg.

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

What Imigran Nasal Spray looks like and contents of the pack

This medicine is provided in a pre-filled nasal spray device and contains sumatriptan in 0.1 ml of a yellow-coloured solution.

Imigran Nasal Spray is packed in a box containing the nasal sprays individually sealed in blisters. They are available in packs of 2 and 6 pre-filled nasal spray devices. Each nasal spray contains one dose of Imigran Nasal Spray.

| POM |    PL No: 15814/0453

This product is manufactured by GlaxoSmithKline Manufacturing S.p.A., Strada Asolana km 11 - 43056 San Polo di Torrile, Italy and is procured from within the EU and repackaged by the Product Licence Holder:

O.P.D Laboratories Ltd, Unit 6 Colonial Way, Watford, Hertfordshire WD24 4PR

Leaflet revision and issue date (Ref.) 16.02.2015.

Imigran is a Trade Mark of GSK Group of Companies.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

Other common side effects include:

Imigran® 20mg/0.1ml Nasal Spray / Imigrane 20mg/0.1ml Nasal Spray

(sumatriptan)

This product is available using either of the above names but will be referred to as Imigran Nasal Spray throughout the following leaflet. Please note that the leaflet also contains information about other strength (Imigran 10mg/0.1ml Nasal Spray).

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.

•    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. See section 4.

What is in this leaflet

1.    What Imigran Nasal Spray is and what it is used for

2.    What you need to know 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 Nasal Spray is and what it is used foi

Each Imigran Nasal Spray contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HTi 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. What you need to know before you use Imigran Nasal Spray|

Don't use Imigran Nasal Spray:

■    If you're allergic to sumatriptan, or any of the other ingredients of this medicine (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 Nasal Spray 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-HT 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 Nasal Spray

Talk to your doctor or pharmacist before using Imigran Nasal Spray:

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 Nasal Spray, 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 Nasal Spray 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 Nasal Spray. 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 Nasal Spray.

If you are taking anti-depressants called SSRIs

(Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)

^ Tell your doctor or pharmacist before using Imigran Nasal Spray.

Also see Other medicines and Imigran Nasal Spray, below.

If you use Imigran Nasal Spray frequently

Using Imigran Nasal Spray too often may make your headaches worse.

^ Tell your doctor if this applies to you. He or she may recommend you stop using Imigran Nasal Spray.

If you feel pain or tightness in your chest after you use Imigran Nasal Spray

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 Nasal Spray

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 Nasal Spray and others may cause adverse effects if they're taken with Imigran Nasal Spray. 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 Nasal Spray at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran Nasal Spray. Don't take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using Imigran Nasal Spray.

■    other triptans/5-HT receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see Section 2). Don't use Imigran Nasal Spray at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran Nasal Spray.

Don't take another triptan/5-HT receptor agonist again for at least 24 hours after using Imigran Nasal Spray.

■    SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors) used to treat depression. Using Imigran Nasal Spray 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 Nasal Spray 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 Nasal Spray 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 Nasal Spray 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 Nasal Spray while you are pregnant.

■    Don't breast-feed your baby for 12 hours after using Imigran Nasal Spray. 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 Spra;

Only use Imigran Nasal Spray after your migraine headache begins Don't use Imigran Nasal Spray to try to prevent an attack.

Always use this medicine 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 20mg 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 Nasal Spray

■    It's best to use Imigran Nasal Spray 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:

^ Ask your doctor or pharmacist for advice.

If you use more Imigran Nasal Spray than you should

■    Don't use more than two Imigran Nasal Sprays in 24 hours.

Using too much Imigran Nasal Spray could make you ill. If you have used more than two sprays in 24 hours:

^ Contact your doctor for advice.

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 Nasal Spray.

Don't press the plunger too soon or you will lose the dose.

Imigran Nasal Spray has three parts:

The nozzle

yThe 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 comfortable - about 1 cm or 1/2 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, this medicine 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 frequency is not known.

■    The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after using Imigran Nasal Spray:

^ Don't use any more. Contact a doctor straight away.

Very common side effects

(affect 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 Nasal Spray.

Some patients 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 heart beat 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

|5. How to store Imigran Nasal Spra;

■    Keep out of the sight and reach of children.

■    You may wish to carry the Imigran Nasal Spray with you in case of a migraine attack.

■    Do not store above 30°C. Do not freeze.

■ Store in the sealed blister, preferably in the carton to protect from light.

■ Do not use Imigran Nasal Spray after the expiry date printed on the pack. The expiry date refers to the last day of that month.

■    If your medicine become discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.

If your doctor stops your treatment do not keep any leftover nasal spray unless your doctor tells you to. Return any unused nasal spray to your pharmacist for safe disposal.

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.

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.

6. Contents of the pack and other information

What Imigran Nasal Spray contains

The active substance is sumatriptan 20mg.

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

What Imigran Nasal Spray looks like and contents of the pack

This medicine is provided in a pre-filled nasal spray device and contains sumatriptan in 0.1 ml of a yellow-coloured solution.

Imigran Nasal Spray is packed in a box containing the nasal sprays individually sealed in blisters. They are available in packs of 2 and 6 pre-filled nasal spray devices. Each nasal spray contains one dose of Imigran Nasal Spray.

| POM |    PL No: 15814/0453

This product is manufactured by GlaxoSmithKline S.p.A., Strada Asolana km 11 - 43056 San Polo di Torrile, Italy and is procured from within the EU and repackaged by the Product Licence Holder:

O.P.D Laboratories Ltd, Unit 6 Colonial Way, Watford, Hertfordshire WD24 4PR

Leaflet revision and issue date (Ref.) 16.02.2015.

Imigran is a Trade Mark of GSK Group of Companies.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.