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S0719 LEAFLET Imigran 20130808

PACKAGE LEAFLET: INFORMATION FOR THE USER IMIGRAN 10mg NASAL SPRAY (sumatriptan)

Your medicine is known as Imigran 10mg Nasal Spray but will be referred to as either Imigran nasal spray or Imigran throughout the following patient information leaflet.

Please note that information regarding other strengths of Imigran nasal spray is also present in the below 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.

•    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.

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

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. WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN NASAL SPRAY

Don’t use Imigran:

•    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 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

Talk to your doctor or pharmacist before using 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-HT-i 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 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 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 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:

^ 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 questions 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 finger-grip

Hold this when you use the spray.

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.

Put the nozzle of the nasal spray into the other nostril, as

far as feels comfortable - about 1 cm or % inch (picture B). Breathe out gently through

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 exact 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:

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

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 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 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 you get any side effects, talk to your doctor or pharmacist.

This includes any side effects not listed in this leaflet.

5. HOW TO STORE IMIGRAN NASAL SPRAY

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 30°C. Store in the original container. Avoid freezing.

•    Do not use after the expiry date printed on the carton label or blister.

•    If your doctor tells you to stop using the nasal spray, please take it back to the pharmacist for safe disposal. Only keep the nasal spray if your doctor tells you to.

•    If the nasal spray shows any signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    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. FURTHER INFORMATION

What Imigran nasal spray contains

•    Each pre-filled single dose nasal spray contains 10mg of the active ingredient sumatriptan in 0.1ml of aqueous solution.

•    Imigran Nasal Spray also contains the following inactive ingredients: potassium dihydrogen phosphate, sodium phosphate dibasic anhydrous, sodium hydroxide, sulphuric acid and purified water

What Imigran nasal spray looks like and contents of the pack

Imigran nasal spray is a grey plastic, single use, nasal spray device with a blue plunger containing 0.1ml of yellow aqueous solution for nasal inhalation.

Imigran Nasal Spray is available in blister packs of 2 or 6 pre-filled nasal spray devices each dispensing a single dose (0.1 ml) of solution.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by

•    GlaxoSmithKline S.p.A, Officina Farmaceutica di S. Polo di Torrile, Parma, Italy

•    GlaxoSmithKline Manufacturing S.p.A, Officina Farmaceutica di S. Polo di Torrile, Parma, Italy.

POM PL No: 19488/0719

Leaflet revision date: 08 August 2013

IMIGRAN is registered trademark of the GlaxoSmithKline group of companies.

S719 LEAFLET Sumatriptan 20130808

PACKAGE LEAFLET: INFORMATION FOR THE USER SUMATRIPTAN 10mg NASAL SPRAY (sumatriptan)

Your medicine is known as Sumatriptan 10mg Nasal Spray but will be referred to as either Sumatriptan nasal spray or Sumatriptan throughout the following patient information leaflet.

Please note that information regarding other strengths of Sumatriptan nasal spray is also present in the below 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.

•    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.

What is in this leaflet

1.    What Sumatriptan nasal spray is and what it is used for

2.    What you need to know before you use Sumatriptan nasal spray

3.    How to use Sumatriptan nasal spray

4.    Possible side effects

5.    How to store Sumatriptan nasal spray

6.    Contents of the pack and other information

1. WHAT SUMATRIPTAN NASAL SPRAY IS AND WHAT IT IS USED FOR

Each Sumatriptan nasal spray contains a single dose of

sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT-i receptor agonists).

Sumatriptan nasal spray is used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan 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 SUMATRIPTAN NASAL SPRAY

Don’t use Sumatriptan:

•    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 Sumatriptan 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-i 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 Sumatriptan nasal spray.

Take special care with Sumatriptan

Talk to your doctor or pharmacist before using Sumatriptan:

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 Sumatriptan, 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 Sumatriptan 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 Sumatriptan. 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 Sumatriptan.

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 Sumatriptan.

Also see Other medicines and Sumatriptan, below.

If you use Sumatriptan frequently

Using Sumatriptan too often may make your headaches worse.

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

If you feel pain or tightness in your chest after you use Sumatriptan

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 Sumatriptan

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

•    other triptans/5-HT₁ receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine, (see Section 2). Don't use Sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan. Don't take another triptan/5-HT-i receptor agonist again for at least 24 hours after using Sumatriptan.

•    SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors) used to treat depression. Using Sumatriptan with these depression. Using Sumatriptan 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 Sumatriptan 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 Sumatriptan 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 Sumatriptan 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 Sumatriptan while you are pregnant.

•    Don’t breast-feed your baby for 12 hours after using Sumatriptan. 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 SUMATRIPTAN NASAL SPRAY

Only use Sumatriptan after your migraine headache begins Don’t use Sumatriptan to try to prevent an attack.

Always use Sumatriptan 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 Sumatriptan 20 mg spray into just one nostril.

But one Sumatriptan 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

Sumatriptan 10 mg spray into one nostril.

Children under 12

•    Sumatriptan nasal spray is not recommended for children under 12 years old.

Older people (aged over 65)

•    Sumatriptan nasal spray is not recommended for people aged over 65.

When to use Sumatriptan

•    It’s best to use Sumatriptan 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 Sumatriptan 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 Sumatriptan preparation for the same attack.

If Sumatriptan doesn't give you any relief:

^ Ask your doctor or pharmacist for advice.

If you use more Sumatriptan than you should

* Don’t use more than two Sumatriptan nasal sprays in 24 hours.

Using too much Sumatriptan 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 questions on the use of this medicine, ask your doctor or pharmacist.

Step-by-step guide to using your Sumatriptan 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 Sumatriptan.

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

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 Sumatriptan.

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 exact 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 Sumatriptan:

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

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by

•    GlaxoSmithKline S.p.A, Officina Farmaceutica di S. Polo di Torrile, Parma, Italy.

•    GlaxoSmithKline Manufacturing S.p.A, Officina Farmaceutica di S. Polo di Torrile, Parma, Italy.

POM PL No: 19488/0719

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.

Leaflet revision date: 08 August 2013

SUMATRIPTAN is registered trademark of the GlaxoSmithKline group of companies.

S719 LEAFLET Sumatriptan 20130808