SUMATRIPTAN 20 MG NASAL SPRAY, IMIGRAN 20 MG NASAL SPRAY - patient leaflet, side effects, dosage

IMIGRAN®20mg 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.

The name of your medicine is IMIGRAN 20mg NASAL SPRAY, but it will be referred to as Imigran nasal spray or Imigran throughout this leaflet. This medicine is also available in another strength such as IMIGRAN 10mg NASAL SPRAY.

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 for

Each Imigran nasal spray contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT 1 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

3 how to 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-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

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 antidepressants called SSRIs

(Selective Serotonin Reuptake Inhibitors ) or SNRIs

(Serotonin Noradrenaline Reuptake Inhibitors )

^ Tell your doctor or pharmacist before using 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 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 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.
• 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 nasal spray may make side effects more likely.

Pregnancy and breastfeeding

• 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 until 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. 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.

Only use Imigran after your migraine headache begins

Don’t use Imigran 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 10mg 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 10mg 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 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 nasal spray 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 nasal spray 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.

3 How to use Imigran nasal spray (continued)

4 Possible side effects

5 How to store Imigran nasal spray

How to use the nasal spray

6 Contents of the pack and other information

What Imigran nasal spray looks like and contents of the pack

Each pack contains 2 single dose nasal sprays in grey plastic with blue pump containing solution for nasal inhalation.

Manufactured by:

GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana n.90, San Polo di Torrile (Parma), Italy.

Package Leaflet: Information for the User

SUMATRIPTAN 20mg

(sumatriptan)

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.

The name of your medicine is SUMATRIPTAN 20mg NASAL SPRAY, but it will be referred to as Sumatriptan nasal spray or Sumatriptan throughout this leaflet. This medicine is also available in another strength such as SUMATRIPTAN 10mg NASAL SPRAY.

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 1 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

3 how to use sumatriptan nasal spray

Don’t use Sumatriptan 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 Sumatriptan 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-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 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 antidepressants called SSRIs

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

^ Tell your doctor or pharmacist before using 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 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 Sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan nasal spray. 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-HT1 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 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 nasal spray may make side effects more likely.

Pregnancy and breastfeeding

• 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 until 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 nasal spray 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.

Only use Sumatriptan after your migraine headache begins

Don’t use Sumatriptan 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 Sumatriptan 20mg spray into just one nostril. But one Sumatriptan 10mg 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 10mg 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 nasal spray

• 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 nasal spray 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 nasal spray 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.

3 How to use Sumatriptan nasal spray (continued)

4 Possible side effects

5 How to store Sumatriptan nasal spray

How to use the nasal spray

6 Contents of the pack and other information

What Sumatriptan nasal spray looks like and contents of the pack

Each pack contains 2 single dose nasal sprays in grey plastic with blue pump containing solution for nasal inhalation.

Manufactured by:

GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana n.90, San Polo di Torrile (Parma), Italy.