Imigran 50mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

Buy It Now

Active ingredient:
Sumatriptan succinate
Available from:
CST Pharma Ltd
ATC code:
N02CC01
INN (International Name):
Sumatriptan succinate
Dosage:
50mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04070401; GTIN: 5055946806082

Imigran 50mg Tablets

(sumatriptan succinate)

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.

*

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.

Your medicine is called Imigran 50mg Tablets but will be referred to as

Imigran throughout the leaflet. Please note that the leaflet also contains

information about other strength of the medicine, Imigran 100mg Tablets

What is in this leaflet

What Imigran is and what it is used for

What you need to know before you use Imigran

How to use Imigran

Possible side effects

How to store Imigran

Contents of the pack and other information

What Imigran is and what it is used for

Each Imigran capsule-shaped tablet contains a single dose of

sumatriptan, which belongs to a group of medicines called triptans

(also known as 5-HT

1

receptor agonists).

Imigran is used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood

vessels in the head. Imigran 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.

What you need to know before you use Imigran

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 maleate; or any

triptan or 5-HT

agonist (such as naratriptan or zolmitriptan)

*

With any of the following anti-depressants:

*

MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI in

the last 2 weeks

*

SSRIs (selective serotonin reuptake inhibitors) including citalopram,

fluoxetine, fluvoxamine, paroxetine and sertaline

*

SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine

and duloxetine

*

For children under 18 years of age.

If any of these apply to you:

Tell your doctor, and don’t use Imigran tablets.

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 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 had high blood pressure Imigran may not be suitable for

you

Tell your doctor or pharmacist before using Imigran.

If you have liver or kidney disease

If either of these apply to you:

Tell your doctor or pharmacist before using Imigran.

If you have an intolerance to some sugars

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 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 (overleaf) 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). 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-HT

1

receptor agonists (such as naratriptan, rizatriptan,

zolmitriptan), also used to treat migraine, (see section 2 Don’t use

Imigran). 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

receptor agonist again for at least 24 hours

after using Imigran.

*

MAOIs used to treat depression. Don’t use Imigran if you have taken

these in the last 2 weeks.

*

SSRIs and SNRIs 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.

*

St John’s Wort (Hypericum perforatum). Taking herbal remedies that

contain St John’s Wort together with 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.

Ref: 1629/200219/1/F

1

1

6

4

5

2

2

3

®

(sumatriptan succinate)

Patient Information Leaflet (continued)

How to use Imigran

Always take this medicine exactly as your doctor has told you. Check with

your doctor or pharmacist if you are not sure.

When to take Imigran

*

It’s best to take Imigran as soon as you feel a migraine coming on,

although - you can take it at any time during an attack

*

Don’t use Imigran to try to prevent an attack - only use it after your

migraine symptoms start.

How much to take

Adults aged 18 to 65

*

The usual dose for adults aged 18 to 65 is one Imigran 50 mg tablet,

swallowed whole with water. Some patients may need a 100 mg

dose - you should follow your doctor’s advice.

Children under 18

*

Imigran is not recommended for children under 18 years old.

Elderly (aged over 65)

*

Imigran is not recommended for people aged over 65.

If your symptoms start to come back

*

You can take a second Imigran tablet if at least 2 hours have passed since

the first tablet. Don’t take more than 300 mg in total in 24 hours.

If the first tablet has no effect

*

Don’t take a second tablet or any other Imigran preparation for the same

attack. Imigran can still be used for your next attack.

If Imigran doesn’t give you any relief:

Ask your doctor or pharmacist for advice.

If you take more Imigran than you should

*

Don’t take more than six 50 mg tablets or three 100 mg tablets

(300 mg in total) in any 24 hours.

Taking too much Imigran could make you ill. If you have taken more than

300 mg in 24 hours:

Contact your doctor for advice.

If you have any further questions about the use of this medicine, ask your

doctor or pharmacist.

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.

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.

Common side effects

(affect up to 1 in 10 people)

*

Pain, heaviness, pressure or tightness in the chest, throat or other parts of

the body, or 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:

*

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 taking Imigran.

Some patients may get 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

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 or search for MHRA Yellow Card in the Google

Play or Apple App Store. By reporting side effects, you can help provide

more information on the safety of this medicine.

How to store Imigran

*

Keep out of the sight and reach of children.

*

Do not store above 25°C.

*

Do not take Imigran after the expiry date which is stated on the

blister label or carton. The expiry date refers to the last day of the month.

*

If your doctor tells you to stop taking this medicine, return any unused

tablet to your pharmacist (chemist) for safe disposal. Only keep this

medicine if your doctor tells you to.

*

If the tablet becomes discoloured or shows any other 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 that are no longer

required. These measures will help to protect the environment.

Contents of the pack and other information

What Imigran contains:

*

Each tablet contains 50mg sumatriptan (as the succinate).

*

The other ingredients are lactose anhydrous, lactose monohydrate,

microcrystalline cellulose, croscarmellose sodium, magnesium stearate,

hypromellose, titanium dioxide (E171), red iron oxide (E172) and triacetin.

What Imigran looks like and contents of the pack

*

Imigran tablets are pink, film-coated, capsule-shaped, engraved 50 on

one face and plain on the other face.

*

Each pack contains 6 Tablets.

Manufacturer and Licence Holder

Manufactured by GlaxoSmithKline Pharmaceuticals SA, Poznan, Poland and

is procured from within the EU and repackaged by the Product Licence

Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,

Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or

pharmacist. They will have additional information about this medicine and

will be able to advise you.

PL 15184/1629

Imigran 50mg Tablets

Imigran is a registered trademark of GlaxoSmithKline Group of companies.

Revision date: 20/02/19

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you

POM

Ref:1629/200219/1/B

4

5

6

Imigran 50mg Tablets

®

3

Imigran 50mg Tablets

(sumatriptan succinate)

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.

*

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.

Your medicine is called Imigran 50mg Tablets but will be referred to as

Imigran throughout the leaflet. Please note that the leaflet also contains

information about other strength of the medicine, Imigran 100mg Tablets

What is in this leaflet

What Imigran is and what it is used for

What you need to know before you use Imigran

How to use Imigran

Possible side effects

How to store Imigran

Contents of the pack and other information

What Imigran is and what it is used for

Each Imigran capsule-shaped tablet contains a single dose of

sumatriptan, which belongs to a group of medicines called triptans

(also known as 5-HT

1

receptor agonists).

Imigran is used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood

vessels in the head. Imigran 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.

What you need to know before you use Imigran

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 maleate; or any

triptan or 5-HT

agonist (such as naratriptan or zolmitriptan)

*

With any of the following anti-depressants:

*

MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI in

the last 2 weeks

*

SSRIs (selective serotonin reuptake inhibitors) including citalopram,

fluoxetine, fluvoxamine, paroxetine and sertaline

*

SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine

and duloxetine

*

For children under 18 years of age.

If any of these apply to you:

Tell your doctor, and don’t use Imigran tablets.

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 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 had high blood pressure Imigran may not be suitable for

you

Tell your doctor or pharmacist before using Imigran.

If you have liver or kidney disease

If either of these apply to you:

Tell your doctor or pharmacist before using Imigran.

If you have an intolerance to some sugars

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 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 (overleaf) 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). 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-HT

1

receptor agonists (such as naratriptan, rizatriptan,

zolmitriptan), also used to treat migraine, (see section 2 Don’t use

Imigran). 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

receptor agonist again for at least 24 hours

after using Imigran.

*

MAOIs used to treat depression. Don’t use Imigran if you have taken

these in the last 2 weeks.

*

SSRIs and SNRIs 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.

*

St John’s Wort (Hypericum perforatum). Taking herbal remedies that

contain St John’s Wort together with 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.

Ref:1629/200219/2/F

1

1

6

4

5

2

2

3

®

(sumatriptan succinate)

Patient Information Leaflet (continued)

How to use Imigran

Always take this medicine exactly as your doctor has told you. Check with

your doctor or pharmacist if you are not sure.

When to take Imigran

*

It’s best to take Imigran as soon as you feel a migraine coming on,

although - you can take it at any time during an attack

*

Don’t use Imigran to try to prevent an attack - only use it after your

migraine symptoms start.

How much to take

Adults aged 18 to 65

*

The usual dose for adults aged 18 to 65 is one Imigran 50 mg tablet,

swallowed whole with water. Some patients may need a 100 mg

dose - you should follow your doctor’s advice.

Children under 18

*

Imigran is not recommended for children under 18 years old.

Elderly (aged over 65)

*

Imigran is not recommended for people aged over 65.

If your symptoms start to come back

*

You can take a second Imigran tablet if at least 2 hours have passed since

the first tablet. Don’t take more than 300 mg in total in 24 hours.

If the first tablet has no effect

*

Don’t take a second tablet or any other Imigran preparation for the same

attack. Imigran can still be used for your next attack.

If Imigran doesn’t give you any relief:

Ask your doctor or pharmacist for advice.

If you take more Imigran than you should

*

Don’t take more than six 50 mg tablets or three 100 mg tablets

(300 mg in total) in any 24 hours.

Taking too much Imigran could make you ill. If you have taken more than

300 mg in 24 hours:

Contact your doctor for advice.

If you have any further questions about the use of this medicine, ask your

doctor or pharmacist.

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.

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.

Common side effects

(affect up to 1 in 10 people)

*

Pain, heaviness, pressure or tightness in the chest, throat or other parts of

the body, or 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:

*

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 taking Imigran.

Some patients may get 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

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 or search for MHRA Yellow Card in the Google

Play or Apple App Store. By reporting side effects, you can help provide

more information on the safety of this medicine.

How to store Imigran

*

Keep out of the sight and reach of children.

*

Do not store above 25°C.

*

Do not take Imigran after the expiry date which is stated on the

blister label or carton. The expiry date refers to the last day of the month.

*

If your doctor tells you to stop taking this medicine, return any unused

tablet to your pharmacist (chemist) for safe disposal. Only keep this

medicine if your doctor tells you to.

*

If the tablet becomes discoloured or shows any other 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 that are no longer

required. These measures will help to protect the environment.

Contents of the pack and other information

What Imigran contains:

*

Each tablet contains 50mg sumatriptan (as the succinate).

*

The other ingredients are lactose anhydrous, lactose monohydrate,

microcrystalline cellulose, croscarmellose sodium, magnesium stearate,

hypromellose, titanium dioxide (E171), red iron oxide (E172) and triacetin.

What Imigran looks like and contents of the pack

*

Imigran tablets are pink, film-coated, capsule-shaped, engraved 50 on

one face and plain on the other face.

*

Each pack contains 6 Tablets.

Manufacturer and Licence Holder

Manufactured by Glaxo Operations UK Ltd, Ware Hertfordshire, UK and is

procured from within the EU and repackaged by the Product Licence Holder:

Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,

Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or

pharmacist. They will have additional information about this medicine and

will be able to advise you.

PL 15184/1629

Imigran 50mg Tablets

Imigran is a registered trademark of GlaxoSmithKline Group of companies.

Revision date: 20/02/19

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5

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Imigran 50mg Tablets

®

3

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Imigran Radis 50mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

50mg sumatriptan base as the succinate salt.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Film-coated dispersible tablet

Pink film-coated, triangular shaped, biconvex tablets debossed with ‘GS 1YM’ on

one face and ‘50’ on the other.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Imigran Radis tablets are indicated for the acute relief of migraine attacks, with or

without aura. Imigran should only be used where there is a clear diagnosis of

migraine.

4.2

Posology and method of administration

Adults

Imigran Radis is indicated for the acute intermittent treatment of migraine. It

should not be used prophylactically.

The recommended dose of Imigran should

not be exceeded.

It is advisable that Imigran be given as early as possible after the onset of

migraine attack but it is equally effective at whatever stage of the attack it is

administered.

The recommended dose of oral Imigran is a 50mg tablet. Some patients may

require 100mg.

If the patient has responded to the first dose but the symptoms recur a second

dose may be given provided that there is a minimum interval of two hours

between the two doses. No more than 300mg should be taken in any 24 hour

period.

Patients who do not respond to the prescribed dose of Imigran Radis should

not take a second dose for the same attack. In these cases the attack can be

treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-

inflammatory drugs. Imigran Radis may be taken for subsequent attacks.

Imigran Radis is recommended as monotherapy for the acute treatment of

migraine and should not be given concomitantly with ergotamine or

derivatives of ergotamine (including methysergide) (see section 4.3).

The tablets should be swallowed whole with water. Patients with swallowing

difficulties may choose to disperse a tablet in a small amount of water before

administration. Sumatriptan dispersed in water has a bitter taste.

Paediatric population

The efficacy and safety of Imigran Radis in children aged less than 10 years

have not been established. No clinical data are available in this age group.

The efficacy and safety of Imigran Radis in children 10 to 17 years of age

have not been demonstrated in the clinical trials performed in this age group.

Therefore the use of Imigran Radis in children 10 to 17 years of age is not

recommended (see section 5.1).

Elderly (Over 65 years of age)

Experience of the use of Imigran Radis in patients aged over 65 years is

limited. The pharmacokinetics do not differ significantly from a younger

population but until further clinical data are available, the use of Imigran Radis

in patients aged over 65 years is not recommended.

4.3

Contraindications

Hypersensitivity to sumatriptan or to any of the excipients listed in section 6.1.

Sumatriptan should not be given to patients who have had myocardial infarction or

have ischaemic heart disease, coronary vasospasm (Prinzmetal’s angina), peripheral

vascular disease or patients who have symptoms or sign consistent with ischaemic

heart disease.

Sumatriptan should not be administered to patients with a history of cerebovascular

accident (CVA) or transient ischaemic attack (TIA).

Sumatriptan should not be administered to patients with severe hepatic impairment.

The use of sumatriptan in patients with moderate and severe hypertension and mild

uncontrolled hypertension is contraindicated.

The concomitant administration of ergotamine or derivatives of ergotamine (including

methysergide) or any triptan/5-hydroxytryptamine

(5-HT

) receptor agonist with

sumatriptan is contraindicated. (see section 4.5)

Concurrent administration of monoamine oxidase inhibitors and sumatriptan is

contraindicated. Sumatriptan must not be used within two weeks of discontinuation

of therapy with monoamine oxidase inhibitors.

4.4

Special warnings and precautions for use

Imigran Radis should only be used where there is a clear diagnosis of

migraine.

Sumatriptan is not indicated for use in the management of hemiplegic, basilar

or ophthalmoplegic migraine.

Before treating with sumatriptan, care should be taken to exclude potentially

serious neurological conditions

(e.g. CVA, TIA) if the patient presents with atypical

symptoms or if they have not received an appropriate diagnosis for sumatriptan use.

Following administration, sumatriptan can be associated with transient

symptoms including chest pain and tightness which may be intense and

involve the throat (see section 4.8). Where such symptoms are thought to

indicate ischaemic heart disease, no further doses of sumatriptan should be

given and appropriate evaluation should be carried out.

Sumatriptan should not be given to patients with risk factors for ischaemic

heart disease, including those patients who are heavy smokers or users of

nicotine substitution therapies, without prior cardiovascular evaluation (see

section 4.3). Special consideration should be given to postmenopausal women

and males over 40 with these risk factors. These evaluations however, may

not identify every patient who has cardiac disease and, in very rare cases,

serious cardiac events have occurred in patients without underlying

cardiovascular disease.

Sumatriptan should be administered with caution to patients with mild

controlled hypertension, since transient increases in blood pressure and

peripheral vascular resistance have been observed in a small proportion of

patients (see section 4.3).

There have been rare post-marketing reports describing patients with serotonin

syndrome (including altered mental status, autonomic instability and

neuromuscular abnormalities) following the use of a selective serotonin

reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been

reported following concomitant treatment with triptans and serotonin

noradrenaline reuptake inhibitors (SNRIs).

If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically

warranted, appropriate observation of the patient is advised (see section 4.5).

Sumatriptan should be administered with caution to patients with conditions

which may affect significantly the absorption, metabolism or excretion of

drugs, e.g. impaired hepatic

(Child Pugh grade A or B; see section 5.2)

or renal

function

(see section 5.2)

. A 50mg dose should be considered in patients with

hepatic impairment.

Sumatriptan should be used with caution in patients with a history of seizures

or other risk factors which lower the seizure threshold, as seizures have been

reported in association with sumatriptan (see section 4.8).

Patients with known hypersensitivity to sulphonamides may exhibit an allergic

reaction following administration of sumatriptan. Reactions may range from

cutaneous hypersensitivity to anaphylaxis. Evidence of cross-sensitivity is

limited, however, caution should be exercised before using sumatriptan in

these patients.

Undesirable effects may be more common during concomitant use of triptans

and herbal preparations containing St John’s Wort (Hypericum perforatum).

Prolonged use of any type of painkiller for headaches can make them worse.

If this situation is experienced or suspected, medical advice should be obtained

and treatment should be discontinued. The diagnosis of medication overuse

headache (MOH) should be suspected in patients who have frequent or daily

headaches despite (or because of) the regular use of headache medications.

4.5

Interaction with other medicinal products and other forms of interaction

Studies in healthy subjects show that sumatriptan does not interact with propranolol,

flunarizine, pizotifen or alcohol.

There are limited data on an interaction with preparations containing ergotamine or

another triptan/5-HT1 receptor agonist. The increased risk of coronary vasospasm is a

theoretical possibility and concomitant administration is contraindicated (see section

4.3).

The period of time that should elapse between the use of sumatriptan and ergotamine-

containing preparations or another triptan/5-HT1 receptor agonist is not known. This

will also depend on the doses and types of products used. The effects may be

additive. It is advised to wait at least 24 hours following the use of ergotamine-

containing

preparations

another

triptan/5-HT1

receptor

agonist

before

administering sumatriptan. Conversely, it is advised to wait at least 6 hours following

use of sumatriptan before administering an ergotamine-containing product and at least

24 hours before administering another triptan/5-HT1 receptor agonist.

An interaction may occur between sumatriptan and monoamine oxidase inhibitors

(MAOIs) and concomitant administration is contraindicated (see section 4.3).

There

have

been

rare

post-marketing

reports

describing

patients

with

serotonin

syndrome (including altered mental status, autonomic instability and neuromuscular

abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has

also been reported following concomitant treatment with triptans and SNRIs (see

section 4.4).

4.6

Fertility, pregnancy and lactation

Pregnancy

Post-marketing data from the use of sumatriptan during the first trimester in

over 1,000 women are available. Although these data contain insufficient

information to draw definitive conclusions, they do not point to an increased

risk of congenital defects. Experience with the use of sumatriptan in the

second and third trimester is limited.

Evaluation of experimental animal studies does not indicate direct teratogenic

effects or harmful effects on peri- and postnatal development. However,

embryofoetal viability might be affected in the rabbit (see section 5.3).

Administration of sumatriptan should only be considered if the expected

benefit to the mother is greater than any possible risk to the foetus.

Lactation

It has been demonstrated that following subcutaneous administration,

sumatriptan is excreted into breast milk. Infant exposure can be minimised by

avoiding breast feeding for 12 hours after treatment, during which time any

breast milk expressed should be discarded.

4.7

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been

performed. Drowsiness may occur as a result of migraine or treatment with

sumatriptan. This may influence the ability to drive and to operate machinery.

4.8

Undesirable effects

Adverse events are listed below by system organ class and frequency.

Frequencies are defined as: very common (

1/10), common (

1/100 to <1/10),

uncommon (

1/1000 to <1/100), rare (

1/10000 to <1/1000), very rare

(<1/10000), not known (cannot be estimated from the available data). Some of

the symptoms reported as undesirable effects may be associated symptoms of

migraine.

Clinical Trial Data

Nervous System Disorders

Common:

Dizziness, drowsiness, sensory disturbance

including paraesthesia and hypoaesthesia.

Vascular Disorders

Common:

Transient increases in blood pressure arising soon

after treatment. Flushing.

Respiratory, Thoracic and Mediastinal Disorders

Common

Dyspnoea.

Gastrointestinal Disorders

Common:

Nausea and vomiting occurred in some patients

but it is unclear if this is related to sumatriptan or

the underlying condition.

Musculoskeletal and Connective Tissue Disorders

Common:

Sensations of heaviness (usually transient and

may be intense and can affect any part of the

body including the chest and throat). Myalgia.

General Disorders and Administration Site Conditions

Common:

Pain, sensations of heat or cold, pressure or

tightness (these events are usually transient and

may be intense and can affect any part of the body

including the chest and throat).

Feelings of weakness, fatigue (both events are

mostly mild to moderate in intensity and

transient).

Investigations

Very rare:

Minor disturbances in liver function tests have

occasionally been observed.

Post-Marketing Data

Immune System Disorders

Not known:

Hypersensitivity reactions ranging from

cutaneous hypersensitivity to anaphylaxis.

Nervous System Disorders

Not known:

Seizures, although some have occurred in

patients with either a history of seizures or

concurrent conditions predisposing to seizures

there are also reports in patients where no such

predisposing factors are apparent.

Tremor, dystonia, nystagmus, scotoma.

Eye Disorders

Not known:

Flickering, diplopia, reduced vision. Loss of

vision including reports of permanent defects.

However, visual disorders may also occur

during a migraine attack itself.

Cardiac Disorders

Not known:

Bradycardia, tachycardia, palpitations, cardiac

arrhythmias, transient ischaemic ECG changes,

coronary artery vasospasm, angina, myocardial

infarction (see sections 4.3 and 4.4).

Vascular Disorders

Not known:

Hypotension, Raynaud’s phenomenon.

Gastrointestinal Disorders

Not known:

Ischaemic colitis.

Diarrhoea.

Musculoskeletal, Connective Tissue and Bone Disorders

Not known:

Neck stiffness.

Arthralgia.

Psychiatric disorders

Not known:

Anxiety.

Skin and subcutaneous tissue disorders

Not known:

Hyperhidrosis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse reactions

via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9

Overdose

Doses up to 100 mg orally were not associated with side effects other than

those mentioned.

If overdosage occurs, the patient should be monitored for at least ten hours and

standard supportive treatment applied as required.

It is unknown what effect haemodialysis or peritoneal dialysis has on the

plasma concentrations of Imigran.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics: Selective 5-HT

receptor agonists.

ATC code: N02CC01

Sumatriptan has been demonstrated to be a specific and selective 5-

Hydroxytryptamine

(5HT

) receptor agonist with no effect on other 5HT

receptor (5-HT

-5-HT

) subtypes. The vascular 5-HT

receptor is found

predominantly in cranial blood vessels and mediates vasoconstriction. In

animals, sumatriptan selectively constricts the carotid arterial circulation but

does not alter cerebral blood flow. The carotid arterial circulation supplies

blood to the extracranial and intracranial tissues such as the meninges and

dilatation of and/or oedema formation in these vessels is thought to be the

underlying mechanism of migraine in man.

In addition, evidence from animal studies suggests that sumatriptan inhibits

trigeminal nerve activity. Both these actions (cranial vasoconstriction and

inhibition of trigeminal nerve activity) may contribute to the anti-migraine

action of sumatriptan in humans.

Sumatriptan remains effective in treating menstrual migraine i.e. migraine

without aura that occurs between 3 days prior and up to 5 days post onset of

menstruation. Sumatriptan should be taken as soon as possible in an attack.

Clinical response begins around 30 minutes following a 100mg oral dose.

Although the recommended dose of oral sumatriptan is 50mg, migraine

attacks vary in severity both within and between patients. Doses of 25-100mg

have shown greater efficacy than placebo in clinical trials, but 25mg is

statistically significantly less effective than 50 and 100mg.

Imigran Radis tablets have not been studied in adolescents, however, a number

of placebo-controlled clinical studies assessed the safety and efficacy of oral

sumatriptan standard tablets in over 650 child and adolescent migraineurs aged

10 to 17 years. These studies failed to demonstrate a statistically significant

difference in headache relief at 2 hours between placebo and any sumatriptan

dose. The undesirable effects profile of oral sumatriptan in children and

adolescents aged 10 - 17 years was similar to that reported from studies in the

adult population.

5.2

Pharmacokinetic properties

Following oral administration, sumatriptan is rapidly absorbed, 70% of

maximum concentration occurring at 45 minutes. After 100mg dose, the

maximum plasma concentration is 54ng/ml. Mean absolute oral

bioavailability is 14% partly due to presystemic metabolism and partly due to

incomplete absorption. The elimination phase half-life is approximately 2

hours, although there is an indication of a longer terminal phase. Plasma

protein binding is low (14-21%), mean volume of distribution is 170 litres.

Mean total plasma clearance is approximately 1160ml/min and the mean renal

plasma clearance is approximately 260ml/min. Non-renal clearance accounts

for about 80% of the total clearance. Sumatriptan is eliminated primarily by

oxidative metabolism mediated by monoamine oxidase A.

Special patient populations

Hepatic Impairment

Sumatriptan pharmacokinetics after an oral dose (50 mg) and a subcutaneous

dose (6 mg) were studied in 8 patients with mild to moderate hepatic

impairment matched for sex, age, and weight with 8 healthy subjects.

Following an oral dose, sumatriptan plasma exposure (AUC and Cmax) almost

doubled (increased approximately 80%) in patients with mild to moderate

hepatic impairment compared to the control subjects with normal hepatic

function. There was no difference between the patients with hepatic

impairment and control subjects after the s.c. dose. This indicates that mild to

moderate hepatic impairment reduces presystemic clearance and increases the

bioavailability and exposure to sumatriptan compared to healthy subjects.

Following oral administration, pre-systemic clearance is reduced in patients

with mild to moderate hepatic impairment and systemic exposure is almost

doubled.

The pharmacokinetics in patients with severe hepatic impairment have not

been studied (see Section 4.3 Contraindications and Section 4.4 Warnings and

Precautions).

The major metabolite, the indole acetic acid analogue of Sumatriptan is mainly

excreted in the urine, where it is present as a free acid and the glucuronide

conjugate. It has no known 5HT

or 5HT

activity. Minor metabolites have

not been identified. The pharmacokinetics of oral Sumatriptan do not appear

to be significantly affected by migraine attacks.

In a pilot study, no significant differences were found in the pharmacokinetic

parameters between the elderly and young healthy volunteers.

5.3

Preclinical safety data

Sumatriptan was devoid of genotoxic and carcinogenic activity in in-vitro systems

and animal studies.

fertility

study

oral

doses

sumatriptan

resulting

plasma

levels

approximately 200 times those seen in man after a 100 mg oral dose were associated

with a reduction in the success of insemination.

This effect did not occur during a subcutaneous study where maximum plasma levels

achieved approximately 150 times those in man by the oral route.

In rabbits embryolethality, without marked teratogenic defects, was seen. The

relevance for humans of these findings is unknown.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Calcium Hydrogen Phosphate, Anhydrous

Microcrystalline Cellulose

Sodium Hydrogen Carbonate

Croscarmellose Sodium

Magnesium Stearate

Hypromellose

Titanium Dioxide

Glycerol Triacetate

Iron Oxide Red

6.2

Incompatibilities

None stated.

6.3

Shelf life

36 months

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

Imigran Recovery, 50 mg, film-coated tablets

PL 00071/0455

UKPAR

TABLE OF CONTENTS

Lay Summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 11

Steps taken after authorisation – summary

Page 12

Summary of Product Characteristics

Page 13

Product Information Leaflet

Page 23

Labelling

Page 25

Annexes 1-4

Page 28

Imigran Recovery, 50 mg, film-coated tablets

PL 00071/0455

LAY SUMMARY

The MHRA granted SmithKline Beecham (SWG) Limited (trading as GlaxoSmithKline

Consumer Healthcare) a Marketing Authorisation for the medicinal product Imigran

Recovery, 50 mg, film-coated tablets (PL 00071/0455) on the 19

April 2006. This product

is for the acute relief of migraine attacks, with or without aura.

Imigran Recovery contains the active ingredient sumatriptan (as the succinate salt).

This is a simple abridged application for Imigran Recovery 50mg Tablets. The cross-

referral product is Imigran Tablets 50mg PL 10949/0222; the licence for this is held by

Glaxo Wellcome UK Ltd, and was granted on 24 June 1994. A letter of informed consent

has been provided, dated 2 June 2004.

This application is associated with a reclassification so that it will be available to people

from a Pharmacy instead of only available with a Prescription.

No new or unexpected safety concerns arose from this simple application and it is,

therefore, judged that the benefits of Imigran Recovery, 50 mg, film-coated tablets being

available from a pharmacy outweigh the risks, and therefore a Marketing Authorisation has

been granted.

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

Imigran Recovery, 50 mg, film-coated tablets

PL 00071/0455

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 4

Pharmaceutical assessment

Page 5

Preclinical assessment

Page 8

Clinical assessment

Page 9

Overall conclusions and risk benefit assessment

Page 10

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

INTRODUCTION

The UK granted a marketing authorisation for the medicinal product Imigran Recovery 50

mg film coated tablets PL 00071/0455 to SmithKline Beecham (SWG) Limited (trading as

GlaxoSmithKline Consumer Healthcare) on the 19

April 2006. This product is a Pharmacy

medicine.

This is a simple abridged application for Imigran Recovery 50mg Tablets. The cross-

referral product is Imigran Tablets 50mg PL 10949/0222; the licence for this is held by

Glaxo Wellcome UK Ltd, and was granted on 24 June 1994. A letter of informed consent

has been provided, dated 2 June 2004.

This application is associated with a POM to P reclassification application.

No new quality data were submitted nor was it necessary for this simple application, as the

data are identical to that of the previously approved cross-reference product. As the cross-

reference product was granted prior to the introduction of current legislation, no Public

Assessment Report has been generated for it.

This product contains the active ingredient sumatriptan (as the succinate salt), and is

indicated for the acute relief of migraine attacks, with or without aura.

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

PHARMACEUTICAL ASSESSMENT

1.

INTRODUCTION

This is a piggy back application for Imigran Recovery, 50 mg, film-coated tablets

submitted under Article 10.1(a)(i) of Directive 2001/83/EC. The proposed MA holder is

SmithKline Beecham (SWG) Limited, 980 Great West Road, Brentford, TW8 9GS, U.K

trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

This application cross refers to the marketing authorisation for Imigran Tablets 50mg PL

10949/0222; the licence for this is held by Glaxo Wellcome UK Ltd, and was granted on 24

June 1994, and is currently approved in the UK. This application is considered valid.

2.

MARKETING AUTHORISATION APPLICATION FORM

2.1 Name(s)

The proposed name for this product is Imigran Recovery, 50 mg, film-coated tablets. The

product has been named in line with the current requirements.

2.2 Strength, pharmaceutical form, route of administration, container and pack sizes

This product contains 50mg of sumatriptan (as the succinate salt). It should be stored in an

aluminium double foil blister pack in a cardboard carton, containing 2 tablets and may

come with a plastic carry case.

The proposed shelf-life (36 months) and storage conditions (Do not store above 30 ºC) are

consistent with the details registered for the cross-reference product.

2.3 Legal status

This product will be a Pharmacy medicine.

2.4 Marketing authorisation holder/Contact Persons/Company

The proposed Marketing Authorisation holder is

SmithKline Beecham (SWG) Limited, 980

Great West Road, Brentford, TW8 9GS, U.K trading as GlaxoSmithKline Consumer

Healthcare, Brentford, TW8 9GS, U.K.

The QP responsible for pharmacovigilance is stated and his CV is included.

2.5

Manufacturers

Evidence of GMP compliance has been provided for the proposed manufacturing sites.

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

2.6 Qualitative and quantitative composition

The proposed composition is consistent with the details registered for the cross-reference

product.

2.7 Manufacturing process

The proposed manufacturing process is consistent with the details registered for the cross-

reference product and the maximum batch size is stated.

2.8 Finished product/shelf-life specification

The proposed finished product specification is in line with the details registered for the

cross-reference product.

2.9 Drug substance specification

The proposed drug substance specification for this product is consistent with the details

registered for the cross-reference product.

2.10 TSE Compliance

A TSE compliance statement for lactose has been submitted which is a copy from the

cross-referral licence. This is acceptable, as TSE safety certificates are no longer essential

for lactose (EMEA/CPMP/517/02).

Magnesium stearate in the formulation is of potential animal/human origin. Appropriate

documentation has been provided to ensure compliance with the current requirements

regarding minimising the risk of TSE.

3.

EXPERT REPORTS

Satisfactory statements have been provided.

4.

PRODUCT NAME & APPEARANCE

See 2.1 for details of the proposed product name. The appearance of the product is

identical to the cross-reference product, apart from the introduction of a tablet marking.

5.

SUMMARY OF PRODUCT CHARACTERISTICS

The proposed SPC is consistent with the details registered for the cross-reference product,

apart from differences which are directly related to the reclassification.

6.

PATIENT INFORMATION LEAFLET/CARTON

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

The patient information leaflet has been prepared in line with current guidelines and has

been subjected to user testing.

Carton and blister

The proposed artwork has been prepared in line with current guidelines and complies with

statutory requirements. In line with current legislation the applicant has also included the

name of the product in Braille on the outer packaging.

7.

CONCLUSIONS

The data submitted with the application are acceptable. A Marketing Authorisation should

be granted.

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

PRECLINICAL ASSESSMENT

No new preclinical data have been supplied with this application and none are required for

an application of this type.

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

CLINICAL ASSESSMENT

With respect to the simple abridged application for PL 00071/0455, no new clinical data have been

supplied and none are required. With respect to the reclassification of sumatriptan from POM to P,

new data have been submitted to establish the suitability of the product for Pharmacy supply.

CONSIDERATION BY COMMITTEE

Date

Committee

Meeting/Subject

Documentation provided

16 March 2005

Clarification meeting

Minutes of meeting (see

ANNEX 1

31 March 2005

Committee meeting

- 3 papers

Summary of assessment reports

(see

ANNEX 2

13 July 2005

Committee meeting

Summary of assessment report

(see

ANNEX 3

9 November

2005

Consideration of

results of consultation

Assessment report (see

ANNEX

4

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

QUALITY

The data for this application are consistent with those previously assessed for the cross-

reference product and as such have been judged to be satisfactory.

PRECLINICAL

No new preclinical data were submitted and none are required for an application of this

type.

EFFICACY

Sumatriptan is a well known drug and has been used for the acute relief of migraine

attacks, with or without aura

for many years.

The data supplied with this application are identical to the previously approved marketing

authorisation for Imigran Tablets 50mg (PL 10949/0222).

No new or unexpected safety concerns arise from this application.

The SPC, PIL and labelling are satisfactory and consistent with that for the cross-reference

product, with appropriate amendments to take into account the reclassification of the

product.

RISK BENEFIT ASSESSMENT

The quality of the product is acceptable and no new preclinical or clinical safety concerns

have been identified. Suitable justification has been provided for the reclassification of this

product from Prescription Only Medicine (POM) to Pharmacy (P). Non-prescription supply

of the product is considered to be acceptably safe when supplied and taken as

recommended. The applicant’s product is identical to the cross-reference product.

Extensive clinical experience with sumatriptan is considered to have demonstrated the

therapeutic value of this compound. The risk benefit is therefore considered to be positive.

MHRA UKPAR

Imigran Recovery, 50 mg, film-coated tablets

PL 00071-0455

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