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Naramig 2.5mg Tablets

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Document: leaflet MAH BRAND_PLPI 15184-0646 change

Ref: 0646/270716/1/F

Naramig ® 2.5mg Tablets

(naratriptan hydrochloride)

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 Naramig 2.5mg tablets but will be referred to as Naramig thoughout this leaflet.

What is in this leaflet

^ What Naramig is and what it is used for

What you need to know before you take Naramig How to take Naramig ^ Possible side effects How to store Naramig

fM Contents of the pack and other information

^ What Naramig is and what it is used for

Naramig tablets contain naratriptan (hydrochloride), which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).

Naramig tablets are used to treat migraine.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Naramig tablets are 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 take Naramig

Do not take Naramig:

*    If you are allergic to naratriptan, or any of the other ingredients of this medicine (listed in section 6)

*    If you have a heart problem such as heart failure 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 take Naramig if your high blood pressure is mild and is being treated

*    If you have kidney or liver disease

*    With other migraine medicines, including those which contain ergotamine, or with similar medicines such as methysergide, or with other 5-HT1 receptor agonists, such as sumatriptan.

If any of these apply to you:

Tell your doctor, and don't take Naramig.

Warnings and precautions

Talk to your doctor or pharmacist before taking Naramig.

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 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

taking Naramig, even though they had no signs of heart disease before.

If any of the points in the list 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 Naramig is prescribed for you.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Naramig. 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 taking Naramig.

If you take Naramig frequently

Taking Naramig too often may make your headaches worse.

Tell your doctor if this applies to you. He or she may recommend you stop taking Naramig.

If you feel pain or tightness in your chest after you take Naramig

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.

Not for older people or children under 18

Naramig is not recommended for people aged over 65 or for children under the age of 18.

Other medicines and Naramig

Tell your doctor if you’re taking, have recently taken or might take any other medicines.

Some medicines must not be taken with Naramig and others may cause adverse effects if they're taken with Naramig. You must tell your doctor if you are taking:

*    any medicines for your migraine which contain any triptan/5-HT1 agonist (such as sumatriptan or zolmitriptan). Don't take Naramig at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naramig.

*    ergotamine also used to treat migraine or similar medicines such as methysergide. Don't take Naramig at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naramig.

*    any antidepressants classed as selective serotonin reuptake inhibitors (SSRIs), such as citalopram, fluoxetine or paroxetine, or serotonin noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine. If you are not sure, talk to your doctor or pharmacist.

*    St John’s Wort (Hypericum perforatum). Using herbal remedies that contain St John's Wort while you are taking Naramig 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 Naramig for pregnant women, though up till now there is no evidence of any increased risk of birth defects. Your doctor may recommend that you do not take Naramig while you are pregnant.

*    Don’t breast-feed your baby for 24 hours after taking Naramig. 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.

Naramig contains lactose

Naramig tablets contain a small amount of a sugar called lactose.

If you have an intolerance to lactose or any other sugars:

Ask your doctor for advice about taking Naramig.

[s) How to take Naramig

Only take Naramig after your migraine headache begins.

Don’t take Naramig to try to prevent an attack.

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

Check with your doctor or pharmacist if you are not sure.

How much to take

*    The usual dose for adults aged 18 to 65 is one Naramig 2.5 mg tablet, swallowed whole with water.

Naramig is not recommended for children under 18 and adults over 65. When to take Naramig

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

although it can be taken at any time during an attack.

If your symptoms start to come back

*    You can take a second Naramig tablet after 4 hours, unless you have kidney or liver damage.

(naratriptan hydrochloride)

Patient Information Leaflet (continued)

*    If you have kidney or liver damage don't take more than one tablet in 24 hours.

*    No one should take more than two tablets in 24 hours.

If the first tablet has no effect

*    Don’t take a second tablet for the same attack.

If Naramig doesn't give you any relief:

Ask your doctor or pharmacist for advice.

If you take more Naramig than you should

*    Don’t take more than two Naramig tablets in 24 hours.

Taking too much Naramig could make you ill. If you have taken more than two tablets in 24 hours:

Contact your doctor for advice.

[4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

*    Heartbeat may go faster, slower or change rhythm (affects up to 1 in 100 people).

*    Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis - affects up to 1 in 1,000 people).

*    Allergic reaction (affects up to 1 in 1,000 people). The signs of allergy include rash; hives; itching; wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after taking Naramig:

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

*    Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body (affects up to 1 in 100 people).

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.

Common:

(may affect up to 1 in 10 people)

*    Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself.

*    Tiredness, drowsiness or sleepiness (somnolence), or generally feeling unwell

*    Dizziness, tingling feelings or getting hot flushes.

If you get any of these effects:

^ Tell your doctor or pharmacist.

Uncommon:

(may affect up to 1 in 100 people)

*    Visual disturbances (although these may be due to the migraine attack itself).

*    Slight increase in blood pressure which may occur up to 12 hours after taking Naramig.

If you get any of these effects:

^ Tell your doctor or pharmacist.

Very rare:

(may affect up to 1 in 10,000 people)

*    Heart problems, including chest pains (angina) and heart attack.

*    Poor blood circulation to the arms and legs, causing pain and discomfort.

If you get these symptoms:

^ Tell your doctor or pharmacist.

If you get side effects

If you notice any unwanted effects, even ones not listed in this leaflet, or if any of the side effects becomes troublesome:

^ Tell your doctor or pharmacist.

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.

How to store Naramig

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30°C.

Do not use this medicine after the expiry date shown on the carton label or blister strip. If your doctor tells you to stop taking this medicine return any unused tablets to your pharmacist (chemist) for safe disposal.

Only keep this medicine if your doctor tells you to.

If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

Contents of the pack and other information

What Naramig contains

Each film-coated tablet contains 2.78mg of the active ingredient naratriptan hydrochloride equivalent to naratriptan 2.5mg.

Inactive ingredients: Microcrystalline cellulose, lactose anhydrous, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide E171, triacetin, iron oxide (yellow) E172, indigo carmine E132.

What Naramig looks like and content of the pack

Naramig tablets are green, D-shaped, film coated tablets, with ‘GX CE5' marked on one side and blank on the other side.

Naramig tablets are available in packs of 4, 8 and 12 tablets.

Additional information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have the information you need, and will advise you.

Manufacturer and Licence Holder

This medicine is manufactured by GlaxoSmithkine 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.

POM PL 15184/0646 Naramig 2.5mg Tablets

Naramig is a registered trademark of the GlaxoSmithKline Group of Companies.

Revision date: 29/07/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

By reporting side effects you can help provide more information on the safety of this medicine.

Naratriptan 2.5mg Tablets

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 Naratriptan 2.5mg tablets but will be referred to as Naratriptan tablets thoughout this leaflet.

What is in this leaflet

0 What Naratriptan tablets is and what it is used for

What you need to know before you take Naratriptan tablets

How to take Naratriptan tablets

Possible side effects

How to store Naratriptan tablets

Contents of the pack and other information

^ What Naratriptan tablets is and what it is used for

Naratriptan tablets contain naratriptan (hydrochloride), which belongs to a group of medicines called triptans (also known as 5-Ht1 receptor agonists).

Naratriptan tablets are used to treat migraine.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Naratriptan tablets are 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 take Naratriptan tablets

Do not take Naratriptan tablets:

*    If you are allergic to naratriptan, or any of the other ingredients of this medicine (listed in section 6)

*    If you have a heart problem such as heart failure 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 take Naratriptan tablets if your high blood pressure is mild and is being treated

*    If you have kidney or liver disease

*    With other migraine medicines, including those which contain ergotamine, or with similar medicines such as methysergide, or with other 5-HT1 receptor agonists, such as sumatriptan.

If any of these apply to you:

Tell your doctor, and don't take Naratriptan tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Naratriptan tablets.

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 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

taking Naratriptan tablets, even though they had no signs of heart disease

before.

If any of the points in the list 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 Naratriptan tablets is prescribed for you.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Naratriptan tablets. 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 taking Naratriptan tablets.

If you take Naratriptan tablets frequently

Taking Naratriptan tablets too often may make your headaches worse.

Tell your doctor if this applies to you. He or she may recommend you stop taking Naratriptan tablets.

If you feel pain or tightness in your chest after you take Naratriptan tablets

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.

Not for older people or children under 18

Naratriptan tablets is not recommended for people aged over 65 or for children under the age of 18.

Other medicines and Naratriptan tablets

Tell your doctor if you’re taking, have recently taken or might take any other medicines.

Some medicines must not be taken with Naratriptan tablets and others may cause adverse effects if they're taken with Naratriptan tablets. You must tell your doctor if you are taking:

*    any medicines for your migraine which contain any triptan/5-HT., agonist (such as sumatriptan or zolmitriptan). Don't take Naratriptan tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan tablets.

*    ergotamine also used to treat migraine or similar medicines such as methysergide. Don't take Naratriptan tablets at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan tablets.

*    any antidepressants classed as selective serotonin reuptake inhibitors (SSRIs), such as citalopram, fluoxetine or paroxetine, or serotonin noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine. If you are not sure, talk to your doctor or pharmacist.

*    St John’s Wort (Hypericum perforatum). Using herbal remedies that contain St John's Wort while you are taking Naratriptan tablets 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 Naratriptan tablets for pregnant women, though up till now there is no evidence of any increased risk of birth defects. Your doctor may recommend that you do not take Naratriptan tablets while you are pregnant.

*    Don’t breast-feed your baby for 24 hours after taking Naratriptan tablets. 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.

Naratriptan tablets contains lactose

Naratriptan tablets contain a small amount of a sugar called lactose.

If you have an intolerance to lactose or any other sugars:

Ask your doctor for advice about taking Naratriptan tablets.

How to take Naratriptan tablets

Only take Naratriptan tablets after your migraine headache begins. Don’t take Naratriptan tablets to try to prevent an attack.

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

Check with your doctor or pharmacist if you are not sure.

How much to take

* The usual dose for adults aged 18 to 65 is one Naratriptan 2.5 mg tablet, swallowed whole with water.

Naratriptan 2.5mg Tablets

Patient Information Leaflet (continued)

Naratriptan tablets is not recommended for children under 18 and adults over 65.

When to take Naratriptan tablets

*    It’s best to take Naratriptan tablets as soon as you feel a migraine coming on, although it can be taken at any time during an attack.

If your symptoms start to come back

*    You can take a second Naratriptan tablet after 4 hours, unless you have kidney or liver damage.

*    If you have kidney or liver damage don't take more than one tablet in 24 hours.

*    No one should take more than two tablets in 24 hours.

If the first tablet has no effect

*    Don’t take a second tablet for the same attack.

If Naratriptan tablets doesn't give you any relief:

Ask your doctor or pharmacist for advice.

If you take more Naratriptan tablets than you should

*    Don’t take more than two Naratriptan tablets in 24 hours.

Taking too much Naratriptan tablets could make you ill. If you have taken more than two tablets in 24 hours:

Contact your doctor for advice.

Reporting of side effects

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

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Naratriptan tablets

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30 °C.

Do not use this medicine after the expiry date shown on the carton label or blister strip.

If your doctor tells you to stop taking this medicine return any unused tablets to your pharmacist (chemist) for safe disposal.

Only keep this medicine if your doctor tells you to.

If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.

^ Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

*    Heartbeat may go faster, slower or change rhythm (affects up to 1 in 100 people).

*    Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis - affects up to 1 in 1,000 people).

*    Allergic reaction (affects up to 1 in 1,000 people). The signs of allergy include rash; hives; itching; wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after taking Naratriptan tablets:

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

*    Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body (affects up to 1 in 100 people).

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.

Common:

(may affect up to 1 in 10 people) -

*    Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself.

*    Tiredness, drowsiness or sleepiness (somnolence), or generally feeling unwell

*    Dizziness, tingling feelings or getting hot flushes.

If you get any of these effects:

^ Tell your doctor or pharmacist.

Uncommon:

(may affect up to 1 in 100 people)

*    Visual disturbances (although these may be due to the migraine attack itself).

*    Slight increase in blood pressure which may occur up to 12 hours after taking Naratriptan tablets.

If you get any of these effects:

^ Tell your doctor or pharmacist.

Very rare:

(may affect up to 1 in 10,000 people) -

* Heart problems, including chest pains (angina) and heart attack.

*    Poor blood circulation to the arms and legs, causing pain and discomfort.

If you get these symptoms:

^ Tell your doctor or pharmacist.

If you get side effects

If you notice any unwanted effects, even ones not listed in this leaflet, or if any of the side effects becomes troublesome:

^ Tell your doctor or pharmacist.

Contents of the pack and other information

What Naratriptan tablets contains

Each film-coated tablet contains 2.78mg of the active ingredient naratriptan hydrochloride equivalent to naratriptan 2.5mg.

Inactive ingredients: Microcrystalline cellulose, lactose anhydrous, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide E171, triacetin, iron oxide (yellow) E172, indigo carmine E132.

What Naratriptan tablets looks like and content of the pack

Naratriptan tablets are green, D-shaped, film coated tablets, with ‘GX CE5' marked on one side and blank on the other side.

Naratriptan tablets tablets are available in packs of 4, 8 and 12 tablets.

Additional information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have the information you need, and will advise you.

Manufacturer and Licence Holder

This medicine is manufactured by GlaxoSmithkine 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.

POM PL 15184/0646 Naratriptan 2.5mg Tablets Revision date: 29/07/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.