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NARAMIG 2.5 MG TABLETS, NARATRIPTAN 2.5 MG TABLETS - patient leaflet, side effects, dosage

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Patient leaflet - NARAMIG 2.5 MG TABLETS, NARATRIPTAN 2.5 MG TABLETS

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

riHWhat Naramig is and what it is used for

^2B What you need to know before you take Naramig

^3! How to take Naramig

Possible side effects

^5H How to store Naramig

r6H Contents of the pack and other information

jHwhat 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

- > get medical help immediately. section 4 of this leaflet has more information about these possible side effects.

MHow 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 i8 to 65 is one Naramig 2.5 mg tablet, swallowed whole with water.

(naratriptan hydrochloride)

Patient Information Leaflet (continued)

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.

  • 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.

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 Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

^HHow 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.

^HPossible 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.

^■

Contents of the pack and other information

What Naramig contains

Each film-coated tablet of Naramig contains 2.5mg of the active ingredient naratriptan (as naratriptan hydrochloride).

Your medicine also contains the following inactive ingredients:

Lactose (anhydrous), microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), and indigo carmine aluminium lake (E132).

What Naramig looks like and content of the pack

Naramig tablets are D-shaped and green in colour.

Packs of Naramig 2.5mg contain blister strips of 6 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 GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, PL-60–322 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 15184/0737 Naramig 2.5mg Tablets

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

Revision date: 08/12/2021

Blind or partially sighted?

Is this leaflet hard to see or read?

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

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 thoughout this leaflet.

What is in this leaflet

HB What Naratriptan is and what it is used for

^B What you need to know before you take Naratriptan

^B How to take Naratriptan

^B Possible side effects

^B How to store Naratriptan

Contents of the pack and other information

jHwhat Naratriptan is and what it is used for

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

Naratriptan are used to treat migraine.

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

^HWhat you need to know before you take Naratriptan

- > get medical help immediately. section 4 of this leaflet has more information about these possible side effects.

^■How to take Naratriptan

Only take Naratriptan after your migraine headache begins.

Don’t take Naratriptan 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.

Patient Information Leaflet (continued)

When to take Naratriptan

  • It’s best to take Naratriptan 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 doesn’t give you any relief:

→ Ask your doctor or pharmacist for advice.

If you take more Naratriptan than you should

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

Taking too much Naratriptan 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 Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

3

How to store Naratriptan

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.

^■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:

^ 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:

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.

^■Contents of the pack and other information

What Naratriptan contains

Each film-coated tablet of Naratriptan contains 2.5mg of the active ingredient naratriptan (as naratriptan hydrochloride).

Your medicine also contains the following inactive ingredients:

Lactose (anhydrous), microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), and indigo carmine aluminium lake (E132).

What Naratriptan looks like and content of the pack

Naratriptan tablets are D-shaped and green in colour.

Packs of Naratriptan 2.5mg contain blister strips of 6 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 GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, PL-60–322 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 15184/0737 Naratriptan 2.5mg Tablets

Revision date: 08/12/2021

Blind or partially sighted?

Is this leaflet hard to see or read?

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