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NARATRIPTAN HYDROCHLORIDE 2.5 MG TABLETS

Active substance(s): NARATRIPTAN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NARAMIG® 2.5MG TABLETS
(naratriptan hydrochloride)




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.

Your medicine is available as Naramig 2.5mg Tablets, but will
be referred to as Naramig throughout this leaflet.

If any of these apply to you:

Tell your doctor, and don’t take Naramig.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

Warnings and precautions







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.

What is in this leaflet

1.
2.
3.
4.
5.
6.

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
Contents of the pack and other information

1. 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.

2. 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.

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.

3. 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 2.5mg tablet, swallowed whole with water.

Naramig is not recommended for children under 18 and
adults over 65.
Page 1 of 2

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

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

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.

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.

4. Possible side effects

Reporting of 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.



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.

5. How to store Naramig










Keep out of the sight and reach of children.
Do not store above 30°C.
Don’t take Naramig after the expiry date shown on the
carton. The expiry date refers to the last day of that
month.
If your tablets appear to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you.
If your doctor decides to stop your treatment, return
any left over tablets to the pharmacist. Only keep them
if your doctor tells you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

Page 2 of 2

6. Contents of the pack and other
information
What Naramig contains

Each film-coated tablet contains 2.78mg naratriptan
hydrochloride equivalent to 2.5mg naratriptan.
tablet core: microcrystalline cellulose, lactose,
croscarmellose sodium and magnesium stearate.
coating: hypromellose, titanium dioxide (E171), triacetin,
iron oxide (E172) and indigo carmine aluminium salt (E132).

What Naramig looks like and contents of the pack

Naramig are green, film-coated, D-shaped tablets, engraved
‘GX CE5’ on one side and plain on the reverse.
Your medicine is available in blister packs of 6 or 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

Your medicine is manufactured by: Glaxo Operations UK Ltd.,
Glaxo Wellcome Operations, Glaxo Wellcome House,
Berkeley Avenue, Greenford, Middlesex, UB6 0NN.
Or
GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189,
60-322 Poznań, Poland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0407

POM

Leaflet issue and revision date (Ref): 07.04.16
Naramig® is a registered trademark of the GlaxoSmithKline
group of companies.

Other formats

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product name:
Naramig 2.5mg Tablets
Reference number:
21828/0407

PACKAGE LEAFLET: INFORMATION FOR THE USER

NARATRIPTAN HYDROCHLORIDE 2.5MG
TABLETS
Your medicine is available as Naratriptan Hydrochloride
2.5mg Tablets, but will be referred to as Naratriptan
Hydrochloride throughout this 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.

What is in this leaflet

1.
2.
3.
4.
5.
6.

What Naratriptan Hydrochloride is and what it is used for
What you need to know before you take Naratriptan
Hydrochloride
How to take Naratriptan Hydrochloride
Possible side effects
How to store Naratriptan Hydrochloride
Contents of the pack and other information

1. What Naratriptan Hydrochloride is and
what it is used for
Naratriptan Hydrochloride tablets contain naratriptan
(hydrochloride), which belongs to a group of medicines called
triptans (also known as 5-HT1 receptor agonists).
Naratriptan Hydrochloride tablets are used to treat
migraine.
Migraine symptoms may be caused by the temporary
widening of blood vessels in the head. Naratriptan
Hydrochloride 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.

2. What you need to know before you take
Naratriptan Hydrochloride
Do not take Naratriptan Hydrochloride:





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 Hydrochloride 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
Hydrochloride.

Warnings and precautions

Talk to your doctor or pharmacist before taking Naratriptan
Hydrochloride.
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 Hydrochloride, 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 Hydrochloride is prescribed
for you.
If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Naratriptan Hydrochloride. 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 Hydrochloride.
If you take Naratriptan Hydrochloride frequently
Taking Naratriptan Hydrochloride too often may make your
headaches worse.

Tell your doctor if this applies to you. He or she may
recommend you stop taking Naratriptan Hydrochloride.
If you feel pain or tightness in your chest after you
take Naratriptan Hydrochloride
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 Hydrochloride is not recommended for
people aged over 65 or for children under the age of 18.

Page 1 of 2

Other medicines and Naratriptan Hydrochloride

Tell your doctor if you’re taking, have recently taken or
might take any other medicines.
Some medicines must not be taken with Naratriptan
Hydrochloride and others may cause adverse effects if they’re
taken with Naratriptan Hydrochloride. 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 Naratriptan Hydrochloride at
the same time as these medicines. Stop taking these
medicines at least 24 hours before taking Naratriptan
Hydrochloride.

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

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 Hydrochloride 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
Hydrochloride 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 Hydrochloride while you are pregnant.
Don’t breast-feed your baby for 24 hours after
taking Naratriptan Hydrochloride. 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 Hydrochloride contains lactose

Naratriptan Hydrochloride 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
Hydrochloride.

3. How to take Naratriptan Hydrochloride
Only take Naratriptan Hydrochloride after your
migraine headache begins. Don’t take Naratriptan
Hydrochloride 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 Hydrochloride 2.5mg tablet, swallowed
whole with water.

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

When to take Naratriptan Hydrochloride


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

Ask your doctor or pharmacist for advice.

If you take more Naratriptan Hydrochloride than
you should

Don’t take more than two Naratriptan
Hydrochloride tablets in 24 hours.
Taking too much Naratriptan Hydrochloride 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
Naratriptan Hydrochloride:

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 Hydrochloride.
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.


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.

5. How to store Naratriptan Hydrochloride






Keep out of the sight and reach of children.
Do not store above 30°C.
Don’t take Naratriptan Hydrochloride after the expiry
date shown on the carton. The expiry date refers to the
last day of that month.
If your tablets appear to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you.

Page 2 of 2





If your doctor decides to stop your treatment, return
any left over tablets to the pharmacist. Only keep them
if your doctor tells you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

6. Contents of the pack and other
information
What Naratriptan Hydrochloride contains

Each film-coated tablet contains 2.78mg naratriptan
hydrochloride equivalent to 2.5mg naratriptan.
tablet core: microcrystalline cellulose, lactose,
croscarmellose sodium and magnesium stearate.
coating: hypromellose, titanium dioxide (E171), triacetin,
iron oxide (E172) and indigo carmine aluminium salt (E132).

What Naratriptan Hydrochloride looks like and
contents of the pack

Naratriptan Hydrochloride are green, film-coated, D-shaped
tablets, engraved ‘GX CE5’ on one side and plain on the
reverse.
Your medicine is available in blister packs of 6 or 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

Your medicine is manufactured by: Glaxo Operations UK Ltd.,
Glaxo Wellcome Operations, Glaxo Wellcome House,
Berkeley Avenue, Greenford, Middlesex, UB6 0NN.
Or
GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189,
60-322 Poznań, Poland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0407

POM

Leaflet issue and revision date (Ref): 07.04.16

Other formats

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product name: Naratriptan Hydrochloride 2.5mg Tablets
Reference number: 21828/0407

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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