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NARATRIPTAN 2.5MG FILM-COATED TABLET

Active substance(s): NARATRIPTAN HYDROCHLORIDE

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Naratriptan 2.5 mg
Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before
you start using 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..

TEVA UK Ref:

231-30-88895-D LEA NARATRIPTAN A/S TAB TUK
Version:

2

20 April 2015

What is in this leaflet:

1. What Naratriptan is and what it is
used for
2. What you need to know before you
take Naratriptan
3. How to take Naratriptan
4. Possible side effects
5. How to store Naratriptan
6. Contents of the pack and other
information

Naratriptan. 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.
If you take naratriptan frequently
Taking naratriptan too often may make
your headaches worse.
Tell your doctor if this applies to you. He
or she may recommend you stop taking
naratriptan.
If you feel pain or tightness in your chest
after you take Naratriptan
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.
If you are taking antidepressants called
SSRIs (Selective Serotonin Reuptake
Inhibitors) or SNRIs (Serotonin
Noradrenaline Reuptake Inhibitors)
Tell your doctor or pharmacist before
taking Naratriptan.
Other medicines and Naratriptan

Tell your doctor or pharmacist if you are
What Naratriptan is and what it is taking, have recently taken or might take
used for
any other medicines.
Your medicine contains naratriptan
Some medicines must not be taken with
(hydrochloride), which belongs to a
Naratriptan and others may cause
group of medicines called triptans (also adverse effects if they’re taken with
known as 5-HT1 receptor agonists).
Naratriptan. You must tell your doctor if
It is used to treat migraine headache.
you are taking:
Migraine symptoms may be caused by
• any triptan or 5-HT1 receptor agonist
the temporary widening of blood vessels used to treat migraine. Don’t take
in the head. Naratriptan is believed to
Naratriptan at the same time as these
reduce the widening of these blood
medicines. Don’t take them again for at
vessels. This in turn helps to take away
least 24 hours after taking Naratriptan.
the headache and relieve other
• ergotamine also used to treat migraine,
symptoms of a migraine attack, such as
or similar medicines such as
feeling or being sick (nausea or
methysergide. Don’t take Naratriptan at
vomiting) and sensitivity to light and
the same time as these medicines. Stop
sound.
taking these medicines at least 24 hours
before taking Naratriptan. Don’t take
What
you
need
to
know
before
2
them again for at least 24 hours after
you take Naratriptan
taking Naratriptan
• SSRIs (Selective Serotonin Reuptake
Do not take Naratriptan if you:
Inhibitors) or SNRIs (Serotonin
• are allergic to naratriptan, or any of
Noradrenaline Reuptake Inhibitors)
the other ingredients of this medicine
used to treat depression. Taking
(listed in section 6).
Naratriptan with these medicines can
• have a heart problem such as
cause confusion, weakness and/or
narrowing of the arteries (ischaemic
lack of co-ordination. Tell your doctor
heart disease) or chest pains (angina),
immediately if you are affected in this
or have already had a heart attack.
way.
• have circulation problems in your legs
that cause cramp-like pains when you • St John’s Wort (Hypericum
perforatum). Using herbal remedies
walk (peripheral vascular disease).
that contain St John’s Wort while you
• have had a stroke or a mini-stroke
are taking Naratriptan may make side
(also called a transient ischaemic
effects more likely.
attack or TIA).
• have high blood pressure. You may be Pregnancy and breast-feeding
able to take Naratriptan if your high
Pregnancy: If you are pregnant or
blood pressure is mild and is being
breast-feeding, think you may be
treated.
pregnant or are planning to have a baby,
• have serious kidney or serious liver
ask to your doctor or pharmacist for
disease.
• are taking other migraine medicines, advice before taking this medicine. There
is only limited information about the
including those which contain
ergotamine, or with similar medicines safety of naratriptan for pregnant
women, though up till now there is no
such as methysergide, or with any
evidence of any increased risk of birth
triptan or 5-HT1 receptor agonists.
defects. Your doctor may recommend
If any of these apply to you, tell your
that you do not take Naratriptan while
doctor, and don’t take Naratriptan.
you are pregnant.
Breast-feeding: Don’t breast-feed your
Warnings and precautions
baby for 24 hours after taking
Talk to your doctor or pharmacist before Naratriptan. If you express any breast
taking Naratriptan.
milk during this time, discard the milk
If you have any extra risk factors
and don’t give it to your baby.
• If you are a heavy smoker or are
Driving and using machines
using nicotine replacement therapy,
Either the symptoms of migraine or your
and especially
medicine may make you drowsy. If you
• If you are a man over 40, or
are affected, don’t drive or operate
• If you are a woman who has been
machinery.
through the menopause.
In very rare cases, people have
Naratriptan contains lactose
developed serious heart conditions after If you have been told by your doctor that
taking Naratriptan, even though they had you have an intolerance to some sugars,
no signs of heart disease before.
contact your doctor before taking this
If any of the points in the list applies to
medicinal product.
you, it could mean you have a greater
risk of developing heart disease – so:
3 How to take Naratriptan

1

Tell your doctor so that your heart
function can be checked before
Naratriptan is prescribed for you.
If you are allergic to antibiotics called
sulphonamides
If so, you may also be allergic to

Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.

20 April 2015

2
Version:

Only take Naratriptan after your migraine Very rare: (may affect up to 1 in 10,000
people):
headache begins.
• Heart problems, including chest pains
Don’t take Naratriptan to try to prevent
(angina) and heart attack.
an attack.
• Poor blood circulation to the arms and
How much to take
legs, causing pain and discomfort.
• The recommended dose for adults
If you get these symptoms, tell your
aged 18 to 65 is one 2.5 mg tablet,
doctor or pharmacist.
swallowed whole with water.
Reporting of side effects
Naratriptan is not recommended for
If you get any side effects, talk to your
children under 18 and adults over 65.
doctor, pharmacist or nurse. This
When to take Naratriptan
includes any possible side effects not
• It’s best to take Naratriptan as soon as listed in this leaflet. You can also report
you feel a migraine headache coming side effects directly via the Yellow Card
on, although it can be taken at any
Scheme at:
time during an attack.
www.mhra.gov.uk/yellowcard
If your symptoms start to come back
By reporting side effects you can help
• You can take a second tablet after 4
provide more information on the safety
hours, unless you have kidney or liver of this medicine.
damage.
• If you have kidney or liver damage
5 How to store Naratriptan
don’t take more than one tablet in 24
hours.
Keep this medicine out of the sight and
• No-one should take more than two
reach of children.
tablets in 24 hours.
Do not use this medicine after the expiry
If the first tablet has no effect
date which is stated on the carton or
• Don’t take a second tablet for the
blister. The expiry date refers to the last
same attack.
day of that month.
If Naratriptan doesn’t give you any relief:
Ask your doctor or pharmacist for advice. This medicinal product does not require
any special storage conditions.
If you take more Naratriptan than you
Do not use this medicine if you notice
should
description of the visible signs of
• Don’t take more than two Naratriptan deterioration.
tablets in 24 hours.
Taking too much naratriptan could make Do not throw away any medicines via
you ill. If you have taken more than two wastewater or household waste. Ask
tablets in 24 hours: Contact your doctor your pharmacist how to throw away
medicines you no longer use. These
for advice.
measures will help protect the
If you have any further questions on the environment.
use of this medicine, ask your doctor or
pharmacist.
6 Contents of the pack and other

information

TEVA UK Ref:

231-30-88895-D LEA NARATRIPTAN A/S TAB TUK
4

Possible side effects

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


Allergic reaction: get a doctor’s help
straight away (may affect up to 1 in
1,000 people): The signs of allergy
include rash; 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.
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 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):
• Heaviness, pressure, tightness or pain
in the chest, throat or other parts of
the body. 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 uncommon side effects include:
• Visual disturbances (although these
may be due to the migraine attack
itself).
• Heart beat may go faster, slower or
change rhythm.
• Slight increase in blood pressure
which may last for up to 12 hours after
taking Naratriptan.
If you get any of these effects tell your
doctor or pharmacist.

What Naratriptan contains
• The active substance is naratriptan.
Each film-coated tablet contains
2.5mg naratriptan (as naratriptan
hydrochloride).
• The other ingredients in the tablet
core are anhydrous lactose,
microcrystalline cellulose, colloidal
anhydrous silica, croscarmellose
sodium and magnesium stearate.
• The other ingredients in the coating
are hypromellose (E464), titanium
dioxide (E171), lactose monohydrate,
macrogol 3350, triacetin, quinoline
yellow aluminium lake (E104), indigo
carmine aluminium lake (E132) and
yellow iron oxide (E172).
What Naratriptan looks like and contents
of the pack
Green, biconvex, round, film-coated
tablets debossed “NT 2.5” on one side
and plain on the other.
Naratriptan is available in blisters of 2, 4,
6, 12 film-coated tablets and hospital
packs of 18 or 50 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
TEVA UK Limited, Brampton Road,
Hampden Park, Eastbourne, East Sussex,
BN22 9AG, United Kingdom.
This leaflet was last revised in March
2015
Product licence number
PL 00289/1106

Rare: (may affect up to 1 in 1,000 people):
• Pain in the lower left side of the
stomach and bloody diarrhoea
(ischaemic colitis).
If you get these symptoms tell your
doctor or pharmacist.

88895-D

TEVA UK Ref:

Version:

231-30-88350-D LEA NARATRIPTAN TAB 2.5mg TUK

2

20 April 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before you
start using 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:

PHARMA CODE 303

105mm from top of the leaflet

1. What Naratriptan is and what it is used for
2. What you need to know before you take
Naratriptan
3. How to take Naratriptan
4. Possible side effects
5. How to store Naratriptan
6. Contents of the pack and other information

1

What Naratriptan is and what it is
used for

Your medicine contains naratriptan
(hydrochloride), which belongs to a group of
medicines called triptans (also known as 5-HT1
receptor agonists).
It is used to treat migraine headache.
Migraine symptoms may be caused by the
temporary widening of blood vessels in the
head. Naratriptan is believed to reduce the
widening of these blood vessels. This in turn
helps to take away the headache and relieve
other symptoms of a migraine attack, such as
feeling or being sick (nausea or vomiting) and
sensitivity to light and sound.

2

What you need to know before you
take Naratriptan

Do not take Naratriptan if you:
• are allergic to naratriptan, or any of the
other ingredients of this medicine (listed in
section 6).
• have a heart problem such as narrowing of
the arteries (ischaemic heart disease) or
chest pains (angina), or have already had a
heart attack.
• have circulation problems in your legs that
cause cramp-like pains when you walk
(peripheral vascular disease).
• have had a stroke or a mini-stroke (also
called a transient ischaemic attack or TIA).
• have high blood pressure. You may be able
to take Naratriptan if your high blood
pressure is mild and is being treated.
• have serious kidney or serious liver disease.
• are taking other migraine medicines,
including those which contain ergotamine,
or with similar medicines such as
methysergide, or with any triptan or 5-HT1
receptor agonists.

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 is prescribed for
you.
If you are allergic to antibiotics called
sulphonamides
If so, you may also be allergic to Naratriptan. 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.
If you take naratriptan frequently
Taking naratriptan too often may make your
headaches worse.
Tell your doctor if this applies to you. He or she
may recommend you stop taking naratriptan.
If you feel pain or tightness in your chest after
you take Naratriptan
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.
If you are taking antidepressants called SSRIs
(Selective Serotonin Reuptake Inhibitors) or
SNRIs (Serotonin Noradrenaline Reuptake
Inhibitors)
Tell your doctor or pharmacist before taking
Naratriptan.
Other medicines and Naratriptan
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Some medicines must not be taken with
Naratriptan and others may cause adverse
effects if they’re taken with Naratriptan. You
must tell your doctor if you are taking:
• any triptan or 5-HT1 receptor agonist used to
treat migraine. Don’t take Naratriptan at the same
time as these medicines. Don’t take them again
for at least 24 hours after taking Naratriptan.
• ergotamine also used to treat migraine, or
similar medicines such as methysergide. Don’t
take Naratriptan at the same time as these
medicines. Stop taking these medicines at
least 24 hours before taking Naratriptan. Don’t
take them again for at least 24 hours after
taking Naratriptan
• SSRIs (Selective Serotonin Reuptake
Inhibitors) or SNRIs (Serotonin
Noradrenaline Reuptake Inhibitors) used to
treat depression. Taking Naratriptan with
these medicines can cause confusion,
weakness and/or lack of co-ordination. Tell
your doctor immediately if you are affected
in this way.
• St John’s Wort (Hypericum perforatum).
Using herbal remedies that contain St John’s
Wort while you are taking Naratriptan may
make side effects more likely.
Pregnancy and breast-feeding

Pregnancy: If you are pregnant or
breast-feeding, think you may be pregnant or
are planning to have a baby, ask to your doctor
or pharmacist for advice before taking this
medicine. There is only limited information
Warnings and precautions
about the safety of naratriptan for pregnant
Talk to your doctor or pharmacist before taking women, though up till now there is no
evidence of any increased risk of birth defects.
Naratriptan.
Your doctor may recommend that you do not
If you have any extra risk factors
take Naratriptan while you are pregnant.
• If you are a heavy smoker or are using
nicotine replacement therapy, and especially Breast-feeding: Don’t breast-feed your baby for
24 hours after taking Naratriptan. If you
• If you are a man over 40, or
express any breast milk during this time,
• If you are a woman who has been through
discard the milk and don’t give it to your baby.
the menopause.
In very rare cases, people have developed
Driving and using machines
serious heart conditions after taking
Naratriptan, even though they had no signs of Either the symptoms of migraine or your
medicine may make you drowsy. If you are
heart disease before.
affected, don’t drive or operate machinery.
If any of these apply to you, tell your doctor,
and don’t take Naratriptan.

Top of page cut-off to middle of registration mark: 44 mm.

Naratriptan 2.5 mg
Film-Coated Tablets

TEVA UK Ref:

Version:

231-30-88350-D LEA NARATRIPTAN TAB 2.5mg TUK

2

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• Slight increase in blood pressure which may
Naratriptan contains lactose
last for up to 12 hours after taking Naratriptan.
If you have been told by your doctor that you
If
you get any of these effects tell your doctor
have an intolerance to some sugars, contact
your doctor before taking this medicinal product. or pharmacist.

3

How to take Naratriptan

Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

Rare: (may affect up to 1 in 1,000 people):
• Pain in the lower left side of the stomach and
bloody diarrhoea (ischaemic colitis).
If you get these symptoms tell your doctor or
pharmacist.

Very rare: (may affect up to 1 in 10,000 people):
Only take Naratriptan after your migraine
• Heart problems, including chest pains
headache begins.
(angina) and heart attack.
Don’t take Naratriptan to try to prevent an attack.
• Poor blood circulation to the arms and legs,
How much to take
causing pain and discomfort.
• The recommended dose for adults aged 18
If you get these symptoms, tell your doctor or
to 65 is one 2.5 mg tablet, swallowed whole pharmacist.
with water.
Reporting of side effects
Naratriptan is not recommended for children
If you get any side effects, talk to your doctor,
under 18 and adults over 65.
pharmacist or nurse. This includes any possible
When to take Naratriptan
side effects not listed in this leaflet. You can
• It’s best to take Naratriptan as soon as you
also report side effects directly via the Yellow
feel a migraine headache coming on, although Card Scheme at: www.mhra.gov.uk/yellowcard
it can be taken at any time during an attack.
By reporting side effects you can help provide
If your symptoms start to come back
more information on the safety of this
• You can take a second tablet after 4 hours,
medicine.
unless you have kidney or liver damage.
• If you have kidney or liver damage don’t take
5 How to store Naratriptan
more than one tablet in 24 hours.
• No-one should take more than two tablets in
Keep this medicine out of the sight and reach
24 hours.
of children.
If the first tablet has no effect
Do not use this medicine after the expiry date
• Don’t take a second tablet for the same attack.
which is stated on the carton or blister. The
If Naratriptan doesn’t give you any relief:
expiry date refers to the last day of that month.
Ask your doctor or pharmacist for advice.
This medicinal product does not require any
If you take more Naratriptan than you should
special storage conditions.
• Don’t take more than two Naratriptan tablets
Do not use this medicine if you notice
in 24 hours.
description of the visible signs of deterioration.
Taking too much naratriptan could make you
ill. If you have taken more than two tablets in
Do not throw away any medicines via
24 hours: Contact your doctor for advice.
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
If you have any further questions on the use of
no longer use. These measures will help
this medicine, ask your doctor or pharmacist.
protect the environment.

4

Possible side effects

6

Contents of the pack and other
information

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
What Naratriptan contains
• The active substance is naratriptan. Each
• Allergic reaction: get a doctor’s help straight
film-coated tablet contains 2.5mg naratriptan
away (may affect up to 1 in 1,000 people):
(as naratriptan hydrochloride).
The signs of allergy include rash; wheezing;
• The other ingredients in the tablet core are
swollen eyelids, face or lips; complete
anhydrous lactose, microcrystalline cellulose,
collapse.
colloidal anhydrous silica, croscarmellose
If you get any of these symptoms soon after
sodium and magnesium stearate.
taking Naratriptan, don’t take any more.
• The other ingredients in the coating are
Contact a doctor straight away.
hypromellose (E464), titanium dioxide
(E171), lactose monohydrate, macrogol 3350,
Common (may affect up to 1 in 10 people):
triacetin, quinoline yellow aluminium lake
• Feeling sick (nausea) or being sick
(E104), indigo carmine aluminium lake
(vomiting), although this may be due to the
(E132) and yellow iron oxide (E172).
migraine itself.
• Tiredness, drowsiness, or generally feeling
What Naratriptan looks like and contents of
unwell.
the pack
• Dizziness, tingling feelings, or getting hot
Green, biconvex, round, film-coated tablets
flushes.
debossed “NT 2.5” on one side and plain on
If you get any of these effects tell your doctor
the other.
or pharmacist.
Naratriptan is available in blisters of 2, 4, 6, 12
Uncommon (may affect up to 1 in 100 people): film-coated tablets and hospital packs of 18 or
50 film-coated tablets.
• Heaviness, pressure, tightness or pain in the
Not all pack sizes may be marketed.
chest, throat or other parts of the body.
These effects may be intense but generally
Marketing Authorisation Holder and
pass quickly.
Manufacturer
If these effects continue or become severe
TEVA UK Limited, Brampton Road, Hampden
(especially the chest pain) get medical help
Park, Eastbourne, East Sussex, BN22 9AG,
urgently. In a very small number of people
United Kingdom.
these symptoms can be caused by a heart
attack.
This leaflet was last revised in March 2015
Other uncommon side effects include:
• Visual disturbances (although these may be
due to the migraine attack itself).
• Heart beat may go faster, slower or change
rhythm.

Product licence number
PL 00289/1106

88350-D
160 x 323

20 April 2015

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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