Skip to Content

NARATRIPTAN 2.5MG FILM-COATED TABLET

Active substance(s): NARATRIPTAN HYDROCHLORIDE / NARATRIPTAN HYDROCHLORIDE / NARATRIPTAN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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.
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

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.

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

1

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.

Only take Naratriptan after your migraine
Very rare: (may affect up to 1 in 10,000
headache begins.
people):
Don’t take Naratriptan to try to prevent
• Heart problems, including chest pains
an attack.
(angina) and heart attack.
How much to take
• Poor blood circulation to the arms and
• The recommended dose for adults
legs, causing pain and discomfort.
aged 18 to 65 is one 2.5 mg tablet,
If you get these symptoms, tell your
swallowed whole with water.
doctor or pharmacist.
Naratriptan is not recommended for
Reporting of side effects
children under 18 and adults over 65.
If you get any side effects, talk to your
When to take Naratriptan
doctor, pharmacist or nurse. This
• It’s best to take Naratriptan as soon as includes any possible side effects not
you feel a migraine headache coming listed in this leaflet. You can also report
on, although it can be taken at any
side effects directly via the Yellow Card
time during an attack.
Scheme at: www.mhra.gov.uk/yellowcard
If your symptoms start to come back
• You can take a second 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.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

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):

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

5

How to store Naratriptan

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton or
blister. The expiry date refers to the last
day of that month.
This medicinal product does not require
any special storage conditions.
Do not use this medicine if you notice
any visible signs of deterioration.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

6

Contents of the pack and other
information

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 or 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
• Heaviness, pressure, tightness or pain Manufacturer
Marketing Authorisation holder: TEVA UK
in the chest, throat or other parts of
the body. These effects may be intense Limited, Brampton Road, Hampden Park,
Eastbourne, East Sussex, BN22 9AG,
but generally pass quickly.
United Kingdom.
If these effects continue or become
Company responsible for manufacture:
severe (especially the chest pain) get
Teva Pharmaceutical Works Private
medical help urgently. In a very small
Limited Company, Pallagi út 13, 4042
number of people these symptoms can
Debrecen, Hungary.
be caused by a heart attack.
This leaflet was last revised in February
Other uncommon side effects include:
2017
• Visual disturbances (although these
may be due to the migraine attack
Product licence number
itself).
PL 00289/1106
• 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.

88895-E

Expand Transcript

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.

Hide