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NARAMIG TABLETS 2.5MG

Active substance(s): NARATRIPTAN HYDROCHLORIDE

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Transcript
What is in this leaflet
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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
tablets for migraine

naratriptan hydrochloride

2.5 mg film-coated tablets

Package Leaflet: Information for the User

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.

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:

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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.

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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.

Pregnancy and breast-feeding

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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.

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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

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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.

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3 How to take Naramig
Only take Naramig after your migraine headache
begins.

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

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.

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

How much to take

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.

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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

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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

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·If the first tablet has no effect
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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.

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

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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.

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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.

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5 How to store Naramig
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.

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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.

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

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. The expiry date refers to the last day of that
month.
Don’t store above 30°C.
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 Naramig contains

The active substance is naratriptan hydrochloride (2.5 mg).
The other ingredients in the tablet core are microcrystalline
cellulose, anhydrous lactose, croscarmellose sodium and
magnesium stearate. Other ingredients in the tablet coating
are methylhydroxypropylcellulose, titanium dioxide (E171),
triacetin, iron oxide yellow (E172), indigo carmine aluminium
lake (E132).

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder: Glaxo Wellcome UK Limited,
Stockley Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer: GlaxoSmithKline Pharmaceuticals S.A., ul.
Grunwaldzka 189, 60-322 Poznań, Poland
Other formats
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Naramig 2.5 mg film-coated tablets
Reference number 10949/0273
This is a service provided by the Royal National Institute of
Blind People.
Leaflet date: April 2014
Naramig and the Naramig logo are registered trade marks of
the GSK group of companies
© 2014 GSK group of companies. All rights reserved

What Naramig looks like and contents of the pack

Naramig tablets are green, film-coated, D-shaped tablets
engraved GX CE5 on one side. They are available in blister
packs of 6 or 12 tablets.
Not all pack sizes may be marketed.

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.

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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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