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NARAMIG 2.5MG TABLETS/NARATRIPTAN 2.5MG TABLETS

Active substance(s): NARATRIPTAN HYDROCHLORIDE

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

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.
The name of your medicine is Naramig® 2.5mg Tablets,
but will be referred to as Naramig throughout this
leaflet.

What is in this leaflet

(naratriptan hydrochloride)
tablets for migrane

Naramig 2.5mg Tablets

Package Leaflet: Information for the User
®

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.

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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
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.
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.

Not for older people or children under 18

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.

Other medicines and Naramig

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.

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.

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.

Naramig is not recommended for people aged over 65
or for children under the age of 18.

Tell your doctor if you’re taking, have recently taken
or might take any other medicines.

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
2.5 mg tablet, swallowed whole with water
Naramig is not recommended for children under 18 and adults
over 65.

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.

6. Contents of the pack and other information

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 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.
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 Naramig
Keep out of the sight and reach of children.
Do not store above 30 °C.
Do not use after the expiry date which is stated on the carton label
after ‘Exp’. The expiry date refers to the last day of that month.
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.

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

What Naramig looks like and
contents of the pack
Each green film coated D-shaped biconvex
tablet is marked ‘GXCE5’ on one side and
plain on the other side and contains 2.5mg of
the active ingredient naratriptan (as
naratriptan hydrochloride).

Migraine Action Association
Unit 6
Oakley Hay Lodge Business Park
Great Folds Road
Great Oakley
Northants NN18 9AS
Telephone: 01536 461333
The Migraine Trust
55-56 Russell Square
London WC1B 4HP
Telephone: 020 7436 1336
You may be able to find out more about
prescribed medicines from books in public
libraries.
Manufactured by : GlaxoSmithKline
Pharmaceuticals S.A. uI. Grunwaldzka 189 - 60322 Poznan – Poland.

Each pack contains a blister strip 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.
Pharmaceutical Companies are not allowed to
answer questions from patients about their
diseases. There are two national
organisations, which offer both help and
advice on migraine:

Procured from within the EU and
repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Naramig 2.5mg Tablets PL: 18799/0594
POM
Leaflet date: 05.06.2015
Naramig and the Naramig logo are registered
trademarks of the GlaxoSmithKline group of
companies
© 2008 GlaxoSmithKline group of companies

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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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