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NARAMIG 2.5 MG TABLETS

Active substance(s): NARATRIPTAN HYDROCHLORIDE

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Naramig® 2.5 mg Tablets

2289
13.08.15[8]

(naratriptan hydrochloride)
PATIENT INFORMATION LEAFLET
Your medicine is available by using the above name but will be referred to
as Naramig throughout the 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. What Naramig is and what it is used for
2. What you need to know before you take Naramig
3. How to take Naramig
4. Possible side effects
5. How to store Naramig
6. 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.

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 2.5 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.

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 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 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 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 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 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.

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.
Don’t take Naramig after the expiry date shown on the carton. The expiry
date refers to the last day of that month.
If you have any unwanted Naramig, don’t dispose of it in your waste water
or household rubbish. Take it back to your pharmacist who will dispose of it
in a way that won’t harm the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Naramig contains
Each tablet contains 2.78 mg naratriptan hydrochloride equivalent to
2.5 mg naratriptan.
The other ingredients in the tablet core are microcrystalline cellulose,
lactose, croscarmellose sodium and magnesium stearate. Other ingredients
in the tablet coating are hypromellose, titanium dioxide (E171), triacetin,
yellow iron oxide (E172), indigo carmine aluminium lake (E132).
What Naramig looks like and contents of the pack
Naramig tablets are green, film-coated, D-shaped tablets engraved 'GX
CE5' on one side and plain on other side.
They are available in blister packs of 4, 6 or 12 tablets.

Product Licence Holder and Manufacturer
Manufactured by GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka
189, 60-322 Poznan, Poland.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2289

Leaflet revision and issue date (Ref.) 13.08.15[8]
Naramig is a trademark of Glaxo Group Ltd.
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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