IMIGRAN RADIS 50MG TABLETS

Active substance: SUMATRIPTAN SUCCINATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package Leaflet:
Information for the User

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.

film-coated dispersible tablets

What is in this leaflet

sumatriptan

50 mg or 100 mg tablets

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.

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

1 What Imigran Radis is and
what it is used for
Each Imigran Radis tablet contains a single
dose of sumatriptan, which belongs to a
group of medicines called triptans (also
known as 5-HT1 receptor agonists).
Imigran Radis is used to treat migraine
headache.
Migraine symptoms may be caused by the
temporary widening of blood vessels in the
head. Imigran Radis 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 use Imigran Radis

Don’t use Imigran Radis:
If you’re allergic to sumatriptan, or any of
the other ingredients of this medicine
(listed in section 6)
If you have a heart problem such as
narrowing of the arteries (Ischaemic heart
disease) 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 use Imigran if your high blood
pressure is mild and is being treated
If you have serious liver disease
With other migraine medicines, including
those which contain ergotamine, or similar
medicines such as methysergide maleate; or
any triptan or 5-HT1 agonist (such as
naratriptan or zolmitriptan)
With any of the following anti-depressants:
MAOIs (monoamine oxidase inhibitors)
or if you have taken an MAOI in the last
2 weeks
SSRIs (selective serotonin reuptake
inhibitors) including citalopram,
fluoxetine, fluvoxamine, paroxetine and
sertaline
SNRIs (serotonin noradrenaline reuptake
inhibitors) including venlafaxine and
duloxetine
For children under 18 years of age.
If any of these apply to you:



Tell your doctor, and don’t use
Imigran Radis.

Take special care with Imigran Radis
Talk to your doctor or pharmacist before using
Imigran.

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 aged 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 using Imigran,
even though they had no signs of heart
disease before. If any of the points above
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 Imigran is
prescribed for you.

If you have a history of fits (seizures)
Or if you have other conditions which might
make it more likely that you’ll have a fit - for
example, a head injury or alcoholism:



Tell your doctor so that you can be
supervised more closely.

If you have liver or kidney disease
If either of these apply to you:
➔ Tell your doctor so that you can be
supervised more closely.
If you are allergic to antibiotics called
sulphonamides
If so, you may also be allergic to Imigran. 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 using
Imigran.

If you are taking anti-depressants called SSRIs
(Selective Serotonin Reuptake Inhibitors) or
SNRIs (Serotonin Noradrenaline Reuptake
Inhibitors)



Tell your doctor or pharmacist before
using Imigran. Also see Other medicines
and Imigran, below.

If you use Imigran frequently.
Using Imigran too often may make your
headaches worse.
➔ Tell your doctor if this applies to you. He
or she may recommend you stop using
Imigran.
If you feel pain or tightness in your chest
after you use Imigran
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
(overleaf) has more information about
these possible side effects.

Other medicines and Imigran
Tell your doctor or pharmacist if you’re
taking, have recently taken or might take any
other medicines. This includes any herbal
products or medicines you’ve bought without
a prescription.
Some medicines must not be taken with
Imigran and others may cause adverse effects
if they’re taken with Imigran. You must tell
your doctor if you are taking:

ergotamine also used to treat migraine, or
similar medicines such as methysergide (see
section 2 Don’t use Imigran Radis). Don’t
use Imigran at the same time as these
medicines. Stop taking these medicines at
least 24 hours before using Imigran. Don’t
take any medicines which contain
ergotamine or compounds similar to
ergotamine again for at least 6 hours after
using Imigran.
other triptans/5-HT1 receptor agonists (such
as naratriptan, rizatriptan, zolmitriptan),
also used to treat migraine, (see section 2
Don’t use Imigran Radis). Don’t use Imigran
at the same time as these medicines. Stop
taking these medicines at least 24 hours
before using Imigran. Don’t take another
triptan/5-HT1 receptor agonist again for at
least 24 hours after using Imigran.
MAOIs used to treat depression. Don’t use
Imigran if you have taken these in the last
2 weeks.
SSRIs and SNRIs used to treat depression.
Using Imigran with these medicines can
cause serotonin syndrome (a collection of
symptoms which can include restlessness,
confusion, sweating, hallucinations,
increased reflexes, muscle spasms, shivering,
increased heartbeat and shaking). Tell your
doctor immediately if you are affected in
this way.
St John’s Wort (Hypericum perforatum).
Taking herbal remedies containing
St John’s Wort together with Imigran 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 Imigran for
pregnant women, though up till now there
is no evidence of any increased risk of birth
defects. Your doctor will discuss with you
whether or not you should use Imigran
while you are pregnant
Don’t breast-feed your baby for 12 hours
after using Imigran. 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.

V4

118233

3 How to use Imigran Radis
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.

When to take Imigran Radis
It’s best to take Imigran Radis as soon as you
feel a migraine coming on, although you can
take it at any time during an attack
Don’t use Imigran Radis to try to prevent an
attack - only use it after your migraine
symptoms start.

How much to take
Adults aged 18 to 65
The usual dose for adults aged 18 to 65 is one
Imigran Radis 50 mg tablet swallowed whole
with water (do not crush or chew it). Some
patients may need a 100 mg dose - you should
follow your doctor’s advice.
If you have problems swallowing tablets,
you can disperse a tablet in a small amount
of water before you take it - although this
may have a bitter taste.
Children under 18
Imigran Radis is not recommended for
children under 18 years old.
Older people (aged over 65)
Imigran Radis is not recommended for
people aged over 65.

If your symptoms start to come back
You can take a second Imigran Radis tablet if
at least 2 hours have passed since the first
tablet. Don’t take more than 300 mg in total
in 24 hours.

5 How to store Imigran Radis
If the first tablet has no effect
Don’t take a second tablet or any other
Imigran preparation for the same attack.
Imigran can still be used for your next attack.
If Imigran Radis doesn’t give you any relief:



Ask your doctor or pharmacist for advice.

If you take more Imigran than you should
Don’t take more than six 50 mg tablets or
three 100 mg tablets (that’s 300 mg in total)
in 24 hours.
Taking too much Imigran Radis could make you
ill. If you have taken more than 300 mg in
24 hours:
➔ Contact your doctor for advice.
If you have any further questions about the use
of this medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, but not everybody gets them.
Some symptoms may be caused by the migraine
itself.
Allergic reaction: get doctor’s help straight
away
The following side effects have occurred but
their exact frequency is not known.
The signs of allergy include rash, hives (itchy
rash); wheezing; swollen eyelids, face or lips;
complete collapse.

If you get any of these symptoms soon after
using Imigran:
➔ Don’t use any more. Contact a doctor
straight away.

Common side effects
(affect up to 1 in 10 people)
Pain, heaviness, pressure or tightness in the
chest, throat or other parts of the body, or
unusual sensations, including numbness,
tingling and warmth or cold. 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 common side effects include:
Feeling sick (nausea) or being sick (vomiting),
although this may be due to the migraine
itself
Tiredness or drowsiness
Dizziness, feeling weak, or getting hot
flushes
Temporary increase in blood pressure
Shortness of breath
Aching muscles.

Very rare side effects
(affect up to 1 in 10,000 people)
Liver function changes. If you have a blood
test to check your liver function, tell your
doctor or nurse that you are taking Imigran
Radis.

Some patients may have the following side
effects but it is not known how often they
occur
Seizures/fits, tremors, muscle spasm, neck
stiffness
Visual disturbances such as flickering,
reduced vision, double vision, loss of vision,
and in some cases even permanent defects
(although these may be due to the migraine
attack itself)
Heart problems, where your heartbeat may
go faster, slower or change rhythm, chest
pains (angina) or heart attack
Pale, blue-tinged skin and/or pain in your
fingers, toes, ears, nose or jaw in response to
cold or stress (Raynaud’s phenomenon)
Feeling faint (blood pressure may go down)
Pain in the lower left side of the stomach
and bloody diarrhoea (ischaemic colitis)
Diarrhoea
Pain in the joints
Feeling anxious
Excessive sweating.
If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet.

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
shown on the carton. The expiry date refers to
the last day of that month.
Do not store above 30°C.
Don’t throw away any medicines via waste
water 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 Imigran Radis contains
The active substance is sumatriptan (50 mg
or 100 mg)
The other ingredients in the tablets are
calcium hydrogen phosphate, sodium
hydrogen carbonate, microcrystalline
cellulose, croscarmellose sodium, magnesium
stearate, hypromellose (E464), titanium
dioxide (E171) and glycerol triacetate. The
50 mg tablet also contains iron oxide, red
(E172).

Imigran Radis 100 mg tablets are white and
printed with ‘GS YE7’ on one side and ‘100’ on
the other. They are available in a blister pack
containing 6 tablets.

Other formats

Marketing authorisation holder and
manufacturer

0800 198 5000 (UK Only)

Product Licence held by GlaxoSmithKline UK
Ltd., Stockley Park West, Uxbridge, Middlesex
UB11 1BT
Manufactured by GlaxoSmithKline
Pharmaceuticals S.A., ul. Grunwaldzka 189,
60-322 Poznań, Poland
The information provided applies only to
Imigran Radis tablets.

To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:
Please be ready to give the following
information:
Product name
Imigran Radis 50 mg tablet
Imigran Radis 100 mg tablet
Reference number 19494/0013
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: July 2013
Imigran and Imigran Radis are registered
trademarks of the GlaxoSmithKline group of
companies
Radis is a trademark of the GlaxoSmithKline
group of companies
© 2013 GlaxoSmithKline group of companies.
All rights reserved

What Imigran Radis looks like and
contents of the pack
Imigran Radis 50 mg tablets are pink and
printed with ‘GS 1YM’ on one side and ‘50’ on
the other. They are available in a blister pack
containing 6 tablets.

V4

118233

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.

Hide
(web5)