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IMIGRAN RADIS 100MG FILM-COATED TABLETS

Active substance(s): SUMATRIPTAN

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Ref: 1084/100816/1/F

Imigran® Radis 100mg film-coated Tablets
(sumatriptan succinate)
Patient Information 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.
Your medicine is called Imigran Radis 100mg film-coated Tablets but will be
referred to as Imigran Radis throughout this leaflet. Please note that the
leaflet aslo contains information about other strengths of the
medicine Imigran Radis 50mg

What is in this leaflet:
1

What Imigran Radis is and what it is used for

2 What you need to know before you use Imigran radis Radis
3 How to use Imigran Radis
4 Possible side effects
5 How to store Imigran Radis

If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Imigran Radis. 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 Radis.
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 Radis. Also see
Other medicines and Imigran radis, below.
If you use Imigran Radis frequently
Using Imigran Radis too often may make your headaches worse.
➔ Tell your doctor if this applies to you. He or she may recommend
you stop using Imigran Radis.
If you feel pain or tightness in your chest after you use Imigran Radis
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 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 radis
Radis 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 radis.
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 radis Radis, 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 Radis is prescribed for you.

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 Radis and others may
cause adverse effects if they’re taken with Imigran Radis. 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 radis at the same time as these medicines. Stop taking these
medicines at least 24 hours before using Imigran Radis. Don’t take any
medicines which contain ergotamine or compounds similar to ergotamine
again for at least 6 hours after using Imigran radis.
* 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 Radis at the same time as these medicines.
Stop taking these medicines at least 24 hours before using Imigran Radis.
Don’t take another triptan/5-HT1 receptor agonist again for at least 24
hours after using Imigran Radis.
* MAOIs used to treat depression. Don’t use Imigran Radis if you have
taken these in the last 2 weeks
* SSRIs and SNRIs used to treat depression.
Using Imigran Radis 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 Radis 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 Radis 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 Radis while you are pregnant
* Don’t breast-feed your baby for 12 hours after using Imigran Radis.
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.

3

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

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 had high blood pressure Imigran Radis may not be suitable
for you
➔ Tell your doctor or pharmacist before using Imigran Radis.
If you have liver or kidney disease
If either of these apply to you:
➔ Tell your doctor or pharmacist before using Imigran Radis.

How to use Imigran Radis

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.
Elderly (aged over 65)
* Imigran Radis is not recommended for people aged over 65.

Ref: 1084/100816/1/B

Imigran® Radis 100mg film-coated Tablets
(sumatriptan succinate)
Patient Information Leaflet (continued)
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.
If the first tablet has no effect
* Don’t take a second tablet or any other Imigran Radis preparation for the
same attack. Imigran Radis 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 Radis than you should
* Don’t take more than six 50 mg tablets or three 100 mg tablets
(that’s 300 mg in total) in any 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.

5

How to store Imigran Radis

Do not use this medicine after the expiry date shown on the carton label or
blister. Only keep this medicine if your doctor tells you to. If your medicine
becomes discoloured or shows any other signs of deterioration, consult your
pharmacist (chemist) who will tell you what to do. You should return any left
over medicine to your pharmacist.
Medicines should not be disposed of via waste water or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.

6

Contents of the pack and other information

What Imigran Radis contains
Each film-coated dispersible tablet contains 100mg of sumatriptan (as the
succinate).
Your medicine also contains the following inactive ingredients:
croscarmellose sodium, titanium dioxide E171, triacetin, calcium hydrogen
phosphate anhydrous, microcrystalline cellulose, sodium hydrogen
carbonate, magnesium stearate, hypromellose.
What Imigran Radis looks like and contents of the pack
Imigran Radis are white, film-coated, triangular shaped, biconvex tablets
debossed with 'GS YE7' on one face and '100' on the other.
They are available in aluminium blister packs of 6 or 12 tablets.

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 Radis:
➔ 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.

Product licence Holder and Manufacturer
The tablets are manufactured by GlaxoSmithKline Pharmaceuticals S.A., ul
Grunwaldzka 189, 60-322 Poznan, Poland and are procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
The information provided applies only to Imigran Radis tablets

POM

PL 15184/1084 Imigran Radis 100mg film-coated Tablets

Imigran Radis is a registered trademark of GlaxoSmithKline group of
companies.
Revision date: 11/08/16

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.
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.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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.

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