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IMIGRAN RADIS 100 MG TABLETS

Active substance(s): SUMATRIPTAN SUCCINATE

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®

Imigran Radis 100 mg Tablets

2282
16.07.15[8]

(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.
Your medicine will be referred to as Imigran Radis throughout this leaflet.
Imigran Radis is also available in other strength.
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
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.
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.
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.

- 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.
5. HOW TO STORE IMIGRAN RADIS
Keep out of the sight and reach of children.
Do not use Imigran Radis 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.
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.
If your tablets become discoloured or any other signs of deterioration please
contact your doctor or pharmacist before taking this medicine.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Imigran Radis contains
- The active substance is sumatriptan 100 mg.
Each film-coated tablet contains 100 mg sumatriptan (as the succinate).
- The other ingredients in the tablets are calcium hydrogen phosphate,
sodium hydrogen carbonate, microcrystalline cellulose, croscarmellose
sodium, magnesium stearate, hypromellose (E464), titanium dioxide
(E 171) and glycerol triacetate.
What Imigran Radis looks like and contents of the pack
Imigran Radis are white, triangular shaped, biconvex tablets debossed with
'GS YE7' on one face and '100' on the other. Imigran Radis tablets are
available in pack sizes of 6 and 18 tablets.
Manufacturer and Product Licence Holder
Manufactured by Glaxo Operations UK Ltd, Ware, Hertfordshire SG12 0DJ
UK and is procured from within in the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2282

Leaflet revision and issue date (Ref) 16.07.15[8]
Imigran Radis is a trademark of the Glaxo Group Ltd.

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

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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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