<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">

<BLOCK>

<EMPH weight="bold">
Patient Information Leaflet
</EMPH>
 <PB n=1> <CB n=1> <FIGURE></FIGURE> 
<EMPH weight="bold">
injection for migraine
</EMPH>
 What you should know about Imigran injection
</BLOCK>


<BLOCK>
Please read this carefully before starting to use your medicine.
</BLOCK>

<DIV type=0>

<HEAD ltag="bullet" >
What your injection does
</HEAD>




<BLOCK>
Imigran injection contains sumatriptan, the first of a new group of medicines developed for the treatment of migraine and a rare condition called cluster headache.
</BLOCK>


<BLOCK>
The symptoms of migraine may be due to swollen blood vessels around the brain. Medicines like Imigran probably work by reducing the size of these blood vessels and are called 5HT1 agonists.
</BLOCK>

<DIV type=1>

<HEAD weight="bold" >
IF YOU ARE NOT SURE WHY THIS HAS BEEN PRESCRIBED FOR YOU ASK YOUR DOCTOR
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>

<EMPH weight="bold">
Before using your injection
</EMPH>

</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Have you been told you are allergic to Imigran or sumatriptan?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you suffer from unexpected shortness of breath or from pain or tightness in the chest (which may o; may not spread to your jaw or upper arms)? If so please inform your doctor of these symptoms before using your injection
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Have you been told you have any of the following medical conditions:
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
heart disease such as - heart failure angina coronary thrombosis (heart attack) high blood pressure disease of the liver or kidneys?
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Are you taking any medicines for your migraine which contain ergotamine? (If so, you should stop taking them at least 24 hours before using Imigran injection).
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you taking any medicines on a doctor's prescription for the treatment of depression or to help you lose weight?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you pregnant, or likely to become pregnant or breast feeding? (See also back of this leaflet)
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you over 65 years of age?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Do you have a family history of heart disease?
</BLOCK>

</ITEM>

</LIST>



</DIV>
<DIV type=1>

<HEAD weight="bold" >
IF THE ANSWER TO ANY OF THESE QUESTIONS IS YES
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Did you tell your doctor at the last visit or an earlier visit?
</BLOCK>

</ITEM>

</LIST>



<BLOCK>

<EMPH weight="bold">
IF YOU DID NOT TELL YOUR DOCTOR THEN YOU
</EMPH>
 SHOULD DO SO AS SOON AS POSSIBLE AND BEFORE USING YOUR INJECTIONS
</BLOCK>


<BLOCK>
You should also talk to your doctor before using these injections if you have been told you have sugar diabetes, or a high blood cholesterol or if you are a regular cigarette smoker or if you are very overweight.
</BLOCK>

<DIV type=2>

<HEAD>
Your doctor will advise you about using the medicine
</HEAD>


<DIV type=3>

<HEAD ltag="bullet" >
Look at the label
</HEAD>




</DIV>

</DIV>
<DIV type=2>

<HEAD>
It should say WHO should use it, WHAT DOSE and
</HEAD>


<BLOCK>
WHEN If it does not or you are not sure, ask your doctor or pharmacist or follow this advice:
</BLOCK>


<BLOCK>
Carefully read the notes with the Imigran SUBJECT injection system on how to use it. Only use the SUBJECT Pen in this way. The Imigran SUBJECT injection system will inject a dose of Imigran just below the skin quickly and without pain. The injection must 
<EMPH weight="bold">
NOT
</EMPH>
 be given in any other way than with the SUBJECT Pen.
</BLOCK>


<BLOCK>
Use one injection as soon as you feel a migraine coming on If your migraine does not go, 
<EMPH weight="bold">
DO NOT
</EMPH>
 use a second one for the same attack.
</BLOCK>


<BLOCK>
If your migraine goes, then comes back, you can repeat the injection provided it is at least an hour since the first injection
</BLOCK>


<BLOCK>

<EMPH weight="bold">
DO NOT
</EMPH>
 use more than two injections in 24 hours.
</BLOCK>


<BLOCK>
Because there is little experience of its use in children or those over 65 years of age it is not usually prescribed for these age groups
</BLOCK>

<DIV type=3>

<HEAD ltag="bullet" >
After starting to use your injection
</HEAD>




<BLOCK>
Within an hour or two of having an injection most people find their migraine is much better If the injection does not ease your migraine, you may then take your usual 'pain killers,' provided they do not contain ergotamine. Wait at least six hours after one injection before taking any medicines containing ergotamine.
</BLOCK>


<BLOCK>
Most people find using this medicine causes no problems. As with most medicines, a few people may find they have side-effects to it See the back of this leaflet for more information
</BLOCK>


</DIV>
<DIV type=3>

<HEAD ltag="bullet" >
Where to keep the injections
</HEAD>




<BLOCK>
You may wish to carry the Imigran SUBJECT carry case and injections with you in case of a migraine attack.
</BLOCK>


<BLOCK>
Keep your injections away from heat and out of the light which could spoil them.
</BLOCK>


<BLOCK>
Always keep your injections in the case provided and at a temperature below 30°C/86°F If they are kept warmer than this for more than 24 hours it could spoil them As with all medicines, keep them safely away from children. A child may be harmed by medicine prescribed for someone else
</BLOCK>


<BLOCK>
Read the notes with the Imigran SUBJECT injection system on what to do with the cartridges containing the used syringes and needles Take care to follow this advice.
</BLOCK>


<BLOCK>

<EMPH  weight="bold"  uline="plain">
YOU WILL FIND OUT MORE ABOUT YOUR INJECTION ON THE BACK OF THIS LEAFLET
</EMPH>
 More information on IMIGRAN INJECTION
</BLOCK>


</DIV>
<DIV type=3>

<HEAD ltag="bullet" >
What your injection contains
</HEAD>




<BLOCK>
Each pre-filled cartridge syringe contains:
</BLOCK>


</DIV>

</DIV>
<DIV type=2>

<HEAD>
The active ingredient -sumatriptan 6mg (as the succinate) in 0.5ml of sterile sodium chloride solution
</HEAD>

<DIV type=3>

<HEAD ltag="bullet" >
Side-effects
</HEAD>




<BLOCK>
Along with its needed effects, a medicine may cause unwanted effects. Most people using this medicine find it causes no problems.
</BLOCK>


<BLOCK>
Check with your doctor immediately if any of the following side-effects occur:
</BLOCK>


<BLOCK>

<EMPH weight="bold">
Rare
</EMPH>
 Sudden wheeziness, fluttering or tightness in the chest Swelling of eyelids, face or lips Skin rash - red spots or hives (skin lumps)
</BLOCK>


<BLOCK>
If you notice any of these side-effects it may be that you are allergic to the medicine.
</BLOCK>


<BLOCK>
Do 
<EMPH weight="bold">
not
</EMPH>
 use any more injections unless your doctor tells you to do so.
</BLOCK>


<BLOCK>
A few people may notice the following side-effects:
</BLOCK>


</DIV>

</DIV>

</DIV>
<DIV type=1>

<HEAD weight="bold" >
Uncommon
</HEAD>


<BLOCK>
Feelings of tingling, warmth, heaviness, pressure, tightness or sometimes pain in different parts of the body, including the chest and throat; although sometimes very strong they usually pass off in a few minutes. If they continue or are particularly severe (especially chest pain) tell your doctor immediately. Do 
<EMPH weight="bold">
NOT
</EMPH>
 use any more injections; your doctor will decide if you should stop using them.
</BLOCK>


<BLOCK>
Also;
</BLOCK>


<BLOCK>
Tiredness or sleepiness (
<EMPH weight="bold">
IMPORTANT
</EMPH>
 if you are driving or working a machine) Dizziness Flushing (redness of face lasting a few minutes) Feelings of weakness Feeling sick (nausea) or being sick (vomiting)-when not part of migraine attack
</BLOCK>


<BLOCK>
These are not usually very troublesome and pass off with time. There is no need to stop treatment unless you find them too unpleasant.
</BLOCK>


<BLOCK>
Sometimes the injections may sting but this soon goes away.
</BLOCK>


<BLOCK>
If you feel unwell or have any other unusual discomfort you don't understand, it is important to tell your doctor as soon as possible.
</BLOCK>


<LIST type="bulleted">

<ITEM>

<BLOCK>

<EMPH weight="bold">
What to do if too many injections are given
</EMPH>
 It is important to keep to the dose on the label. Using more than this could make you ill. If an overdose is given, 
<EMPH weight="bold">
DO NOT DELAY
</EMPH>
, ask your doctor what to do or contact your nearest hospital emergency department.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>

<EMPH weight="bold">
Pregnancy and breast feeding
</EMPH>

</BLOCK>

</ITEM>

</LIST>



<BLOCK>
As with most medicines it is better not to use Imigran injection if you are pregnant, especially during the first few months of the pregnancy Your doctor will advise you.
</BLOCK>


<BLOCK>
The sumatriptan in Imigran injection may pass into mothers' milk. It is better, therefore, that breast feeding mothers do 
<EMPH  weight="bold"  uline="plain">
NOT
</EMPH>
 use this injection.
</BLOCK>

<DIV type=2>

<HEAD ltag="bullet" >
If you do not feel better
</HEAD>




<BLOCK>
If you do not get satisfactory relief of your migraine by using Imigran injection then tell your doctor at your next visit.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD ltag="bullet" >
What to do with any unused injections
</HEAD>




<BLOCK>
If your doctor stops your treatment do not keep any left-over injections unless your doctor tells you to. Return any injections to your pharmacist for safe disposal.
</BLOCK>


<BLOCK>
Do not use Imigran injection after the expiry date printed on the pack but return it to your pharmacist.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD ltag="bullet" >
Remember
</HEAD>




<BLOCK>
These injections are for YOU. Only a doctor can prescribe them for you. Never let someone else use them. There may be reasons why they could harm that person.
</BLOCK>


</DIV>
<DIV type=2>

<HEAD ltag="bullet" >
Further information
</HEAD>




<BLOCK>
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 has the information you need and will advise you. 
</BLOCK>


<BLOCK>
Pharmaceutical Companies are not allowed to answer questions from patients about their diseases.
</BLOCK>


<BLOCK>
There are two national organisations which offer both help and advice on migraine:
</BLOCK>


<BLOCK>
The British Migraine Association 178a High Road Byfleet Weybridge Surrey KT14 7ED Telephone: 0932-352468 The Migraine Trust 45 Gt. Ormond Street London WC1N 3HD Telephone: 071-278 2676
</BLOCK>


<BLOCK>
You may well be able to find out more about prescribed medicines from books in public libraries.
</BLOCK>


<BLOCK>

<EMPH  weight="bold"  uline="plain">
YOU MAY WANT TO READ THIS LEAFLET AGAIN.
</EMPH>

</BLOCK>


<BLOCK>

<EMPH  weight="bold"  uline="plain">
PLEASE DO NOT THROW IT AWAY UNTIL YOU HAVE FINISHED YOUR MEDICINE.
</EMPH>

</BLOCK>


<BLOCK>

<EMPH weight="bold">
This leaflet has been produced in accordance with guidance issued by the Association of the British Pharmaceutical Industry. The information provided applies only to IMIGRAN INJECTION.
</EMPH>

</BLOCK>


<BLOCK>
Product Licence held by Glaxo Pharmaceuticals UK Limited Stockley Park, England Manufactured by Glaxo Pharmaceuticals UK Limited Speke, Liverpool, England
</BLOCK>


<BLOCK>
IMIGRAN, IMIGRAN logo, SUBJECT and SUBJECT logo are trade marks owned by the Glaxo Group of Companies.
</BLOCK>

<DIV type=3>

<HEAD>
Leaflet written October 1993   
</HEAD>


<PB n=2>


<CB n=2>


<FIGURE></FIGURE>


<BLOCK>

<EMPH weight="bold">
Glaxo Laboratories Limited
</EMPH>
 Stockley Park West Uxbridge, Middlesex UB11 1BT
</BLOCK>

</DIV>

</DIV>

</DIV>

</DIV>

</DOCUMENT>
