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Imigran Injection

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Document: leaflet SET 1 - UNSPECIFIED_PLPI 10383-0352 change

IMIGRAN INJECTION

(sumatriptan succinate)

Patient Information Leaflet

Please read this information leaflet about Imigran Injection carefully before you stan using your injection It contains all the information you should need to know. If you have any further questions or are not sure about anything, ask your doctor or pharmacist.

Please keep this leaflet in a safe place, you may need to refer to it again.

Your medicine is called Imigran Injection. Each pre-filled syringe contains the active ingredient Sumatriptan succinate equivalent to 6mg sumatriptan base in 0.5ml isotonic solution.

Imigran Injection also contains the following: sodium chloride and water

Imigran Injection is available as either packs containing an auto-injector pen and a cartridge pacK containing two pre-filled injection syringes or as refill packs containing two pre-filled injection syringes.

Sumatriptan succinate belongs to a group of medicines known as 5-HT1 receptor agonists.

POM


PL No: 10383/0352

This product is manufactured by Glaxo SpA, Officma Consortile di San Polo di Torriie, Parma Italy and is procured from within the EU by the Product Licence holder:    ’ y

Primecrown Ltd. 28, Sarum Complex, Uxbridge, Middlesex UB8 2RZ

Why you need to use tnis medicine:

Imigran Injection is used in treatment of migraine attacks and a rare condition calleo cluster headaches

5 m'9raine may be due t0 swollen blood vessels around the brain. Imigran Injection probably works by reducing the size of these blood vessels.    U 1

Before you take your medicine:

Make sure it is safe for you to use Imigran Injection.

ChecK to see if any of the following apply to you, and consult your doctor before using the injection for the first time if the answer is YES to any of them:    J ' r lne

Are you allergic to Imigran or Sumatriptan or to any of the other contents of the injection?

Are you pregnant, or trying to become pregnant?

Are you breast feeding?

Do you suffer from any liver or kidney problems?

high blood pressure?11631^ diS6aSe SUCh 353* failure' Coronary thrombosis (hear‘ attacks) or angina or

Do you take any ergotamine-containing drugs? (If so, you should stop .akir.g them at least 24 hours before using imigran Injection).

lithium?00 y°U 3ny °ther drU9S' pariicularly those known as selective 5-HT reup.ake inhibitors or

v . Arey°u ,akln9' or have you taken within the last two weeks, any medicines known as monoamine oxioase innicitors <

Are you taking any medicines on a doctor's prescription for the treatment of depression c' to helo you lose weight or for epilepsy?    p

Do you have a family nistory of heart disease?

Are you allergic to medicines called sulphonamides?

Do you suffer from unexpected shortness of breath or from pain or tightness in the chest (which may or may net spread to your jaw or upper arms)?

Are you a woman who has stopped having periods altogether?

Are you a man over 40 years of age*?

Do you have sugar diabetes or a high blood cholesterol level?

Are you a regular cigarette smoker or are you very overweight?

Are you over 65 years of age?

Warnings:

1)    Imigran Injection should NOT be given intraveneously.

2)    No more than the recommended doses of Imigran Injection should be used.

3)    Drowsiness or tiredness may be caused by either the migraine or its treatment with imigran Injection and this may affect the ability to drive a car or operate machines.

4)    Take care to dispose of the used needles and syringes safely as these may still contain small amounts of medicine.

When to use your injection:

It is important to follow the doctor's instructions, and check the directions on the pharmacy label, which should tell you what dose to use and when to use the injection. If you are not sure about anything ask your doctor or pharmacist.

Read the section of this leaflet called 'How to use Imigran Injection' very carefully. The injection must ONLY be given in the way described in this leaflet. The injection must ONLY be given using the autoinjector pen. The auto-injector will give a dose of Imigran, subcutaneously (beneath the skin), quickly and painlessly.

The recommended adult dose is one single 6mg subcutaneous injection as soon as you feel a migraine attack coming on. If your migraine does not go DO NOT use a second injection for the same attack.

If your migraine goes and then comes back you can repeat the injection provided it is at least one hour since the first injection. Do not use more than 2 injections in 24 hours.

These injections are not for use in children or patients over 65 years of age.

Within an hour or two of having an injection most people find that 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 eraotamine Wait at least 6 hours after one injection before taking any medicines containing ergotamine.

How to use Imigran Injection

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Button

Cartridge

Button Ho'm

Cartridge Pack

Carry Case

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rose end


Description of parts

Locating

Buttons


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Learn the names of the parts in the picture above.

How to give an injection using the auto-injector pen:

Each Imigran Injection treatment pack comes complete with a cartridge pack which contains two pre-filled injection syringes. Read the following carefully before using the autoinjector pen.

DO NOT LOAD THE PEN UNTIL YOU ARE READY TO GIVE THE INJECTION.

1. Swing open the lid of the carry case ’. Tear off the tamper-evident seal from one of the syringes . Take out the auto-injector pen from the carry case. The tiring mechanism will be primed ready for use - the white

plunger rod should not be sticking out beyond the end of the



4, Push the auto-injector pen firmly into the cartridge pack and screw it clockwise (about half 3 turn) until it will twist no further.

5. Keeping your fingers off the blue release button, pull the loaded auto-injector pen straight out of the carry case. You may have to pull quite hard to do this. A safety catch stops accidental injection until you are ready.

6. The loaded pen is now ready for immediate use.

DO NOT try to put the loaded pen back into the carry case as this will damage the needle.

7. Press the nose end of the loaded auto-injector pen firmly onto a clean area of skin - usually the outside of the thigh (as in the picture) - so the grey part slides over the blue part. This releases the safety catch.

8. Now press the blue release button at the top of the autoinjector pen and count slowly to 10 keeping the pen very still DO NOT TAKE IT AWAY FROM THE SKIN TOO SOON OR SOME OF THE INJECTION MAY BE WASTED.

Then lift it off taking care to AVOID THE NEEDLE POINT.

9. Immediately return the used syringe to the cartridge pack -pushing the pen down into the empty space in the pack as far as it will go.

10. Then unscrew the auto-injector pen by twisting it anticlockwise (about half a turn) until the pen comes off the used syringe.

11. Withdraw the auto-injector pen from the cartridge pack. Close the lid of the pack over the used syringe.


12. Put the pen back into its place in the carry case and push it down until it stays down. It will click into place. The autoinjector pen is then primed ready for use next time.

13. Close the lid on the carry case until you need to use the next syringe. When you have used both syringes, remove and replace the cartridge pack.

How to remove the used cartridge pack:

1. When both syringes have been used, the cartridge pack may be removed for disposal.


2. Hold the carry case and press the blue locating buttons with one hand.


3. Gently pull out the cartridge pack with the other hand.


4. Be careful to dispose of your empty cartridge packs safely The cartridge pack will hold the used auto-injector syringes and needles until you can safely dispose of them. You should be able to do this at your doctor’s surgery - so ask your doctor or practice nurse.


How to put a new cartridge pack into the carry case:

1. Swing open the lid of the carry case, the auto-injector pen is already in its place.


2. Push the cartridge pack into the carry case, pressing the blue buttons on either side so it slides in smoothly.



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4.    The cartridge pack is in the correct position when the blue locating outtons show through the holes on either side of the carry case.

5.    Close the carry case by swinging back the lid and snapping it shut.

6.    NO HARM WILL COME TO THE CARTRIDGE PACK WHEN IT IS KEPT LIKE THIS IN THE CARRY CASE.

What to do if an overdose is taken:

It is important to keep to the dose on the label. Using more than this could make you ill. Consult your doctor or go to the nearest hospital casualty department immediately if too many injections are used. Take Imigran Injection or this leaflet with you so that the doctor knows what medicine you have used.

Side Effects:

As with all medicines Imigran Injection can cause unwanted side-effects in some patients.

If you experience any of the following you should see your doctor IMMEDIATELY.

-Sudden wheeziness, fluttering, or tightness in the chest -Swelling of eyelids face or lips,

-Skin rash - red spots or hives (skin lumps)    „

If you notice any of these side-effects you may be allergic to the medicine. DO NOT use any more injections unless your doctor tells you to do so.

A few people may notice the following side-effects:    .....

-Tingling feelings, warmth, heaviness, pressure, tightness or sometimes pain in oirrerent parts or 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 as there have been rare reports of such problems being caused by a heart attack. DO NOT uss any more injections: your doctor will decide if you should stop using them.

Other side-effects reported include tiredness or sleepiness (IMPORTANT if you are driving or working a

machine).    ,    ,

-Flushing (redness of the face lasting a few minutes), dizziness, feelings or weakness.

-Sometimes sickness and nausea (when not part of a migraine attack). These are not usually very troublesome and pass off with time. There is no need to stop treatment unless you fino them too unpleasant. Sometimes the injection may sting but this should soon go away.

You should also see your doctor if you feel any other unusual or unexpected side effects not mentioned above He or she will have more information about Imigran Injection and will tell you what to do.

If you do not get satisfactory relief of your migraine by taking Imigran Injection tell your doctor at your next visit.

Expiry Date:

Do not use after the expiry date printed on the carton or syringe cartridge pack label.

Storage:

Imigran Injection should be stored in the case provided below 30°C and protected from light. If the injections are kept warmer than this for more than 24 hours it could spoil them.

KEEP OUT OF REACH OF CHILDREN    . . .    .

If your doctor tells you to stop using the injections, please take them back to the pha..r.acist tor sate disposal. Only keep the injections if your doctor tells you to. It the injections show any signs of deterioration, seek the advice of your pharmacist who will tell you what to do. Always dispose of your empty syringes and needles safely. The cartridge pack will hold them until you are abie to re«wn them to your doctor's surgery or practice nurse.

IMPORTANT:

This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to a;-,one else, it may harm them even if tneir symptoms are the same as yours.

This leaflet does not contain complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist who has access to additional information.

Leaflet revision and issue date (Ref) 17.1.97