IMIGRAN INJECTION
Active substance: SUMATRIPTAN SUCCINATE
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Transcript
Pharmacode Ref No is: 7239
10000000079332
Dont use Imigran Subject:
2 Before you use Imigran Subject
Take special care with Imigran Subject
Your doctor needs to know certain information before you use 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 youll have a fit for example, a head injury or alcoholism. 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.
Package Leaflet: Information for the User
sumatriptan solution for injection in pre-filled cartridges
.
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist (chemist). This medicine has been prescribed for you. Do not pass it on to others - it may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet 1 What Imigran Subject is and what it is used for 2 Before you use Imigran Subject 3 How to use Imigran Subject 4 Possible side effects 5 How to store Imigran Subject 6 Further information 7 Step-by-step guide to using your Imigran Subject injection system
1 What Imigran Subject is and what it is used for
Each Imigran Subject pre-filled cartridge syringe contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists). Imigran Subject is used to treat migraine headache and a rare condition called cluster headache. Migraine and cluster headache symptoms may be caused by the temporary widening of blood vessels in the head. Imigran Subject is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.
If youre allergic (hypersensitive) to sumatriptan, or any of the other ingredients (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 sertraline SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine or duloxetine For children under 18 years of age. If any of these apply to you: Tell your doctor, and dont use Imigran Subject.
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 dont pass quickly, or they become severe: Get medical help immediately. Section 4 (below) has more information about these possible side effects.
MAOIs used to treat depression. Dont 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 Johns Wort (Hypericum perforatum). Taking herbal remedies containing St Johns Wort while using Imigran may make side effects more likely. If you are pregnant or could be pregnant, talk to your doctor before you use Imigran. 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 Dont breast-feed your baby for 12 hours after using Imigran. If you express any breast milk during this time, discard the milk and dont give it to your baby.
Pregnancy and breast-feeding
Other medicines and Imigran
Tell your doctor if youre taking any other medicines or have recently taken any. This includes any herbal products, dietary supplements such as vitamins, iron or calcium or medicines youve bought without a prescription. Some medicines must not be taken with Imigran and others may cause adverse effects if theyre taken with Imigran. You must tell your doctor if you are taking: ergotamine also used to treat migraine, or similar medicines such as methysergide maleate; or any triptan or 5-HT1 agonist (such as naratriptan or zolmitriptan). Dont use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Dont take them again for at least 6 hours after using Imigran
Driving and using machines
Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, dont drive or operate machinery.
3 How to use Imigran Subject
Always use Imigran Subject exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Imigran Subject is usually injected into the thigh. Theres a step-by-step guide to using the syringe at the end of this leaflet (see Section 7 overleaf).
If you use more Imigran than you should
When to use Imigran
Dont use more than two Imigran injections in 24 hours. Using too much Imigran could make you ill. If you have used more than two injections in 24 hours: Contact your doctor for advice. If you have further questions about the use of this product, ask your doctor or pharmacist.
Other common side effects include:
If you get side effects
If you notice any unwanted effects, even ones not listed in this leaflet, or if any of the effects becomes troublesome: Tell your doctor or pharmacist.
Marketing authorisation holder and manufacturer
Product Licence held by Glaxo Wellcome UK Ltd., trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufactured by Glaxo Operations UK Ltd., Harmire Road, Barnard Castle, County Durham DL12 8DT The information provided applies only to Imigran Subject. If you need more help or advice on migraine please contact the following national organisations: Migraine Action Association Unit 6 Oakley Hay Lodge Business Park Great Folds Road Great Oakley Northants NN18 9AS Telephone: 01536 461333 The Migraine Trust 55-56 Russell Square London WC1B 4HP Telephone: 020 7463 1336 The following national organisation offers help and advice on cluster headaches: Organisation for the Understanding of Cluster Headaches
(OUCH UK)
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
Its best to use Imigran as soon as you feel a migraine or a cluster headache coming on, although you can use it at any time during an attack Dont use Imigran to try to prevent an attack only use it after your migraine symptoms start.
4
Possible side effects
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.
0800 198 5000 (UK Only)
Please be ready to give the following information: Product name Imigran Subject Reference number 10949/0113 This is a service provided by the Royal National Institute of Blind People. Leaflet date: January 2010 Imigran, Imigran Subject and the Imigran logo are registered trademarks of the GlaxoSmithKline group of companies The Subject logo is a trademark of the GlaxoSmithKline group of companies 2010 GlaxoSmithKline group of companies
5 How to store Imigran Subject
Keep out of the reach and sight of children. You may wish to carry Imigran Subject with you in case of a migraine attack Always keep your injections in the case provided to protect them from the light. Do not store above 30C Dont use Imigran injection after the expiry date shown on the carton. The expiry date refers to the last day of that month. Ask your doctor, practice nurse or pharmacist how to dispose of your empty Cartridge Packs safely. You may be able to do this at your doctors surgery.
How much to use
Adults aged 18 to 65 The usual dose for adults aged 18 to 65 with migraine or a cluster headache is one 6 mg injection. Children under 18 Imigran is not recommended for children under 18 years old. Older people (aged over 65) Imigran is not recommended for people aged over 65.
Like all medicines, Imigran Subject can cause side effects, but not everybody gets them. Allergic reaction: get doctors 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: Dont use any more. Contact a doctor straight away.
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 using Imigran. 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 (Raynauds 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.
Very common side effects
6 Further information
What Imigran Subject contains
If your symptoms start to come back
You can use a second Imigran injection if at least 1 hour has passed since the first injection, but dont use more than two injections in 24 hours.
(affect more than 1 in 10 people) Temporary pain at the site of injection Stinging or burning, redness, swelling, bruising and bleeding at the site of injection.
The active substance is sumatriptan (6 mg) The other ingredient is 0.5 ml sterile sodium chloride solution.
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.
What Imigran Subject looks like and contents of the pack
Each Imigran injection treatment pack comes complete with an injection device (Pen) and a Cartridge Pack which contains two pre-filled syringes. Imigran injection is also available as refill packs, which contain one cartridge of 2 pre-filled syringes.
If the first injection has no effect
Dont use a new injection or any other Imigran preparation for the same attack. If Imigran doesnt give you any relief: Ask your doctor or pharmacist for advice.
Pyramid House 956 High Road London N12 9RX Telephone: 01646 651979 You may be able to find out more about prescribed medicines from books in public libraries. TEXT FREE AREA
7 Step-by-step guide to using your Imigran Subject injection system
This leaflet shows you how to load the Subject Pen and how to use it to give a dose of Imigran medicine. Please read this leaflet before using the injection system. The GlaxoSmithKline Subject injection system is designed for use with a medicine called Imigran. Each Subject injection system comes complete with an Imigran Cartridge Pack. The Cartridge pack contains two pre-filled cartridge syringes. Subject refill packs containing one Imigran Subject Cartridge are also available. Important: In the unlikely event that you have a problem with the Imigran Subject injection mechanism, please: Return it to your pharmacist who will replace it; or Contact GlaxoSmithKline Customer Contact Centre on Freephone 0800 221441 and they will tell you how to return it. Keep out of the reach and sight of children
How to give an injection using the Subject Pen
4
1 2
Read the leaflet fully and carefully before using the Subject Pen Each Imigran Subject injection system comes complete with a Cartridge Pack which contains two cartridge syringes pre-filled with Imigran Use the photo on the left to help you identify the different parts of the injection system Do not load the Pen until you are ready to give the injection. Swing open the Lid of the Carrycase. Tear off the red Seal from one of the cartridges. Open the blue hinged lid underneath the Seal.
Push the Subject Pen firmly into the opened Cartridge Pack and gently screw it clockwise (about half a turn) until it will twist no further.
7
Press the Pen with the long blue Nose End firmly against a clean area of skin usually the outside of the thigh (as in picture) so the grey part slides down to cover part of the blue nose. This releases the safety catch. Hold the Pen firmly and press the blue Release Button at the top of the Subject Pen. Count slowly to 10 keeping the Subject Pen very still and the Release Button depressed. Do not take the Pen away from the skin too soon or some of the injection may be wasted. Then lift the Pen away taking care not to touch the needle point.
8 5
Keeping your finger away from the blue Release Button, pull the Subject Pen out of the Cartridge Pack. You may have to pull quite hard to do this. A safety catch stops accidental injection before you are ready.
TEXT FREE AREA
Description of parts
Cartridge Button Holes Seal Cartridge Pack Locating Buttons
Lid Release Button Subject Pen Carrycase Nose End White Rod (inside Nose End)
3
Take out the Subject Pen from the Carrycase. Check that the White Rod is not sticking out beyond the end of the Pen (see picture11). If it is sticking out, place the Pen back inside the Carrycase, push firmly and the Rod should click into place. The Pen is now ready for use.
6
The loaded Pen is now ready for immediate use. Do not try to put the loaded Pen back into the Carrycase until after you have used the injection, or the needle may be damaged and the Pen will not inject correctly.
7 Step-by-step guide to using your Imigran Subject injection system (continued)
9
Return the used cartridge syringe to the empty space in the Cartridge Pack straight away.
11
Withdraw the Subject Pen from the Cartridge Pack. Close the blue hinged lid over the used syringe.
How to remove the used Cartridge Pack
How to put a new Cartridge Pack into the Carrycase
Each Subject Pen comes complete with an Imigran Cartridge Pack which contains two pre-filled cartridge syringes. 1 Swing open the Lid of the Carrycase, the Subject Pen is already in its place.
1 2
When both syringes have been used, you can remove the Cartridge Pack. Hold the Carrycase and press the two blue Locating Buttons with one hand.
2 3
Push the Cartridge Pack into the Carrycase, pressing the blue buttons on either side so it slides in smoothly. It does not matter which side of the Cartridge Pack is closest to the Subject Pen.
10
Pushing the Pen down into the Cartridge Pack as far as it will go, unscrew the Pen by twisting it anti-clockwise (about half a turn) until it comes away.
12
13
Put the Subject Pen back into the Carrycase and push it down until it stays down. It will click into place. The Subject Pen is then ready for use next time. Close the Lid of the Carrycase until you need to use the next cartridge syringe. When you have used both cartridges, remove and replace the Cartridge Pack. (See right.)
3 4
Gently pull out the Cartridge Pack with the other hand. Be careful to dispose of your empty Cartridge Packs safely. The Cartridge Pack will hold the used Subject cartridge syringes and needles until you can safely dispose of them. You should be able to do this at your doctors surgery, so ask your doctor or practice nurse.
4
The Cartridge Pack is in the right position when the blue Locating Buttons show through the holes on either side of the Carrycase. Close the Carrycase by swinging back the Lid and snapping it shut. You can keep your Cartridge Pack safely in the Carrycase until you need to give yourself an injection.
5 6
7
Keep your Carrycase and any refill Cartridge Packs at a temperature below 30C/86F. If they are kept warmer than this for more than 24 hours it could spoil them.
10000000079332
Pharmacode Ref No is: 7239
10000000079332
Dont use Imigran Subject:
2 Before you use Imigran Subject
Take special care with Imigran Subject
Your doctor needs to know certain information before you use 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 youll have a fit for example, a head injury or alcoholism. 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.
Package Leaflet: Information for the User
sumatriptan solution for injection in pre-filled cartridges
.
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist (chemist). This medicine has been prescribed for you. Do not pass it on to others - it may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet 1 What Imigran Subject is and what it is used for 2 Before you use Imigran Subject 3 How to use Imigran Subject 4 Possible side effects 5 How to store Imigran Subject 6 Further information 7 Step-by-step guide to using your Imigran Subject injection system
1 What Imigran Subject is and what it is used for
Each Imigran Subject pre-filled cartridge syringe contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists). Imigran Subject is used to treat migraine headache and a rare condition called cluster headache. Migraine and cluster headache symptoms may be caused by the temporary widening of blood vessels in the head. Imigran Subject is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.
If youre allergic (hypersensitive) to sumatriptan, or any of the other ingredients (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 sertraline SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine or duloxetine For children under 18 years of age. If any of these apply to you: Tell your doctor, and dont use Imigran Subject.
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 dont pass quickly, or they become severe: Get medical help immediately. Section 4 (below) has more information about these possible side effects.
MAOIs used to treat depression. Dont 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 Johns Wort (Hypericum perforatum). Taking herbal remedies containing St Johns Wort while using Imigran may make side effects more likely. If you are pregnant or could be pregnant, talk to your doctor before you use Imigran. 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 Dont breast-feed your baby for 12 hours after using Imigran. If you express any breast milk during this time, discard the milk and dont give it to your baby.
Pregnancy and breast-feeding
Other medicines and Imigran
Tell your doctor if youre taking any other medicines or have recently taken any. This includes any herbal products, dietary supplements such as vitamins, iron or calcium or medicines youve bought without a prescription. Some medicines must not be taken with Imigran and others may cause adverse effects if theyre taken with Imigran. You must tell your doctor if you are taking: ergotamine also used to treat migraine, or similar medicines such as methysergide maleate; or any triptan or 5-HT1 agonist (such as naratriptan or zolmitriptan). Dont use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Dont take them again for at least 6 hours after using Imigran
Driving and using machines
Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, dont drive or operate machinery.
3 How to use Imigran Subject
Always use Imigran Subject exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Imigran Subject is usually injected into the thigh. Theres a step-by-step guide to using the syringe at the end of this leaflet (see Section 7 overleaf).
If you use more Imigran than you should
When to use Imigran
Dont use more than two Imigran injections in 24 hours. Using too much Imigran could make you ill. If you have used more than two injections in 24 hours: Contact your doctor for advice. If you have further questions about the use of this product, ask your doctor or pharmacist.
Other common side effects include:
If you get side effects
If you notice any unwanted effects, even ones not listed in this leaflet, or if any of the effects becomes troublesome: Tell your doctor or pharmacist.
Marketing authorisation holder and manufacturer
Product Licence held by Glaxo Wellcome UK Ltd., trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT Manufactured by Glaxo Operations UK Ltd., Harmire Road, Barnard Castle, County Durham DL12 8DT The information provided applies only to Imigran Subject. If you need more help or advice on migraine please contact the following national organisations: Migraine Action Association Unit 6 Oakley Hay Lodge Business Park Great Folds Road Great Oakley Northants NN18 9AS Telephone: 01536 461333 The Migraine Trust 55-56 Russell Square London WC1B 4HP Telephone: 020 7463 1336 The following national organisation offers help and advice on cluster headaches: Organisation for the Understanding of Cluster Headaches
(OUCH UK)
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
Its best to use Imigran as soon as you feel a migraine or a cluster headache coming on, although you can use it at any time during an attack Dont use Imigran to try to prevent an attack only use it after your migraine symptoms start.
4
Possible side effects
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.
0800 198 5000 (UK Only)
Please be ready to give the following information: Product name Imigran Subject Reference number 10949/0113 This is a service provided by the Royal National Institute of Blind People. Leaflet date: January 2010 Imigran, Imigran Subject and the Imigran logo are registered trademarks of the GlaxoSmithKline group of companies The Subject logo is a trademark of the GlaxoSmithKline group of companies 2010 GlaxoSmithKline group of companies
5 How to store Imigran Subject
Keep out of the reach and sight of children. You may wish to carry Imigran Subject with you in case of a migraine attack Always keep your injections in the case provided to protect them from the light. Do not store above 30C Dont use Imigran injection after the expiry date shown on the carton. The expiry date refers to the last day of that month. Ask your doctor, practice nurse or pharmacist how to dispose of your empty Cartridge Packs safely. You may be able to do this at your doctors surgery.
How much to use
Adults aged 18 to 65 The usual dose for adults aged 18 to 65 with migraine or a cluster headache is one 6 mg injection. Children under 18 Imigran is not recommended for children under 18 years old. Older people (aged over 65) Imigran is not recommended for people aged over 65.
Like all medicines, Imigran Subject can cause side effects, but not everybody gets them. Allergic reaction: get doctors 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: Dont use any more. Contact a doctor straight away.
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 using Imigran. 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 (Raynauds 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.
Very common side effects
6 Further information
What Imigran Subject contains
If your symptoms start to come back
You can use a second Imigran injection if at least 1 hour has passed since the first injection, but dont use more than two injections in 24 hours.
(affect more than 1 in 10 people) Temporary pain at the site of injection Stinging or burning, redness, swelling, bruising and bleeding at the site of injection.
The active substance is sumatriptan (6 mg) The other ingredient is 0.5 ml sterile sodium chloride solution.
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.
What Imigran Subject looks like and contents of the pack
Each Imigran injection treatment pack comes complete with an injection device (Pen) and a Cartridge Pack which contains two pre-filled syringes. Imigran injection is also available as refill packs, which contain one cartridge of 2 pre-filled syringes.
If the first injection has no effect
Dont use a new injection or any other Imigran preparation for the same attack. If Imigran doesnt give you any relief: Ask your doctor or pharmacist for advice.
Pyramid House 956 High Road London N12 9RX Telephone: 01646 651979 You may be able to find out more about prescribed medicines from books in public libraries. TEXT FREE AREA
7 Step-by-step guide to using your Imigran Subject injection system
This leaflet shows you how to load the Subject Pen and how to use it to give a dose of Imigran medicine. Please read this leaflet before using the injection system. The GlaxoSmithKline Subject injection system is designed for use with a medicine called Imigran. Each Subject injection system comes complete with an Imigran Cartridge Pack. The Cartridge pack contains two pre-filled cartridge syringes. Subject refill packs containing one Imigran Subject Cartridge are also available. Important: In the unlikely event that you have a problem with the Imigran Subject injection mechanism, please: Return it to your pharmacist who will replace it; or Contact GlaxoSmithKline Customer Contact Centre on Freephone 0800 221441 and they will tell you how to return it. Keep out of the reach and sight of children
How to give an injection using the Subject Pen
4
1 2
Read the leaflet fully and carefully before using the Subject Pen Each Imigran Subject injection system comes complete with a Cartridge Pack which contains two cartridge syringes pre-filled with Imigran Use the photo on the left to help you identify the different parts of the injection system Do not load the Pen until you are ready to give the injection. Swing open the Lid of the Carrycase. Tear off the red Seal from one of the cartridges. Open the blue hinged lid underneath the Seal.
Push the Subject Pen firmly into the opened Cartridge Pack and gently screw it clockwise (about half a turn) until it will twist no further.
7
Press the Pen with the long blue Nose End firmly against a clean area of skin usually the outside of the thigh (as in picture) so the grey part slides down to cover part of the blue nose. This releases the safety catch. Hold the Pen firmly and press the blue Release Button at the top of the Subject Pen. Count slowly to 10 keeping the Subject Pen very still and the Release Button depressed. Do not take the Pen away from the skin too soon or some of the injection may be wasted. Then lift the Pen away taking care not to touch the needle point.
8 5
Keeping your finger away from the blue Release Button, pull the Subject Pen out of the Cartridge Pack. You may have to pull quite hard to do this. A safety catch stops accidental injection before you are ready.
TEXT FREE AREA
Description of parts
Cartridge Button Holes Seal Cartridge Pack Locating Buttons
Lid Release Button Subject Pen Carrycase Nose End White Rod (inside Nose End)
3
Take out the Subject Pen from the Carrycase. Check that the White Rod is not sticking out beyond the end of the Pen (see picture11). If it is sticking out, place the Pen back inside the Carrycase, push firmly and the Rod should click into place. The Pen is now ready for use.
6
The loaded Pen is now ready for immediate use. Do not try to put the loaded Pen back into the Carrycase until after you have used the injection, or the needle may be damaged and the Pen will not inject correctly.
7 Step-by-step guide to using your Imigran Subject injection system (continued)
9
Return the used cartridge syringe to the empty space in the Cartridge Pack straight away.
11
Withdraw the Subject Pen from the Cartridge Pack. Close the blue hinged lid over the used syringe.
How to remove the used Cartridge Pack
How to put a new Cartridge Pack into the Carrycase
Each Subject Pen comes complete with an Imigran Cartridge Pack which contains two pre-filled cartridge syringes. 1 Swing open the Lid of the Carrycase, the Subject Pen is already in its place.
1 2
When both syringes have been used, you can remove the Cartridge Pack. Hold the Carrycase and press the two blue Locating Buttons with one hand.
2 3
Push the Cartridge Pack into the Carrycase, pressing the blue buttons on either side so it slides in smoothly. It does not matter which side of the Cartridge Pack is closest to the Subject Pen.
10
Pushing the Pen down into the Cartridge Pack as far as it will go, unscrew the Pen by twisting it anti-clockwise (about half a turn) until it comes away.
12
13
Put the Subject Pen back into the Carrycase and push it down until it stays down. It will click into place. The Subject Pen is then ready for use next time. Close the Lid of the Carrycase until you need to use the next cartridge syringe. When you have used both cartridges, remove and replace the Cartridge Pack. (See right.)
3 4
Gently pull out the Cartridge Pack with the other hand. Be careful to dispose of your empty Cartridge Packs safely. The Cartridge Pack will hold the used Subject cartridge syringes and needles until you can safely dispose of them. You should be able to do this at your doctors surgery, so ask your doctor or practice nurse.
4
The Cartridge Pack is in the right position when the blue Locating Buttons show through the holes on either side of the Carrycase. Close the Carrycase by swinging back the Lid and snapping it shut. You can keep your Cartridge Pack safely in the Carrycase until you need to give yourself an injection.
5 6
7
Keep your Carrycase and any refill Cartridge Packs at a temperature below 30C/86F. If they are kept warmer than this for more than 24 hours it could spoil them.
10000000079332
Pharmacode Ref No is: 7239
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
