Consumer medicine information

Imigran Migraine

Sumatriptan

BRAND INFORMATION

Brand name

Imigran Migraine

Active ingredient

Sumatriptan

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Imigran Migraine.

SUMMARY CMI

IMIGRAN MIGRAINE®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using IMIGRAN MIGRAINE?

IMIGRAN MIGRAINE contains the active ingredient Sumatriptan. IMIGRAN MIGRAINE is used to relieve a migraine attack in patients who have a stable, well-established pattern of symptoms. IMIGRAN MIGRAINE may be used for migraine headaches with or without what is known as ‘aura’. For more information, see Section 1. Why am I using IMIGRAN MIGRAINE? in the full CMI.

2. What should I know before I use IMIGRAN MIGRAINE?

Do not use if you have ever had an allergic reaction to IMIGRAN MIGRAINE or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use IMIGRAN MIGRAINE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with IMIGRAN MIGRAINE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use IMIGRAN MIGRAINE?

The recommended dose for adults aged 18 to 65 years is 50 mg (one tablet). If the first tablet helps your migraine, but the migraine comes back later, you may take another 50 mg tablet. Wait at least two hours after the first tablet was taken. Do not take more than 100 mg (2 tablets) in any 24-hour period.

Swallow IMIGRAN MIGRAINE whole with a drink of water. Do NOT crush or chew tablet as it has a bitter taste.

More instructions can be found in Section 4. How do I use IMIGRAN MIGRAINE? in the full CMI.

5. What should I know while using IMIGRAN MIGRAINE?

Things you should doRemind any doctor, dentist or pharmacist you visit that you are using IMIGRAN MIGRAINE.
Tell your doctor if, for any reason you have not taken your medicine exactly as directed.
Things you should not doDo not give this medication to anyone else, even if their symptoms seem similar to yours.
Driving or using machinesBe careful driving or operating machinery until you know how IMIGRAN MIGRAINE tablets affect you. IMIGRAN MIGRAINE may cause drowsiness in some people.
Looking after your medicineKeep this medicine where children cannot reach it, such as in a locked cupboard.
Keep IMIGRAN MIGRAINE tablets in the blister pack in a cool, dry place where the temperature stays below 30°C.
Keep IMIGRAN MIGRAINE tablets in their pack until time to take them.
Do not leave them in a car, on a window sill or in a bathroom.

For more information, see Section 5. What should I know while using IMIGRAN MIGRAINE? in the full CMI.

6. Are there any side effects?

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking IMIGRAN MIGRAINE tablets. Some mild side effects include pain, tingling, heat or flushing in any part of the body, feeling of sleepiness, dizziness or tiredness, nausea (feeling sick) or vomiting, a change in blood pressure, feeling of faintness, problem with your eyesight and pain in the lower tummy and bloody diarrhea (ischemic colitis), shaking or tremors, uncontrolled movements, shortness of breath. Some serious side effects which may require medical attention include feel irregular heartbeats, suffer from a fit or convulsion, have wheezing or swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (“hives”) or fainting, feel heaviness, pressure or tightness in any part of the body including the chest or throat and have persistent purple discoloration and/or pain in the fingers, toes, ears, nose or jaw in response to cold.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CM



FULL CMI

IMIGRAN MIGRAINE®

Active ingredient: Sumatriptan succinate

Consumer Medicine Information (CMI)

This leaflet provides important information about using IMIGRAN MIGRAINE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using IMIGRAN MIGRAINE.

Where to find information in this leaflet:

1. Why am I using IMIGRAN MIGRAINE?
2. What should I know before I use IMIGRAN MIGRAINE?
3. What if I am taking other medicines?
4. How do I use IMIGRAN MIGRAINE?
5. What should I know while using IMIGRAN MIGRAINE?
6. Are there any side effects?
7. Product details

1. Why am I using IMIGRAN MIGRAINE?

IMIGRAN MIGRAINE contains the active ingredient sumatriptan succinate. Migraine headache is due to widening of certain blood vessels in the head. IMIGRAN MIGRAINE works by making those vessels normal again and eases the symptoms of migraine.

IMIGRAN MIGRAINE is used to relieve a migraine attack in patients who have a stable, well-established pattern of symptoms.

They should not be used to prevent migraine attacks from occurring.

IMIGRAN MIGRAINE does not work in other types of headache which are not a migraine.

2. What should I know before I use IMIGRAN MIGRAINE?

Warnings

Do not use IMIGRAN MIGRAINE if:

you are allergic to sumatriptan succinate, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

  • You have had heart disease or heart attack.
  • Shortness of breath, pain or tightness in chest, jaw or upper arm.
  • Peripheral vascular disease (pain in the back of the legs) or are prone to cold, tingling or numb hands and feet.
  • Prinzmental's angina (an uncommon form of angina where pain is experienced at rest rather than during activity).
  • Angina.
  • High blood pressure.
  • Severe liver disease.
  • If you have taken any of the following medication in the last 24 hours: ergotamine (eg cafergot), Dihydroergotamine (eg Dihydergot), Methsergide (eg Deseril), naratriptan (eg Naramig) and Zolmitriptan (eg Zomig).
  • If you have taken any of the following medicines in the last two weeks: Monoamine oxidase inhibitors (MAOIs), a type of medication used for depression. SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin-noradrenaline Reuptake Inhibitors) used to treat depression.
  • The expiry date (EXP) printed on the pack has passed. The packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • Are allergic to foods, dyes, preservatives or any other medicines, including any that contain sulfur (eg sulphonamide antibiotics).
  • Are allergic to lactose
  • Are taking or have taken medicines in the last two weeks, including medicines you buy without a prescription, particularly herbal preparations containing St John's Wort and medicines prescribed for depression.
  • Are breastfeeding, pregnant or trying to become pregnant.
  • If you have medical conditions such as, liver or kidney problems, heart problems.
  • Risk factors including high blood pressure even if it is under control, high blood cholesterol levels, a family history of heart problems, obesity, diabetes, you are a male and over 40 years of age, you are female and have undergone menopause or you smoke.
  • If you suffer from epilepsy, seizures, or fits or been told that you are prone to this problem.
  • Have had a stroke.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with IMIGRAN MIGRAINE and affect how it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect IMIGRAN MIGRAINE.

Some medicines may interfere with IMIGRAN MIGRAINE and affect how it works

4. How do I use IMIGRAN MIGRAINE?

How much to take / use

The recommended dose for adults aged 18 to 65 years is 50 mg (one tablet). If the first tablet helps your migraine, but the migraine comes back later, you may take another 50 mg tablet. Wait at least two hours after the first tablet was taken. Do not take more than 100 mg (2 tablets) in any 24-hour period.

Do NOT take more IMIGRAN MIGRAINE tablets, or any other form of IMIGRAN MIGRAINE, if the first dose has not provided any relief from your symptoms. You may take your usual headache relief medication provided it does not contain ergotamine or methysergide. If you are not sure what to do, ask your doctor or pharmacist.

If your migraine is not relieved by IMIGRAN MIGRAINE, you may use IMIGRAN MIGRAINE tablets on another occasion to treat another migraine attack.

When to take / use IMIGRAN MIGRAINE

It is best to take IMIGRAN MIGRAINE tablets when the migraine headache begins; or

When other symptoms of the migraine begin, such as nausea (feeling sick), vomiting or your eyes becoming sensitive to light.

If you take your tablet later during the migraine attack it will still work for you. DO NOT take your IMIGRAN MIGRAINE tablet before the above symptoms occur.

If you use too much IMIGRAN MIGRAINE

If you think that you have used too much IMIGRAN MIGRAINE, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre (by calling 13 11 26),
  • or contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using IMIGRAN MIGRAINE?

Things you should do

Tell your doctor or pharmacist if, for any reason, you have not taken your medicine exactly as directed.

Otherwise, your doctoror pharmacist may think that is not working and change your treatment unnecessarily.

Call your doctor straight away if you:

  • Feel heaviness, pressure or tightness in any part of the body including the chest or throat.
  • Feel irregular heart beats
  • Have a fit or convulsion
  • Have wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (“hives”) or fainting. These could be symptoms of allergic an allergic reaction.
  • Have persistent purple discolouration and/or pain in the fingers, toes, ears, nose or jaw in response to cold.

These side effects are likely to be serious. Stop taking IMIGRAN MIGRAINE tablets and seek medical attention straight away.

Remind any doctor, dentist or pharmacist you visit that you are using IMIGRAN MIGRAINE

Things you should not do

Do not give his medicine to anyone else, even if their symptoms seem similar to yours.

Driving or using machines

IMIGRAN MIGRAINE tablets may cause drowsiness in some people.

Be careful before you drive or use any machines or tools until you know how IMIGRAN MIGRAINE affects you.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Keep IMIGRAN MIGRAINE tablets in the blister pack in a cool, dry place, where it stays below 30°C; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it, such as in a locked cupboard.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Pain, tingling, heat or flushing in any part of the body.
Feeling of sleepiness, dizziness or tiredness.
Nausea (feeling sick) or vomiting.
A change in blood pressure.
Feeling of faintness.
Hay fever
Shaking of tremors.
Uncontrolled movements.
Shortness of breath.		Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Feeling heaviness, pressure or tightness in any parts of the body including the chest or throat.
Feel irregular heart beats
Have a fit of convulsion.
Have wheezing, swelling of the lips/mouth.
Difficulty in breathing.
Problems with your eyesight.
Pain in the lower tummy and bloody diarrhea (ischemic colitis).
Lumpy rash (“hives”)
Fainting
Persistent purple discolouration and/or pain in the fingers, toes, ears, nose or jaw in response to cold.		Call your doctor straight away, or;
go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What IMIGRAN MIGRAINE tablets contain

Active ingredient
(main ingredient)		Sumatriptan succinate
Other ingredients
(inactive ingredients)		Lactose
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate
Potential allergensLactose

IMIGRAN MIGRAINE tablets contain lactose

IMIGRAN MIGRAINE tablets 50mg are coated with Opadry YS-1-1441-G

Do not take this medicine if you are allergic to any of these ingredients.

What IMIGRAN MIGRAINE looks like

IMIGRAN MIGRAINE 50mg tablet are pink, film-coated, capsule shaped bivconvex tablets, engraved ‘50’ on one face and plain on the other.

A box contains 2 tablets.

The tablets have a film coating to protect the tablet, and this gives the colour.

Australia Registration Number for IMIGRAN MIGRAINE 50mg tablets: AUST R 409791

Who distributes IMIGRAN MIGRAINE

Your IMIGRAN MIGRAINE tablets are supplied by:

Aspen Pharmacare Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065

This leaflet was prepared in May 2023

Published by MIMS July 2024

BRAND INFORMATION

Brand name

Imigran Migraine

Active ingredient

Sumatriptan

Schedule

S3

 

1 Name of Medicine

Sumatriptan.

2 Qualitative and Quantitative Composition

(Sumatriptan) succinate equivalent to 50 mg sumatriptan is the therapeutically active ingredient in Imigran Migraine tablets.

Excipients with known effect.

Sugars (as lactose).

3 Pharmaceutical Form

Imigran Migraine brand tablets 50 mg are pink, film-coated, capsule-shaped biconvex tablets engraved '50' on one face and plain on the other face.

4 Clinical Particulars

4.1 Therapeutic Indications

Imigran Migraine tablets (2 tab pack) are indicated for the acute relief of migraine attacks in patients who have a stable, well-established pattern of symptoms.

4.2 Dose and Method of Administration

Migraine.

It is recommended to start the treatment at the first sign of a migraine headache or associated symptoms such as nausea, vomiting or photophobia. The efficacy of sumatriptan is independent of the duration of the attack when starting treatment. Administration during a migraine aura prior to other symptoms occurring may not prevent the development of a headache.
If a patient does not respond to the first dose of Imigran Migraine, a second dose should not be taken for the same attack. Imigran Migraine may be used for subsequent attacks.

Tablets.

The initial recommended adult dose of oral Imigran Migraine is 50 mg. The tablet should be swallowed whole with water. If symptoms recur, a further dose of 50 mg may be given. Maximum of 100 mg (2 tablets) in 24 hours.

4.3 Contraindications

Imigran Migraine should not be used in patients who have:
Hypersensitivity to any component of the preparation (see Section 6.1 List of Excipients);
A history of myocardial infarction;
Peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease;
Prinzmetal's angina/coronary vasospasm;
Uncontrolled hypertension;
Cerebrovascular accident or transient ischaemic attack;
Severe hepatic impairment.
Imigran Migraine should not be used within 24 hours of treatment with an ergotamine-containing or ergot-type medication such as dihydroergotamine or methysergide.
Imigran Migraine should not be given to patients receiving monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of MAOI therapy.
Imigran Migraine should not be administered to patients with hemiplegic, basilar or ophthalmoplegic migraine.

4.4 Special Warnings and Precautions for Use

Imigran Migraine should only be used where there is a clear diagnosis of migraine. However, if a patient does not respond to the first dose, the opportunity should be taken to review the diagnosis before a second dose is given. The recommended doses of Imigran Migraine should not be exceeded.

Drowsiness.

Drowsiness may occur as a result of migraine or its treatment with Imigran Migraine. Caution is recommended in patients performing skilled tasks, e.g. driving or operating machinery.

Use in hepatic or renal impairment.

Imigran Migraine should also be administered with caution to patients with diseases which may affect significantly the metabolism, absorption and excretion of the drug, such as impaired hepatic or renal function. Studies have shown reduced sumatriptan clearance in patients with hepatic impairment. Lower doses should be considered in these patients. If appropriate, the first dose should be given under supervision to these patients.

Hypersensitivity to sulphonamides.

Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of Imigran Migraine. Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross sensitivity is limited, however, caution should be exercised before using sumatriptan in these patients.

Overuse.

Overuse of acute migraine treatments has been associated with the exacerbation of headache (medication overuse headache, MOH) in susceptible patients. Withdrawal of the treatment may be necessary.

Co-administration with 5-HT1 agonists.

Co-administration of sumatriptan within 24 hours of other 5-HT1 agonists is not recommended due to the potential for vasoconstrictive effects.

Cardiovascular precautions.

It is strongly recommended that sumatriptan not be given to patients in whom risk factors indicate a possibility of unrecognised coronary artery disease (CAD) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischaemic myocardial disease or other significant underlying cardiovascular disease. The risk factors include hypertension, hypercholesterolaemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best and, in extremely rare cases (less than 1 in 10,000), serious cardiac events have occurred in patients without underlying cardiovascular disease. If during the cardiovascular evaluation, the patient's medical history of electrocardiographic investigations reveal findings indicative of, or consistent with coronary artery vasospasm or myocardial ischaemia, sumatriptan should not be administered (see Section 4.3 Contraindications).
Imigran Migraine may cause short lived elevation of blood pressure and peripheral vascular resistance. Sumatriptan should therefore be administered with caution to patients with controlled hypertension. Transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.
Serious cardiac events, including some that have been fatal, have occurred within a few hours following the use of Imigran Migraine Tablets. These events are extremely rare (less than 1 in 10,000) and the majority of these case reports were confounded by patients having pre-existing heart disease or risk factors for ischaemic heart disease and may reflect underlying disease and spontaneous events. Under these circumstances the specific contribution of Imigran Migraine cannot be determined. Events reported have included coronary artery vasospasm, transient myocardial ischaemia, myocardial infarction, and cardiac arrhythmias including ventricular tachycardia and ventricular fibrillation. Therefore, Imigran Migraine should not be given to patients in whom unrecognised cardiac disease is likely without a prior evaluation for underlying cardiovascular disease. Such patients include postmenopausal women, males over 40 and patients with risk factors for coronary artery disease. Significant cardiovascular sequelae have been reported in patients in whom risk factors were not readily identifiable. There is no experience in patients with recent cardiac arrhythmias (especially tachycardias). Until further information is available, the use of Imigran Migraine is not recommended in these patients.
A myocardial infarct has been reported in a 14 year old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration.
Following administration, Imigran Migraine can be associated with transient symptoms, including chest pain and tightness, which may be intense and involve the throat. If symptoms consistent with ischaemic heart disease occur, appropriate investigations should be carried out and further doses should not be given until the results of these investigations are known. Patients should be advised to contact their doctor immediately if they experience symptoms consistent with ischaemic heart disease (see Section 4.3 Contraindications).

Cerebrovascular precautions.

Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with oral sumatriptan, and some have resulted in fatalities. The relationship of sumatriptan to these events is uncertain. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Sumatriptan should not be administered if the headache being experienced is atypical of the patient. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g. cerebrovascular accident, transient ischaemia attack).
Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.
Imigran Migraine should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold.
There is no experience in patients with recent cerebrovascular accidents. Until further information is available, the use of Imigran Migraine is not recommended in these patients (see Section 4.3 Contraindications).
There is no information available on the use of Imigran Migraine in the treatment of ophthalmoplegic migraine.

Other vasospastic events.

Sumatriptan may cause vasospastic reactions other than coronary artery vasospasm. Both peripheral vascular ischaemia and colonic ischaemia with abdominal pain and bloody diarrhoea have been reported.

Use in adolescents (12-17 years).

The efficacy of oral sumatriptan has not been established in placebo-controlled trials carried out in 794 adolescent migraineurs. High placebo responses were found in these studies and there was a lack of statistically significant difference between placebo and oral doses ranging from 25 to 100 mg. The safety profile of oral sumatriptan is similar to that of adults.

Paediatric use.

The safety and effectiveness of sumatriptan in children under the age of 12 years has not been established.

Use in the elderly.

Experience of the use of Imigran Migraine in patients aged over 65 is limited. However, the pharmacokinetics do not differ significantly from a younger population. Until further clinical data are available, the use of Imigran Migraine in patients aged over 65 is not recommended.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacodynamic.

Prolonged vasospastic reactions have been reported with ergotamine. As these effects may be additive, concomitant use of ergotamine or ergotamine derivatives and Imigran Migraine should be avoided. Twenty-four hours should elapse before Imigran Migraine is taken following any ergotamine containing preparation. Conversely, ergotamine containing preparations should not be taken until 6 hours have elapsed following Imigran Migraine administration (see Section 4.3 Contraindications).

Pharmacokinetic.

An interaction may occur between sumatriptan and MAOIs and concomitant administration is contraindicated (see Section 4.3 Contraindications). Rarely an interaction may occur between sumatriptan and selective serotonin reuptake inhibitors. There have been rare post marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability, neuromuscular abnormalities, weakness, hyper-reflexia and incoordination) following the use of a SSRI. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs).
If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised.
The concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.
There is no evidence of interactions with propranolol, flunarizine, pizotifen or alcohol.
Although there is no clear evidence, it is possible that an interaction may occur between serotonin 5-HT1 agonists and the herbal remedy St John's Wort (Hypericum perforatum), which may result in an increase in side effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
No obvious teratogenic effects have been seen in rats given oral doses of 500 mg/kg and intravenous doses up to 12.5 mg/kg or in rabbits given oral doses up to 100 mg/kg and intravenous doses up to 8 mg/kg during organogenesis (although it is noted that the number of pregnant rabbits investigated was limited).
Reproduction studies in rats have not revealed any clear evidence of impaired fertility (oral doses up to 500 mg/kg, subcutaneous doses up to 60 mg/kg, given before and during mating) or of impaired post-natal pup development (oral doses up to 1000 mg/kg, subcutaneous doses up to 81 mg/kg, given during the peri and post-natal period). In the rabbit embryotoxicity cannot be ruled out. After oral administration, at doses of 5, 25 and 100 mg/kg on days 8-20 of gestation (severe maternal toxicity at 100 mg/kg) there was evidence of a small, increasing dose-related trend in post-implantation intrauterine death with a similar, and significant trend being recorded after intravenous treatment (0.5 to 8 mg/kg, days 8-20 of gestation).
Term foetuses from Dutch Stride rabbits treated during the period of organogenesis with oral sumatriptan exhibited an increased incidence of cervicothoracic vascular defects and skeletal abnormalities.
When administered to pregnant rabbits throughout the period of organogenesis sumatriptan has occasionally caused embryolethality at doses which were sufficiently high to produce maternal toxicity.
Administration of this drug should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
 Sumatriptan is excreted in breast milk in animals. In rats given oral sumatriptan at 1000 mg/kg during the lactation period, 3 dams out of 20 showed total litter loss whilst in another litter, only 9/15 survived to the end of nursing. It has been demonstrated that following subcutaneous administration sumatriptan is excreted into breast milk. Infant exposure can be minimised by avoiding breastfeeding for 24 hours after treatment. Caution should be exercised when considering the administration of sumatriptan to a breastfeeding woman.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed. Drowsiness may occur as a result of migraine or its treatment with sumatriptan. This may influence the ability to drive and to operate machinery.

4.8 Adverse Effects (Undesirable Effects)

The most common side effects associated with treatment with Imigran Migraine are:
Pain, sensations of tingling, heat or cold, heaviness, pressure or tightness. These are usually transient and may be intense and can affect any part of the body including the chest and throat.
Flushing, dizziness and feelings of weakness. These are mostly mild to moderate in intensity and transient.
Fatigue, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia have been reported.
Nausea and vomiting occurred in some patients but the relationship to Imigran Migraine is not clear.
Transient increases in blood pressure arising soon after treatment have been recorded.
Dyspnoea.
Serious coronary events have been reported (see Section 4.4 Special Warnings and Precautions for Use). Other cardiovascular adverse reactions include hypotension, bradycardia, tachycardia and palpitations. Very rarely (less than 1 in 10,000) Raynaud's phenomenon, angina and ischaemic colitis have been reported.
There have been rare (less than 1 in 1,000) reports of seizures following migraine attacks treated with sumatriptan. Although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures, there are also reports in patients where no such predisposing factors are apparent.
Patients treated with Imigran Migraine very rarely (less than 1 in 10,000) exhibit visual disorders like flickering and diplopia. Additionally, cases of nystagmus, scotoma and reduced vision have been observed. Very rarely loss of vision has occurred, which is usually transient. However, visual disorders may also occur during a migraine attack itself.
Hypersensitivity reactions ranging from cutaneous hypersensitivity (e.g. rash, urticaria, pruritus or erythema) to, in rare (less than 1 in 10,000) cases, anaphylaxis have been recorded (see Section 4.4 Special Warnings and Precautions for Use).
Minor disturbances of liver function tests have occasionally been observed. There is no evidence that clinically significant abnormalities occurred more frequently than with placebo.
In the clinical trial programme, decreased lymphocyte count post treatment was observed in a number of patients receiving oral Imigran Migraine. This effect was not dose-related and was also observed in patients receiving placebo. The significance of these findings is uncertain.
In the clinical trial programme, a similar profile of clinical adverse events was reported in the adolescent and adult populations taking Imigran Migraine tablets or nasal spray.

Post-marketing data.

In addition to the drug-related adverse reactions reported from clinical trials, the following serious spontaneous events, reported to be possibly, probably or almost certainly caused use of oral sumatriptan in patients less than 18 years of age have been identified.

Cardiovascular.

Myocardial infarction.

Cerebrovascular.

Cerebellar infarction.

Neurology.

Seizures, tremor and dystonia.

Non-site specific.

Anaphylaxis.

Skin.

Urticaria, rash.

General disorders.

"Pain trauma activated" and "Pain inflammation activated" - frequency not known.
See Table 1.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Single doses up to 400 mg with Imigran Migraine tablets orally were not associated with side effects other than those mentioned. There is no experience of doses greater than these.
If overdosage with Imigran Migraine occurs, the patient should be monitored for at least ten hours and standard supportive treatment applied as required.
It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sumatriptan has been demonstrated to be a specific vascular 5-hydroxytryptamine-1 (5HT1) receptor agonist with no effect at other 5HT receptor (5HT2-5HT7) subtypes. The vascular 5HT1 receptor is found predominantly in cranial blood vessels and mediates vasoconstriction. In animals, sumatriptan selectively constricts the carotid arterial circulation, but does not alter cerebral blood flow. The carotid arterial circulation supplies blood to the extracranial and intracranial tissues such as the meninges, and dilatation and/or oedema formation in these vessels is thought to be the underlying mechanism of migraine in man. In addition, experimental evidence suggests that sumatriptan inhibits trigeminal nerve activity. Both these actions may contribute to the anti-migraine action of sumatriptan in humans.

Clinical trials.

Clinical studies conducted in the adult population.

Table 2 demonstrates 2 and 4 hour efficacy results in two placebo-controlled studies of sumatriptan tablets in 332 adult migraineurs experiencing moderate or severe pain.
Specific studies involving asthmatic patients have not been conducted, however a few asthmatic patients were included in the clinical trials.

5.2 Pharmacokinetic Properties

After oral administration, sumatriptan is rapidly absorbed, 70% of maximum concentration occurring at 45 minutes. After a 100 mg dose the mean maximum plasma concentration is 54 nanogram/mL. Mean absolute oral bioavailability is 14% partly due to pre-systemic metabolism and partly due to incomplete absorption. Oral absorption of sumatriptan is not significantly affected by food.
Imigran Migraine Lactose Free tablets and Imigran Migraine tablets have been established to be bioequivalent in the fasted state. In the fasted state, sumatriptan tmax was, on average, 10-15 minutes earlier for Imigran Migraine Lactose Free relative to Imigran Migraine tablets. Imigran Migraine Lactose Free after a high fat meal resulted in an average 12% increase in AUC(0-∞) and 15% increase in Cmax relative to Imigran Migraine Lactose Free in the fasted state. AUC(0-2) was estimated to be an average of only 5% lower and tmax delayed by only 6.5 minutes for Imigran Migraine Lactose Free in the fed, relative to the fasted state. These variations are not considered to be of clinical significance.
Non-renal clearance accounts for about 80% of the total clearance. Sumatriptan is eliminated primarily by oxidative metabolism mediated by monoamine oxidase A. The major metabolite, the indole acetic acid analogue of sumatriptan, is mainly excreted in the urine, where it is present as a free acid and the glucuronide conjugate. It has no known 5HT1 or 5HT2 activity. Minor metabolites have not been identified. The pharmacokinetics of oral or intranasal sumatriptan do not appear to be significantly affected by migraine attacks.
In a pilot study no significant differences were found in the pharmacokinetic parameters between elderly and young healthy volunteers.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Imigran Migraine tablets 50 mg.

Each tablet contains 50 mg sumatriptan base as the succinate salt.
The tablets also contain: lactose, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, Opadry YS-1-1441-G.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Tablets.

Store below 30°C.

6.5 Nature and Contents of Container

Imigran Migraine tablets 50 mg are available in packs containing 2 tablets in aluminium foil blisters.
Not all strengths, dose forms, pack sizes, container types are being distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The chemical name of sumatriptan is 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methane sulphonamide. The molecular formula of sumatriptan is C14H21N3O2S, the relative molecular mass is 295.4. It takes the form of a white to pale yellow powder.
Chemically, sumatriptan succinate is: 3-[2-(dimethylamino) ethyl]-N-methyl-1H-indole-5-methane sulphonamide, butane-1,4-dioate (1:1). The molecular formula of sumatriptan succinate is C14H21N3O2SC4H6O4, the relative molecular mass is 413.5. It takes the form of a white to off-white powder.

Chemical structure.


CAS number.

103628-48-4.

7 Medicine Schedule (Poisons Standard)

Schedule 3: pharmacist only medicine.

Summary Table of Changes