Consumer medicine information

Sumatriptan Migraine Relief

Sumatriptan

BRAND INFORMATION

Brand name

Sumatriptan Migraine Relief

Active ingredient

Sumatriptan

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sumatriptan Migraine Relief.

SUMMARY CMI

Sumatriptan Migraine Relief

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 Sumatriptan Migraine Relief?

Sumatriptan Migraine Relief contains the active ingredient sumatriptan succinate. Sumatriptan Migraine Relief is used to relieve a migraine attack in patients who have a stable, well-established pattern of symptoms.

For more information, see Section 1. Why am I using Sumatriptan Migraine Relief? in the full CMI.

2. What should I know before I use Sumatriptan Migraine Relief?

Do not use if you have ever had an allergic reaction to sumatriptan 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 Sumatriptan Migraine Relief? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sumatriptan Migraine Relief 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 Sumatriptan Migraine Relief?

  • The usual recommended dose for adults aged 18 to 65 years is 50 mg (one tablet).
  • If the first Sumatriptan Migraine Relief tablet helps your migraine, but the migraine comes back later, you may take another Sumatriptan Migraine Relief tablet. Wait at least two hours after the first tablet was taken.
  • Do not take more Sumatriptan Migraine Relief tablets, or any other form of sumatriptan, if the first dose has not provided any relief from your symptoms.
  • Do not take more than 100 mg (2 tablets) in any twenty-four hour period.

More instructions can be found in Section 4. How do I use Sumatriptan Migraine Relief? in the full CMI.

5. What should I know while using Sumatriptan Migraine Relief?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Sumatriptan Migraine Relief.
  • Tell your doctor or pharmacist if your migraine lasts for longer than 24 hours.
Things you should not do
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Sumatriptan Migraine Relief affects you. Drowsiness may occur as a result of migraine or its treatment with sumatriptan. This may influence the ability to drive and to operate machinery.
Drinking alcohol
  • Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
  • Store the tablets in a place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using Sumatriptan Migraine Relief? in the full CMI.

6. Are there any side effects?

Common side effects: pain, tingling, heat or flushing in any part of the body, feeling of sleepiness, dizziness or tiredness

Serious side effects: heaviness, pressure or tightness in any part of the body, irregular heartbeats, fit or convulsion

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



FULL CMI

Sumatriptan Migraine Relief

Active ingredient: Sumatriptan succinate


Consumer Medicine Information (CMI)

This leaflet provides important information about using Sumatriptan Migraine Relief. 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 Sumatriptan Migraine Relief.

Where to find information in this leaflet:

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

1. Why am I using Sumatriptan Migraine Relief?

Sumatriptan Migraine Relief contains the active ingredient sumatriptan succinate. Sumatriptan Migraine Relief belongs to a group of drugs called serotonin agonists.

Sumatriptan Migraine Relief tablets are used to relieve a migraine attack in patients who have a stable, well-established pattern of symptoms. Sumatriptan Migraine Relief should not be used to prevent migraine attacks from occurring.

It is thought that migraine headache is due to widening of certain blood vessels in the head. Sumatriptan Migraine Relief work by making those vessels normal again and ease the symptoms of migraine.

Your Sumatriptan Migraine Relief do not work in other types of headache which are not a migraine.

Do not use Sumatriptan Migraine Relief unless your condition has been diagnosed by a doctor.

2. What should I know before I use Sumatriptan Migraine Relief?

Warnings

Do not use Sumatriptan Migraine Relief 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 or have had:
    - heart disease or heart attack
    - shortness of breath, pain or tightness in the 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
    - Variant angina (an uncommon form of angina where pain is experienced at rest rather than during activity)
    - angina
    - high blood pressure
    - stroke
    - severe liver disease
  • you have taken any of these medicines in the last 24 hours:
    - Ergotamine
    - Dihydroergotamine
    - Methysergide
    - Naratriptan
    - Zolmitriptan
    - Rizatriptan
    - Eletriptan
  • you have taken any of these medicines in the last two weeks:
    - Monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression
    - SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin-noradrenaline reuptake inhibitors) used to treat depression

Check with your doctor or pharmacist if you:

  • have any other medical conditions:
    - liver or kidney problems
    - heart problems 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
    - epilepsy, seizures, or fits or been told that you are prone to this problem
    - stroke
  • take any medicines for any other condition
  • are allergic to foods, dyes, preservatives or any other medicines, including any that contain sulphur (eg sulphonamide antibiotics)
  • are allergic to lactose
  • are taking or have taken any other 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 breast feeding, pregnant or trying to become pregnant

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 or pharmacist if you are pregnant or intend to become pregnant.

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

Use in Children and Adolescents (under 18 years)

  • Do not use in children or adolescents under the age of 18 years

Use in Patients (over 65 years)

  • Not recommended for patient over the age of 65 years

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.

Tell your doctor or pharmacist if you are taking any other medicines, including:

  • herbal preparations containing St John's Wort
  • medicines prescribed for depression
  • oral contraceptive pill

Some medicines may be affected by Sumatriptan Migraine Relief or may affect how well 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 Sumatriptan Migraine Relief.

4. How do I use Sumatriptan Migraine Relief?

How much to take

Adults 18 to 65 years

  • The usual recommended dose for adult is 50 mg (one tablet)
  • If the first Sumatriptan Migraine Relief tablet helps your migraine, but the migraine comes back later, you may take another Sumatriptan Migraine Relief tablet. Wait at least two hours after the first tablet was taken. Do not take more than 100 mg (2 tablets) in any twenty-four hour period.
  • Do not take more Sumatriptan Migraine Relief tablets, or any other form of sumatriptan, 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 Sumatriptan Migraine Relief tablets, you may use Sumatriptan Migraine Relief tablets on another occasion to treat another migraine attack.
  • Follow the instructions provided with the medicine.
  • Do not take more than 2 tablets in 24 hours.
  • Do not exceed the recommended dosage.

When to take Sumatriptan Migraine Relief

Sumatriptan Migraine Relief should be used:

  • when the migraine headache begins; or
  • when other symptoms of the migraine begin, such as nausea (feeling sick), vomiting or your eyes become sensitive to light

If you take your first tablet during the migraine attack, and not at the beginning as recommended, it may still work for you.

How to take Sumatriptan Migraine Relief

  • Sumatriptan Migraine Relief tablet should be swallowed with a drink of water. Do not crush or chew the tablet as it has a bitter taste.

If you use too much Sumatriptan Migraine Relief

If you think that you have used too much Sumatriptan Migraine Relief, 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 Sumatriptan Migraine Relief?

Things you should do

  • Tell your doctor if, for any reason, you have not taken your medicine exactly as directed
  • Tell your doctor or pharmacist if your migraine headache lasts for longer than 24 hours
  • Tell your doctor or pharmacist if your pattern of symptoms has changed
  • Tell your doctor of pharmacist if you generally have four or more migraine attacks each month
  • Tell your doctor or pharmacist if you feel this headache is different or worse than your usual migraine e.g. more frequent, more persistent, more severe, or you don't recover between attacks
  • Tell your doctor or pharmacist if you have these symptoms with your migraine headache; weakness on one side of your body, double vision, clumsy and uncoordinated movements, tinnitus (ringing in the ears), reduced levels of consciousness, seizure like movements, recent rash with a headache

Remind any doctor, dentist, pharmacist or other health professionals you visit that you are using Sumatriptan Migraine Relief.

Things you should not do

  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours

Medication overuse headaches

Overuse of migraine medications, such as sumatriptan, have been associated with worsening of headaches (medication overuse headache or MOH) in some patients.

Overuse of medications for relief of headache and migraine can worsen your condition and lead to:

  • Increase of headache frequency, and
  • Can make your condition less responsive to treatments

If you are experiencing frequent or daily headaches, it is possible that you may be experiencing medication overuse headache. If your migraines have become more frequent, you should speak with your doctor or pharmacist.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sumatriptan Migraine Relief affects you.

Drowsiness may occur as a result of migraine or its treatment with sumatriptan. This may influence the ability to drive and to operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

  • Keep your tablets in their blister pack until it is time to take them.
  • Store the tablets in a place where the temperature stays below 25°C.

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

Store it in a cool dry place away from moisture, heat or sunlight; 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.

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.

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: (headaches, dizziness, chest pain)
  • Feeling of faintness
  • Problems with your eyesight
  • Pain in the lower tummy and bloody diarrhoea (ischaemic colitis)
  • Shaking or tremors
  • Uncontrolled movements
  • Shortness of breath
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • Feel heaviness, pressure or tightness in any part of the body including the chest or throat
  • Feel irregular heartbeats
  • 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 a symptom of an allergic reaction
  • Have 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.

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.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What Sumatriptan Migraine Relief contains

Active ingredient
(main ingredient)
Sumatriptan succinate
Other ingredients
(inactive ingredients)
  • Croscarmellose sodium
  • Hypromellose
  • Iron oxide red
  • Lactose monohydrate
  • Magnesium stearate
  • Microcrystalline cellulose
  • Titanium dioxide
  • Triacetin
Potential allergensLactose, milk and milk products, sulfites

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

What Sumatriptan Migraine Relief looks like

Sumatriptan Migraine Relief 50 mg film-coated tablet is a pink coloured, capsule shaped, biconvex tablet plain on both sides. Pack size of 2 tablets (Aust R 372451).

Who distributes Sumatriptan Migraine Relief

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park NSW 2113
Australia

Tel: 1800 726 369

This leaflet was revised in July 2021.

Published by MIMS June 2022

BRAND INFORMATION

Brand name

Sumatriptan Migraine Relief

Active ingredient

Sumatriptan

Schedule

S3

 

1 Name of Medicine

Sumatriptan succinate.

2 Qualitative and Quantitative Composition

Active: sumatriptan (as succinate salt) 50 mg.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sumatriptan Migraine Relief is available in tablets.

Sumatriptan Migraine Relief 50 mg (AUST R 372451).

Each film-coated tablet contains sumatriptan succinate equivalent to 50 mg sumatriptan.
Pink-coloured, capsule shaped biconvex film coated tablets, plain on both sides. Available in packs containing 2 tablets in AI/AI blister packs.

4 Clinical Particulars

4.1 Therapeutic Indications

Sumatriptan Migraine Relief is indicated for the acute relief of migraine, in patients who have a stable, well-established pattern of symptoms.
There is not information available on the use of sumatriptan in the treatment of basilar or hemiplegic migraine.

4.2 Dose and Method of Administration

Sumatriptan is indicated for the acute intermittent relief of migraine. It should not be used prophylactically.
Ergotamine or ergotamine derivatives and sumatriptan should not be administered concurrently, see Section 4.3 Contraindications; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

Migraine.

It is recommended that treatment be started 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.
The initial recommended adult dose of sumatriptan is 50 mg. If symptoms recur, a further dose may be given in the next 24 hours. The tablet should be swallowed whole with water.
If a patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. Sumatriptan may be used for subsequent attacks.
Sumatriptan Migraine Relief should not be used prophylactically.

4.3 Contraindications

Sumatriptan 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.
Sumatriptan should not be used within 24 hours of treatment with an ergotamine-containing or ergot-type medication such as dihydroergotamine or methysergide.
Sumatriptan should not be given to patients receiving monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of MAOI therapy.
Sumatriptan should not be administered to patients with hemiplegic, basilar or ophthalmoplegic migraine.

4.4 Special Warnings and Precautions for Use

Identified precautions.

General.

Sumatriptan 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 sumatriptan should not be exceeded.
Sumatriptan tablets should only be used where a clear diagnosis of migraine has been made by a doctor. For pharmacy supply, patients should have an established pattern of migraine (a history of five or more migraine attacks occurring over a period of at least 1 year). Sumatriptan tablets should not be taken concomitantly with other migraine therapies containing any triptan, ergotamine or derivatives of ergotamine. See Section 4.3 Contraindications.
Patients with migraine that persist for longer than 24 hours should seek advice from a doctor. Patients in whom the pattern of symptoms has changed, or whose attacks have become more frequent, more persistent, or more severe, or who do not recover completely between attacks, should seek advice from their doctor.
Patients with atypical symptoms which include, but are not limited to, unilateral motor weakness, double vision, clumsy and uncoordinated movements, tinnitus, reduced level of consciousness, seizure-like movements, or recent onset of rash with headache should seek advice from their doctor.
Patients whose migraine symptoms appear for the first time after age 50 should seek advice from their doctor as there may be a more serious underlying cause.
Patients who experience four or more migraine attacks per month should be referred to a doctor for ongoing management.
Women with migraine who are taking the combined oral contraceptive pill have an increased risk of stroke and should seek medical advice from their doctor if migraine attacks started recently (within the last 3 months), migraine symptoms have worsened or they have migraine with aura.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Drowsiness may occur as a result of migraine or its treatment with sumatriptan. Caution is recommended in patients performing skilled tasks, e.g. driving or operating machinery. Sumatriptan should be administered with caution to patients with diseases which may significantly affect 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.
Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan. 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 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. Prolonged use of any type of painkillers for headaches can make migraine worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of Medication Overuse Headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache medications.
Co-administration of sumatriptan within 24 hours of other 5-HT1 agonists is not recommended due to the potential for vasoconstrictive effects.

Cardiovascular.

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.
Sumatriptan 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 sumatriptan. 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 sumatriptan cannot be determined. Event reported have included coronary artery vasospasm, transient myocardial ischaemia, myocardial infarction, and cardiac arrhythmias including ventricular tachycardia and ventricular fibrillation.
Therefore, sumatriptan 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 sumatriptan 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, sumatriptan 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.

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.
Sumatriptan 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 sumatriptan is not recommended in these patients, see Section 4.3 Contraindications.
There is no information available on the use 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 hepatic impairment.

Sumatriptan should be administered with caution to patients with diseases which may significantly affect the metabolism, absorption and excretion of the drug, such as impaired hepatic 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.

Use in renal impairment.

Sumatriptan should be administered with caution to patients with diseases which may significantly affect the metabolism, absorption and excretion of the drug, such as impaired renal function.

Use in the elderly.

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

Paediatric use.

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

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 sumatriptan should be avoided. Twenty-four hours should elapse before sumatriptan is taken following any ergotamine containing preparation. Conversely, ergotamine containing preparations should not be taken until 6 hours have elapsed following sumatriptan 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.

Ophthalmic.

Intermittent transient changes on the surface of the cornea have been observed in toxicology studies in dogs. No causative mechanism has been established for these changes but there is no evidence to suggest that this is relevant to clinical exposure.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

See Use in pregnancy.
(Category B3)
Drugs which have been taken by only a limited number of pregnant women and women of child bearing age without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal damage, the significance of which is considered uncertain in humans.
No obvious teratogenic effects have been seen in rats given oral doses of 500 mg/kg or in rabbits given oral doses up to 100 mg/kg and 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 given before and during mating) or of impaired post-natal pup development (oral doses up to 1000 mg/kg given during the pre 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.
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. 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 breast feeding 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 sumatriptan 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 and drowsiness, sensory disturbance including paraesthesia and hypoaesthesia have been reported.
Nausea and vomiting occurred in some patients but the relationship to sumatriptan is not clear.
Transient increases in blood pressure arising soon after treatment has 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 sumatriptan 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 sumatriptan. This effect was not dose-related and was also observed in patients receiving placebo. The significance of these findings is uncertain.

Post marketing data.

In addition to the drug-related adverse reaction reported from clinical trials, the following serious spontaneous events, reported to be possibly, probably or almost certainly caused following use of either subcutaneous events, oral or intranasal 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.
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 of sumatriptan orally were not associated with side effects other than those mentioned. There is no experience of doses greater than these.
If overdosage with sumatriptan 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 to 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 humans. In addition, experimental evidence suggests that inhibits trigeminal nerve activity. Both these actions may contribute to the anti-migraine action of 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.

5.2 Pharmacokinetic Properties

In a pilot study no significant differences were found in the pharmacokinetic parameters between elderly and young healthy volunteers.

Absorption.

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.

Distribution.

Population pharmacokinetic modelling indicated that clearance and volume of distribution both increase with body size in the adolescent population resulting in higher exposure in lower bodyweight adolescents. The model predicted that a subject with a body weight of 40 kg would have an apparent clearance of 222 L/h and a volume of distribution of 850 L whilst the corresponding figures for a body weight of 66 kg would be 366 L/h and 1204 L. The predicted dependence of these parameters on body size should not pose any significant safety concern as the recommended initial dose range is 10-20 mg.

Metabolism and excretion.

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 sumatriptan does not appear to be significantly affected by migraine attacks.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose and magnesium stearate.
The tablets also contain Opadry complete film coating system 03K54036 Pink.

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

Store below 25°C.

6.5 Nature and Contents of Container

Sumatriptan Migraine Relief 50 mg is available in packs of 2 tablets. The tablets are in Al/Al blister pack.

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

Chemical structure.


Chemical name: 3-[2-(dimethylamino) ethyl]-N-methyl-1H-indole-5-methane sulphonamide (sumatriptan); 3-[2-(dimethylamino) ethyl]-N-methyl-1H-indole-5-methane sulphonamide, butane-1,4-dioate (1:1) (sumatriptan succinate).
Molecular structure: C14H21N3O2S (sumatriptan); C14H21N3O2S.C4H6O4 (sumatriptan succinate).
Molecular weight: 295.4 (sumatriptan); 413.5 (sumatriptan succinate).

CAS number.

103628-48-4 (sumatriptan succinate).

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist only Medicine.

Summary Table of Changes