Consumer medicine information

APO-Sumatriptan

Sumatriptan

BRAND INFORMATION

Brand name

APO-Sumatriptan

Active ingredient

Sumatriptan

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Sumatriptan.

What is in this leaflet

This leaflet answers some common questions about sumatriptan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What this medicine is used for

Sumatriptan is used to relieve a migraine attack. This medicine may be used for migraine headaches with or without what is known as 'aura'.

Sumatriptan belongs to a group of drugs called serotonin agonists.

How it works

It is thought that a migraine headache is due to widening of certain blood vessels in the head. Sumatriptan works by making the affected vessels normal again, to ease the symptoms of migraine.

This medicine does not work in other types of headache which are not a migraine. It should not be used to prevent migraine attacks from occurring.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

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

This medicine is not addictive.

The effectiveness of this medicine has not been established in adolescents between 12 and 17; and the safety and effectiveness of this medicine in children under the age of 12 years has not been established.

Sumatriptan is not recommended for use in people aged over 65 years.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:

  • sumatriptan succinate
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine if you have or have had any of the following medical conditions:

  • 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 you are prone to cold, tingling or numb hands and feet
  • Prinzmetal's angina (an uncommon form of angina where pain is experienced at rest rather than during activity)
  • angina
  • high blood pressure which is not controlled by medication
  • stroke or "mini-stroke"
  • severe liver disease
  • types of migraine called hemiplegic, basilar or ophthalmoplegic migraine

Do not take this medicine if you are taking or have taken any of these medicines in the last 24 hours:

  • ergotamine (e.g. Cafergot)
  • dihydroergotamine (e.g. Dihydergot)
  • methysergide (e.g. Deseril)

Do not take this medicine if you are taking or have taken Monoamine Oxidase Inhibitors (MAOIs) in the last two weeks, such as:

  • phenelzine, tranylcypromine and moclobemide, used to treat depression
  • selegiline, used to treat Parkinson's disease
  • linezolid, used to treat certain infections
  • methylene blue, used to diagnose certain medical conditions.

Do not take this medicine if you are taking or have taken SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin-Noradrenaline Reuptake Inhibitors) used to treat depression in the last two weeks.

Do not use this medicine after the expiry date printed on the pack or the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are allergic to any medicines that contain sulphur, such as sulphonamide antibiotics.

Tell your doctor if you are lactose-intolerant or unable to consume lactose, as these tablets contain lactose.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Do not take this medicine until you and your doctor have discussed the risks and benefits involved.

Tell your doctor if you have or have had any of the following medical conditions:

  • liver or kidney problems
  • heart problems or you have conditions which may make you prone to heart problems such as:
    - high blood pressure, even if it is under control
    - high blood cholesterol levels
    - a family history of heart problems
    - obesity
    - diabetes
    - you are male and over 40 years of age
    - you are female and have undergone menopause
    - smoking
  • epilepsy, seizures, or fits, or been told that you are prone to this problem
  • stroke or 'mini-stroke'

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, or you have taken any medicine in the last 2 weeks, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and sumatriptan may interfere with each other. These include:

  • MAO inhibitors, such as phenelzine, tranylcypromine, moclobemide, selegiline, linezolid, and methylene blue. Do not take this medicine with MAOIs or for two weeks after stopping taking a MAOI.
  • other triptans (similar to sumatriptan) such as naratriptan and zolmitriptan. Do not take sumatriptan for 24 hours before or after taking another triptan.
  • other medicines for treating migraine such as ergotamine, dihydroergotamine or methysergide. Do not take sumatriptan for 6 hours before or 24 hours after taking ergotaminetype medicines.
  • medicines for treating depression such as SSRIs and SNRIs (e.g. fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, venlafaxine, nefazodone, mirtazapine)
  • St John's wort, a herbal medicine.

These medicines may be affected by this medicine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Other medicines not listed above may also interact with sumatriptan.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully. They may differ to the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines. If you have liver problems you may be prescribed a lower dose.

The recommended starting dose for adults aged 18 to 65 is 50 mg, however your dose may be increased to 100 mg if needed.

If the first tablet helps your migraine, but the migraine comes back again later, you may take another tablet.

If the first dose has not provided any relief from your symptoms, do not take any more sumatriptan for this attack. Your doctor should review your treatment to check if this medicine is still appropriate for you.

Do not take more than 300 mg of this medicine in any 24 hours. Six pink (50 mg strength) or three white (100 mg strength) tablets contain 300 mg of sumatriptan.

You may take your usual headache relief medication provided it does not contain ergotamine, methysergide, naratriptan or zolmitriptan. If you are not sure what to do, ask your doctor or pharmacist.

If your migraine is not relieved by this medicine, you may use sumatriptan tablets on another occasion to treat another migraine attack. Provided there are no side effects, you can use sumatriptan tablets to treat at least three separate migraine attacks before you and your doctor decide this medicine is ineffective for you.

How to take it

Swallow the tablets whole with a glass of water. Do not crush or chew this medicine as it has a bitter taste.

When to take it

It is best to take this medicine:

  • 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 this medicine later during the migraine attack, it will still work for you. Do not take this medicine before the above symptoms occur.

It does not matter if you take it with or without food.

How long to take it for

This medicine is not to be used on a regular basis. Use it only when you have migraine symptoms, and if the tablets do not relieve your migraine then do not take any more for that migraine.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking this medicine

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell your doctor if, for any reason, you have not taken this medicine exactly as directed. Otherwise your doctor may think that it is not working and change your treatment unnecessarily.

If you become pregnant while taking this medicine, tell your doctor immediately.

Tell your doctor if you are going to have surgery or are going into hospital.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not take your medicine to treat any other complaint unless your doctor tells you to.

Do not change the dosage without first checking with your doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you. This medicine may cause drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

If you use this medicine too often, it may make your headache worse. If this happens, your doctor may tell you to stop taking this medicine.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking sumatriptan.

This medicine helps most people with migraine headaches, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • pain, tingling, burning, prickling, cold or flushing in any part of the body
  • loss of touch sensitivity
  • feeling of sleepiness, dizziness weakness or tiredness
  • nausea (feeling sick) or vomiting
  • a change in blood pressure
  • feeling of faintness
  • problems with your eye sight or jittery eye movements
  • shaking or tremors, uncontrolled movements

The above list includes the more common side effects of your medicine. Mostly, these are mild and short-lived.

Tell your doctor as soon as possible if you notice any of the following:

  • pain in the lower tummy and bloody diarrhoea (signs of ischemic colitis)
  • breathing problems
  • feeling faint due to a drop in blood pressure

The above list includes serious side effects that may need medical attention.

If any of the following happen, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; hayfever-like symptoms (signs of an allergic reaction)
  • neck pain or stiffness, feeling of heaviness, pressure or tightness in any part of the body including the head, chest or throat
  • chest pain or angina; or symptoms of a heart attack such as chest pain, shortness of breath nausea, vomiting, palpitations, sweating, anxiety
  • fast, slow, thumping or irregular heartbeats
  • seizures (fits)
  • problems with speech, and/or lack of muscle movement on one side of your body (signs of a stroke)
  • persistent purple or white discolouration and/or pain in the fingers, toes, ears, nose or jaw, sometimes in response to cold

The above list includes very serious side effects. Stop taking sumatriptan tablets and seek medical attention straight away. Most of these side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some patients.

Storage and disposal

Storage

Keep your medicine in the pack until it is time to take it. If you take your medicine out of the pack it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 30°C.

Do not store your medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine left over.

Product description

What it looks like

50 mg tablets: pink coloured, capsule shaped, biconvex film coated tablets, debossed with '50' on one side and plain on the other side.

Available in blister packs containing 2 or 4 tablets. AUST R 160188.

100 mg tablets: white, capsule shaped, biconvex film coated tablets debossed with '100' on one side and plain on the other side.

*Not all strengths and/or pack sizes may be available.

Ingredients

Each tablet contains 50 mg or 100 mg of sumatriptan (as succinate) as the active ingredient.

It also contains the following:

  • lactose
  • croscarmellose sodium
  • microcrystalline cellulose
  • crospovidone
  • colloidal silica anhydrous
  • magnesium stearate
  • Opadry Pink (50 mg only) which contains hypromellose, macrogol 400, titanium dioxide, iron oxide red and iron oxide black
  • Opadry White (100 mg only) which contains hypromellose, macrogol 400, titanium dioxide

This medicine does not contain gluten, sucrose, tartrazine or any other azo dyes.

Contains sugars (as lactose).

Sponsor

Arrotex Pharmaceuticals Pty Ltd,
15 – 17 Chapel st.,
Cremorne VIC 3121

This leaflet was prepared in December 2022.

Published by MIMS February 2023

BRAND INFORMATION

Brand name

APO-Sumatriptan

Active ingredient

Sumatriptan

Schedule

S4

 

1 Name of Medicine

Sumatriptan succinate.

2 Qualitative and Quantitative Composition

For APO-Sumatriptan brand:
Each tablet contains 50 mg sumatriptan (as succinate), as the active ingredient.
In addition, each tablet contains the following inactive ingredients: lactose, microcrystalline cellulose, crospovidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and Opadry 03B84755 Pink as coating material. The coating material contains hypromellose, titanium dioxide, macrogol 400, iron oxide red and iron oxide black.
APO-Sumatriptan tablets are intended for oral administration.

Excipients with known effect.

Contains sugars (as lactose).

3 Pharmaceutical Form

For APO-Sumatriptan brand:
Pink coloured, capsule shaped, biconvex film coated tablets, debossed with "50" on one side and plain on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Sumatriptan tablets are indicated for the acute relief of migraine attacks with or without aura.
There is no information available on the use of sumatriptan tablets in the treatment of basilar or hemiplegic migraine.

4.2 Dose and Method of Administration

Sumatriptan is indicated for the acute intermittent relief of both migraine and cluster headache. It should not be used prophylactically.
Ergotamine or ergotamine derivatives and sumatriptan should not be administered concurrently (see Section 4.3 Contraindications).

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 sumatriptan, a second dose should not be taken for the same attack. Sumatriptan may be used for subsequent attacks.
The initial recommended adult dose of oral sumatriptan tablets is 50 mg. Some patients may require 100 mg. The dose should be adjusted according to the individual's response. If symptoms recur further doses may be given in the next 24 hours provided not more than 300 mg are taken in any 24 hour period. The tablet should be swallowed whole with water.

4.3 Contraindications

Sumatriptan should not be used in patients who have:
hypersensitivity to any component of the preparation (see Section 2 Qualitative and Quantitative Composition; Section 3 Pharmaceutical Form);
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

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.
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 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.
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.
Coadministration of sumatriptan within 24 hours of other 5HT1 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 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 sumatriptan 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 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 of sumatriptan 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 the elderly.

Experience of the use of sumatriptan 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 Sumatriptan in patients aged over 65 is not recommended.

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.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacodynamics.

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).

Pharmacokinetics.

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 postmarketing 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/ SRNI is clinically warranted, appropriate observation of the patient is advised.
The concomitant administration of any triptan/ 5HT1 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 5HT1 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.

No data available.
(Category B3)
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 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 postnatal pup development (oral doses up to 1000 mg/kg, given during the peri and postnatal 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 postimplantation 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 1,000 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 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, 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 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 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 oral sumatriptan. 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 sumatriptan tablets.

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 following 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 http://www.tga.gov.au/reporting-problems and contact Arrotex Medical Information enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.9 Overdose

Symptoms.

Single doses up to 400 mg with sumatriptan orally were not associated with side effects other than those mentioned. There is no experience of doses greater than these.

Treatment.

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 Poison Information Centre on 131126 (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 antimigraine 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.

5.2 Pharmacokinetic Properties

In a pilot study no significant differences were found in the pharmacokinetic parameters between elderly and young healthy volunteers.
The pharmacokinetics of oral sumatriptan do not appear to be significantly affected by migraine attacks.

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 presystemic 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 1,204 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.

See Section 5.2 Pharmacokinetic Properties, Excretion.

Excretion.

Nonrenal 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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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 30°C.

6.5 Nature and Contents of Container

50 mg tablets.

Blister pack (Aluminium/Aluminium silver foil) of 2 or 4 tablets (AUST R 160188).
Not all pack sizes may be available.

6.6 Special Precautions for Disposal

In Australia, any used medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Sumatriptan takes the form of a white to pale yellow powder. Sumatriptan succinate takes the form of a white to off-white powder.

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).
Structural Formula:
Molecular Formula: 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)

S4 - Prescription Only Medicine.

Summary Table of Changes