Consumer medicine information

Sumagran Aspen Tablets

Sumatriptan

BRAND INFORMATION

Brand name

Sumagran Aspen Tablets

Active ingredient

Sumatriptan

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sumagran Aspen Tablets.

What is in this leaflet

Please read this leaflet carefully before you start taking SUMAGRAN ASPEN tablets.

This leaflet answers some common questions about SUMAGRAN ASPEN tablets. It does not contain all of 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 expected benefits of you taking SUMAGRAN ASPEN against the risks this medicine could 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 need to read it again.

What SUMAGRAN ASPEN is used for

SUMAGRAN ASPEN contain the active ingredient sumatriptan succinate. This medicine belongs to a group of drugs called serotonin agonists.

SUMAGRAN ASPEN are used to relieve a migraine attack. They should not be used to prevent migraine attacks from occurring. SUMAGRAN ASPEN may be used for migraine headaches with or without what is known as 'aura'.

It is thought that migraine headache is due to widening of certain blood vessels in the head.

SUMAGRAN ASPEN works by making those vessels normal again and eases the symptoms of migraine.

SUMAGRAN ASPEN does not work in other types of headache that are not a migraine.

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

SUMAGRAN ASPEN are not addictive.

SUMAGRAN ASPEN is available only with a doctor's prescription.

Use in children and adolescents
SUMAGRAN ASPEN is not recommended for use in children and adolescents under 12 years of age, as the safety and efficacy in this age group has not been established.

Use in elderly
SUMAGRAN ASPEN is not recommended for use in elderly patients aged over 65, as experience of its use in this age group is limited.

Before you take it

When you must not take it

Do not take SUMAGRAN ASPEN if you are allergic to sumatriptan succinate or 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 or other parts of the body; rash, itching or hives on the skin.

Do not take SUMAGRAN ASPEN if 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
  • Prinzmetal’s angina (uncommon form of angina where pain is experienced at rest rather than during activity)
  • angina
  • high blood pressure
  • stroke
  • severe liver disease.

Do not take SUMAGRAN ASPEN if you have taken any of these medicines in the last 24 hours:

  • ergotamine (eg Cafergot)
  • dihydroergotamine (eg Dihydergot)
  • methysergide (eg Deseril)
  • naratriptan (eg Naramig)
  • zolmitriptan (eg Zomig).

Do not take SUMAGRAN ASPEN if you have taken monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression, in the last two weeks.

Do not take SUMAGRAN ASPEN if the expiry date (EXP) printed on the pack has passed.

Do not take SUMAGRAN ASPEN if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are allergic to foods, dyes, preservatives or any other medicines including those containing sulphur (eg sulphonamide antibiotics) or lactose (SUMAGRAN ASPEN tablets contain lactose).

Tell your doctor if you are taking or have taken any other medicines in the last two weeks, including those you buy without a prescription, particularly herbal preparations containing St John's wort.

Tell your doctor if you are breastfeeding, pregnant or trying to become pregnant.

Tell your doctor if you have or have had medical conditions like:

  • liver or kidney problems
  • heart problems; risk factors including high blood pressure (even it is under control), high blood cholesterol levels, a family history of heart problem, obesity, diabetes, smoking, male and over 40 years of age, female and have undergone menopause
  • epilepsy, seizures or fits or been told that you are prone to this problem
  • stroke.

Tell your doctor if you:

  • have not had your headache diagnosed as migraine by a doctor
  • think that this headache is different and worse than your usual migraine
  • have difficulty moving one side of your body when you have the “migraine” headache
  • have not responded to your first dose of SUMAGRAN ASPEN.

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

Taking other medicines

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

Some medicines may be affected by SUMAGRAN ASPEN, or may affect how well it works. These include:

  • ergotamine
  • dihydroergotamine
  • methysergide
  • triptans such as naratriptan, zolmitriptan
  • monoamine oxidase inhibitors
  • St John’s wort
  • other medicines for depression.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

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

How to take it

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand what you should do, ask your doctor or pharmacist.

How much to take

The recommended starting dose for adults is 50 mg. However, you may need to have your dose increased to 100 mg. Your doctor will tell you which dose is right for you.

If the first SUMAGRAN ASPEN tablet helps your migraine, but the migraine comes back later, you may take another SUMAGRAN ASPEN tablet. Do not take more than 300 mg of SUMAGRAN ASPEN tablets in any 24-hour period. Six 50 mg or three 100 mg tablets contain 300 mg.

Do not take more SUMAGRAN ASPEN tablets, or any other form of medications containing 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, dihydroergotamine or methysergide. If you are not sure what to do, ask your doctor or pharmacist.

If your migraine is not relieved by SUMAGRAN ASPEN, you may use it on another occasion to treat another migraine attack.

Provided there are no side effects, you can use SUMAGRAN ASPEN to treat at least three separate migraine attacks before you and your doctor decide this medicine is ineffective for you.

How to take SUMAGRAN ASPEN

Swallow the tablets with a drink of water. Do not crush or chew the tablet as it has a bitter taste.

When to take SUMAGRAN ASPEN

It is best to take your SUMAGRAN ASPEN:

  • 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 SUMAGRAN ASPEN before the above symptoms occur.

If you take too much SUMAGRAN ASPEN (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much SUMAGRAN ASPEN.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking it

Things you must do

Tell any other doctors, dentists and pharmacists who treat you that you are taking SUMAGRAN ASPEN.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking SUMAGRAN ASPEN.

Tell your doctor if you become pregnant or are trying to become pregnant while taking SUMAGRAN ASPEN.

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

Otherwise, your doctor may think that it is not working and change your treatment unnecessarily.

Things you must not do

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

Do not use SUMAGRAN ASPEN to treat any other medical complaints unless your doctor tells you to.

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

Things to be careful of

Be careful driving or operating machinery until you know how SUMAGRAN ASPEN affect you.

As with many other medicines, SUMAGRAN ASPEN may cause drowsiness in some people.

Side effects

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

Like all other medicines, SUMAGRAN ASPEN may have unwanted side effects in some people. 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 this list of possible side effects.

You may not experience any of them.

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

Tell your doctor if you experience any of the following after taking SUMAGRAN ASPEN:

  • 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
  • problems with your eyesight
  • pain in the lower tummy and bloody diarrhoea (ischaemic colitis)
  • shaking or tremors
  • uncontrolled movements.

If you notice any of the following while taking SUMAGRAN ASPEN, stop taking it and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

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

These side effects are likely to be serious. You may need urgent medical attention or hospitalisation.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

After using it

Storage

Keep SUMAGRAN ASPEN 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.

Keep the tablets in a cool, dry place where the temperature stays below 30°C.

Keep the tablets in their pack until time to take.

If you take it out of the pack, it may not keep well.

Do not store SUMAGRAN ASPEN in the bathroom or near a sink.

Do not leave SUMAGRAN ASPEN in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking SUMAGRAN ASPEN, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

SUMAGRAN ASPEN tablets come in two strengths:

  • SUMAGRAN ASPEN 50 - pink, capsule shaped, biconvex film coated tablets debossed with “50” on one side and plain on the other. Each pack contains 2 or 4 tablets.
  • SUMAGRAN ASPEN 100 - white, capsule shaped, biconvex film coated tablets debossed with “100” on one side and plain on the other. Each pack contains 2 tablets.

Ingredients

The active ingredient in SUMAGRAN ASPEN is sumatriptan (as succinate).

  • each SUMAGRAN ASPEN 50 contains 50 mg of sumatriptan
  • each SUMAGRAN ASPEN 100 contains 100 mg of sumatriptan.

The tablets also contain:

  • microcrystalline cellulose
  • croscarmellose sodium
  • magnesium stearate
  • anhydrous lactose
  • crospovidone
  • Opadry complete film coating system
  • silica - colloidal anhydrous

The tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Aspen Pharma Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

Australian registration numbers:
SUMAGRAN ASPEN 50 - AUST R 160185
SUMAGRAN ASPEN 100 - AUST R 160193

Date of preparation: January 2012

BRAND INFORMATION

Brand name

Sumagran Aspen Tablets

Active ingredient

Sumatriptan

Schedule

S4

 

Name of the medicine

Sumatriptan succinate.

Excipients.

Lactose, croscarmellose sodium, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, and the relative colourants Opadry 03B84755 White and Opadry 03B28796 Pink contain hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, iron oxide black, depending on the colour.

Description

Sumatriptan.

Chemical name: 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methane sulphonamide. Molecular formula: C14H21N3O2S. MW: 295.4. It takes the form of a white to pale yellow powder.

Sumatriptan succinate.

Chemical name: 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methane sulphonamide, butane-1,4-dioate (1:1). Molecular formula: C14H21N3O2SC4H6O4. MW: 413.5. CAS: 103628-48-4. It takes the form of a white to off white powder.

Pharmacology

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.

Pharmacokinetics.

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.
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 bodyweight 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 bodyweight 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.
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. The pharmacokinetics of oral 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.

Clinical Trials

Clinical studies conducted in the adult population.

Table 1 demonstrates 2 and 4 hour efficacy results in two placebo controlled studies of sumatriptan tablets in 332 adult migraineurs experiencing moderate or severe pain.

Indications

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

Contraindications

Sumatriptan should not be used in patients who have the following.
Hypersensitivity to any component of the preparation (see 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.

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.
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 5-HT1 agonists is not recommended due to the potential for vasocontrictive 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 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 preexisting 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 Contraindications).

Cerebrovascular.

Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with oral or subcutaneous 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 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.

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.

Use in pregnancy.

(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 postnatal pup development (oral doses up to 1000 mg/kg, subcutaneous doses up to 81 mg/kg, given during the perinatal and postnatal period). In rabbits, 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.
Administration of this drug should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

Use in lactation.

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.

Special populations.

Adolescents (12-17 years) and children (under 12 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. The safety and effectiveness of sumatriptan in children under the age of 12 years has not been established.

Patients over 65 years.

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.

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 Contraindications).

Pharmacokinetic.

An interaction may occur between sumatriptan and MAOIs and concomitant administration is contraindicated (see 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/ 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.

Adverse Effects

The most common side effects associated with treatment with sumatriptan are the following.
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 Precautions). 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 Precautions).
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 either oral or subcutaneous 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.

Postmarketing 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 either subcutaneous, oral or intranasal sumatriptan in patients less than 18 years of age have been identified.

Cardiovascular.

Myocardial infarction.

Cerebrovascular.

Cerebellar infarction.

Neurology.

Seizures, tremor & dystonia.

Nonsite specific.

Anaphylaxis.

Skin.

Urticaria, rash.

Dosage and 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 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 Sumagran Aspen 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.

Overdosage

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.
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.
Contact the Poisons Information Centre (telephone 131 126) for advice on overdose management.

Presentation

Tablets (capsule shaped, biconvex film coated, plain on reverse. 50 mg (pink, marked 50 on one side): 2's, 4's (blister pack); 100 mg (white, marked 100 on one side): 4's (blister pack).

Storage

Store below 30°C.

Poison Schedule

S4.