Consumer medicine information

SUMATRIPTAN SANDOZ [10825]

Sumatriptan

BRAND INFORMATION

Brand name

Sumatriptan Sandoz Tablets

Active ingredient

Sumatriptan

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using SUMATRIPTAN SANDOZ [10825].

What Is In This Leaflet

Please read this leaflet carefully before you start taking Sumatriptan Sandoz tablets.

This leaflet answers some common questions about Sumatriptan Sandoz 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 Sumatriptan Sandoz tablets 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 are Sumatriptan Sandoz tablets used for?

Sumatriptan Sandoz tablets contain the active ingredient sumatriptan succinate.

This medicine belongs to a group of drugs called serotonin agonists.

Sumatriptan Sandoz tablets are used to relieve a migraine attack. They should not be used to prevent migraine attacks from occurring.

Sumatriptan Sandoz tablets 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.

Sumatriptan Sandoz tablets work by making those vessels normal again and ease the symptoms of migraine.

Your Sumatriptan Sandoz tablets do not work in other types of headache which are not a migraine.

Sumatriptan Sandoz tablets are not addictive.

Before you take Sumatriptan Sandoz tablets

Do not take if:

You must not take Sumatriptan Sandoz tablets if:

  • You have ever had an allergic reaction to sumatriptan succinate (See "Side-Effects") or any of the ingredients listed toward the end of this leaflet. (See "Ingredients").
  • 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 (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 (eg Cafergot)
    - Dihydroergotamine (eg Dihydergot)
    - Methysergide (eg Deseril)
    - Naratriptan (eg Naramig)
    - Zolmitriptan (eg Zomig).
  • You have taken any of these medicines in the last two weeks:
    - Monoamine oxidase inhibitors (MAOIs), a type of medicine used for depression.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn or shows signs of tampering.

Tell your doctor if:

You must tell your doctor if:

  • You are allergic to foods, dyes, preservatives or any other medicines, including any that contain sulphur (eg sulphonamide antibiotics).
  • You are allergic to lactose.
  • You 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.
  • You are breast feeding, pregnant or trying to become pregnant.
  • You have or have had medical conditions like:
    - Liver or kidney problems.
    - Heart problems. Risk factors including high blood pressure, even if it is under control, high blood cholesterol levels, a family history of heart problems, obesity, diabetes, you are 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

How do I take Sumatriptan Sandoz tablets?

Take your medicine as your doctor has told you. The label on the pack will tell you how many tablets to take and how often you should take them. 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 of Sumatriptan Sandoz tablets increased to 100 mg. Your doctor will tell you which dose is right for you. If the first Sumatriptan Sandoz tablet helps your migraine, but the migraine comes back later, you may take another Sumatriptan Sandoz tablet. Do not take more than 300 mg of Sumatriptan Sandoz tablets in any twenty-four hours. Six pink (50 mg strength) or three white (100 mg strength) tablets contain 300 mg.

Do not take more Sumatriptan Sandoz 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 Sandoz tablets, you may use Sumatriptan Sandoz tablets on another occasion to treat another migraine attack.

Provided there are no side effects, you can use Sumatriptan Sandoz 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

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

When to take it

It is best to take your Sumatriptan Sandoz tablet -

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

If you take your tablet later during the migraine attack it will still work for you. Do not take your Sumatriptan Sandoz tablet before the above symptoms occur.

What do I do if I take too much? (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have taken too many Sumatriptan Sandoz tablets, 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 Sumatriptan Sandoz tablets

Things you must do

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 this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

As with many other medicines, Sumatriptan Sandoz tablets may cause drowsiness in some people.

Be careful driving or operating machinery until you know how Sumatriptan Sandoz tablets affect you.

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

What are the side effects?

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Sumatriptan Sandoz tablets, even if the problem is not listed below.

Like other medicines, Sumatriptan Sandoz tablets can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

Tell your doctor if you experience any of the following after taking Sumatriptan Sandoz tablets:

  • 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,
  • Shortness of breath.

Tell your doctor immediately, or seek urgent medical attention, and do not take any more Sumatriptan Sandoz tablets if you:

  • Feel heaviness, pressure or tightness in any part of the body including the chest or throat.
  • Feel irregular heart beats.
  • Have a fit or convulsion.
  • Have wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash ("hives") or fainting.

These could be 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.

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

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

How do I store Sumatriptan Sandoz tablets?

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

Keep Sumatriptan Sandoz tablets in the blister pack in a cool, dry place where it stays below 25°C.

Do not leave them in a car, on a window sill or in a bathroom.

Keep Sumatriptan Sandoz tablets in their pack until it is time to take them.

Return any unused or expired medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

Sumatriptan Sandoz comes in 50 mg & 100 mg:

  • Sumatriptan Sandoz 50 mg
    (AUST R 187214)
    Pink coloured, capsule shaped biconvex film coated tablets, plain on both sides. In packs of 2 & 4.
  • Sumatriptan Sandoz 100 mg
    (AUST R 187215)
    White to off-white coloured, capsule shaped biconvex film coated tablets, plain on both sides. In packs of 2.

Ingredients

Active ingredients

  • Sumatriptan Sandoz tablets 50 mg containing Sumatriptan succinate equivalent to 50 mg Sumatriptan per tablet
  • Sumatriptan Sandoz tablets 100 mg containing Sumatriptan succinate equivalent to 100 mg Sumatriptan per tablet

Inactive ingredients

  • Lactose,
  • cellulose microcrystalline,
  • croscarmellose sodium,
  • Hypromellose and magnesium stearate.

Sumatriptan Sandoz tablets 50 mg also contain OPADRY complete film coating system 03K54036 PINK.

Sumatriptan Sandoz tablets 100 mg also contain OPADRY complete film coating system 03A58900 WHITE.

Sumatriptan Sandoz tablets do not contain gluten or sugar.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
Level 2, 19 Harris Street
Pyrmont NSW 2009
Australia
Tel: 1800 634 500

This leaflet was revised in June 2013.

Australian Register Numbers:

  • 100mg tablets: AUST R 187215
  • 50mg tablets: AUST R 187214

BRAND INFORMATION

Brand name

Sumatriptan Sandoz Tablets

Active ingredient

Sumatriptan

Schedule

S4

 

1 Name of Medicine

Sumatriptan succinate.

2 Qualitative and Quantitative Composition

Sumatriptan Sandoz is available in two strengths, 50 mg and 100 mg.

List of excipients with known effects.

Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sumatriptan Sandoz 50 mg (AUST R 187214).

Each film-coated tablet contains Sumatriptan succinate equivalent to 50 mg Sumatriptan.
Pink coloured, capsule shaped biconvex film coated tablets, plain on both sides.

Sumatriptan Sandoz 100 mg (AUST R 187215).

Each film-coated tablet contains Sumatriptan succinate equivalent to 100 mg Sumatriptan.
White to off-white coloured, capsule shaped biconvex film coated tablets, plain on both sides.

4 Clinical Particulars

4.1 Therapeutic Indications

Sumatriptan Sandoz is indicated for the acute relief of migraine attacks with or without aura.

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.

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.
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 sumatriptan 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 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.
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.
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. 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 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/SNRI 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.

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 postnatal pup development (oral doses up to 1000 mg/kg given during the pre 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.
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.
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 breastfeeding woman.

4.7 Effects on Ability to Drive and Use Machines

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 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.

Postmarketing 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.

Nonsite 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 antimigraine 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 presystemic metabolism and partly due to incomplete absorption. Oral absorption of sumatriptan is not significantly affected by food.

Metabolism and 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. 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, microcrystalline cellulose, croscarmellose sodium, hypromellose and magnesium stearate.
The 50 mg tablets also contain Opadry complete film coating system 03K54036 Pink, and the 100 mg tablets also contain Opadry complete film coating system 03A58900 White.

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 Sandoz 50 mg is available in packs of 2 and 4 tablets, and Sumatriptan Sandoz 100 mg is available in pack 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)

S4 - Prescription Only Medicine.

Summary Table of Changes