5HT1 -agonists.

Sumatriptan

50mg sumatriptan base as the succinate salt. 100mg sumatriptan base as the succinate salt.

Tablet 50 mg tablet: Pink, film-coated, capsule-shaped, biconvex tablet (nominal dimensions: 12 mm x 6.5 mm), engraved “GX ES3” on one face and plain on the other face or“50” on one face and plain on the other face. 100 mg tablet: White or off-white, film-coated, capsule-shaped, biconvex tablet engraved “GX ET2” on one face and plain on the other face or “100” on one face and plain on the other face.

Imigran tablets are indicated for the acute relief of migraine attacks, with or without aura. Imigran should only be used where there is a clear diagnosis of migraine.

Adults

Imigran is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically.

It is advisable that Imigran be given as early as possible after the onset of migraine attack but it is equally effective at whatever stage of the attack it is administered.

The recommended dose of oral Imigran is a single 50mg tablet. Some patients may require 100mg. If the patient has responded to the first dose but the symptoms recur a second dose may be given in the next 24 hours provided that there is a minimum interval of two hours between the two doses and no more than 300mg is taken in any 24 hour period.

Patients who do not respond to the prescribed dose of Imigran should not take a second dose for the same attack. Imigran may be taken for subsequent attacks.

Imigran is recommended as monotherapy for the acute treatment of migraine and should not be given concomitantly with other acute migraine therapies. If a patient fails to respond to a single dose of Imigran there are no reasons, either on theoretical grounds or from limited clinical experience, to withhold products containing aspirin or non-steroidal anti-inflammatory drugs for further treatment of the attack.

The tablets should be swallowed whole with water.

Children (under 12 years of age)

Sumatriptan tablets are not recommended for use in children below 12 as sumatriptan tablets have not been studied in children.

Adolescents (12 to 17 years of age)

The efficacy of sumatriptan tablets in adolescents could not be demonstrated in the clinical studies performed in this age group. Therefore the use in adolescent is not recommended.

Elderly (Over 65)

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

Hypersensitivity to any component of the preparation.

Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or patients who have symptoms or sign consistent with ischaemic heart disease.

Sumatriptan should not be administered to patients with a history of cerebovascular accident (CVA) or transient ischaemic attack (TIA).

Sumatriptan should not be administered to patients with severe hepatic impairment.

The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contraindicated.

The concomitant administration of ergotamine or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine₁ (5-HT₁) receptor agonist with sumatriptan is contraindicated.

Concurrent administration of monoamine oxidase inhibitors and sumatriptan is contraindicated.

Imigran Tablets must not be used within two weeks of discontinuation of therapy with monoamine oxidase inhibitors.

Imigran should only be used where there is a clear diagnosis of migraine.

Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine.

The recommended doses of sumatriptan should not be exceeded. As with other migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.

It should be noted that migraineurs may be at risk of certain cerebrovascular events (e.g. cerebrovascular accident, transient ischaemic attack).

Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat. Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given and appropriate evaluation should be carried out.

Sumatriptan should not be given to patients with risk factors for ischaemic heart disease without prior cardiovascular evaluation. Special consideration should be given to postmenopausal women and males over 40 with these risk factors. These evaluations however, may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.

Sumatriptan should be administered with caution to patients with controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. 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.

Sumatriptan should be administered with caution to patients with conditions which may affect significantly the absorption, metabolism or excretion of drugs, e.g. impaired hepatic or renal function. A 50mg dose should be considered in patients with hepatic impairment.

Sumatriptan should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold, as seizures have been reported in association with sumatriptan.

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.

Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John's Wort (Hypericum perforatum).

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose.

Studies in healthy subjects show that sumatriptan does not interact with propranolol, flunarizine, pizotifen or alcohol. Sumatriptan has the potential to interact with monoamine oxidase inhibitors (MAOIs), ergotamine and derivatives of ergotamine. The increased risk of coronary vasospasm is a theoretical possibility and concomitant administration is contra-indicated.

There are limited data on an interaction with preparations containing ergotamine or another triptan/5-HT1 receptor agonist. The increased risk of coronary vasospasm is a theoretical possibility and concomitant administration is contraindicated.

The period of time that should elapse between the use of sumatriptan and ergotamine-containing preparations or another triptan/5-HT1 receptor agonist is not known. This will also depend on the doses and types of products used. The effects may be additive. It is advised to wait at least 24 hours following the use of ergotamine-containing preparations or another triptan/5-HT1 receptor agonist before administering sumatriptan. Conversely, it is advised to wait at least 6 hours following use of sumatriptan before administering an ergotamine-containing product and at least 24 hours before administering another triptan/5-HT1 receptor agonist.

There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs.

Adverse events are listed below by system organ class and frequency [4]. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports.

Clinical Trial Data

Nervous System Disorders

Common: Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

Vascular Disorders

Common: Transient increases in blood pressure arising soon after treatment. Flushing.

Respiratory, Thoracic and Mediastinal Disorders

Common Dyspnoea.

Gastrointestinal Disorders

Common: Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition.

Musculoskeletal and Connective Tissue Disorders

Common: Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat).

General Disorders and Administration Site Conditions

Common: Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat).

Feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient).

Investigations

Very rare: Minor disturbances in liver function tests have occasionally been observed

Post-Marketing Data

Immune System Disorders

Very rare: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.

Nervous System Disorders

Very rare: Seizures, 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.

Tremor, dystonia, nystagmus, scotoma.

Eye Disorders

Very rare: Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself.

Cardiac Disorders

Very rare: Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction.

Vascular Disorders

Very rare: Hypotension, Raynaud's phenomenon.

Gastrointestinal Disorders

Very rare: Ischaemic colitis

Musculoskeletal, Connective Tissue and Bone Disorders

Very rare: Neck stiffness.

GlaxoSmithKline(GSK)

(POM)

22 June 2009