IMIGRAN Tablet

Indication:

IMIGRAN tablets are indicated for the acute relief of migraine attacks with or without aura, including the acute treatment of migraine attacks associated with the menstrual period in women.

Dosage and administration:

Populations Adults

The recommended dose of oral IMIGRAN is a single 50 mg tablet. Some patients may require 100 mg.

If a patient does not respond to the first dose of IMIGRAN, a second dose should not be taken for the same attack. IMIGRAN tablets may be taken for subsequent attacks.

If the patient has responded to the first dose, but the symptoms recur a second dose may be given, provided that there is a minimum interval of two hours between doses and not more than 300 mg is taken in any 24-hour period.

The tablets should be swallowed whole with water.

Children and Adolescents (under 18 years of age)

The efficacy of sumatriptan tablets in this population has not been demonstrated (see Clinical Studies).

Elderly (over 65 years of age)

Experience of the use of sumatriptan tablets 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.

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

•IMIGRAN should not be administered to patients with a history of previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

•The use of IMIGRAN in patients with uncontrolled hypertension is contraindicated.

•IMIGRAN should not be administered to patients with severe hepatic impairment.

•The concomitant use of ergotamine or derivatives of ergotamine (including methysergide) is contraindicated (see Interactions).

•Concurrent administration of monoamine oxidase inhibitors (MAOIs) and IMIGRAN is contraindicated. IMIGRAN must not be used within 2 weeks of discontinuation of therapy with MAOIs.

Nervous system disorders

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

Vascular disorders

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

There is no evidence of interactions with propanolol, flunarizine, pizotifen or alcohol.

Prolonged vasospastic reactions have been reported with ergotamine. As these effects may be additive, 24 hours should elapse before sumatriptan can be taken following any ergotamine containing preparation. Conversely, ergotamine containing preparations should not be taken until six hours have elapsed following IMIGRAN administration.

An interaction may occur between IMIGRAN and MAOIs and concomitant administration is contraindicated (see Contraindications).

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 (see Warnings and Precautions).

Pregnancy

Caution should be exercised by considering the expected benefit to the mother against possible risk to the foetus. Post-marketing data from multiple prospective pregnancy registries have documented the pregnancy outcomes in over 1,000 women exposed to sumatriptan. Although there is insufficient information to draw definitive conclusions, the findings have not detected an increase in the frequency of birth defects nor a consistent pattern of birth defects, amongst women exposed to sumatriptan compared with the general population.

Lactation

It has been demonstrated that following subcutaneous administration sumatriptan is excreted into breast milk. Infant exposure can be minimized by avoiding breast feeding for 12 hours after treatment.

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

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

Before treating with IMIGRRAN, care should be taken to exclude potentially serious neurological conditions (e.g. CVA, TIA) if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for IMIGRAN use. Following administration, IMIGRAN 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 (IHD) appropriate evaluation should be carried out.

IMIGRAN should not be given to patients in whom unrecognized cardiac disease is likely without a prior evaluation for underlying cardiovascular disease. Such patients include post-menopausal women, males over 40 and patients with risk factors for coronary artery disease. However, these evaluations 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.

IMIGRAN 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 re-uptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline re-uptake inhibitors (SNRIs).

If concomitant treatment with IMIGRN and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised.

The concomitant administration of any triptan/5-HI1 agonist with IMIGRAN is not recommended.

IMIGRAN should be administered with caution to patients with conditions that may affect significantly the absorption. metabolism or excretion of the drug, e.g. impaired hepatic (Child Pugh grade A or B) or renal function.

IMIGRAN should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold.

Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of IMIGRAN. Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross-sensitivity is limited, however, caution should be exercised before using IMIGRAN in these patients.

Overuse of acute headache treatments has been associated with the exacerbation of headache (medication overuse headache, MOH) in susceptible patients. Withdrawal of the treatment may be necessary.