Auro-Sumatriptan Tablets

AURO-SUMATRIPTAN TABLETS is indicated for the acute relief of migraine attacks with or without aura.

AURO-SUMATRIPTAN TABLETS is indicated for the acute intermittent treatment of migraine. AURO-SUMATRIPTAN TABLETS SHOULD NOT BE USED PROPHYLACTICALLY

Tablets: The recommended dose for initial therapy is 50 mg, depending on response this may be increased to 100 mg. If symptoms recur, a further dose may be given at any time in the next 24 hours provided not more than 3 x 100 mg tablets or 6 x 50 mg tablets are taken in any 24 hour period and that each dose is separated by at least two hours. A second dose has not proven to provide relief if the first dose did not have a beneficial effect on the migraine. The tablet should be swallowed whole with water. The dose of AURO-SUMATRIPTAN TABLETS should be reduced in patients with impaired liver function. It is recommended that AURO-SUMATRIPTAN TABLETS be administered as early as possible after the onset of migraine however it is equally effective at whatever stage of the attack it is given.

AURO-SUMATRIPTAN TABLETS is contra-indicated in patients with hypersensitivity to any component of the preparation. Following administration of AURO-SUMATRIPTAN TABLETS patients with known hypersensitivity to sulphonamides can experience an allergic reaction. Hypersensitivity reactions may range from cutaneous hypersensitivity to anaphylaxis. AURO-SUMATRIPTAN TABLETS should not be used in patients who have had a myocardial infarction, ischaemic heart disease, Prinz metalu2019s angina/coronary vasospasm or ischaemic cerebro-vascular disease. AURO-SUMATRIPTAN TABLETS is not recommended in patients with uncontrolled hypertension. The concomitant use of AURO-SUMATRIPTAN TABLETS and ergotamine containing preparations is contra-indicated. Concurrent administration of monoamine oxidase inhibitors or use within two weeks of discontinuation of MAOI therapy is contra-indicated. AURO-SUMATRIPTAN TABLETS should not be administered to patients with severe hepatic impairment. AURO-SUMATRIPTAN TABLETS is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine.

Following administration of AURO-SUMATRIPTAN TABLETS patients with known hypersensitivity to sulphonamides can experience an allergic reaction. Hypersensitivity reactions may range from cutaneous hypersensitivity to anaphylaxis. The use of AURO-SUMATRIPTAN TABLETS can be associated with transient symptoms, including chest pain and chest tightness, which may be intense and involve the throat. Although these symptoms can mimic angina pectoris, they are only in exceptional circumstances the result of myocardial ischaemia/coronary vasospasm. Vasospasm may present as an arrhythmia. The recommended dose of AURO-SUMATRIPTAN TABLETS should not be exceeded. Drowsiness may occur as a result of migraine or its treatment with AURO-SUMATRIPTAN TABLETS. Caution is advised in patients performing skilled tasks, e.g. operating machinery or driving. AURO-SUMATRIPTAN TABLETS should only be used where there is clear diagnosis of migraine. 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. It should be noted that migraineurs may be at risk of certain cerebrovascular events (e.g. CVA, TIA). AURO-SUMATRIPTAN TABLETS 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 years of age and patients with risk factors for coronary artery disease. However, these evaluations may not identify every patient who has cardiac disease. Serious cardiac events have occurred in patients without underlying cardiovascular disease. AURO-SUMATRIPTAN TABLETS should be administered with caution to patients with controlled hypertension as increases in blood pressure and peripheral vascular resistance have been observed. If concomitant treatment with AURO-SUMATRIPTAN TABLETS and a selective serotonin reuptake inhibitor (SSRI) is clinically warranted, appropriate observation of the patient is advised as there is a risk of serotonin syndrome (see u201cInteractionsu201d). AURO-SUMATRIPTAN TABLETS should be used with caution in patients with a history of epilepsy or structural brain lesions, which lower their convulsion threshold. Children (under 18 years of age) and patients aged more than 65 years: The safety and effectiveness of AURO-SUMATRIPTAN TABLETS in children (under 18 years of age) and patients over 65 years has not yet been established.

Prolonged vasospastic reactions have been reported with ergotamine. Since these effects may be additive, 24 hours should pass before AURO-SUMATRIPTAN TABLETS can be administered following an ergotamine preparation. Conversely, ergotamine containing preparations should not be taken until 6 hours having passed following AURO-SUMATRIPTAN TABLETS administration. There is no evidence of interactions with flunarizine, propranolol, dihydroergotamine, pizotifen or alcohol. An interaction may occur between AURO-SUMATRIPTAN TABLETS and MAOIu2019s and concomitant administration is contraindicated. Rarely an interaction may occur between AURO-SUMATRIPTAN TABLETS and SSRIs.

Safety in pregnancy and lactation has not been established.

Drowsiness may occur as a result of migraine or its treatment with AURO-SUMATRIPTAN TABLETS. Caution is advised in patients performing skilled tasks, e.g. operating machinery or driving.

Side-effects which have been reported include the following: Cardiac Disorders Less frequent: chest-pain, sensations of tingling, heaviness, heat, pressure or tightness. These symptoms are usually transient and may be intense and can affect any part of the body including the throat and chest. In extremely rare cases serious coronary events have been reported which have included cardiac arrhythmias, transient ischaemic ECG changes or myocardial infarction. Thus AURO-SUMATRIPTAN TABLETS should not be given to patients in whom unrecognised cardiac disease is likely without a prior evaluation for underlying cardiovascular disease. These patients include males over 40 years of age, postmenopausal women and patients with risk factors for coronary disease. If any symptoms that are consistent with ischaemic heart disease occur, appropriate evaluation must be performed. The following side effects have been reported and frequencies are unknown: Transient increases in blood pressure, peripheral vascular resistance, bradycardia, hypotension, palpitations and tachycardia. Gastrointestinal Disorders: Frequent: Nausea and vomiting occurred in some patients but the relationship to AURO-SUMATRIPTAN TABLETS is not clear. The following side effects have been reported and frequencies are unknown: Disturbances in liver function tests have been observed. AURO-SUMATRIPTAN TABLETS should also be administered with caution to patients with diseases which may alter the absorption, metabolism or excretion of drugs, such as impaired hepatic function. Lower doses should be considered in patients with hepatic impairment. Nervous System Disorders: Less frequent: Seizures AURO-SUMATRIPTAN TABLETS should be used with caution in patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold. Vascular Disorders: Less frequent: Flushing General Disorders: Less frequent: Dizziness, feelings of weakness, fatigue and drowsiness.

The patient should be monitored for at least ten hours and supportive treatment applied as required in the case of overdosage. It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of AURO-SUMATRIPTAN TABLETS.