ZOLMITRIPTAN

5 mg. If symptoms persist or return within 24 hours, a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose. 5 mg doses, subsequent attacks can be treated with 5 mg doses of Zolmitriptan.

In those patients who respond, significant efficacy is apparent within 1 hour of dosing. 5 mg film-coated tablet is taken as early as possible after the onset of migraine headache. 5 mg film-coated tablets in a 24 hour period should not exceed 10 mg.

5 mg film-coated tablets is not indicated for prophylaxis of migraine. 5 mg film-coated tablets in children aged 0-12 years has not yet been established. No data are available. 5 mg film-coated tablets in children is therefore not recommended.

5 mg film-coated tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. 5 mg film-coated tablets in adolescents is therefore not recommended. 5 mg film-coated tablets in individuals aged over 65 years have not been systematically evaluated.

2). Therefore for patients with moderate or severe hepatic impairment a maximum dose of 5 mg in 24 hours is recommended. 2). Method of administration To be taken by oral administration.

Summary of the safety profile Zolmitriptan is well tolerated. Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment. Possible adverse reactions tend to occur within four hours of dosing, and are no more frequent following repeated dosing.

The following definitions apply to the incidence of the undesirable effects:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). The following undesirable effects have been reported following administration of zolmitriptan: System Organ Class Frequency Undesirable Effect Immune system disorders Rare Anaphylaxis/Anaphylactoid Reactions; Hypersensitivity reactions.

Nervous system disorder Common Abnormalities or disturbances of sensation; Dizziness; Headache; Hyperaesthesia; Paraesthesia; Somnolence; Warm sensation. Common Palpitations. Uncommon Tachycardia. Cardiac disorders Very rare Angina pectoris; Coronary vasospasm; Myocardial infarction.

Vascular disorders Uncommon Transient increases in systemic blood pressure Gastrointestinal disorders Common Abdominal pain; Dry mouth; Nausea; Vomiting Dysphagia. Very rare Bloody diarrhoea; Gastrointestinal infarction or necrosis; Gastrointestinal ischaemic events; Ischaemic colitis; Splenic infarction.

Skin and subcutaneous tissue disorders Rare Angioedema; Urticaria. Musculoskeletal and connective tissue disorders Common Muscle weakness; Myalgia. Uncommon Polyuria; Increased urinary frequency. Renal and urinary disorders Very rare Urinary urgency.

General disorders and administration site conditions Common Asthenia; Heaviness, tightness, pain or pressure in throat, neck, limbs or chest. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Zolmitriptan should only be used where a clear diagnosis of migraine has been established. As with other acute migraine therapies, 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.

Zolmitriptan is not indicated for use in hemiplegic, basilar migraine. Stroke and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists. It should be noted that migraneurs may be at risk of certain cerebrovascular events.

Cerebral haemorrhage, subarachnoid haemorrhage, stroke and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists. Zolmitriptan should not be given to patients with symptomatic Wolff-Parkinson- White syndrome or arrhythmias associated with other cardiac accessory conduction pathways.

In very rare cases, as with other 5HT1B/1D agonists, coronary vasospasm, angina pectoris and myocardial infarction have been reported. g. 3). 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. 8) have been reported after the administration of zolmitriptan.

If chest pain or symptoms consistent with ischaemic heart disease occur, no further doses of zolmitriptan should be taken until after appropriate medical evaluation has been carried out. As with other 5HT1B/1D agonists transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension.

Very rarely these increases in blood pressure have been associated with significant clinical events. As with other 5HT1B/1D agonists, there have been rare reports of anaphylaxis/anaphylactoid reactions in patients receiving Zolmitriptan.

1 • Uncontrolled hypertension. • Ischaemic heart disease • Coronary vasospasm/Prinzmetal’s angina • A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA) • Concomittant administration of Zolmitriptan with ergotamine or ergotamine derivatives (including methysergide) or other 5-HT1 receptor agonists.