ZOLMITRIPTAN

5mg. If symptoms of migraine persist or recur within 24 hours, a second dose of zolmitriptan 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 with5 mg doses of zolmitriptan could be considered.

Zolmitriptan is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that zolmitriptan is taken as early as possible after the onset of migraine headache. In the event of recurrent attacks, it is recommended that the total intake of zolmitriptan in a 24-hour period should not exceed 10 mg.

Zolmitriptan is not indicated for prophylaxis of migraine. Elderly The safety and efficacy of zolmitriptan in individuals aged over 65 years have not been established. 2). Therefore, for patients with moderate or severe hepatic impairment, a maximum dose of 5 mg in 24 hours is recommended.

2). Paediatric population Children (below 12 years of age) The safety and efficacy of zolmitriptan tablets in children aged 0-12 years has not been evaluated. No data are available. Use of zolmitriptan in children is therefore not recommended.

Adolescents (12 - 17 years of age) The efficacy of zolmitriptan tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of zolmitriptan in adolescents is therefore not recommended. Method of administration To be taken by oral administration.

The tablet need not be taken with liquid; the tablet dissolves when placed on the tongue and is swallowed with the patient’s saliva. A drink of water is not required when taking Zolmitriptan Tablet. Zolmitriptan Tablet can be taken when water is not available thus allowing early administration of treatment for a migraine attack This formulation may also be beneficial for patients who suffer from nausea and are unable to drink during a migraine attack, or for patients who do not like swallowing conventional tablets 4 CLINICAL PARTICULARS

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 4 hours of dosing and are no more frequent following repeated dosing.

Tabulated list of adverse reactions Adverse reactions are classified according to frequency and system organ class.

Frequency categories are defined according to the following convesntion:

Very common (≥1/10); Common (≥1/100 < 1/10); Uncommon (≥1/1,000 < 1/100); Rare (≥1/10,000 < 1/1,000); Very rare (<1/10,000 Not known (cannot be estimated from the available data). 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 disorders Common Abnormalities or disturbances of sensation; Dizziness; Headache; Hyperaesthesia; Paraesthesia; Somnolence; Warm sensation Common Palpitations Uncommon Tachycardia Cardiac disorders Very rare Myocardial infarction; Angina pectoris; Coronary vasospasm Vascular disorders Uncommon Transient increases in systemic blood pressure Common Abdominal pain; Nausea; Vomiting; Dry mouth Dysphagia Gastrointestinal disorders 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.

Zolmitriptan should only be used where a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. There are no data on the use of zolmitriptan in hemiplegic or basilar migraine.

Migraineurs may be at risk of certain cerebrovascular events. Cerebral haemorrhage, subarachnoid haemorrhage, stroke and other cerebrovascular events have been reported in patients treated with 5-HT1B/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 5-HT1B/1D agonists, coronary vasospasm, angina pectoris and myocardial infarction have been reported. 3). 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 5-HT1B/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 5-HT1B/1D agonists, there have been rare reports of anaphylaxis/anaphylactoid reactions in patients receiving zolmitriptan. Patients with phenylketonuria should be informed that Zolmitriptan contains phenylalanine (a component of aspartame).

25 mg of aspartame. 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 should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

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

4. CLINICAL PARTICULARS