ZOLMITRIPTAN

5 mg. It is advisable that zolmitriptan is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken.

If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not respond to the first dose, it is unlikely that a second dose will be of benefit in the same attack. 5 mg doses, for subsequent attacks 5 mg doses of zolmitriptan could be considered.

Caution is advised due to an increased incidence of side effects. 5 mg dose. Nevertheless a 5 mg dose may be of benefit in some patients. The total daily intake should not exceed 10 mg. Not more than 2 doses of Zolmitriptan should be taken in any 24-hour period.

Special populations Use in patients aged over 65 years The safety and efficacy of zolmitriptan in individuals aged over 65 years have not been evaluated. Use of Zolmitriptan in the elderly is therefore not recommended. 2). For patients with moderate or severe hepatic impairment, a maximum dose of 5 mg in 24 hours is recommended.

However, no dose adjustment is required for patients with mild hepatic impairment. 2). 5) For patients taking MAO-A inhibitors, a maximum dose of 5 mg in 24 hours is recommended. A maximum dose of 5 mg zolmitriptan in 24 hours is recommended in patients taking cimetidine.

ciprofloxacin). Paediatric population Use in Children (under 12 years of age) The safety and efficacy of zolmitriptan tablets in children aged birth < 12 years have not been established. Use of Zolmitriptan in children is therefore not recommended.

Adolescents (12 - 17 years of age) The efficacy of zolmitriptan tablets in children aged 12 to 17 years have not been established. 1 but no recommendation on a posology can be made. Use of Zolmitriptan in adolescents is therefore not recommended.

Method of administration For oral use. The tablet need not be taken with liquid; the tablet dissolves on the tongue and is swallowed with saliva. This formulation can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.

However, a delay in the absorption of zolmitriptan from Zolmitriptan can occur which may delay onset of action. The blister pack should be peeled open as shown on the foil (tablets should not be pushed through the foil). The Zolmitriptan tablet should be placed on the tongue, where it will dissolve and be swallowed with the saliva.

Possible undesirable effects are typically transient, tend to occur within four hours of dosing, are no more frequent following repeated dosing and resolve spontaneously without additional treatment.

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

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100), rare (≥1/ 10000 to <1/1000), very rare (<1/10000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. intestinal ischaemia, intestinal infarction, splenic infarction) which may present as bloody diarrhoea or abdominal pain 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 disorders Common Asthenia; Heaviness, tightness, pain or pressure in throat, neck, limbs or chest.

Certain symptoms, may be part of the migraine attack itself. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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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 or ophthalmoplegic migraine. Stroke and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists. It should be noted that migraineurs may be at risk of certain cerebrovascular events.

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.

The dose recommendation for zolmitriptan should not be exceeded. Serotonin syndrome has been reported with combined use of triptans and serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin- norepinephrine reuptake inhibitors (SNRIs).

1. Moderate or severe hypertension, and mild uncontrolled hypertension. This class of compounds (5HT1B/1D receptor agonists), has been associated with coronary vasospasm, as a result, patients with ischaemic heart disease were excluded from clinical trials.

Therefore zolmitriptan 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 signs consistent with ischaemic heart disease.

5). Zolmitriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). Zolmitriptan is contraindicated in patients with a creatinine clearance of less than 15 ml/min.