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.

The total daily intake should not exceed 10 mg. Not more than 2 doses of Zolmitriptan should be taken in any 24-hour period. Zolmitriptan is not indicated for prophylaxis of migraine. Special populations Elderly population (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. Paediatric population Children (under 12 years of age) Safety and efficacy of zolmitriptan tablets in paediatric patients have not been evaluated.

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 tablets in adolescents is therefore not recommended.

g. ciprofloxacin). For doses not realisable/practicable with this strength other medicinal products are available. Method of administration 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.

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 (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following undesirable effects have been reported following administration of zolmitriptan: System Organ Class Frequency Undesirable effect Immune system disorders Rare Hypersensitivity reactions including urticaria, angioedema and anaphylactic reactions.

Nervous system disorders Common Abnormalities or disturbances or 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 Slight increases in blood pressure, transient increases in systemic blood pressure. Common Abdominal pain, nausea, vomiting, dry mouth, dysphagia. 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. System Organ Class Frequency Undesirable effect 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.

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. Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John’s wort (Hypericum perforatum). Serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been reported following concomitant treatment with triptans and selective serotonin reuptake inhibitors (SSRIs) or 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 must 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 must 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.