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.

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. 2). Patients with mild hepatic impairment require no dose adjustment. However, for patients with moderate or severe hepatic impairment, a maximum dose of 5 mg in 24 hours is recommended.

Patients with renal impairment No dosage adjustment required in patients with a creatinine clearance of more than 15 ml/min. 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.

g. ciprofloxacin). 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 in adolescents is therefore not recommended. Older people 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.

Method of administration For oral use. Zolmitriptan tablets should be swallowed with a drink of water.

Adverse reactions are typically transient 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. The following table lists the adverse reactions associated with zolmitriptan therapy.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The frequency terms listed are defined as follows:

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). FrequencySystem organ class Common Uncommon Rare Very rare Immune System Disorders Anaphylaxis/ Analphylactoid reactions Hypersensitivity reactions Nervous System Disorders Abnormalities or disturbances of sensation Dizziness Headache Hyperaesthesia Paraesthesia Somnolence Warm sensation Cardiac Disorders Palpitations Tachycardia Angina pectoris Coronary Vasospasm Myocardial Infarction Vascular Disorders Transient increases in systemic blood pressure Gastrointestinal Disorders Abdominal Pain Dry mouth Nausea Bloody diarrhoea Gastrointestinal infarction or Vomiting Dysphagia necrosis Gastrointestinal ischaemic events Ischaemic colitis Splenic Infarction Skin and subcutaneous tissue disorders Angiodema Urticaria Musculoskeletal and Connective Tissue Disorders Muscle weakness Myalgia Renal and Urinary Disorders Polyuria Increased urinary frequency Urinary Urgency General Disorders and Administration Site Conditions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 ophtalmoplegic migraine. 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 vasopasm, 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. 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. Serotonin Syndrome has been reported with combined use of triptans, and Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).

g. g. g. g. nausea, vomiting, diarrhoea). 5). This medicinal product contains lactose. Patients with rare hereditary problems of galacotose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.

1. • Moderate to severe hypertension, and mild uncontrolled hypertension. • Ischaemic heart disease. Coronary vasospasm/ Prinzmetal's angina. • A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). • Concomitant administration of zomitriptan with ergotamine or ergotamine derivatives (including methysergide), sumatriptan, naratriptan or other 5-HT1 receptor agonists.