Zomig Rapimelt 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. Zomig Rapimelt is not indicated for use in hemiplegic, basilar or ophthalmoplegic 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.
Zomig Rapimelt 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. In patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment with this class of compound, including Zomig Rapimelt, is recommended (see section 4.3). Such patients include postmenopausal women, males over 40 and patients with risk factors for coronary artery disease.
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.
As with other 5HT1B/1D receptor agonists, heaviness, pressure or tightness over the precordium (see section 4.8) have been reported after the administration of zolmitriptan. If symptoms consistent with ischaemic heart disease occur, no further doses of zolmitriptan should be given and appropriate evaluation should be 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.
As with other 5HT1B/1D agonists, there have been rare reports of anaphylaxis/ anaphylactoid reactions in patients receiving Zomig.
Serotonin Syndrome has been reported with combined use of triptans, and Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs). Serotonin Syndrome is a potentially life-threatening condition, and it may include signs and symptoms such as: mental status changes (e.g. agitation, hallucinations, coma), autonomic instability, (e.g. tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, in-coordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Careful observation of the patient is advised, if concomitant treatment with Zomig and an SSRI or SNRI is necessary particularly during treatment initiation and dosage increases (see section 4.5).
Patients with phenylketonuria should be informed that Zomig Rapimelt orally dispersible tablets contain phenylalanine (a component of aspartame). Each 2.5 mg orally dispersible tablet contains 2.81 mg of phenylalanine.
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 daily headaches despite (or because of) the regular use of headache medications.
The safety and efficacy of Zomig Rapimelt in individuals aged over 65 years have not been established. Use of Zomig Rapimelt in the elderly is therefore not recommended.
Refer to sections 4.2 and 5.2 when treating patients with hepatic impairment.