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Zomig Rapimelt 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 Zomig Rapimelt in hemiplegic or basilar 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, this class of compounds (5HT1B/1D agonists), has been associated with coronary vasospasm, angina pectoris and myocardial infarction. In patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment with this class of compounds, including Zomig Rapimelt, is recommended (see Contraindications). 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 agonists, atypical sensations over the precordium (see Adverse Reactions) 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 Zomig.
Patients with phenylketonuria should be informed that Zomig Rapimelt orodispersible tablets contain phenylalanine (a component of aspartame). Each 2.5mg orodispersible tablet contains 2.81 mg of phenylalanine.
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). Serotonin Syndrome is a potentially life-threatening condition, and diagnosis is likely when (in presence of a serotonergic agent) one of the following is observed: Spontaneous clonus; Inducible or ocular clonus with agitation or diaphoresis; Tremor and hyperreflexia; Hypertonia and body temperature >38°C and inducible or ocular clonus.
Careful observation of the patient is advised, if concomitant treatment with Zomig and an SSRI or SNRI is clinically warranted, particularly during treatment initiation and dosage increases (see Interactions).
Withdrawal of the serotonergic drugs is a key therapeutic principle. Further treatment depends on the type and severity of the symptoms.
Excessive use of an acute anti-migraine medicinal product may lead to an increased frequency of headache, potentially requiring withdrawal of treatment.
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 (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Effect on ability to drive and use machinery: There was no significant impairment of performance of psychomotor tests with doses up to 20 mg Zomig Rapimelt. Use is unlikely to result in an impairment of the ability of patients to drive or operate machinery. However, it should be taken into account that somnolence may occur.
