Adverse events should be reported. Reporting forms and information can be found at: yellowcard.mhra.gov.uk. Adverse events should also be reported to Aspire Pharma Ltd on +44 (0)1730 231148.
Rizatriptan Orodispersible Tablets Prescribing Information
(please refer to the full SmPC before prescribing)
Indications: Acute treatment of the headache phase of migraine attacks, with or without aura in adults. Available strengths: 5mg and 10mg orodispersible tablets Dosage: Adults 18 years of age and older: The recommended dose is 10mg. Redosing: Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period. For headache recurrence within 24 hours: If headache returns after relief of the initial attack, one further dose may be taken. The above dosing limits should be observed. After non-response: The effectiveness of a second dose for treatment of the same attack, when an initial dose is ineffective, has not been examined in controlled trials. Therefore, if a patient does not respond to the first dose, a second dose should not be taken for the same attack. Clinical studies have shown that patients who do not respond to treatment of an attack are still likely to respond to treatment for subsequent attacks. Some patients should receive the lower (5mg) dose of rizatriptan, in particular the following patient groups: Patients on propranolol: Administration of rizatriptan should be separated by at least two hours from administration of propranolol. Patients with mild or moderate renal insufficiency. Patients with mild to moderate hepatic insufficiency. Paediatric population, Children and Adolescents (under 18 years of age): The safety and efficacy of Rizatriptan in children and adolescents under 18 years of age has not yet been established, no recommendation on a posology can be made. Elderly: The safety and effectiveness of rizatriptan in patients older than 65 years have not been systematically evaluated. Administration: Rizatriptan should not be used prophylactically. Rizatriptan orodispersible tablets need not be taken with liquid. The orodispersible tablet 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. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Concurrent administration of monoamine oxidase (MAO) inhibitors or use within two weeks of discontinuation of MAO inhibitor therapy. Rizatriptan is contraindicated in patients with severe hepatic or severe renal insufficiency. Rizatriptan is contraindicated in patients with a previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). Moderately severe or severe hypertension or untreated mild hypertension. Established coronary artery disease, including ischaemic heart disease (angina pectoris, history of myocardial infarction or documented silent ischaemia), signs and symptoms of ischaemic heart disease or Prinzmetal’s angina. Peripheral vascular disease. Concomitant use of rizatriptan and ergotamine, ergot derivatives (including methysergide) or other 5-HT1B/1D receptor agonists. Special warnings and precautions for use: Rizatriptan should only be administered to patients in whom a clear diagnosis of migraine has been established. Rizatriptan should not be administered to patients with basilar or hemiplegic migraine. Rizatriptan should not be used to treat ‘atypical’ headaches, i.e. those that might be associated with potentially serious medical conditions (e.g. CVA, ruptured aneurysm) in which cerebrovascular vasoconstriction could be harmful. Rizatriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat. Where such symptoms are thought to indicate ischaemic heart disease, no further dose should be taken and appropriate evaluation should be carried out. As with other 5-HT1B/1D receptor agonists, rizatriptan should not be given, without prior evaluation, to patients in whom unrecognised cardiac disease is likely or to patients at risk for coronary artery disease (CAD) [e.g. patients with hypertension, diabetics, smokers or users of nicotine substitution therapy, men over 40 years of age, post-menopausal women, patients with bundle branch block and those with strong family history for CAD]. Cardiac evaluations 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 when 5-HT1 agonists have been administered. Those in whom CAD is established should not be given rizatriptan. 5-HT1B/1D receptor agonists have been associated with coronary vasospasm. In rare cases, myocardial ischaemia or infarction have been reported with 5-HT1B/1D receptor agonists including rizatriptan. Other 5-HT1B/1D agonists (e.g. sumatriptan) should not be used concomitantly with rizatriptan. It is advised to wait at least six hours following use of rizatriptan before administering ergotamine-type medicinal products (e.g. ergotamine, dihydro-ergotamine or methysergide). At least 24 hours should elapse after the administration of an ergotamine-containing preparation before rizatriptan is given. Although additive vasospastic effects were not observed in a clinical pharmacology study in which 16 healthy males received oral rizatriptan and parenteral ergotamine, such additive effects are theoretically possible. 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 noradrenaline reuptake inhibitors (SNRIs). These reactions can be severe. If concomitant treatment with rizatriptan and an SSRI or SNRI is clinically warranted, appropriate observation of the patient is advised, particularly during treatment initiation, with dose increases, or with addition of another serotonergic medicinal product. Undesirable effects may be more common during concomitant use of triptans (5-HT1B/1D agonists) and herbal preparations containing St John’s wort (Hypericum perforatum). Angioedema (e.g. facial oedema, tongue swelling and pharyngeal oedema) may occur in patients treated with triptans, among which rizatriptan. If angioedema of the tongue or pharynx occurs, the patient should be placed under medical supervision until symptoms have resolved. Treatment should promptly be discontinued and replaced by an agent belonging to another class of active substances. The potential for interaction should be considered when rizatriptan is administered to patients taking CYP 2D6 substrates. Medication overuse headache (MOH): Prolonged use of any 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 MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. Rizatriptan orodispersible tablets contain aspartame, a source of phenylalanine. It may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Interactions: Ergotamine, ergot derivatives (including methysergide), other 5-HT1B/1D receptor agonists: Due to an additive effect, the concomitant use of rizatriptan and ergotamine, ergot derivatives (including methysergide) or other 5-HT1B/1D receptor agonists (e.g. sumatriptan, zolmitriptan, naratriptan) increase the risk of coronary artery vasoconstriction and hypertensive effects. This combination is contraindicated. Monoamine oxidase inhibitors: Rizatriptan is principally metabolised via monoamine oxidase, ‘A’ subtype (MAO-A). Plasma concentrations of rizatriptan and its active N-monodesmethyl metabolite were increased by concomitant administration of a selective, reversible MAO-A inhibitor. Similar or greater effects are expected with non-selective, reversible (e.g. linezolid) and irreversible MAO inhibitors. Due to a risk of coronary artery vasoconstriction and hypertensive episodes, administration of rizatriptan to patients taking inhibitors of MAO is contraindicated. Beta-blockers: Plasma concentrations of rizatriptan may be increased by concomitant administration of propranolol. This increase is most probably due to first-pass metabolic interaction between the two active substances, since MAO-A plays a role in the metabolism of both rizatriptan and propranolol. This interaction leads to a mean increase in AUC and Cmax of 70-80%. In patients receiving propranolol, the 5 mg dose of Rizatriptan should be used. In an interaction study with other medicinal products, nadolol and metoprolol did not alter plasma concentrations of rizatriptan. Selective Serotonin Reuptake Inhibitors (SSRIs) /Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) and Serotonin Syndrome: There have been reports describing patients with symptoms compatible with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans. In vitro studies indicate that rizatriptan inhibits cytochrome P450 2D6 (CYP 2D6). Clinical interaction data are not available. The potential for interaction should be considered when rizatriptan is administered to patients taking CYP 2D6 substrates. Fertility, Pregnancy and lactation: Pregnancy: The safety of rizatriptan for use in human pregnancy has not been established. Animal studies do not indicate harmful effects at dose levels that exceed therapeutic dose levels with respect to the development of the embryo or foetus, or the course of gestation, parturition and post-natal development. Because animal reproductive and developmental studies are not always predictive of human response, rizatriptan should be used during pregnancy only if clearly needed. Breast feeding: Studies in rats indicated that very high milk transfer of rizatriptan occurred. No data exist in humans. Therefore, caution should be exercised when administering rizatriptan to women who are breast-feeding. Infant exposure should be minimised by avoiding breast-feeding for 24 hours after treatment. Fertility: Effects on human fertility have not been investigated. Ability to drive and use machines: Migraine or treatment with rizatriptan may cause somnolence in some patients. Dizziness has also been reported in some patients receiving rizatriptan. Patients should, therefore, evaluate their ability to perform complex tasks during migraine attacks and after administration of rizatriptan. Adverse reactions: For full list of side effects consult SmPC. ‘Very Common’, ‘Common’ and ‘Serious’ side effects included in this prescribing information: Common: Insomnia, dizziness, somnolence, paresthesia, headache, hypoesthesia, decreased mental acuity, palpitation, pharyngeal discomfort, nausea, dry mouth, vomiting, diarrhoea, dyspepsia, flushing, regional heaviness, neck pain, stiffness, asthenia/fatigue, pain in abdomen or chest. Serious: anaphylaxis/anaphylactoid reaction, ataxia, syncope, seizure, serotonin syndrome, arrhythmia, ECG abnormalities, tachycardia, Cerebrovascular accident, bradycardia, Myocardial ischaemia or infarction, hypertension, peripheral vascular ischaemia, dyspnoea, wheezing, Ischaemic Colitis, angioedema, toxic epidermal necrolysis. MA number: 5mg: PL 35533/0002, 10mg: PL 35533/0003 Cost: 5mg (x6) £18.98, 10mg (x6) £18.98 MAH: Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom Legal category: POM. Date last reviewed: February 2026 Version Number: MAT-UK-RIZ-0001-1 | March 2026
MAT-UK-COR-0085-1 | March 2026
