RIZATRIPTAN

Posology Adults 18 years of age and older The recommended dose is 10 mg daily. Other medicinal products in a lower strength (5mg) are available and should be used by those patients requiring a lower dose. 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 (5 mg) dose of Rizatriptan Orodispersible Tablets, in particular the following patient groups: − patients on propranolol. Administration of rizatriptan should be separated by at least two hours from administration of propranolol.

5). − patients with mild or moderate renal insufficiency. − patients with mild to moderate hepatic insufficiency. Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period. Patients older than 65 years The safety and efficacy of rizatriptan in patients older than 65 years have not been systematically evaluated.

Paediatric population The safety and efficacy of rizatriptan in children and adolescents under 18 years of age has not yet been established. 2, but no recommendation on a posology can be made. Method of administration. For oral use.

Effects of food:

Onset of effect may be delayed when rizatriptan is administered in the fed state. 2). Rizatriptan Orodispersible Tablets need not be taken with liquid. Rizatriptan Orodispersible Tablets are packaged in a perforated unit dose blister.

Patients should be instructed to peel open the blister pack with dry hands and to place the orodispersible tablet on the tongue, where it will dissolve and be swallowed with the saliva. Orodispersible Tablets 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.

Summary of the safety profile Rizatriptan was evaluated in over 8,630 patients for up to one year in controlled clinical studies. The most common undesirable effects evaluated in clinical studies were dizziness, somnolence, and asthenia/fatigue.

The following undesirable effects have been evaluated in clinical studies and/or reported in post-marketing experience: (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], not known [cannot be estimated from the available data]).

g. 4), rash, sweating Not known Toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Common Regional heaviness, neck pain, stiffness Uncommon Regional tightness, stiffness, muscle weakness, facial pain, myalgia General disorders and Common Asthenia/fatigue, pain in abdomen administration site conditions or chest 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.

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. e. g. CVA, ruptured aneurysm) in which cerebrovascular vasoconstriction could be harmful.

8). Where such symptoms are thought to indicate ischaemic heart disease, no further dose should be taken and appropriate evaluation should be carried out. 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.

3). 5-HT1B/1D receptor agonists have been associated with coronary vasospasm. 8). g. 5). g. ergotamine, dihydro-ergotamine or methysergide). At least 24 hours should elapse after the administration of an ergotamine-containing preparation before rizatriptan is given.

3). 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. 5). 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). g. facial oedema, tongue swelling and pharyngeal oedema) may occur in patients treated with triptans, among which is 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 drugs.

5). 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.

Excipients This medicinal product contains aspartame, which is a source of phenylalanine. Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

1. 5). Patients with severe hepatic or severe renal insufficiency. Patients with a previous cerebrovascular accident (CVA) or transient ischemic attack (TIA). Moderately severe or severe hypertension, or untreated mild hypertension. Established coronary artery disease, including ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischaemia), signs and symptoms of ischemic heart disease, or Prinzmetal's angina.

Peripheral vascular disease. 5).