Product

MAXALT®
(rizatriptan)
MAXALT® Melt
(rizatriptan)
PRESCRIBING INFORMATION
Refer to Summary of Product Characteristics (SPC) before prescribing.

Adverse events should be reported. Reporting forms and information can be
found at to Merck Sharp & Dohme Limited (Tel: 01992 467272).

PRESENTATION

‘Maxalt’ Tablets: 5 mg and 10 mg tablets each containing either 5 mg or 10 mg of rizatriptan (as
benzoate).
‘Maxalt’ Melt oral lyophilisates (wafers): 10 mg oral lyophilisates containing 10 mg of rizatriptan
(as benzoate).
USES

Acute treatment of the headache phase of migraine attacks with or without aura in adults.
DOSAGE AND ADMINISTRATION

Do not use prophylactically. Adults 18 years of age and older: 10 mg. Redosing: Separate doses
by at least two hours, with no more than two doses to be taken in any 24-hour period. For
headache recurrence within 24 hours: one further dose may be taken, observing the above dosing
limits. After non-response: Patients not responding to the first dose should not take a second dose
for the same attack. Patients not responding to treatment of an attack are still likely to respond to
treatment for subsequent attacks.
The absorption of rizatriptan is delayed by approximately one hour when administered together
with food. Therefore onset of effect may be delayed if ‘Maxalt’ is administered after meals.
5 mg of ‘Maxalt’, is recommended for patients on propranolol, with administration of the two drugs
separated by at least two hours, and for patients with mild or moderate renal insufficiency or with
mild to moderate hepatic insufficiency.
Children and Adolescents (under 18 years): The safety and efficacy has not yet been established.
Elderly (over 65 years): Safety and effectiveness have not been evaluated.

CONTRA-INDICATIONS

Hypersensitivity. Concurrent administration of monoamine oxidase (MAO) inhibitors or use within
two weeks of their discontinuation. Severe hepatic or renal insufficiency. 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 with ergotamine, ergot derivatives (including methysergide), or other 5-HT1B/1D
receptor agonists.
PRECAUTIONS

Only use ‘Maxalt’ when there is a clear diagnosis of migraine. Do not use for basilar or hemiplegic
migraine, or to treat ‘atypical’ headaches, i.e. those that might be associated with potentially serious
medical conditions, (e.g. CVA, ruptured aneurysm).
'Maxalt' can be associated with transient symptoms including chest pain and tightness which may be
intense and involve the throat. Stop dosing and evaluate in instances where such symptoms are
thought to indicate ischaemic heart disease.
As with other 5-HT1B/1D receptor agonists, do not give ‘Maxalt’ without prior evaluation to patients
where unrecognised cardiac disease is likely, or 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 a
strong family history for CAD]. Do not use ‘Maxalt’ in those in whom CAD is established.
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
‘Maxalt’
Place patients experiencing hypersensitivity, e.g. angioedema, under medical supervision until
symptoms have resolved. Discontinue triptan therapy promptly and replace by an agent belonging
to another class of drugs.
Wait at least six hours following use of rizatriptan before administering ergotamine-type
medications, (e.g. ergotamine, dihydro-ergotamine or methysergide). Wait at least 24 hours after
administration of an ergotamine-containing preparation before giving rizatriptan. 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). If
concomitant treatment is warranted, ensure appropriate observation of the patient, particularly
during treatment initiation, with dose increases, or with addition of another serotonergic
medication.
Due to the lactose content of the tablets do not give to patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Medication overuse headache (MOH): Prolonged use of any headache painkillers can worsen headaches. If this is experienced or suspected, seek medical advice and discontinue treatment. Diagnosis of MOH should be suspected in patients suffering frequent or daily headaches despite (or because of) regular use of headache medications Phenylketonurics: ‘Maxalt’ Melt oral lyophilisates contain phenylalanine (2.10 phenylalanine/10 mg wafer). Interactions: Beta-blockers: plasma concentrations of rizatriptan
may be increased by concomitant administration of propranolol, therefore use the 5 mg dose of
‘Maxalt’. CYP 2D6 substrates: the potential for interaction should be considered in patients taking
CYP 2D6 substrates. Herbal: Undesirable effects may be more common with concomitant use of
triptans (5-HT1B/1D receptor agonists) and herbal preparations containing St. John’s wort
(Hypericum perforatum). Use during pregnancy: use only if clearly needed. Use during lactation:
exercise caution in use of ‘Maxalt’ in breast-feeding women. Avoid breast-feeding for 24 hours
after taking ‘Maxalt’.
SIDE EFFECTS
Refer to SPC for complete information on side effects

In studies of up to one year, the most common side effects were dizziness, somnolence, and
asthenia/fatigue. Side effects evaluated in clinical studies and/or reported in post-marketing
experience include:
Common: [≥1/100, <1/10]
Pain in abdomen or chest, palpitation, tachycardia, nausea, vomiting, dry mouth, diarrhoea, regional
heaviness, headache, paraesthesia, decreased mental acuity, tremor, hypoaesthesia, hot
flushes/flashes, pharyngeal discomfort, dyspnoea, flushing, sweating, dizziness, somnolence,
asthenia/fatigue and rash.
Uncommon: [≥1/1000, <1/100]
Dyspepsia, thirst, neck pain, stiffness, regional tightness, muscle weakness, insomnia, ataxia,
nervousness, vertigo, disorientation, pruritus, urticaria, blurred vision, hypertension,
hypersensitivity reaction and angioedema (e.g. facial oedema, tongue swelling, pharyngeal
oedema).
Rare: [≥1/10,000, <1/1,000]
Reports of myocardial ischaemia or infarction and CVA, mostly in patients with risk factors for
CAD. Wheezing, toxic epidermal necrolysis, facial pain, syncope, serotonin syndrome,
dysgeusia/bad taste and anaphylaxis/anaphylactoid reaction have also been reported.
Not known: [cannot be estimated from the available data]
Seizure, peripheral vascular ischaemia, arrhythmia, bradycardia, ischemic colitis and myalgia.
Investigations:
Not known:
ECG abnormalities.
Package Quantities:

‘Maxalt’ Melt 10 mg 3 lyophilisates £13.37 6
Product Licence numbers:
‘Maxalt’ Tablets 5 mg
‘Maxalt’ Melt 10 mg oral lyophilisate PL 0025/0372
Product Licence holder:
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
Date of review of prescribing information: March 2012
Merck Sharp & Dohme Limited 2012. All rights reserved. PI.MXT-M.12.UK.3625

Source: http://www.maxalt.co.uk/static/images/maxalt_PI.pdf