Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Rizatriptan belongs to a class of medicines called selective serotonin 5-HT1B/1D receptor agonists.
Rizatriptan is used to treat the headache phase of the migraine attack in adults.
Treatment with Rizatriptan:
Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
Do not take Rizatriptan • if you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6).
• if you have moderately severe or severe high blood pressure, or mild high blood pressure that is not controlled by medication
• if you have or have ever had heart problems including heart attack or pain on the chest (angina) or you have experienced heart disease related signs
• if you have severe liver or severe kidney problems
• if you have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attack TIA)
• if you have blockage problems with your arteries (peripheral vascular disease)
• if you are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline (drugs against depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAO inhibitors
• if you are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• if you are taking any other drug in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine. (See Other medicines and Rizatriptan below)
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan.
Warnings and precautions Talk to your doctor or pharmacist before taking Rizatriptan :
• if you have any of the following risk factors for heart disease: high blood pressure, diabetes, you smoke or you are using nicotine substitution, your family has a history of heart disease, you are a man over 40 years of age, or you are a post-menopausal woman
• if you have kidney or liver problems
• if you have a particular problem with the way your heart beats (bundle branch block)
• if you have or have had any allergies.
• if your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm
• if you use herbal preparation containing St. John's wort
• if you have had allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/ or swallowing (angioedema).
• if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression.
• if you have had short lived symptoms including chest pain and tightness.
• if you are taking buprenorphine-containing medicinal products. The use of these medicines together with Rizatriptan can lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Rizatriptan").
If you take Rizatriptan too often this may result in you getting a chronic headache. In such cases you should contact your doctor as you may have to stop taking Rizatriptan.
Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take Rizatriptan only for a migraine attack. Rizatriptan should not be used to treat headaches that might be caused by other, more serious conditions.
Please tell your doctor if you are taking or have recently taken or plan to take, any other medicines including medicines obtained without a prescription. This includes herbal medicines and those you normally take for a migraine. This is because Rizatriptan can affect the way some medicines work. Also other medicines can affect Rizatriptan.
Other medicines and Rizatriptan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Rizatriptan:
• if you are already taking a 5HT1B/1D agonist (sometimes referred to as 'triptans'), such as sumatriptan, naratriptan or zolmitriptan.
• if you are taking a monoamine oxidase (MAO) inhibitor such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it has been less than two weeks since you stopped taking an MAO inhibitor.
• if you use ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine
• if you use methysergide to prevent a migraine attack.
The above listed medicines when taken with Rizatriptan may increase the risk of side effects.
You should wait at least 6 hours after taking Rizatriptan before you take ergotamine-type medications such as ergotamine or dihydro-ergotamine or methysergide.
You should wait at least 24 hours after taking ergotamine-type medications before taking Rizatriptan.
Ask your doctor for instructions and the risks about taking Rizatriptan
• if you are taking propranolol (see section 3: How to take Rizatriptan )
• if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.
Some medicines may increase the side effects of Rizatriptan and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Rizatriptan without first talking to your doctor, especially:
• buprenorphine-containing medical products. These medicines may interact with Rizatriptan and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
Rizatriptan with food and drink Rizatriptan can take longer to work if it is taken after food. Although it is better to take it on an empty stomach, you can still take it if you have eaten.
Pregnancy breast-feeding and fertility It is not known whether Rizatriptan is harmful to an unborn baby when taken by a pregnant woman after the first 3 months of pregnancy.
If you are breastfeeding, you may postpone breastfeeding for 12 hours after treatment to avoid exposure in your baby.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Available data on the safety of rizatriptan when used during the first 3 months of pregnancy do not suggest an increased risk of birth defects.
Children and adolescents The use of Rizatriptan in children under 18 years of age is not recommended.
Use in patients older than 65 years There have been no full studies to look at how safe and effective Rizatriptan is amongst patients older than 65 years.
Driving and using machines You may feel sleepy or dizzy while taking Rizatriptan. If this happens, do not drive or use any tools or machines.
Rizatriptan contains Aspartame Rizatriptan contains aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Rizatriptan is used to treat migraine attacks. Take Rizatriptan as soon as possible after your migraine headache has started. Do not use it to prevent an attack.
The recommended dose is 10 mg.
If you are currently taking propranolol or have kidney or liver problems you should use the 5-mg dose of rizatriptan. You should leave at least 2 hours between taking propranolol and Rizatriptan up to a maximum of 2 doses in a 24-hour period.
If migraine returns within 24 hours In some patients, migraine symptoms can return within a 24-hour period. If your migraine does return you can take an additional dose of Rizatriptan. You should always wait at least 2 hours between doses.
If after 2 hours you still have a migraine If you do not respond to the first dose of Rizatriptan during an attack, you should not take a second dose of Rizatriptan for treatment of the same attack. It is still likely, however, that you will respond to Rizatriptan during the next attack.
Do not take more than 2 doses of Rizatriptan in a 24-hour period, (for example, do not take more than two 10-mg or 5 mg orodispersible tablets or tablets in a 24-hour period). You should always wait at least 2 hours between doses.
If your condition worsens, seek medical attention.
How to administer Rizatriptan orodispersible tablets • Rizatriptan orodispersible tablets dissolves in the mouth.
• Open the blister pack with dry hands.
• The orodispersible tablets should be placed on your tongue, where it dissolves and can be swallowed with the saliva.
• The 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.
Rizatriptan is also available as a tablet to be taken with liquids.
If you take more Rizatriptan than you should If you take more Rizatriptan than you should, talk to your doctor or pharmacist straight away. Take the medicine pack with you.
Signs of over-dosage can include dizziness, drowsiness, vomiting, fainting and slow heart rate.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, severe shedding of the skin with or without fever, heart attack or stroke. In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking Rizatriptan
The following side effects may happen with this medicine.
In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.
Common (may affect up to 1 in 10 people)
• tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), decreased mental sharpness, tremor, insomnia.
• fast or irregular heart beat (palpitation)
• flushing (redness of the face lasting a short time)
• throat discomfort
• feeling sick (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia).
• feeling of heaviness in parts of the body, neck pain, stiffness.
• pain in abdomen or chest
Uncommon (may affect up to 1 in 100 people)
• bad taste in your mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flushes, sweating.
• rash;itching and lumpy rash (hives),swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea).
• feeling of tightness in parts of the body, muscle weakness.
• changes in the rhythm or rate of the heartbeat (arrhythmia); abnormalities of the electrocardiogram (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• facial pain; muscle pain.
Rare (may affect up to 1 in 1,000 people)
• wheezing.
• allergic reaction (hypersensitivity); sudden life-threatening allergic reaction (anaphylaxis); stroke (this generally occur in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, man over 40 years of age, post-menopausal women, particular problem with the way your heart beats [bundle branch block])).
• slow heartbeat (bradycardia).
Not known (frequency cannot be estimated from the available data):
• heart attack, spasm of the blood vessels of the heart (these generally occur in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, man over 40 years of age, postmenopausal women, particular problem with the way your heart beats (bundle branch block)).
• a syndrome called "serotonin syndrome" that may cause side effects like coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation, and hallucinations.
• severe shedding of the skin with or without fever (toxic epidermal necrolysis).
• seizure (convulsions/fits)
• spasm of blood vessels of the extremities including coldness and numbness of the hands or feet
• spasm of the blood vessels of the colon (large bowel), which can cause abdominal pain
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, carton and bottle label after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Rizatriptan contains • The active substance is rizatriptan.
Each orodispersible tablet contains 14.530 mg of rizatriptan benzoate equivalent to 10 mg of rizatriptan.
• The other ingredients are:
Cellulose, Microcrystalline, starch pregelatinized, mannitol, crospovidone (Type A), aspartame (see section 2), peppermint flavor (maltodextrin, natural flavors, modified corn starch), sodium stearyl fumarate.
What Rizatriptan looks like and contents of pack Orodispersible tablets
White to off-white coloured, circular, biconvex, uncoated tablets debossed with 'F25' on one side and plain on other side with a peppermint flavor.
Rizatriptan orodispersible tablets are available in Polyamide/ Aluminium/ PVC - Aluminium foil blister packs of: 2, 3, 6, 10, 12 and 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder Milpharm Limited
1 Roundwood Avenue
Stockley Park
Uxbridge
UB11 1AF
United Kingdom
Manufacturer APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia
BBG 3000
Malta
or
Milpharm Limited
1 Roundwood Avenue
Stockley Park
Uxbridge
UB11 1AF
United Kingdom
This leaflet was last revised in 10/2025.
P1540256
Aurobindo Pharma - Milpharm Ltd.
Address
Milpharm Limited, 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF, UK
WWW
http://www.aurobindo.com
Telephone
+ 44 (0)208 845 8811
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)208 845 8811
Medical Information Fax
+44 (0)208 845 8795
• Contact us
• Links
• Accessibility
• Legal and privacy notice
• Cookie notice
• Cookie Settings
• Glossary
• Site Maps
Delivered to you by
Rizatriptan 10 mg orodispersible tablets comes as tablet containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Rizatriptan 10 mg orodispersible tablets is rizatriptan benzoate.
Medicines with the same active substance, strength and form include: Maxalt 10mg Tablets, Rizatriptan 10 mg Orodispersible Tablets, Rizatriptan 10 mg Tablets. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Rizatriptan 10 mg orodispersible tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Acute treatment of the headache phase of migraine attacks, with or without aura in adults.
General
Rizatriptan should not be used prophylactically.
Rizatriptan orodispersible tablets need not be taken with liquid.
The orodispersible tablet is packaged in an aluminium blister. Patients should be instructed not to remove the orodispersible tablet from the blister until just prior to dosing. The orodispersible tablet should then be removed from the aluminium blister with dry hands and the placed on the tongue, where it will dissolve and be swallowed with the saliva.
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.
Posology
Adults 18 years of age and older
The recommended dose is 10 mg.
Redosing: Doses should be separated by at least 2 hours; no more than 2 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, in particular the following patient groups:
- patients on propranolol. Administration of rizatriptan should be separated by at least 2 hours from administration of propranolol. (See section 4.5)
- patients with mild or moderate renal insufficiency.
- patients with mild to moderate hepatic insufficiency.
Doses should be separated by at least 2 hours; no more than 2 doses should be taken in any 24-hour period.
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.
Currently available data are described in section 5.1 and 5.2, but no recommendation on a posology can be made.
Patients older than 65 years
The safety and effectiveness of rizatriptan in patients older than 65 years have not been systematically evaluated.
Hypersensitivity to rizatriptan or to the any of the excipients listed in section 6.1.
Concurrent administration of monoamine oxidase (MAO) inhibitors or use within two weeks of discontinuation of MAO inhibitor therapy. (See section 4.5)
Rizatriptan is contra-indicated in patients with severe hepatic or severe renal insufficiency.
Rizatriptan is contra-indicated in 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 ischemia), signs and symptoms of ischemic 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. (See section 4.5).
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 (see section 4.8). 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. (See section 4.3)
5-HT1B/1D receptor agonists have been associated with coronary vasospasm. In rare cases, myocardial ischemia or infarction have been reported with 5-HT1B/1D receptor agonists including Rizatriptan (see section 4.8)
Other 5-HT1B/1D agonists, (e.g. sumatriptan) should not be used concomitantly with Rizatriptan. (See section 4.5).
It is advised to wait at least 6 hours following use of rizatriptan before administering ergotamine-type medications, (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, (see section 4.3)
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. 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 medication (see section 4.5).
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).
Angioedema (e.g. facial edema, tongue swelling and pharyngeal edema) 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.
The potential for interaction should be considered when rizatriptan is administered to patients taking CYP 2D6 substrates (see section 4.5)
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.
Phenylketonurics: Phenylketonuric patients should be informed that phenylalanine may be harmful. Rizatriptan orodispersible tablets contain aspartame (which contains phenylalanine).
Excipients
Aspartame
This medicine contains 3.741 mg of aspartame in each 10 mg orodispersible tablets.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Sodium
This medicine contains less than 1 mmol sodium (23 mg) per orodispersible tablet, that is to say essentially 'sodium-free'.
Ergotamine, ergot derivatives (including methysergide), other 5 HT 1B/1D receptor agonists: Due to an additive effect, the concomitant use of rizatriptan and ergotamine, ergot derivatives (including methysergide), or other 5 HT 1B/1D receptor agonists (e.g. sumatriptan, zolmitriptan, naratriptan) increase the risk of coronary artery vasoconstriction and hypertensive effects. This combination is contraindicated (see section 4.3).
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. (See section 4.3)
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 drugs, 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. (See section 4.2)
In a drug-interaction study, 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 (see section 4.4).
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.
Pregnancy
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity following first trimester exposure. Animal studies do not indicate reproductive toxicity (see section 5.3). There is limited data in relation to use of rizatriptan in the second and third trimester of pregnancy. Use of rizatriptan may be considered during pregnancy, if clinically necessary
Breastfeeding
Rizatriptan is excreted in low concentration in human milk with an average relative infant dose less than < 1% (less than 6% in worst case scenario based on Cmax in breastmilk). Caution should be exercised when administering rizatriptan to women who are breast-feeding. Infant exposure may be minimised by avoiding breast-feeding for 12 hours after treatment.
Fertility
Effects on human fertility have not been investigated. Animal studies only revealed minimal effects on fertility at plasma concentrations far in excess of human therapeutic concentrations (more than 500-fold).
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.
Rizatriptan (as the tablet and orodispersible tablet formulation) was evaluated in 8630 adult patients for up to one year in controlled clinical studies. The most common side effects evaluated in clinical studies were dizziness, somnolence, and asthenia/fatigue. The following side effects have been evaluated in clinical studies and/or reported in post-marketing experience:
(Very common [≥1/10]; Common [≥1/100 ro, <1/10]; Uncommon: [≥1/1000 to, <1/100]; Rare [≥1/10,000 to <1/1,000]; Very rare [≤1/10000], not known [cannot be estimated from the available data]).
Immune system disorders:
Rare:
hypersensitivity reaction, anaphylaxis/anaphylactoid reaction.
Psychiatric disorders:
Common:
insomnia.
Uncommon:
disorientation, insomnia, nervousness.
Nervous system disorders:
Common:
dizziness, somnolence, paraesthesia, headache, hypoaesthesia, decreased mental acuity.
Uncommon:
ataxia, vertigo, dysgeusia/bad taste, tremor, syncope.
Not known:
seizure, serotonin syndrome.
Eye disorders:
Uncommon:
blurred vision.
Cardiac disorders:
Common:
palpitation.
Uncommon:
arrhythmia, ECG abnormalities, tachycardia.
Rare:
cerebrovascular accident(most of these adverse reactions have been reported in patients with risk factors predictive of coronary artery disease), bradycardia.
Not known:
myocardial ischaemia or infarction (most of these adverse reactions have been reported in patients with risk factors predictive of coronary artery disease).
Vascular disorders:
Uncommon:
hypertension, hot flushes/flashes.
Not known:
peripheral vascular ischaemia.
Respiratory, thoracic and mediastinal disorders:
Common:
pharyngeal discomfort, dyspnoea.
Uncommon:
dyspnoea.
Rare:
wheezing
Gastro-intestinal disorders:
Common:
nausea, dry mouth, vomiting, diarrhoea, dyspepsia.
Uncommon:
thirst.
Not known:
ischemic colitis.
Skin and subcutaneous tissue disorders:
Common:
flushing, sweating, rash
Uncommon:
pruritus, urticaria, angioedema (e.g. facial oedema, tongue swelling, pharyngeal edema) (for angioedema see also section 4.4) , rash, sweating.
Not known:
toxic epidermal necrolysis
Musculoskeletal and connective tissue disorders:
Common:
regional heaviness, neck pain, stiffness.
Uncommon:
regional tightness, muscle weakness, facial pain, myalgia.
General disorders and administration site conditions:
Common:
asthenia/fatigue, pain in abdomen 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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Rizatriptan 40 mg (administered as either a single tablet dose or as two doses with a 2-hour interdose interval) was generally well tolerated in over 300 adult patients; dizziness and somnolence were the most common drug-related adverse effects.
In a clinical pharmacology study in which 12 adult subjects received rizatriptan, at total cumulative doses of 80 mg (given within four hours), two subjects experienced syncope and/or bradycardia. One subject, a female aged 29 years, developed vomiting, bradycardia, and dizziness beginning three hours after receiving a total of 80 mg rizatriptan (administered over two hours). A third-degree AV block, responsive to atropine, was observed an hour after the onset of the other symptoms. The second subject, a 25 year-old male, experienced transient dizziness, syncope, incontinence, and a 5-second systolic pause (on ECG monitor) immediately after a painful venipuncture. The venipuncture occurred two hours after the subject had received a total of 80 mg rizatriptan (administered over four hours).
In addition, based on the pharmacology of rizatriptan, hypertension or other more serious cardiovascular symptoms could occur after overdosage. Gastro-intestinal decontamination, (e.g. gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with Rizatriptan. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.
The effects of haemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.
Ask anything about Rizatriptan 10 mg orodispersible tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.