Patient leaflet - Rizatriptan 5 mg orodispersible tablets
1. What Rizatriptan is and what it is used for
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. Do not use it to prevent an attack.
Treatment with rizatriptan: reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
2. What you need to know before you take Rizatriptan
Do not take rizatriptan if you:
- are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6).
- have moderately severe or severe high blood pressure or mild high blood pressure that cannot be controlled by medication
- have or have ever had heart disease such as heart attack or chest pain (angina) or you have had symptoms related to heart disease
- have severe liver or kidney problems.
- have had a stroke (CVA) or have had transient lack of oxygen in the brain (Transient Ischemic Attack TIA).
- have blockage problems with your arteries (peripheral vascular disease).
- are currently 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 an MAOI
- are currently taking ergotamine type medications such as ergotamine or dihydroergotamine for the treatment of migraine or methysergide in order to prevent a migraine attack.
- are taking other medicines in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine (see Other medicines and rizatriptan).
- are unsure whether one or more of the above points apply to you, please contact your doctor or pharmacist before you start taking rizatriptan.
Warnings and precautions
Before you take rizatriptan, tell your doctor or pharmacist, if you:
- have any of the following risk factors for heart disease such as high blood pressure or diabetes, you smoke or you use nicotine substitutes, your family has a history of heart disease, you are a man over 40 years of age, or you are a menopausal/post-menopausal woman
- have kidney or liver problems
- have a particular problem with the way your heart beats (bundle branch block)
- have or have had any allergies
- have a headache which is associated with dizziness, difficulty in walking, lack of coordination or weakness in arm and leg
- are using herbal preparations containing St. John’s wort
- have had allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing and/or swallowing (angioedema)
- are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression
- have had short lived symptoms including chest pain and tightness.
If you take rizatriptan too often this may result in you getting a chronic headache. In such cases contact your doctor as you may have to stop taking rizatriptan.
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.
Children and adolescents up to 18 years
The use of rizatriptan in children and adolescents under 18 years is not recommended.
Other medicines and rizatriptan
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines and medicines normally taken for a migraine.
Do not take rizatriptan if you are taking:
- a 5-HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.
- a monoamine oxidase (MAO) inhibitor such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it’s less than two weeks ago since you stopped taking an MAO inhibitor.
- ergotamine-type medications such as ergotamine or dihydroergotamine to treat your migraine.
- 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)
- SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.
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 and breast-feeding
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. 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.
Driving and using machines
Do not drive or operate machinery or any other equipment, because you may feel sleepy or dizzy after taking rizatriptan.
Important information about some of the ingredients in Rizatriptan orodispersible tablets Rizatriptan contains aspartame which may be harmful for people with phenylketonuria. Each 5 mg tablet contains 1 mg of aspartame (which contains phenylalanine).
Rizatriptan also contains mannitol which may have a mild laxative effect. Each 5 mg tablet contains 45.81 mg of mannitol.
Rizatriptan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Rizatriptan
Rizatriptan is used for the treatment of migraine attacks. Take rizatriptan as soon as possible after the beginning of your migraine headache. Do not use it to prevent a migraine attack. Always take rizatriptan exactly as your doctor has told you. Check with your doctor if you are not sure. The recommended dose is 10 mg.
If you are currently taking propranolol or if you have kidney or liver problems, use the 5 mg dose of rizatriptan. You should leave at least two hours between taking propranolol and rizatriptan. Do not take more than 2 doses in a 24 hour period.
Use in patients older than 65 years
There are no full studies to assess the safety and efficacy of rizatriptan in patients over 65 years.
If migraine returns within 24 hours
In some patients, migraine symptoms can return within 24 hours. If the migraine returns, you can still take a dose of rizatriptan. However, you need to wait at least 2 hours between doses.
If you still have migraine after two hours
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.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rizatriptan 5 mg
Orodispersible Tablets 000 Do not take more than 2 doses of rizatriptan in a 24-hour period, (for example, do not take more than two 5 mg 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 take Rizatriptan orodispersible tablets
- Rizatriptan (rizatriptan benzoate) is available as a 5 mg or 10 mg orodispersible tablet that dissolves in the mouth.
- Open the blister pack with dry hands.
- The orodispersible tablet should be placed on your tongue, where it dissolves and can 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.
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 overdosage 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following serious side effects, talk to your doctor or go to hospital immediately:
- allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness, sudden life-threatening allergic reaction (anaphylaxis)
- rash, itching, hives, swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing and/or swallowing (angioedema)
- severe blisters on the skin/peeling of the skin with or without fever (toxic epidermal necrolysis). If you experience symptoms of an allergic reaction, serotonin syndrome, heart attack or stroke, contact your doctor immediately.
In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking rizatriptan. In studies in adults, the most commonly reported adverse events were dizziness, sleepiness and fatigue.
Common (occurring in less than 1 in 10 users)
- tingling (paraesthesia), headache, decreased skin sensitivity (hypoesthesia) decreased sharpness of mind, lack of sleep (insomnia)
- heart beat (palpitations)
- flushing (transient redness of the face)
- throat symptoms
- feeling sick (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
- regional heaviness, neck pain, stiffness
- abdominal pain, chest pain.
Uncommon (affecting less than 1 in 100 users)
- bad taste in the mouth
- feeling of being out of balance when walking (ataxia), dizziness (vertigo), blurred vision, trembling, fainting (syncope)
- confusion, nervousness
- high blood pressure (hypertension), thirst, hot flashes, sweating
- shortness of breath (dyspnoea)
- regional tightness, muscle weakness
changes in the rhythm or rate of the heartbeat (arrhythmia), derogations from the
electrocardiogram (a test that measures the electrical activity of your heart), fast heart rate (tachycardia)
facial pain, muscle pain.
Rare (occurring in less than 1 in 1,000 users)
- wheezing
- stroke (this is especially common in patients with risk factors for cardiovascular disease [high blood pressure, diabetes, smoking, use of nicotine replacement, heart disease or stroke in the family, arrhythmia (bundle), or if you are a man over 40 or a menopausal woman])
- slow heart rate (bradycardia).
Not known (frequency cannot be estimated from the available data)
- heart attack, spasm of blood vessels of the heart (this is especially common in patients with [high blood pressure risk factors for cardiovascular disease, diabetes, smoking, use of nicotine replacement, heart disease or stroke in the family, arrhythmia (bundle), or if you are a man over 40 or a woman in menopause])
- a syndrome ‘serotonin syndrome’ with side effects such as coma, fluctuations in blood pressure, extremely high body temperature, lack of muscle coordination, can cause agitation and hallucinations
- seizures (convulsions/fits)
- constriction of blood vessels in the hands and feet, with coldness and numbness
- contraction of the blood vessels in the colon, which may 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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Rizatriptan
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 carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°C.
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.
6. Contents of the pack and other information
What Rizatriptan orodispersible tablet contains
The active substance is rizatriptan.
One orodispersible tablet contains 5 mg of rizatriptan as 7.265 mg of rizatriptan benzoate.
- The other ingredients are mannitol (E 421), calcium silicate (E 552), crospovidone, aspartame (E 951), peppermint flavour, silica colloidal anhydrous, sodium stearyl fumarate
What Rizatriptan orodispersible tablet looks like and content of the pack
Rizatriptan 5 mg orodispersible tablets are white, round, flat faced beveled edge tablets, debossed with “HP” on one side and “238” on other side. Pack size: Blister pack of 3, 6 or 18 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
This leaflet was last revised in 04/2025
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