• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in Section 6)
• you have moderately severe or severe high blood pressure, or mild high blood pressure that is not controlled by medicine
• you have or have ever had heart problems including heart attack or pain in the chest (angina) or you have experienced heart disease related signs
• you have severe liver or severe kidney problems
• you have had a stroke (cerebrovascular accident, CVA) or mini stroke (transient ischaemic attack, TIA)
• you have blockage problems with your arteries (peripheral vascular disease)
• you are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline (medicines against depression), linezolid (an antibiotic) or if it has been less than two weeks since you stopped taking MAO inhibitors
• you are taking ergotamine-type medicines, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other medicine 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 this medicine.

Talk to your doctor or pharmacist before taking this medicine 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
• you have kidney or liver problems
• you have a particular problem with the way your heart beats (bundle branch block)
• you have or have had any allergies
• you have headaches associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm
• you use any herbal preparation containing St. John’s Wort
• you have had an allergic reaction involving swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate and fluoxetine, or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, or duloxetine for depression
• you have had short lived symptoms including chest pain and tightness

If you take rizatriptan too often, you may get a chronic headache.

In such cases you should contact your doctor as you may have to stop taking this medicine.

Tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have a migraine. You should take this medicine only for a migraine attack. This medicine should not be used to treat headaches that might be caused by other, more serious conditions.

Tell your doctor or pharmacist if you are taking, have recently taken or might 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 this medicine.

• a 5-HT_1B/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 has been less than two weeks since you stopped taking a MAO inhibitor
• ergotamine-type medicines such as ergotamine or dihydro-ergotamine 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 this medicine before you take ergotamine-type medicines such as ergotamine or dihydro-ergotamine or methysergide.

You should wait at least 24 hours after taking ergotamine-type medicines before taking this medicine.

Ask your doctor for instructions and the risks about taking this medicine if you are also taking:

• propranolol (see section 3)
• SSRIs such as sertraline, escitalopram oxalate, and fluoxetine
• SNRIs such as venlafaxine, and duloxetine for depression

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

This medicine 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.

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.

It is not known whether rizatriptan is harmful to an unborn baby when taken by a pregnant woman.

Breast-feeding should be avoided for 24 hours after treatment.

You may feel sleepy or dizzy while taking rizatriptan. If this happens, do not drive or use any tools or machines.

In some patients, migraine symptoms can return within a 24-hour period. If your migraine does return you can take an additional dose of this medicine. You should always wait at least 2 hours between doses.

If you do not respond to the first dose of this medicine 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 this medicine during the next attack.

Do not take more than 2 doses of rizatriptan in a 24-hour period. You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

The use of this medicine in children under 18 years of age is not recommended.

There have been no full studies to look at how safe and effective this medicine is amongst patients older than 65 years.

If you take more rizatriptan than you should, talk to your doctor or pharmacist straight away. Take the medicine pack with you.

Signs of overdose can include dizziness, drowsiness, vomiting, fainting and slow heart rate.

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 (website: 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.

The active substance is rizatriptan.

Each 5mg tablet contains 7.265mg of rizatriptan benzoate equivalent to 5mg of rizatriptan.

Each 10mg tablet contains 14.53mg of rizatriptan benzoate equivalent to 10mg of rizatriptan.

The other ingredients are: microcrystalline cellulose, maize starch, pregelatinised, starch (maize), iron oxide red (E172), magnesium stearate.

5mg tablets are pale pink, round and biconvex with dimensions 6.0±0.1mm and 3.0±0.2mm in thickness.

10mg tablets are pale pink, round and biconvex, with a score line in one side and dimensions 8.0±0.1mm and 3.5 ±0.2mm in thickness.

Pack sizes: 2, 3, 6, 12 or 18 tablets.

Not all pack sizes may be marketed.

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