Rizatriptan

• Used to treat migraines
• Tablet for oral use
• Take as soon as possible after onset of the migraine attack
• Do not use to prevent a migraine attack

Rizatriptan is used to treat migraine attacks in adults. During a migraine attack, the blood vessels surrounding the brain widen, resulting in a pounding pain, usually to one side of the head. In addition to severe headache, migraines are often also accompanied by nausea, sensitivity to light and sounds. The onset of a migraine may be preceded by an aura: visual disturbances such as flashing lights, zigzag patterns or stars.

Rizatriptan reduces swelling of blood vessels surrounding the brain. This helps to reduce the headache pain of a migraine attack.

Take Rizatriptan as soon as possible after your migraine headache has started. Do not use it to prevent an attack.

The tablet should be swallowed whole with some water. 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.

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 two hours between doses.

If after two hours you still have 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 two doses of Rizatriptan in a 24-hour period. You should always wait at least two hours between doses.

If your condition worsens, seek medical attention.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. Guidelines for use in adults:

• 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 two hours between taking propranolol and Rizatriptan up to a maximum of two doses in a 24-hour period.

Children and adolescents under 18 years of age should not be given Rizatriptan.

Alcohol/driving

This medicine does not interact with alcohol.

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

If you use more Rizatriptan than you should

If you take more Rizatriptan than you should, talk to your doctor or pharmacist straight away.

Rizatriptan is not suitable for everyone. Do not take Rizatriptan if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Rizatriptan contains').
• You have moderately severe or severe high blood pressure or mild high blood pressure that is not controlled by medication.
• You have or have ever had heart problems including heart attack or pain on the chest (angina pectoris) or you have experienced heart disease-related signs.
• You have severe liver or kidney problems.
• You have had a previous stroke with bleeding into the brain, or you have had a mini stroke (transient ischaemic attack TIA).
• You have blockage problems with your arteries (peripheral vascular disease).
• You are taking monoamine oxidase (MAO) inhibitors or 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 medicines in the same class as rizatriptan, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking using 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.
• 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.
• Your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg or arm.
• You use herbal preparation containing St. John's wort.
• You have had allergic reactions.
• You are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) for depression.
• You 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 you should contact your doctor as you may have to stop taking Rizatriptan.

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.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to have a baby or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Breastfeeding should be avoided for 24 hours after treatment.

Other medicines and Rizatriptan

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

Do not take Rizatriptan if:

• You are already taking a 5HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.
• You are taking a monoamine oxidase (MAO) inhibitor or if it has been less than two weeks since you stopped taking an MAO inhibitor.
• You use ergotamine-type medicines such as ergotamine or dihydro-ergotamine to treat your migraine.
• 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 six hours after taking Rizatriptan 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 Rizatriptan.

Ask your doctor for instructions and the risks about taking Rizatriptan if you are taking:

• Propranolol or SSRIs such as sertraline, escitalopram oxalate and fluoxetine, or SNRIs such as venlafaxine and duloxetine.

In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Abnormal sensation of the skin (tingling, pricking, itching) with no apparent physical cause (paresthesia), headache, decreased sensitivity of skin (hypaesthesia), decreased mental sharpness, tremor, insomnia.
• Feeling of increased heart rate (palpitations).
• Flushing (redness of the face lasting a short time).
• Throat discomfort.
• Feeling sick (nausea), dry mouth, vomiting, diarrhoea.
• Feeling of heaviness in parts of the body.
• Pain in the abdomen or chest.
• Feeling of fullness or pain in the abdomen, burping, nausea, vomiting and/or indigestion (dyspepsia).
• Neck pain, stiffness.

Uncommon (may affect up to 1 in 100 people)

• Bad taste in your mouth.
• Unsteadiness when walking (ataxia), a spinning sensation when standing or sitting (vertigo), blurred vision.
• Confusion, nervousness, involuntary movement of the body (tremor), sudden loss of consciousness (syncope).
• High blood pressure (hypertension), thirst, increased heart rate (tachycardia), hot flushes, sweating, disorder of heart rhythm (arrhythmia), abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).
• Pain radiating from the jaw, nerve cells in the brain, root implants or muscles (facial pain), muscle pain.

For a complete list of rare side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active substance of Rizatriptan is rizatriptan. One 5 mg tablet contains 5 mg rizatriptan as 7.265 mg of rizatriptan benzoate. One 10 mg tablet contains 10 mg rizatriptan as 14.53 mg of rizatriptan benzoate.  

Read the package leaflet before use.