Rizatriptan 10mg tablets

• 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.

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.

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.

In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking this medicine.

Common: may affect up to 1 in 10 people

• tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), decreased mental sharpness, insomnia
• fast or irregular heartbeat (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 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 1000 people

• wheezing
• allergic reaction (hypersensitivity), sudden life-threatening allergic reaction (anaphylaxis)
• stroke (this generally occurs 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, men over 40 years of age, postmenopausal 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 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, men over 40 years of age, post-menopausal women, particular problem with the way your heart beats [bundle branch block])
• a syndrome called ‘serotonin syndrome’ that may cause side effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle co-ordination, 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.

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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