Rizatriptan 10mg Orodispersible Tablets
Package leaflet: Information for the user
Rizatriptan 10mg Orodispersible Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have 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.
• The full name of this medicine is Rizatriptan 10mg Orodispersible Tablets but within the leaflet it will be referred to as Rizatriptan tablets.
What is in this leaflet:
T| What Rizatriptan tablets are and what they are used for
^ What you need to know before you take Rizatriptan tablets ^ How to take Rizatriptan tablets Possible side effects T| How to store Rizatriptan tablets « Contents of the pack and other information
j What Rizatriptan tablets are and what they are used for
Rizatriptan tablets belong to a class of medicines called selective serotonin 5-HT1B/1D receptor agonists.
Your doctor has prescribed Rizatriptan tablets to treat the headache phase of your migraine attack.
Treatment with Rizatriptan tablets reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
^ What you need to know before you take Rizatriptan tablets
Do not take Rizatriptan tablets if you:
• are allergic to rizatriptan benzoate 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 is not controlled by medication
• have or have ever had heart problems including heart attack or pain on the chest (angina) or you have experienced heart disease related signs
• have severe liver or severe kidney problems
• have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attack TIA)
• have blockage problems with your arteries (peripheral vascular disease)
• 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
• are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• are taking any other drug in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine (see "Taking other medicines” below).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Rizatriptan tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rizatriptan tablets 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 and arm
• you use herbal preparations containing St. John's wort (may increase the risk of side effects)
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• you have had allergic reaction like 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 noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression
• you have had short lived symptoms including chest pain and tightness.
If you take Rizatriptan tablets 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 tablets.
Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take Rizatriptan tablets only for a migraine attack. Rizatriptan tablets 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 tablets can affect the way some medicines work. Other medicines can also affect Rizatriptan tablets.
Other medicines and Rizatriptan tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines Do not take Rizatriptan tablets:
• 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 tablets may increase the risk of side effects.
You should wait at least 6 hours after taking Rizatriptan tablets 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 tablets.
Ask your doctor for instructions and the risks about taking Rizatriptan tablets
• if you are taking propranolol (see section 3: How to take Rizatriptan tablets)
• if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.
Rizatriptan tablets with food and drink:
Rizatriptan tablets 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.
It is not known whether Rizatriptan tablets is harmful to an unborn baby when taken by a pregnant woman.
Breastfeeding should be avoided for 24 hours after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Children and adolescents
There is no experience with the use of Rizatriptan tablets in children under 18 years of age, therefore children should not be given Rizatriptan tablets.
Use in patients older than 65 years
There have been no full studies to look at how safe and effective Rizatriptan tablets is amongst patients older than 65 years.
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Driving and using machines
You may feel sleepy or dizzy while taking Rizatriptan tablets.
If this happens, do not drive or use any tools or machines.
Rizatriptan tablets contain a source of phenylalanine
Phenylketonuric patients: Contains a source of phenylalanine. May be harmful for people with phenylketonuria (a genetic metabolism disorder). Each Rizatriptan tablet contains 8.8mg aspartame (which contains phenylalanine).
^ How to take Rizatriptan tablets
Rizatriptan tablets are used to treat migraine attacks. Take Rizatriptan tablets as soon as possible after your migraine headache has started. Do not use it to prevent an attack.
Always take Rizatriptan tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 10mg (one Rizatriptan 10mg Orodispersible Tablet).
If you are currently taking propranolol or have kidney or liver problems you should use a 5mg dose of Rizatriptan tablets. You should leave at least 2 hours between taking propranolol and Rizatriptan tablets up to a maximum of 2 doses in a 24-hour period.
Rizatriptan tablets (rizatriptan benzoate) dissolve in the mouth.
• Open the Rizatriptan tablets 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 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.
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 tablets. 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 tablets during an attack, you should not take a second dose of Rizatriptan tablets for treatment of the same attack. It is still likely, however, that you will respond to Rizatriptan tablets during the next attack.
Do not take more than 2 doses of Rizatriptan tablets in a 24-hour period, (for example, do not take more than two 10mg or 5mg orodispersible tablets in a 24-hour period). You should always wait at least 2 hours between doses.
Rare (affects less than 1 in 1000 people)
• bad taste in your mouth
• fainting (syncope), a syndrome called "serotonin syndrome” that may cause side effects like coma, unstable blood pressure, extremely high body temperature, lack of muscle co-ordination, agitation, and hallucinations
• facial pain, wheezing
• allergic reaction like swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/ or swallowing (angioedema); rash, severe shedding of the skin including accompanied by fever (toxic epidermal necrolysis)
• heart attack, spasm of blood vessels of the heart, stroke. They 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]).
Frequency not known:
• seizure (convulsions/fits)
• irregular or slow heartbeat, abnormalities of the electrocardiogram (a test that records the electrical activity of your heart)
• 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
• muscle pain
Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, 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 tablets.
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
By reporting side effects you can help provide more information on the safety of this medicine.
How to store
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 pack and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not be 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.
If your condition worsens, seek medical attention.
If you take more Rizatriptan tablets than you should:
If you take more Rizatriptan tablets 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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contents of the pack and other information
What Rizatriptan tablets contain
The active substance is rizatriptan.
One Rizatriptan 10mg Orodispersible Tablet contains 10mg rizatriptan as 14.53mg of rizatriptan benzoate.
The other ingredients are: mannitol (E421), microcrystalline cellulose, calcium silicate, crospovidone type A (E1202), aspartame (E951), colloidal anhydrous silica, peppermint flavour and magnesium stearate (E470b).
What Rizatriptan tablets look like and contents of pack
Rizatriptan 10mg Orodispersible Tablets are white, round, 9mm in diameter, flat, bevel-edged tablets, with "IZ 10” engraved on one side.
In studies, the most common side effects reported were dizziness, sleepiness and tiredness.
Common (affects less than 1 in 10 people)
• tingling (paraesthesia), headache, decreased sensitivity of skin (hypoesthesia), decreased mental sharpness, tremor
• fast or irregular heart beat (palpitation), very fast heartbeat (tachycardia)
• flushing (redness of the face lasting a short time), hot flushes, sweating
• throat discomfort, difficulty breathing (dyspnoea)
• feeling sick (nausea), dry mouth, vomiting, diarrhoea
• feeling of heaviness in parts of the body
• pain in abdomen or chest.
Uncommon (affects less than 1 in 100 people)
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision
• confusion, insomnia, nervousness
• high blood pressure (hypertension); thirst, indigestion (dyspepsia)
• itching and lumpy rash (hives)
• neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness.
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OPA/Aluminium/PVC-Aluminium blister packs with push through foil.
Pack sizes: 3 and 6 orodispersible tablets
Marketing Authorization Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
This leaflet was last revised in March 2014.
If you would like a leaflet with larger text, please contact 01271 385257.
Actavis
Actavis, Barnstaple, EX32 8NS, UK