Rizatriptan 10 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Rizatriptan 5mg and 10mg Tablets
(rizatriptan)
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.
What is in this leaflet:
1. What Rizatriptan Tablets are and what they are used for
2. What you need to know before you take Rizatriptan Tablets
3. How to take Rizatriptan Tablets
4. Possible side effects
5. How to store Rizatriptan Tablets
6. Contents of the pack and other information
1. WHAT RIZATRIPTAN TABLETS ARE AND WHAT THEY ARE USED FOR_
Rizatriptan Tablets belongs to a class of medicines called selective serotonin 5-HTib/id receptor agonists.
Rizatriptan Tablets are used to treat the headache phase of the
migraine attack in adults.
Treatment with Rizatriptan:
Rizatriptan reduces swelling of the 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 TABLETS_
Do not take Rizatriptan Tablets
- if you are allergic (hypersensitive) to rizatriptan benzoate
- if you are allergic to Rizatriptan or any of the other ingredients of this medicine (listed in section 6)
- if you have moderately severe or severe high blood pressure or mild high blood pressure that is not controlled by medication.
- if you have or have ever had heart problems including heart attack or pain on the chest (angina) or you have experienced signs related to heart disease.
- if you have severe liver or severe kidney problems.
- if you have had a stroke (cerebrovascular accident (CVA)) or mini stroke (transient ischaemic attack (TIA)).
- if you have blockage problems with your arteries (peripheral vascular disease).
- if you are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine or pargyline (medicines for depression), or linezolid (an antibiotic),
or if you have taken them in the last two weeks.
- if you are currently taking ergotamine-type medicines, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack.
- if you are taking any similar medicines called "triptans" such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see "Other medicines and Rizatriptan Tablets" 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.
Tell your doctor
- if you have any of the following risk factors for heart disease:
high blood pressure, diabetes, if 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
- if you have kidney or liver problems
- if you have a particular problem with the way your heart beats (bundle branch block)
- if you have or have had any allergies
- If your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg or arm
- if you use any herbal preparation containing St. John's wort
- if you have had an allergic reaction like swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).
- if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
- if 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.
Children and adolescents
The use of rizatriptan in children under 18 years of age is not recommended.
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.
Other medicines and Rizatriptan Tablets
Do not take Rizatriptan Tablets if you are taking:
- a 5HTib/id 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 you have taken them in the last two weeks.
- ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine.
- 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 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.
Please tell your doctor or pharmacist 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 and other medicines can affect the way Rizatriptan Tablets work.
Rizatriptan Tablets with food and drink
Rizatriptan can take longer to work if it is taken after food. Although it is better to take your tablets on an empty stomach, you can still take them if you have eaten.
Pregnancy, breast-feeding and fertility
It is not known whether Rizatriptan Tablets are harmful to an unborn baby when taken by a pregnant woman.
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. Breast-feeding should be avoided for 24 hours after treatment.
Driving or using machines
These tablets may make you feel drowsy or dizzy. If this happens you should not drive or use any tools or machines.
Rizatriptan Tablets contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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3. HOWTO TAKE RIZATRIPTAN TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOWTO STORE RIZATRIPTAN TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Always take Rizatriptan Tablets exactly as your doctor has told you.
You should check with your doctor or your pharmacist if you are not sure.
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.
Rizatriptan Tablets should be taken by mouth and swallowed whole with liquid.
The usual dose is 10 mg.
If you are currently taking propranolol or have kidney or liver problems you should use the 5mg dose of Rizatriptan Tablets. You should leave at least 2 hours between taking propranolol and rizatriptan up to a maximum of 2 doses in a 24-hour period.
Rizatriptan Tablets is also available as a 5 or 10mg orodispersible tablet / wafer (referred to technically as an oral lyophilisate) that dissolve in the mouth. These dosage forms 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 10 mg or 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.
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. Remember to take the medicine pack and any remaining tablets 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.
Like all medicines, Rizatriptan Tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Tell your doctor right away if you have symptoms of the following rare side effects:
- allergic reaction (hypersensitivity): swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema); rash, sudden life threatening allergic reaction (anaphylaxis), severe shedding of the skin with or without fever (toxic epidermal necrolysis).
- 'serotonin syndrome': symptoms may include coma, unstable blood pressure, extremely high body temperature, lack of muscle co-ordination, agitation and hallucinations
- heart attack or stroke. 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, man over 40 years of age, post-menopausal women, particular problem with the way your heart beats [bundle branch block]).
In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.
The following side effects have also been reported:
Common (may affect up to 1 in 10 people)
- tingling (paraesthesia), headache, decreased sensitivity of skin (hypaesthesia), 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 (may affect up to 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.
Rare (may affect up to 1 in 1000people)
- bad taste in your mouth
- fainting (syncope)
- facial pain, wheezing.
Not known (frequency cannot be estimated from the available data):
- 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
- muscle pain
- changes in the rhythm or rate of the heartbeat (arrhythmia),
slow heartbeat (bradycardia), abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).
If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
Do not use Rizatriptan Tablets after the expiry date which is stated on the carton and blister after EXP The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.
What Rizatriptan Tablets contain
• The active substance is rizatriptan. Each tablet contains 5 or 10 mg of rizatriptan as 7.265 or 14.530 mg of rizatriptan benzoate.
• The other ingredients are mannitol, sorbitol (E420), iron oxide red, crospovidone, colloidal anhydrous silica and magnesium stearate.
What Rizatriptan Tablets look like and contents of pack
• The 5 mg tablets are pale pink, convex capsule shaped tablet with 'RZ5' on one side and '>' logo on the other side.
• The 10 mg tablets are pale pink, convex capsule shaped tablet with 'RZ10' on one side and '>' logo on the other side.
The tablets are packed in blister packs of 2, 3, 6, 12 or 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage,
Hertfordshire, SG1 4SZ, UK
Manufacturer
Arrow Pharm (Malta) Limited, HF62 Hal Far Industrial Estate,
Hal Far, BBG 3000, Malta
This leaflet was last revised in 10/2012.
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