Rizatriptan 10mg Tablets
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Read all of this leaflet carefully, before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What rizatriptan is and what it is used for
2. Before you take rizatriptan
3. How to take rizatriptan
4. Possible side effects
5. How to store rizatriptan
6. Further information
1. WHAT RIZATRIPTAN IS AND WHAT IT IS USED FOR
The name of your medicine is Rizatriptan 5mg or 10mg Tablets (referred to as rizatriptan throughout this leaflet).
Rizatriptan belongs to the group of antimigraine medicines called selective serotonin 5 HTi receptor agonists (also known as triptans).
Your doctor has given you rizatriptan to treat the headache phase of your migraine attack. Rizatriptan works by reducing the swelling of blood vessels surrounding the brain, which cause the headache phase of a migraine attack.
Rizatriptan is used to treat migraine attacks. Do not use it to prevent an attack.
2. BEFORE YOU TAKE USE RIZATRIPTAN
Do not take rizatriptan and tell your doctor if:
• you are allergic (hypersensitive) to rizatriptan (active substance) or any of the other ingredients of rizatriptan (see section 6: Further Information)
• you are taking medicines for depression or Parkinson's disease called monoamine oxidase inhibitors (MAOIs). Also do this if it has been less than two weeks since you stopped taking MAOIs
• you have severe liver or kidney problems
• you have had a stroke or mini stroke (TIA)
• you have very high blood pressure or high blood pressure which is not controlled by medicine
• you have or have ever had heart problems such as a heart attack or pain in your chest (angina)
• you have narrow or blocked arteries which affect the blood supply to your arms or legs. This can cause pain or cramping in your limbs, or, coldness or numbness of your hands or feet.
• you are taking
o an antibiotic called linezolid
o you are taking medicines such as ergotamine or dihydro-ergotamine or
methysergide(known as ergotamine-type medicines), used to treat or prevent your migraine. Wait at least 6 hours after taking rizatriptan before you take any ergotamine-type medicine. Wait at least 24 hours after taking any ergotamine-type medicine before you take rizatriptan.
o you are taking other medicines used to treat migraine, known as triptans (5HT 1B/1D agonists)
Do not take rizatriptan if any of the above apply to you. If you are not sure talk to your doctor or pharmacist before taking rizatriptan.
Take special care with rizatriptan:
Check with your doctor before taking rizatriptan if
• you have any of the following risk factors for heart and blood vessel disease: high blood pressure, diabetes, you smoke or you are using a nicotine substitute, your family has a history of heart disease, you are a man over 40 years of age, or a post-menopausal woman
• you have a particular problem with the way your heartbeat called bundle branch block
• you have kidney or liver problems
• your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in your arms or legs
Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. 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.
If you take rizatriptan too often this may result in you getting a chronic (constant) headache.
If you think this is happening to you, tell your doctor as you may have to stop taking rizatriptan.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without precription and herbal products. This is because rizatriptan can affect the way some other medicines work. Also other medicines can affect the way rizatriptan works.
Tell your doctor if you are taking:
• Propranolol (used to treat high blood pressure, irregular heartbeat, heart attack, migraine, and tremors). Leave at least 2 hours between taking propranolol and rizatriptan.
• Medicines for depression such as paroxetine, citalopram or venlafaxine (known as SSRIs or SNRIs)
• Herbal products containing St. John's wort.
Taking any of these medicines with Rizagren may increase your risk getting side-effects.
Taking rizatriptan with food and drink
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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Talk to your doctor before taking this medicine if:
• You are pregnant or planning to get pregnant. This is because it is not known whether rizatriptan is harmful to an unborn baby when taken by a pregnant woman
• You are breast-feeding. You should not breast-feed for 24 hours after taking this medicine.
Driving and using machines
Some people feel sleepy or dizzy after taking rizatriptan. If this happens, do not drive or use any machines.
Important information about some of the ingredients of Rizatriptan 5mg and 10mg Tablets
Rizatriptan 5mg and 10mg Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you take this medicinal product.
3. HOW TO TAKE RIZATRIPTAN
Always take rizatriptan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to take
Adults aged 18 years and over
The usual dose is 10mg.
Special patient groups
If you are currently taking propranolol or have kidney or liver problems, the usual dose is 5 mg (one rizatriptan 5mg tablet or half of one rizatriptan 10mg tablet)
Children and adolescents under 18 years of age
Rizatriptan should not be given to children or adolescents under 18 years of age.
If after 2 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.
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. Always wait at least 2 hours between doses.
Do not take more than 2 doses of rizatriptan in a 24-hour period (more than two 10mg or 5mg tablets in a 24-hour period - according to your prescribed dose).
Always wait at least 2 hours between doses.
If your condition worsens, seek medical attention.
Taking this medicine
Take rizatriptan as soon as possible after your migraine headache has started.
• Swallow the tablets whole with a drink of water
• If possible, take rizatriptan on an empty stomach,
• You can still take rizatriptan if you have already eaten. However, it may take longer to work.
If you take more rizatriptan than you should
If you take more tablets than you should or someone accidentally swallows some, contact your doctor or go to the nearest hospital straight away. Take the medicine pack and any remaining tablets with you so that the doctor knows what has been taken.
Signs that someone has taken too much rizatriptan can include feeling dizzy or drowsy, being sick (vomiting), fainting or having a slow heart rate.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, rizatriptan can cause side effects, althought not everybody gets.
Stop taking your medicine and contact a doctor or go to a hospital immediately if:
• You get swelling of your hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
• You have chest pain, feel short of breath or feel clammy or sweaty. You may also have a grey complexion. These could be signs of a heart attack. This is more likely to happen if you have risk factors for heart and blood vessel disease (see Section 2 “Take special care”
• Your face seems to have fallen on one side, you may not be able to smile, or your mouth or eye may have drooped. You may have problems raising both arms and keeping them there because of weakness or numbness. Your speech is slurred. These may be signs of a stroke. This is more likely to happen if you have risk factors for heart and blood vessel disease (see Section 2 “Take special care”
• You feel agitated or confused, sweat more than usual, have diarrhoea, a high temperature, higher blood pressure than usual, sudden jerking of your muscles or an unusually fast heartbeat. These could be signs of an illness called “serotonin syndrome”
If any of the following side effects gets serious or lasts longer than a few days, tell your
doctor or pharmacist:
Common (affects 1 to 10 users in 100)
- Feeling dizzy, sleepy or tired, headaches, shaking (tremor)
- Numbness or tingling on your skin (paraesthesia), decreased sensitivity of the skin
- decreased mental sharpness
- very fast, uneven or forceful heartbeat
- redness of the face lasting a short time, hot flushes, sweating
- tightness in your throat, breathing problems
- feeling sick, dry mouth, vomiting, diarrhoea
- a feeling of heaviness in your chest, throat or other parts of your body
- pain in your stomach or chest
Uncommon (affects 1 to 10 users in 1000)
- feeling confused or nervous
- difficulty sleeping (insomnia)
- feeling unsteady or clumsy when you walk, lack of co-ordination (ataxia)
- feeling dizzy, possibly with a "spinning" feeling (vertigo)
- blurred vision
- high blood pressure
- feeling thirsty, indigestion
- itching, skin rash
- neck pain, muscle stiffness or weakness
- a feeling of tightness in your chest, throat or other parts of your body
Rare (affects 1 to 10 users in 10000)
- fainting
- bad taste in your mouth
- facial pain
- wheezing
Frequency not known ( frequency cannot be estimated from the available data)
- fits or seizures
- Narrow or blocked arteries which affect the blood supply to your arms or legs. This can cause pain or cramping in your limbs, or coldness or numbness of your hands or feet.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE RIZATRIPTAN
• Keep out of the reach and sight of children.
• Do not use rizatriptan after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Rizatriptan 5mg and 10mg Tablets contain
The active substance is rizatriptan.
Each Rizatriptan 5mg Tablet contains 5mg of rizatriptan (as rizatriptan benzoate)
Each Rizatriptan 10mg Tablet contains 10mg of rizatriptan (as rizatriptan benzoate)
The other ingredients are lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium starch glycolate type A, colloidal anhydrous silica, sodium stearyl fumarate.
What Rizatriptan 5mg and 10mg Tablets look like and contents of the pack
Rizatriptan 5mg Tablets are white to off white oblong, biconvex tablets.
Rizatriptan 10mg Tablets are white to off white oblong biconvex tablets with break line on one side. The tablet can be divided into equal halves.
Pack size: 1, 2, 3, 6, 12 or 18 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
Winthrop Pharmaceuticals UK Limited
PO Box 611
Guildford
Surrey
GU1 4YS
United Kingdom
Manufacturer
ZENTIVA k.s.
U kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic
This medicinal product is authorised in the Member States of the EEA under the following names:
ProarpeH 5 (10) mg TaG^eTKu Rizagren 5 (10) mg tabletid Rizatriptan Winthrop 5 (10) mg Tabletten Rizatriptan Winthrop Rizagren 5 (10)
Rizagren 5 (10) mg, tablety Rizatriptan 5 (10) mg Tablets
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Slovac Republic United Kingdom