Maxalt 10mg Tablets
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MAXALT® 10mg Tablets
(rizatriptan benzoate)
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 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is MAXALT 10mg Tablets, but will be referred to as MAXALT throughout this leaflet. Please note that this leaflet also contains information about other strength: MAXALT 5mg Tablets. In this leaflet:
1. What MAXALT is and what it is used for
2. Before you take MAXALT
3. How to take MAXALT
4. Possible side effects
5. How to store MAXALT
6. Further information
1. WHAT MAXALT IS AND WHAT IT IS USED FOR
MAXALT belongs to a class of medicines called selective serotonin 5-HT1B/id receptor agonists.
MAXALT is used to treat the headache phase of the migraine attack in adults.
Treatment with MAXALT:
Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
2. BEFORE YOU TAKE MAXALT
Do not take MAXALT if:
• you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of MAXALT
• 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) 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 (drugs against depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAO inhibitors
• you are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other drug in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine. (See ‘Taking with other medicines' below).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking MAXALT.
Take special care with MAXALT if you:
Before you take MAXALT, tell your doctor or pharmacist, 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 preparation containing St. John's wort
• 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 norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression.
• you have had short lived symptoms including chest pain and tightness.
If you take MAXALT 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 MAXALT.
that might be take for a migraine.
Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take MAXALT only for a migraine attack. MAXALT should not be used to treat headaches 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 This is because MAXALT can affect the way some medicines work. Also other medicines can affect MAXALT.
Taking with other medicines
Do not take MAXALT:
• if you are already taking a 5-HT1B/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 MAXALT may increase the risk of side-effects.
You should wait at least 6 hours after taking MAXALT 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 MAXALT.
Ask your doctor for instructions and the risks about taking MAXALT
• if you are taking propranolol (see section 3: ‘How to take MAXALT')
• 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 any other medicines, including medicines obtained without a prescription.
Taking MAXALT with food and drink:
MAXALT 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
It is not known whether MAXALT is harmful to an unborn baby when taken by a pregnant woman.
Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant or are breastfeeding. Breastfeeding should be avoided for 24 hours after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Use in children
The use of MAXALT tablets 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 MAXALT is amongst patients older than 65 years.
Driving or using machines
You may feel sleepy or dizzy while taking MAXALT. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of MAXALT
The 5mg tablet contains 30.25mg of lactose monohydrate and the 10-mg tablet contains 60.50mg of lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MAXALT
MAXALT is used to treat migraine attacks. Take MAXALT as soon as possible after your migraine headache has started. Do not use it to prevent an attack.
Always take MAXALT exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.
The usual dose is 10mg.
If you are currently taking propranolol or have kidney or liver problems you should use the 5mg dose of MAXALT. You should leave at least 2 hours between taking propranolol and MAXALT up to a maximum of 2 doses in a 24-hour period.
MAXALT (rizatriptan benzoate) tablets should be taken by mouth and swallowed whole with liquid.
MAXALT is also available as a 10mg oral lyophilisate that dissolves in the mouth. The oral lyophilisate 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 and 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 MAXALT. 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 MAXALT during an attack, you should not take a second dose of MAXALT for treatment of the same attack. It is still likely, however, that you will respond to MAXALT during the next attack.
Do not take more than 2 doses of MAXALT in a 24-hour period, (for example, do not take more than two 10mg or 5mg tablets or oral lyophilisate 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 MAXALT than you should:
If you take more MAXALT 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 further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, MAXALT can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.
Common (affects 1 to 10 users in 100)
• tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), 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,
• rash.
Uncommon (affects 1 to 10 users in 1,000)
• bad taste in your mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision.
• confusion, insomnia, nervousness.
• high blood pressure (hypertension); thirst, indigestion (dyspepsia).
• rash, itching and lumpy rash (hives),; swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).
• neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness.
• changes in the rhythm or rare of the heartbeat (arrhythmia);abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).
• facial pain; muscle pain.
Rare (affects 1 to 10 users in 10,000)
• fainting (syncope).
• wheezing
• allergic reaction like (hypersensitivity); sudden life threatening allergic reaction (anaphylaxis).
• stroke( this 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).
• Slow heart beat (bradycardia).
Not known (frequency cannot be estimated from the available data):
• heart attack, spasm of the 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, man 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 like 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.
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 MAXALT.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. HOW TO STORE MAXALT
Keep MAXALT out of the sight and reach of children.
Do not use MAXALT after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of the month.
Do not store MAXALT above 30°C.
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. If the tablets get discoloured or show any other signs of deterioration, seek the advice of your pharmacist.
6. FURTHER INFORMATION
What MAXALT contains
Each 10 mg tablet contains 14.53 mg rizatriptan benzoate equivalent to 10 mg rizatriptan. Active ingredients: The active ingredient in MAXALT Tablets is rizatriptan (present as rizatriptan benzoate). Other ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, red ferric oxide (E172) (colouring agent) and magnesium stearate (E572).
What MAXALT looks like and contents of pack
Maxalt Tablets are pale pink, capsule shaped tablets marked ‘MAXALT' on one side and ‘MSD 267' on the other.
The tablets are available in blister packs of 3 or 6 tablets.
Not all pack sizes may be marketed.
Manufactured by: For pack size 3: Merck Sharp & Dohme BV, waarderweg 39, 2031 BN, Haarlem, Netherlands For pack size 6: Frosst Iberica S.A., Via Complutense 140, 28805 Alcala de Henares, Madrid, Spain.
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN, Haarlem, Netherlands.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, U.K..
Maxalt® 10mg Tablets PL No: 18799/2074 I POM I
How can you obtain more information about MAXALT?
This leaflet gives you some of the most important about MAXALT. If you have any questions after you have read it, ask your doctor or pharmacist who can give you further information.
Further information about migraine is available from the following organizations:
Migraine Action Association, 4th Floor, 27 East Street Leicester, LE1 6NB, Tel: 0116 275 8317, Fax: 0116 254 2023 and
The Migraine Trust, 52-53 Russell Square, London, WC1B 4HP, Tel: 020 7631 6970, Fax: 020 7436 2886 Leaflet date: 25.03.2014
MAXALT is a registered trademark of Merck & Co., Inc.
RIZATRIPTAN 10mg Tablets
(rizatriptan benzoate)
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 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is RIZATRIPTAN 10mg Tablets, but will be referred to as RIZATRIPTAN throughout this leaflet. Please note that this leaflet also contains information of other strength: RIZATRIPTAN 5mg Tablets. 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
RIZATRIPTAN belongs to a class of medicines called selective serotonin 5-HT1B/iD receptor agonists.
RIZATRIPTAN is used to treat the headache phase of the migraine attack in adults.
Treatment with RIZATRIPTAN:
Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
2. BEFORE YOU TAKE RIZATRIPTAN
Do not take RIZATRIPTAN if:
• you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of RIZATRIPTAN
• 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) 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 (drugs against depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAO inhibitors
• you are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other drug in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine. (See ‘Taking with 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.
Take special care with RIZATRIPTAN if you:
Before you take RIZATRIPTAN, tell your doctor or pharmacist, 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 preparation containing St. John's wort
• 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 norepinephrine 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 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.
used to treat headaches that you normally take for a migraine.
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 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 This is because RIZATRIPTAN can affect the way some medicines work. Also other medicines can affect RIZATRIPTAN.
Taking with other medicines
Do not take RIZATRIPTAN:
• if you are already taking a 5-HT1B/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 may increase the risk of side-effects.
You should wait at least 6 hours after taking RIZATRIPTAN 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.
Ask your doctor for instructions and the risks about taking RIZATRIPTAN
• if you are taking propranolol (see section 3: ‘How to take RIZATRIPTAN')
• 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 any other medicines, including medicines obtained without a prescription.
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
It is not known whether RIZATRIPTAN is harmful to an unborn baby when taken by a pregnant woman.
Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant or are breastfeeding. Breastfeeding should be avoided for 24 hours after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Use in children
The use of RIZATRIPTAN tablets 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 is amongst patients older than 65 years.
Driving or using machines
You may feel sleepy or dizzy while taking RIZATRIPTAN. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of RIZATRIPTAN
The 5mg tablet contains 30.25mg of lactose monohydrate and the 10mg tablet contains 60.50mg of lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE RIZATRIPTAN
RIZATRIPTAN is used to treat migraine attacks. Take RIZATRIPTAN as soon as possible after your migraine headache has started. Do not use it to prevent an attack.
Always take RIZATRIPTAN exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.
The usual dose is 10mg.
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 2 hours between taking propranolol and RIZATRIPTAN up to a maximum of 2 doses in a 24-hour period.
RIZATRIPTAN (rizatriptan benzoate) tablets should be taken by mouth and swallowed whole with liquid.
RIZATRIPTAN is also available as a 10-mg oral lyophilisate that dissolves in the mouth. The oral lyophilisate 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 and 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. You should always wait at least 2 hours between doses.
If after 2 hours you still have a migraine
is still likely, however, that you will respond to RIZATRIPTAN in a 24-hour period). You should always wait at least 2 hours
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 during the next attack.
Do not take more than 2 doses of RIZATRIPTAN in a 24-hour period, (for example, do not take more than two 10mg or 5mg tablets or oral lyophilisate between doses.
If your condition worsens, seek medical attention.
If you take more RIZATRIPTAN than you should:
If you take more RIZATRIPTAN 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 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, although not everybody gets them. The following side effects may happen with this medicine.
In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.
Common (affects 1 to 10 users in 100)
• tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), 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,
• rash.
Uncommon (affects 1 to 10 users in 1,000)
• bad taste in your mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision.
• confusion, insomnia, nervousness.
• high blood pressure (hypertension); thirst, indigestion (dyspepsia).
• rash, itching and lumpy rash (hives),; swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).
• neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness.
• changes in the rhythm or rare of the heartbeat (arrhythmia);abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).
• facial pain; muscle pain.
Rare (affects 1 to 10 users in 10,000)
• fainting (syncope).
• wheezing
• allergic reaction like (hypersensitivity); sudden life threatening allergic reaction (anaphylaxis).
• stroke( this 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).
• Slow heart beat (bradycardia).
Not known (frequency cannot be estimated from the available data):
• heart attack, spasm of the 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, man 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 like 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.
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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. HOW TO STORE RIZATRIPTAN
Keep RIZATRIPTAN out of the sight and reach of children.
Do not use RIZATRIPTAN after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of the month.
Do not store RIZATRIPTAN above 30°C.
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. If the tablets get discoloured or show any other signs of deterioration, seek the advice of your pharmacist.
6. FURTHER INFORMATION
What RIZATRIPTAN contains
Each 10 mg tablet contains 14.53 mg rizatriptan benzoate equivalent to 10 mg rizatriptan. Active ingredients: The active ingredient in RIZATRIPTAN Tablets is rizatriptan (present as rizatriptan benzoate). Other ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, red ferric oxide (E172) (colouring agent) and magnesium stearate (E572).
What RIZATRIPTAN looks like and contents of pack
RIZATRIPTAN Tablets are pale pink, capsule shaped tablets marked ‘MAXALT' on one side and ‘MSD 267' on the other.
The tablets are available in blister packs of 3 or 6 tablets.
Not all pack sizes may be marketed.
Manufactured by: For pack size 3: Merck Sharp & Dohme BV, waarderweg 39, 2031 BN, Haarlem, Netherlands
For pack size 6: Frosst Iberica S.A., Via Complutense 140, 28805 Alcala de Henares, Madrid, Spain.
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN, Haarlem, Netherlands.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU. I POM I
RIZATRIPTAN 10mg Tablets PL No: 18799/2074
How can you obtain more information about RIZATRIPTAN?
This leaflet gives you some of the most important about RIZATRIPTAN. If you have any questions after you have read it, ask your doctor or pharmacist who can give you further information.
Further information about migraine is available from the following organizations: Migraine Action Association, 4th Floor, 27 East Street Leicester, LE1 6NB, Tel: 0116 275 8317, Fax: 0116 254 2023 and The Migraine Trust, 52-53 Russell Square, London, WC1B 4HP, Tel: 020 7631 6970, Fax: 020 7436 2886
Leaflet date: 25.03.2014