Medication Guide App

RIZATRIPTAN 10MG ORAL WAFERS

Active substance: RIZATRIPTAN BENZOATE

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S761LEAFLET Maxalt Melt 20120803

PACKAGE LEAFLET: INFORMATION FOR USER

MAXALT MELT 10mg ORAL WAFERS
(rizatriptan benzoate)
Your medicine is known as Maxalt Melt 10mg Oral Wafers but will
be referred to as Maxalt Melt throughout the following leaflet.
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:

If you take Maxalt Melt 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 Melt.
Please tell your doctor or pharmacist about your symptoms. Your
doctor will decide if you have migraine. You should take Maxalt Melt
only for a migraine attack. Maxalt Melt 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 Maxalt Melt can
affect the way some medicines work. Also, other medicines can
affect Maxalt Melt.
Taking with other medicines
Do not take Maxalt Melt:


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.

1. What Maxalt Melt is and what it is used for
2. Before you take Maxalt Melt
3. How to take Maxalt Melt
4. Possible side effects
5. How to store Maxalt Melt
6. Further information

The above listed medicines when taken with Maxalt Melt may
increase the risk of side effects.

1. WHAT MAXALT MELT IS AND WHAT IT IS USED FOR?

You should wait at least 6 hours after taking Maxalt Melt before you
take ergotamine-type medications such as ergotamine or dihydroergotamine or methysergide.

Maxalt Melt belongs to a class of medicines called selective
serotonin 5‑HT1B/1D receptor agonists.
Maxalt Melt is used to treat the headache phase of the migraine
attack in adults.
Treatment with Maxalt Melt:
Reduces swelling of blood vessels surrounding the brain. This
swelling results in the headache pain of a migraine attack.
2. BEFORE YOU TAKE MAXALT MELT
Do not take Maxalt Melt if:


you are allergic (hypersensitive) to rizatriptan benzoate or any
of the other ingredients of Maxalt Melt



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 Melt.
Take special care with Maxalt Melt if you:
Before you take Maxalt Melt, tell your doctor or pharmacist, if:

You should wait at least 24 hours after taking ergotamine-type
medications before taking Maxalt Melt.
Ask your doctor for instructions and the risks about taking Maxalt
Melt


if you are taking propranolol (see section 3: How to take
Maxalt Melt).



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 Melt with food and drink:
Maxalt Melt 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 Melt 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 Melt oral lyophilisates in children under 18 years
is not recommended.
Use in patients older than 65 years
There have been no full studies to look at how safe and effective
Maxalt Melt is amongst patients older than 65 years.
Driving or using machines
You may feel sleepy or dizzy while taking Maxalt Melt. If this
happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Maxalt
Melt
Phenylketonuric patients: Contains a source of phenylalanine. May
be harmful for people with phenylketonuria. Each Maxalt Melt oral
lyophilisate contains 3.75 mg of aspartame (which contains
phenylalanine).



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 postmenopausal
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

The usual dose is 10 mg.



you have had allergic reaction like swelling of the face, lips,
tongue and/or throat which may cause difficulty breathing
and/or swallowing (angioedema).



If you are currently taking propranolol or have kidney or liver
problems you should use the 5‑mg dose of Maxalt. You should
leave at least 2 hours between taking propranolol and Maxalt Melt
up to a maximum of 2 doses in a 24-hour period.

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.

3. HOW TO TAKE MAXALT MELT
Maxalt Melt is used to treat migraine attacks. Take Maxalt Melt
as soon as possible after your migraine headache has started.
Do not use it to prevent an attack.
Always take Maxalt Melt exactly as your doctor has told you. You
should check with your doctor or your pharmacist if you are not
sure.

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 Melt. 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 Melt during an
attack, you should not take a second dose of Maxalt Melt for
treatment of the same attack. It is still likely, however, that you will
respond to Maxalt Melt during the next attack.
Do not take more than 2 doses of Maxalt Melt in a 24-hour
period, (for example, do not take more than two 10-mg oral
lyophilisates or more than two 10 mg or 5 mg tablets in a 24hour period). You should always wait at least 2 hours between
doses.

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 your condition worsens, seek medical attention.
How to administer Maxalt Melt oral lyophilisates


Maxalt (rizatriptan benzoate) is available as a 10 mg oral
lyophilisate that dissolves in the mouth.



Open the Maxalt Melt oral lyophilisate blister pack with dry
hands.



The oral lyophilisate should be placed on your tongue, where it
dissolves and can be swallowed with the saliva.



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 with liquids.

Maxalt is also available as a tablet to be taken with liquids.

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 Melt.
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 MAXALT MELT


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Maxalt Melt should be not stored above 30°C.



Do not remove the oral lyophilisate from its blister or the
aluminium sachet until you are ready to take it.



Keep the oral lyophilisate in the carrying case for protection.



Do not put the oral lyophilisate into another container, as they
might get mixed up.



Do not use after the expiry date printed on the carton label or
blister strip.

Like all medicines, Maxalt Melt can cause side effects, although not
everybody gets them. The following side effects may happen with
this medicine.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

In adult studies, the most common side effects reported were
dizziness, sleepiness and tiredness.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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 you take more Maxalt Melt than you should:
If you take more Maxalt Melt 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.
4. POSSIBLE SIDE EFFECTS

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,

6. FURTHER INFORMATION



throat discomfort, difficulty breathing (dyspnoea),

What Maxalt Melt contains



feeling sick (nausea), dry mouth, vomiting, diarrhoea,



feeling of heaviness in parts of the body,

Each lyophilisate contains 14.53mg rizatriptan benzoate equivalent
to 10.00mg of rizatriptan



pain in abdomen or chest,



rash.

Maxalt Melt oral lyophilisate also contain the following inactive
ingredients: gelatin, mannitol, glycine, aspartame (E951) and
peppermint flavour.

Uncommon (affects 1 to 10 users in 1000)

What Maxalt Melt looks like and contents of the pack



unsteadiness when walking (ataxia), dizziness (vertigo), blurred
vision,



confusion, insomnia, nervousness,

Maxalt Melt is a white to off-white, round, peppermint flavoured oral
lyophilisate embossed with a rounded square. Maxalt Melt is a
freeze-dried oral lyophilisate which dissolves in the mouth.



high blood pressure (hypertension); thirst, indigestion
(dyspepsia),



itching and lumpy rash (hives), allergic reaction
(hypersensitivity; 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

Rare (affects 1 to 10 users in 10,000)


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



sudden life-threatening allergic reaction (anaphylaxis), severe
shedding of the skin with or without 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, post-menopausal women, particular
problem with the way your heart beats [bundle branch block]).

Maxalt Melt is available in packs of 3 individually sealed oral
lyophilisate.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
These products are manufactured by Catalent UK Swindon Zydis
Ltd, Swindon, UK.
POM

PL No: 19488/0761

Leaflet revision date: 03 August 2012
Maxalt is a registered trade mark of Merck & Co. Inc., USA.
Further information about migraine is available from the following
organisations:
Migraine Action Association
4th Floor, 27 East Street
Leicester
LE1 6NB
Tel: 0116 275 8317
Fax: 0116 254 2023
and
The Migraine Trust
55-56 Russell Square
London
WC1B 4HP
Tel: 020 7631 6970
Fax: 020 7436 2886
Email: info@migrainetrust.org
Helpline: 020 7462 6601, Monday to Friday 10am - 5pm
S761 LEAFLET Maxalt Melt 20120803

S761 LEAFLET Rizatriptan 20120803

PACKAGE LEAFLET: INFORMATION FOR USER

RIZATRIPTAN 10mg ORAL WAFERS
(rizatriptan benzoate)
Your medicine is known as Rizatriptan 10mg Oral Wafers but will be
referred to as Rizatriptan throughout the following leaflet.
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:

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.
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.
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 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.

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

The above listed medicines when taken with Rizatriptan may
increase the risk of side effects.

1. WHAT RIZATRIPTAN IS AND WHAT IT IS USED FOR?

You should wait at least 6 hours after taking Rizatriptan before you
take ergotamine-type medications such as ergotamine or dihydroergotamine or methysergide.

Rizatriptan belongs to a class of medicines called selective
serotonin 5-HT1B/1D 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 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 oral lyophilisates in children under 18 years
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
Phenylketonuric patients: Contains a source of phenylalanine. May
be harmful for people with phenylketonuria. Each Rizatriptan oral
lyophilisate contains 3.75 mg of aspartame (which contains
phenylalanine).



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 postmenopausal
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

The usual dose is 10 mg.



you have had allergic reaction like swelling of the face, lips,
tongue and/or throat which may cause difficulty breathing
and/or swallowing (angioedema).



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.

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.

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.

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
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.
Do not take more than 2 doses of Rizatriptan in a 24-hour
period, (for example, do not take more than two 10-mg oral
lyophilisates or more than two 10 mg or 5 mg tablets in a 24hour period). You should always wait at least 2 hours between
doses.

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 your condition worsens, seek medical attention.
How to administer Rizatriptan oral lyophilisates


Rizatriptan (rizatriptan benzoate) is available as a 10 mg oral
lyophilisate that dissolves in the mouth.



Open the Rizatriptan oral lyophilisate blister pack with dry
hands.



The oral lyophilisate should be placed on your tongue, where it
dissolves and can be swallowed with the saliva.



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

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 with liquids.

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.

Tell your doctor right away if you have symptoms of allergic
reactions, serotonin syndrome, heart attack or stroke.

Rizatriptan is also available as a tablet to be taken with liquids.
If you take more Rizatriptan than you should:

5. HOW TO STORE RIZATRIPTAN


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Rizatriptan should be not stored above 30°C.

Signs of overdosage can include dizziness, drowsiness, vomiting,
fainting and slow heart rate.



Do not remove the oral lyophilisate from its blister or the
aluminium sachet until you are ready to take it.

If you have any further questions on the use of this product ask your
doctor or pharmacist.



Keep the oral lyophilisate in the carrying case for protection.



Do not put the oral lyophilisate into another container, as they
might get mixed up.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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 you take more Rizatriptan than you should, talk to your doctor or
pharmacist straight away. Take the medicine pack with you.

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 1000)


unsteadiness when walking (ataxia), dizziness (vertigo), blurred
vision,



confusion, insomnia, nervousness,



high blood pressure (hypertension); thirst, indigestion
(dyspepsia),



itching and lumpy rash (hives), allergic reaction
(hypersensitivity; 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

6. FURTHER INFORMATION
What Rizatriptan contains
Each lyophilisate contains 14.53mg rizatriptan benzoate equivalent
to 10.00mg of rizatriptan
Rizatriptan oral lyophilisate also contain the following inactive
ingredients: gelatin, mannitol, glycine, aspartame (E951) and
peppermint flavour.
What Rizatriptan looks like and contents of the pack
Rizatriptan is a white to off-white, round, peppermint flavoured oral
lyophilisate embossed with a rounded square. Rizatriptan is a
freeze-dried oral lyophilisate which dissolves in the mouth.
Rizatriptan is available in packs of 3 individually sealed oral
lyophilisate
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Rare (affects 1 to 10 users in 10,000)

Manufacturer



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

These products are manufactured by Catalent UK Swindon Zydis
Ltd, Swindon, UK.



facial pain, wheezing



sudden life-threatening allergic reaction (anaphylaxis), severe
shedding of the skin with or without 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, post-menopausal women, particular
problem with the way your heart beats [bundle branch block]).

POM

PL No: 19488/0761

Leaflet revision date: 03 August 2012
Further information about migraine is available from the following
organisations:
Migraine Action Association
4th Floor, 27 East Street
Leicester
LE1 6NB
Tel: 0116 275 8317
Fax: 0116 254 2023
and
The Migraine Trust
55-56 Russell Square
London
WC1B 4HP
Tel: 020 7631 6970
Fax: 020 7436 2886
Email: info@migrainetrust.org
Helpline: 020 7462 6601, Monday to Friday 10am - 5pm
S761 LEAFLET Rizatriptan 20120803

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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