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RIZATRIPTAN 10 MG ORAL LYOPHILISATES

Active substance(s): RIZATRIPTAN BENZOATE

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503974/PL1e

®

Maxalt Melt 10 mg Oral Lyophilisates
(rizatriptan)
Patient Information Leaflet
®
The name of your medicine is Maxalt Melt 10 mg Oral
Lyophilisates, throughout this leaflet it will be referred to as
®
Maxalt Melt.
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.

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.
®

Other medicines and Maxalt
®
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.
®

What is in this leaflet:
®
1) What Maxalt Melt is and what it is used for
®
2) What you need to know before you take Maxalt Melt
®
3) How to take Maxalt Melt
4) Possible side effects
®
5) How to store Maxalt Melt
6) Contents of the pack and other information
®

1) WHAT MAXALT MELT IS AND WHAT IT IS USED FOR
®
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.

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

Melt

®

You should wait at least 6 hours after taking Maxalt Melt
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 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.

®

Treatment with Maxalt Melt:
Reduces swelling of 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
®
MAXALT MELT
®
Do not take Maxalt Melt if:
• you are allergic (hypersensitive) to rizatriptan benzoate
or any of the other ingredients of this medicine (listed
in section 6)
• 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 Other medicines and Maxalt below).
If you are not sure if any of the above apply to you, talk to
®
your doctor or pharmacist before taking Maxalt Melt.
Warnings and precautions:
®
Before you take Maxalt Melt, 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 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 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 or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
®

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
If you are pregnant or breast-feeding, think you are pregnant
or planning to have a baby ask your doctor or pharmacist for
advice before taking this medicine.
®

It is not known whether Maxalt Melt is harmful to an unborn
baby when taken by a pregnant woman. Breast-feeding
should be avoided for 24 hours after treatment.
Children and adolescents
®
The use of Maxalt Melt oral lyophilisates 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 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.
®

Maxalt Melt contains a source of phenylalanine
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).
®

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.
The usual dose is 10 mg.
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.
If migraine returns within 24 hours
In some patients, migraine symptoms can return within a 24hour 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 24-hour period). You should always wait at
least 2 hours between doses.
If your condition worsens, seek medical attention.
Continued overleaf

®

How to administer Maxalt oral lyophilisates
®
• Maxalt (rizatriptan benzoate) is available as a 5 or
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.
®

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.

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 MELT
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton/carry case/sachet/blister after ‘EXP’. The expiry
date refers to the last day of the month.
Do not store above 30°C.
Do not remove the oral lyophilisate blister from the outer
aluminium sachet until you are ready to take the medicine
inside. Do not use the medicine if the aluminium sachet is
damaged.
Always keep the aluminium sachets in the carrying case.

If you have any further questions on the use of this product
ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 (hypoesthesia), decreased mental
sharpness, insomnia
• fast or irregular heart beat (palpitation),
• flushing (redness of the face lasting a short time)
• throat discomfort
• feeling sick (nausea), dry mouth, vomiting, diarrhoea,
indigestion (dyspepsia)
• feeling of heaviness in parts of the body, neck pain,
stiffness
• pain in abdomen or chest
Uncommon (affects 1 to 10 users in 1000)
• bad taste in your mouth,
• unsteadiness when walking (ataxia), dizziness
(vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness,
• high blood pressure (hypertension); thirst, hot flushes,
sweating
• rash, itching and lumpy rash (hives); swelling of face,
lips, tongue and/or throat which may cause difficulty
breathing and/or swallowing (angioedema), difficulty
breathing (dyspnoea)
• feeling of tightness in parts of the body, muscle
weakness,
• changes in the rhythm or rate of the heartbeat
(arrhythmia); abnormalities of the electrocardiogram (a
test that records the electrical activity of your heart),
very fast heartbeat (tachycardia)
• facial pain; muscle pain.
Rare (affects 1 to 10 users in 10,000)
• wheezing,
• allergic reaction (hypersensitivity); sudden lifethreatening allergic reaction (anaphylaxis),
• stroke (this generally occurs 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,
men over 40 years of age, post-menopausal women,
particular problem with the way your heart beats
(bundle branch block)),
• Slow heartbeat (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, men 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
coordination, 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.

Do not 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 you notice any sign of deterioration or discolouration of your
medicine consult your pharmacist.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
®
What Maxalt Melt contains
Each oral lyophilisate contains 14.53 mg of rizatriptan
benzoate as 10 mg rizatriptan.
®

The other ingredients of Maxalt Melt are: gelatin, mannitol
(E421), glycine, aspartame (E951) and peppermint flavour
(composed of peppermint oil, maltodextrin and dextrin).
®

What Maxalt Melt looks like and contents of pack
White to off-white, round oral lyophilisate with a modified
square on one side, with a peppermint flavour.
Pack sizes: 2, 3 or 6 sachets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by:
Merck Sharp & Dohme B.V, Waarderweg 39, 2031 BN,
Haarlem, The Netherlands.
®

Maxalt Melt 10 mg Oral Lyophilisates
PL No: 18067/0342

POM

®

Maxalt is a registered trademark of the Merck Sharp &
Dohme Corporation.
th

This leaflet was last approved on 24 February 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.
®

How can you obtain more information about Maxalt
Melt?
This leaflet gives you some of the most important information
®
about Maxalt Melt. 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 organisations:
Migraine Action Association
th
4 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
Email: info@migrainetrust.org
The Migraine Action Association and The Migraine Trust are
independent organisations and are not associated Ginova Ltd
or Ginova UK Ltd.

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.

503974/PL1e

503975/PL1e

Rizatriptan 10 mg Oral Lyophilisates
Patient Information Leaflet
The name of your medicine is Rizatriptan 10 mg Oral
Lyophilisates, throughout this leaflet it will be referred to as
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. See section 4.
What is in this leaflet:
1) What Rizatriptan is and what it is used for
2) What you need to know before you take Rizatriptan
3) How to take Rizatriptan
4) Possible side effects
5) How to store Rizatriptan
6) Contents of the pack and other information
1) WHAT RIZATRIPTAN IS AND WHAT IT IS USED FOR
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) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RIZATRIPTAN
Do not take Rizatriptan if:
• you are allergic (hypersensitive) to rizatriptan benzoate
or any of the other ingredients of this medicine (listed
in section 6)
• 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 Other medicines and Rizatriptan
below).
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Rizatriptan.
Warnings and precautions:
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 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.
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.
Other medicines and Rizatriptan
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.
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
If you are pregnant or breast-feeding, think you are pregnant
or planning to have a baby ask your doctor or pharmacist for
advice before taking this medicine.
It is not known whether Rizatriptan is harmful to an unborn
baby when taken by a pregnant woman. Breast-feeding
should be avoided for 24 hours after treatment.
Children and adolescents
The use of Rizatriptan oral lyophilisates 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.
Rizatriptan contains a source of phenylalanine
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).
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 10 mg.
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.
If migraine returns within 24 hours
In some patients, migraine symptoms can return within a 24hour 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 24-hour period). You should always wait at least 2
hours between doses.
If your condition worsens, seek medical attention.
Continued overleaf

How to administer Rizatriptan oral lyophilisates
• Rizatriptan (rizatriptan benzoate) is available as a 5 or
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.
• 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.
Rizatriptan is also available as a tablet to be taken with
liquids.

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 out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton/carry case/sachet/blister after ‘EXP’. The expiry
date refers to the last day of the month.
Do not store above 30°C.

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 any further questions on the use of this product
ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 (hypoesthesia), decreased mental
sharpness, insomnia
• fast or irregular heart beat (palpitation),
• flushing (redness of the face lasting a short time)
• throat discomfort
• feeling sick (nausea), dry mouth, vomiting, diarrhoea,
indigestion (dyspepsia)
• feeling of heaviness in parts of the body, neck pain,
stiffness
• pain in abdomen or chest
Uncommon (affects 1 to 10 users in 1000)
• bad taste in your mouth,
• unsteadiness when walking (ataxia), dizziness
(vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness,
• high blood pressure (hypertension); thirst, hot flushes,
sweating
• rash, itching and lumpy rash (hives); swelling of face,
lips, tongue and/or throat which may cause difficulty
breathing and/or swallowing (angioedema), difficulty
breathing (dyspnoea)
• feeling of tightness in parts of the body, muscle
weakness,
• changes in the rhythm or rate of the heartbeat
(arrhythmia); abnormalities of the electrocardiogram (a
test that records the electrical activity of your heart),
very fast heartbeat (tachycardia)
• facial pain; muscle pain.
Rare (affects 1 to 10 users in 10,000)
• wheezing,
• allergic reaction (hypersensitivity); sudden lifethreatening allergic reaction (anaphylaxis),
• stroke (this generally occurs 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,
men over 40 years of age, post-menopausal women,
particular problem with the way your heart beats
(bundle branch block)),
• Slow heartbeat (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, men 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
coordination, 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.

Do not remove the oral lyophilisate blister from the outer
aluminium sachet until you are ready to take the medicine
inside. Do not use the medicine if the aluminium sachet is
damaged.
Always keep the aluminium sachets in the carrying case.
Do not 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 you notice any sign of deterioration or discolouration of your
medicine consult your pharmacist.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Rizatriptan contains
Each oral lyophilisate contains 14.53 mg of rizatriptan
benzoate as 10 mg rizatriptan.
The other ingredients of Rizatriptan are: gelatin, mannitol
(E421), glycine, aspartame (E951) and peppermint flavour
(composed of peppermint oil, maltodextrin and dextrin).
What Rizatriptan looks like and contents of pack
White to off-white, round oral lyophilisate with a modified
square on one side, with a peppermint flavour.
Pack sizes: 2, 3 or 6 sachets.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufactured by:
Merck Sharp & Dohme B.V, Waarderweg 39, 2031 BN,
Haarlem, The Netherlands.
Rizatriptan 10 mg Oral Lyophilisates
PL No: 18067/0342

POM

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This leaflet was last approved on 24 February 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.
How can you obtain more information about Rizatriptan?
This leaflet gives you some of the most important information
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 organisations:
Migraine Action Association
th
4 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
Email: info@migrainetrust.org
The Migraine Action Association and The Migraine Trust are
independent organisations and are not associated Ginova Ltd
or Ginova UK Ltd.

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.

503975/PL1e

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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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