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RIZATRIPTAN 10MG ORAL WAFERS

Active substance(s): RIZATRIPTAN BENZOATE

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S761 LEAFLET Maxalt 20180205

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.

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 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.

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.
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:

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.

The above listed medicines when taken with Maxalt Melt may
increase the risk of side effects.
You should wait at least 6 hours after taking Maxalt Melt before you
take ergotamine-type medications such as ergotamine or dihydroergotamine 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.

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



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

Children and adolescents



you have had a stroke (cerebrovascular accident CVA) or mini
stroke (transient ischaemic attack TIA)

The use of Maxalt Melt oral lyophilisates in children under 18 years
of age is not recommended.



you have blockage problems with your arteries (peripheral
vascular disease)

Use in patients older than 65 years



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 Melt below).

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Maxalt Melt.

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 women. Breastfeeding should be
avoided for 24 hours after treatment.

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).

Warnings and precautions:
Before you take Maxalt Melt, tell your doctor or pharmacist, if:

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.

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



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.

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 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.
If your condition worsens, seek medical attention.

How to administer Maxalt Melt oral lyophilisates

Reporting of side effects

-

Maxalt Melt (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.

If you get any side effects, tell your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly in UK via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card
in the Google Play or Apple App Store. By reporting side affects
you can help provide more information on the safety of this
medicine.

-

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.

5. HOW TO STORE MAXALT MELT

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Maxalt Melt should be not stored above 30°C.

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.

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.

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



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

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



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


Like all medicines, this medicine 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.

4. POSSIBLE SIDE EFFECTS

Common (affects 1 to 10 users in 100)


tingling (paraesthesia), headache, decreased sensitivity of skin
(hypoaesthesia), 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

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Maxalt Melt contains
Each lyophilisate contains 14.53mg rizatriptan benzoate equivalent
to 10.00mg of rizatriptan
Maxalt Melt oral lyophilisate also contain the following inactive
ingredients: gelatin, mannitol, glycine, aspartame (E951) and
peppermint flavour.
What Maxalt Melt looks like and contents of the pack



bad taste in your mouth.



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.

unsteadiness when walking (ataxia), dizziness (vertigo), blurred
vision, tremor, fainting (syncope)



Maxalt Melt is available in packs of 3 individually sealed oral
lyophilisate.

confusion, nervousness.



high blood pressure (hypertension); thirst, hot flushes, sweating

Product Licence holder



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)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



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)

Uncommon (affects 1 to 10 users in 1000)



facial pain; muscle pain.

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


wheezing.



allergic reaction (hypersensitivity); sudden life-threatening
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, man over 40 years of age, postmenopausal
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,
man over 40 years of age, postmenopausal 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.

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.

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

PL: 19488/0761

Leaflet revision date: 05 February 2018

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Maxalt® is a registered trade mark of Merck Sharp & Dohme Corp.,
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
52-53 Russell Square
London
WC1B 4HP
Tel: 020 7631 6970
Fax: 020 7436 2886
Email: info@migrainetrust.org
S761 LEAFLET Maxalt 20180205

S761 LEAFLET Rizatriptan 20180205

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.

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

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:

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 dihydroergotamine 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



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

Children and adolescents



you have had a stroke (cerebrovascular accident CVA) or mini
stroke (transient ischaemic attack TIA)

The use of Rizatriptan oral lyophilisates in children under 18 years
of age is not recommended.



you have blockage problems with your arteries (peripheral
vascular disease)

Use in patients older than 65 years



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.

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 women. Breastfeeding should be
avoided for 24 hours after treatment.

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).

Warnings and precautions:
Before you take Rizatriptan, tell your doctor or pharmacist, if:

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.

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



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.

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 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.
If your condition worsens, seek medical attention.

How to administer Rizatriptan oral lyophilisates

Reporting of side effects

-

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.

If you get any side effects, tell your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly in UK via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card
in the Google Play or Apple App Store. By reporting side affects
you can help provide more information on the safety of this
medicine.

-

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.

5. HOW TO STORE RIZATRIPTAN

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Rizatriptan should be not stored 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.

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.

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



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

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



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


Like all medicines, this medicine 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.

4. POSSIBLE SIDE EFFECTS

Common (affects 1 to 10 users in 100)


tingling (paraesthesia), headache, decreased sensitivity of skin
(hypoaesthesia), 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

6. CONTENTS OF THE PACK AND OTHER 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



bad taste in your mouth.



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.

unsteadiness when walking (ataxia), dizziness (vertigo), blurred
vision, tremor, fainting (syncope)



Rizatriptan is available in packs of 3 individually sealed oral
lyophilisate

confusion, nervousness.



high blood pressure (hypertension); thirst, hot flushes, sweating

Product Licence holder



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)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



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)

Uncommon (affects 1 to 10 users in 1000)



facial pain; muscle pain.

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


wheezing.



allergic reaction (hypersensitivity); sudden life-threatening
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, man over 40 years of age, postmenopausal
women, particular problem with the way your heart beats
[bundle branch block]).



Slow heartbeat (bradycardia).

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

PL: 19488/0761

Leaflet revision date: 05 February 2018

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.

Not known (frequency cannot be estimated from the available
data):

Further information about migraine is available from the following
organisations:



Migraine Action Association



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, postmenopausal 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.

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.

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
Email: info@migrainetrust.org
S761 LEAFLET Rizatriptan 20180205

+ Expand Transcript

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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