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RIZATRIPTAN 10 MG ORODISPERSIBLE TABLETS

Active substance(s): RIZATRIPTAN BENZOATE / RIZATRIPTAN BENZOATE / RIZATRIPTAN BENZOATE

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Rizatriptan
10 mg Orodispersible Tablets
(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 any 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. Do not use it to
prevent an attack.
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:

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! are allergic (hypersensitive) to rizatriptan
benzoate or any of the other ingredients of this
medicine (listed in section 6)
! have moderately severe or severe high blood
pressure or mild high blood pressure that is
not controlled by medication
! have or have ever had heart problems
including heart attack or pain on the chest
(angina) or you have experienced heart
disease related signs
! have severe liver or severe kidney problems
! have had a stroke (cerebrovascular accident
CVA) or mini stroke (transient ischaemic attack
TIA)
! have blockage problems with your arteries
(peripheral vascular disease)
! 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
! are now taking ergotamine-type medications,
such as ergotamine or dihydroergotamine to
treat your migraine or methysergide to
prevent a migraine attack
! 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
! have kidney or liver problems
! have a particular problem with the way your
heart beats (bundle branch block)
! have or have had any allergies
! have a headache which is associated with
dizziness, difficulty in walking, lack of coordination or weakness in the leg and arm
! use herbal preparations containing St. John's
wort
! have had allergic reaction like swelling of face,
lips, tongue and/or throat which may cause
difficulty breathing and/or swallowing
(angioedema)
! are taking selective serotonin reuptake
inhibitors (SSRIs) such as ser traline,
escitalopram oxalate, and fluoxetine or
serotonin norepinephrine reuptake inhibitors
(SNRIs) such as venlafaxine and duloxetine for
depression
! 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
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contact your doctor as you may have to stop
taking rizatriptan.
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.
Other medicines and rizatriptan
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.
Do not take rizatriptan if you are taking
! a 5-HT1B/1D agonist (sometimes referred to
as 'triptans'), such as sumatriptan, naratriptan
or zolmitriptan.
! 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.
! ergotamine-type medications such as
ergotamine or dihydro-ergotamine to treat
your migraine
! 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 How to take Rizatriptan)
! SSRIs such as sertraline, escitalopram oxalate,
and fluoxetine or SNRIs such as venlafaxine,
and duloxetine for depression.
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 pregnant women.
Breastfeeding should be avoided for 24 hours
after treatment.
Driving and 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 in Rizatriptan orodispersible
tablets
Rizatriptan contains aspartame a source of
phenylalanine which may be harmful for people
with phenylketonuria. Each 10 mg tablet contains
2.0 mg of aspar tame (which contains
phenylalanine).
Rizatriptan also contains mannitol which may
have a mild laxative effect. Each 10 mg tablet
contains 91.620 mg of mannitol.
3 How to take Rizatriptan
Rizatriptan is used to treat migraine attacks.
Take rizatripan 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 recommended dose is 10 mg.
If you are currently taking propanolol 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 upto 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.

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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 orodispersible tablets 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.

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!
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How to take Rizatriptan orodispersible tablets
- Rizatriptan (rizatriptan benzoate) is available
as a 5 or 10 mg orodispersible tablet that
dissolves in the mouth.
- Open the blister with dry hands.
- The orodispersible tablet should be placed on
your tongue, where it dissolves and can be
swallowed with the saliva.
- The orodispersible tablet 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.

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

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

Reporting of side effects

!

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

There are no full studies to asess the safety and
efficacy of rizatriptan in patients over 65 years.

If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the national
reporting system listed in the Yellow Card Scheme
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

If you take more rizatriptan than you should:

5 How to store rizatriptan

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

Keep this medicine out of the sight and reach of
children.

Use in children and adolescents
The use of rizatriptan in children under 18 years of
age is not recommended.
Use in patients older than 65 years

Signs of overdosage can include dizziness,
drowsiness, vomiting, fainting and slow heart
rate.
If you have any further questions on the use of this
medicine ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. In
adult studies, the most common side effects
reported were dizziness, sleepiness and
tiredness.
The following side effects may happen with this
medicine
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

Do not use this medicine after the expiry date
which is stated on the carton after "EXP". The
expiry date refers to the last day of the month.
Do not store above 30°C.
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.
6 Contents of the pack and other

information
What Rizatriptan orodispersible Tablet
contains
- The active substance is rizatriptan. One
orodispersible tablet contains 10 mg
rizatriptan as 14.530 mg of rizatriptan
benzoate.
- The other ingredients are mannitol (E 421),
calcium silicate (E 552), crospovidone,
aspartame (E 951), peppermint flavor, silica
colloidal anhydrous, sodium stearyl fumarate
What Rizatriptan orodispersible tablet looks
like and content of the pack
Rizatriptan 10 mg orodispersible tablets are
white, round, flat faced beveled edge tablets,
debossed with “HP” on one side and and ''239'' on
other side.
Pack size: Blister pack of 3 and 6 orodispersible
tablets.

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.
! a l l e r g i c re a c t i o n ( hy p e r s e n s i t i v i t y ) ;
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
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Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon, St Neots
Cambridgeshire
PE19 8ET
United Kingdom
Manufacturer
Tillomed Laboratories Ltd
220 Butterfield, Great Marlings
Luton, LU2 8DL
United Kingdom
For any information about this medicine,
please contact the local representative of the
Marketing Authorisation Holder:
This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom Rizatriptan 10 mg
Orodispersible Tablets
Germany
Rizatriptan Tillomed 10mg
Schmelztabletten
Spain
Rizatriptán Tillomed 10 mg
comprimidos
bucodispersables EFG
Italy
ECUHEAD
This leaflet was last revised in July 2017
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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.

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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