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RIZATRIPTAN 10 MG ORODISPERSIBLE TABLET

Active substance(s): RIZATRIPTAN BENZOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 Orodispersible
Tablets are and what they are
used for.
2. What you need to know
before you take Rizatriptan
Orodispersible Tablets.
3. How to take Rizatriptan
Orodispersible Tablets.
4. Possible side effects.
5. How to store Rizatriptan
Orodispersible Tablets.
6. Contents of the pack and other
information.
1. WHAT RIZATRIPTAN
ORODISPERSIBLE TABLETS ARE
AND WHAT THEY ARE USED FOR
Rizatriptan belongs to a group of
medicines called selective serotonin
(5-HT1B/1D) receptor agonists that are
used to treat migraine attacks in adults.
Migraine symptoms may be caused
by the temporary widening of blood
vessels in the head. Rizatriptan is
believed to reduce the widening of
these blood vessels.
Rizatriptan is used only in the
treatment of migraine headaches,
with or without aura (warning
signs). It should not be used for the
prevention of headaches.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE RIZATRIPTAN
ORODISPERSIBLE TABLETS
Do not take Rizatriptan
Orodispersible Tablets:
• if you are allergic to rizatriptan or
to any of the other ingredients of
this medicine (listed in section 6)
• if you have severe liver or severe
kidney problems
• if you have had a stroke
(cerebrovascular accident CVA) or
mini stroke (transient ischaemic
attack TIA)
• if you have moderately severe or
severe high blood pressure or mild
high blood pressure that is not
controlled by medication
• if 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
• if you suffer from reduced blood
flow to your arms and/or legs
due to narrow or blocked arteries
(Peripheral Vascular Disease)
• if 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 Orodispersible
Tablets below)
• if 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
• if you are now taking ergotaminetype medications, such as ergotamine
or dihydro-ergotamine to treat your
migraine or methysergide to prevent
a migraine attack.
If you are not sure whether any of
the above applies to you, ask your
pharmacist or your doctor.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Rizatriptan
Orodispersible Tablets:
• if your headache is associated with
dizziness, difficulty in walking, lack
of co-ordination or weakness in the
leg and arm
• if you have any of the following risk
factors for heart disease: high blood
pressure, diabetes, you smoke or
you are using nicotine substitution,
you are a man over 40 years of age,
you are a post-menopausal woman
or there is a history of heart disease
in your family
• if you use herbal preparation
containing St. John's wort
• 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
• 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 Orodispersible
Tablets too often this may result in you
getting a chronic headache. In such
cases you should contact your doctor
as you may to have to stop taking
Rizatriptan Orodispersible Tablets.

Please tell your doctor or pharmacist
about your symptoms. Your doctor
will decide if you have migraine. You
should take Rizatriptan Orodispersible
Tablets only for migraine attacks.
Rizatriptan Orodispersible Tablets
should not be used to treat
headaches that may be caused by
other, more serious conditions.
Children and adolescents
The use of Rizatriptan Orodispersible
Tablets in children and adolescents
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 Orodispersible Tablets is
amongst patients older than 65 years.
Other medicines and Rizatriptan
Orodispersible Tablets
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
This is because Rizatriptan
Orodispersible Tablets can affect
the way some medicines work.
Also, other medicines can affect
Rizatriptan Orodispersible Tablets.
Do not take Rizatriptan
Orodispersible Tablets:
• 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
Orodispersible Tablets may increase
the risk of side effects.
You must wait at least six hours
following use of rizatriptan before
taking ergotamine-type medications
(e.g. ergotamine, dihydroergotamine
or methysergide).
You must wait at least 24 hours after
the administration of an ergotaminecontaining preparation before the
administration of rizatriptan.
Ask your doctor for instructions and
the risks about taking Rizatriptan
Orodispersible Tablets:
• if you are currently taking
propranolol to lower blood
pressure (see section 3)
• if you are taking selective serotonin
uptake inhibitors (SSRIs) e.g.
sertraline, escitalopram oxalate,
citalopram, fluoxetine, paroxetine,
or serotonin noradrenaline uptake
inhibitors (SNRIs) e.g. venlafaxine,
duloxetine for depression.
Rizatriptan Orodispersible Tablets
with food and drink
Rizatriptan works best on an empty
stomach. You can still take it though
when you have eaten but it can take
longer to work.
Rizatriptan Orodispersible Tablets
need not be taken with liquid.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant
or are 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.
Rizatriptan is excreted in the
breast milk. Do not breast-feed for
24 hours after taking Rizatriptan
Orodispersible Tablets.
Driving and using machines
Rizatriptan can make you feel sleepy
or dizzy, in which case you should not
drive or use any tools or machines.
Rizatriptan Orodispersible Tablets
contain aspartame.
This medicine contains aspartame,
a source of phenylalanine. This
may be harmful to people with
phenylketonuria.
3. HOW TO TAKE RIZATRIPTAN
ORODISPERSIBLE TABLETS
Always take this medicine exactly
as your doctor or pharmacist has
told you. Check with your doctor or
pharmacist if you are not sure. The
dose is decided by your doctor.
Rizatriptan Orodispersible
Tablets are used to treat migraine
attacks in adults. Take Rizatriptan
Orodispersible Tablets as soon
as possible after your migraine
headache has started. Do not use it
to prevent an attack.
Adults (between 18 – 65 years)
The amount of Rizatriptan
Orodispersible Tablets you take is
called the dose.
The recommended dose is 10 mg.

Date: 11 Nov 2014
Description Rizatriptan benzoate 10 mg 6/3
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 470128

SAP No. N/A

Superceded Affiliate Item Code 10004894

Vendor Job No. 234763

TrackWise PR No. 470128

Proof No. 4

MA No. 04569/1149

Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours
Non-Print
Colours

1

Time: 08:32
Page Count

1/2

Black

Barcode
Area

Equate CMYK
with
Main Font Myriad Pro
Dimensions 130 x 560 mm

Body Text Size 10 pt

If you are taking propranolol to
lower your blood pressure, or have
mild or moderate problems with
your kidney or liver your doctor
will tell you to take a lower (5 mg)
dose. If you are taking propranolol,
you must not take Rizatriptan
Orodispersible Tablets within 2
hours of taking your propranolol.
If you still have a migraine after
2 hours
If the first dose of Rizatriptan
Orodispersible Tablets did not
relieve your migraine
DO NOT take a second dose for
treatment of the same attack.
However, there is a possibility that
Rizatriptan Orodispersible Tablets
may help the next time you have
a migraine.
If migraine returns within 24 hours
In some patients, migraine
symptoms can return within a
24-hour period. If you responded
to the first dose but your migraine
symptoms return within 24 hours,
you can take an additional dose of
Rizatriptan Orodispersible Tablets.
You should always wait at least 2
hours between doses.
DO NOT take more than 2 tablets
of Rizatriptan Orodispersible
Tablets within 24 hours, (for
example, do not take more than
5 mg or 10 mg oral dispersible
tablets in a 24-hour period). You
should always wait at least 2 hours
between doses.
If your condition worsens, seek
medical attention.
Use in children and adolescents
(less than 18 years of age) and
older people (over 65 years)
Children, adolescents or older
people should not take Rizatriptan
Orodispersible Tablets because there
is not enough experience with its
use in these age groups.
Method and route of
administration
Peel back the blister with dry hands
just before dosing and place the
tablet on your tongue where it
will dissolve.
Rizatriptan Orodispersible Tablets
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 you take more Rizatriptan
Orodispersible Tablets than
you should
Contact your doctor or local hospital
immediately. Take the medicine
pack with you. Possible signs of
overdose 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. A list of
possible side effects is given below.
In adult studies, the most common
side effects reported were dizziness,
sleepiness and tiredness.
If you get any of the following
contact your doctor straight
away or seek emergency help
immediately:
Rare (may affect up to 1 in
1,000 people):
• you have an allergic reaction. Such
reactions may appear in the form
of anaphylaxis (a severe form of
allergic reaction) with symptoms
such as:
* rash,
* swelling of the face, lips, mouth,
tongue or throat which may
cause difficulty in swallowing or
breathing (angioedema),
* anaphylactoid reaction (sudden
wheezing, swelling of your lips,
tongue and throat or body,
rash, fainting or difficulties in
swallowing).
• 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 stroke, man over 40 years of age,
post-menopausal women, particular
problem with the way your heart
beats [bundle branch block]).
Not known (frequency cannot be
estimated from the available data):
• seizures (convulsions/fits).
• a widespread rash with blisters and
skin peeling on much of the body
surface, may be accompanied by
fever (toxic epidermal necrolysis),
• 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.
• heart attack, spasm of blood
vessels of the heart. 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, man over 40 years
of age, post-menopausal women,
particular problem with the way
your heart beats [bundle branch
block]).

In the following, please find the
other side effects that may occur:
Common (may affect up to 1 in
10 people):
• tingling or numbness of the hands
and feet (paraesthesia), headaches,
decreased feeling or sensitivity of
skin (hypoaesthesia)
• tremor, feeling mentally less sharp
• dizziness, drowsiness
• fast or irregular heartbeat
(palpitation), very fast heart beat
(tachycardia)
• redness of the face lasting a short
time (flushing), hot flushes, sweating
• sore throat, difficulty breathing
(dyspnoea)
• feeling sick (nausea) or being sick
(vomiting), dry mouth, diarrhoea
• feeling tired or heavy in parts of
the body
• pain in the stomach or chest.
Uncommon (may affect up to 1 in
100 people):
• problems with coordinating
muscle movement (ataxia)
• spinning sensation or a feeling that
the ground is tilting (vertigo)
• altered taste, bad taste in your mouth,
• changes in the rhythm or rate of
the heartbeat (arrhythmia),
• abnormalities of the
electrocardiogram (a test that
records the electrical activity of
your heart),
• high blood pressure (hypertension)
• feeling thirsty
• indigestion (dyspepsia)
• itchiness, red raised itchy bumps
(hives)
• neck pain, stiffness, muscle
weakness, feeling of tightness in
parts of the body
• difficulty sleeping (insomnia)
confusion, nervousness
• blurred vision
• rash
• muscle pain, myalgia)
• facial pain.
Rare (may affect up to 1 in 1,000
people):
• loss of consciousness, fainting
• slow heartbeat (bradycardia)
• wheezing
Not known (frequency cannot be
estimated from the available data):
• 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
• blockage of blood vessels
• inflammation of the bowels
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. 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
ORODISPERSIBLE TABLETS
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after
the expiry date, which is stated on
the label.
Do not store above 25°C. Store in
the original container, in order to
protect from moisture.
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
Tablets contain:
• The active substance is rizatriptan.
Each orodispersible tablet contains
10 mg of rizatriptan (as rizatriptan
benzoate).
The other ingredients are colloidal
anhydrous silica, crospovidone
(Type B), crospovidone (Type A),
mannitol, microcrystalline cellulose,
Guar galactomannan, magnesium
stearate, aspartame (E951) and
peppermint flavour (contains natural
flavouring, maize maltodextrin,
modified corn starch).
What Rizatriptan Orodispersible
Tablets look like and contents of
the pack
White to off-white, round flat faced
tablets with beveled edge debossed
with 'M' on one side and 'RN2' on
other side.
Rizatriptan Orodispersible
Tablets are packed in OPA/Al/PVC
perforated unit dose blisters of 2 x 1,
3 x 1, 6 x 1, 12 x 1, 18 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road,
Dublin 13, Ireland.
Mylan Hungary Kft., H-2900,
Komárom, Mylan utca 1, Hungary.

This leaflet was last revised in 04/2014
Code No.: MH/DRUGS/25/NKD/89

Date: 11 Nov 2014
Description Rizatriptan benzoate 10 mg 6/3
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 470128

SAP No. N/A

Superceded Affiliate Item Code 10004894

Vendor Job No. 234763

TrackWise PR No. 470128

Proof No. 4

MA No. 04569/1149

Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

Sign-offs

No. of colours
Colours
Non-Print
Colours

1

470128

Time: 08:32
Page Count

2/2

Black

Barcode
Area

Equate CMYK
with
Main Font Myriad Pro
Dimensions 130 x 560 mm

Body Text Size 10 pt

Expand view ⇕

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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