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RIZATRIPTAN 5 MG ORODISPERSIBLE TABLETS

Active substance(s): RIZATRIPTAN BENZOATE

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Rizatriptan
5 mg Orodispersible Tablets
(rizatriptan)

If you take rizatriptan too often this may result in
you getting a chronic headache. In such cases,
contact your doctor as you may have to stop
taking 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, pharmacist or nurse.
- 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.

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.
Children and adolescents upto 18 years
The use of rizatriptan in children and adolescents
under 18 years is not recommended.

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

Other medicines and rizatriptan
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines. This also applies if you are using herbal
medicines or medicines normally used for
migraine.
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's less than two
weeks ago since you stopped taking an MAO
inhibitor.
! ergotamine-type medications such as
ergotamine or dihydroergotamine to treat
your migraine.
! methysergide to prevent a migraine attack.

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.

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

2 What you need to know before you

take rizatriptan

You should wait at least 6 hours after taking
rizatriptan before you take ergotaminetype
medications such as ergotamine or dihydroergotamine or methysergide. You should wait at
least 24 hours after taking ergotamine-type
medications before taking rizatriptan.

Do not take rizatriptan if you:
! are allergic to rizatriptan 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
cannot be controlled by medication
! have or have ever had heart disease such as
heart attack or chest pain (angina) or you have
had symptoms related to heart disease
! have severe liver or kidney problems.
! have had a stroke (CVA) or have had transient
lack of oxygen in the brain (Transient Ischemic
Attack).
! have blockage problems with your arteries
(peripheral vascular disease).
! are currently using 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 an MAOI
! are currently using ergotamine type
medications such as ergotamine or
dihydroergotamine for the treatment of
migraine or methysergide in order to prevent a
migraine attack.
! are taking other medicines in the same class,
such as sumatriptan, naratriptan or
zolmitriptan to treat your migraine (see Other
medicines and rizatriptan).
! are unsure whether one or more of the above
points apply to you, please contact your
doctor or pharmacist before you start taking
rizatriptan.

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Ask your doctor for instructions and the risks
about taking rizatriptan if you are taking:
! propranolol (see section 3: 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 a pregnant
women.
Breast-feeding should be avoided for 24 hours
after treatment.
Driving and using machines
Do not drive or operate machinery or any other
equipment, because you may feel sleepy or dizzy
after 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 such as high blood pressure or
diabetes, you smoke or you use nicotine
substitutes, your family has a history of heart
disease, you are a man over 40 years of age, or
you are a menopausal/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 allergies
! have a headache which is associated with
dizziness, difficulty in walking, lack of
coordination or weakness in arm and leg
! are using herbal preparations containing St.
John's wort
! have had allergic reactions such as swelling of
the face, lips, tongue and / or throat, which
may cause difficulty in breathing and / or
swallowing (angioedema)
! are taking selective serotonin reuptake
inhibitors (SSRIs) such as sertraline, and
escitalopram oxalate, fluoxetine or serotonin
norepinephrine reuptake inhibitors (SNRIs)
such as venlafaxine, and duloxetine for
depression
! have had short lived symptoms including
chest pain and tightness.

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 5 mg tablet contains
1.0 mg of aspar tame (which contains
phenylalanine).
Rizatriptan also contains mannitol which may
have a mild laxative effect. Each 5 mg tablet
contains 45.810 mg of mannitol.
3 How to take rizatriptan
Rizatriptan is used for the treatment of migraine
attacks. Take rizatriptan as soon as possible after
the beginning of your migraine headache. Do not
use it to prevent an migraine attack.
Always take rizatriptan exactly as your doctor has
told you. Check with your doctor if you are not
sure.
The recommended dose is 10 mg.
If you are currently taking propranolol or if you
have kidney or liver problems, use the 5 mg dose
of rizatriptan. You should wait at least two hours
between taking propranolol and rizatriptan. Do
not take more than 2 doses in a 24 hour period.

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Front

Product Name

Rizatriptan 5 mg Orodispersible Tablets

Sap code :

Packaging Material

Pack Insert Artwork

Reason of change : Change in address

Size : Foil Width

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Country :

UK

Size : Foil Repeat Length

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Pack Size :

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Size : Strip Size

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Barcode No. :

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Size : Carton/Label

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Pharmacode :

1956

Size : PI - Open Size
PI - Close Size

L. 148 x H. 450 mm
L. 148 x H. 30 mm

No. of colours :

1

PM Style/Type :

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Min. Font Size :

9 Pt.

Remark (If any) :

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Black

510009306GB02

Reference Artwork

510009306GB01

Proof 1

16.09.2017

Developed For :

Emcure - Hinjawadi
Ms. Priyanka Khillare

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Package leaflet: Information for the patient

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Use in patients older than 65 years
There are no full studies to assess the safety and
efficacy of rizatriptan in patients over 65 years.
If migraine returns within 24 hours

!

In some patients, migraine symptoms can return
within 24 hours. If the migraine returns, you can
still take a dose of rizatriptan. However, you need
to wait at least 2 hours between doses.
!
If you still have migraine after two hours
If you do not respond to rizatriptan during an
attack, you should not take a second dose for the
treatment of the same attack. However, if you
have not reacted to rizatriptan during a migraine
attack, there is a chance 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 5 mg tablets in a 24-hour
period). You should always wait at least 2
hours between doses.
If your condition worsens, contact your doctor.
How to take Rizatriptan orodispersible tablets
! Rizatriptan (rizatriptan benzoate) is available
as a 5 mg orodispersible tablet that dissolves
in the mouth.
! Open the blister pack 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.
If you take more rizatriptan than you should

!

If you experience symptoms of an allergic
reaction, serotonin syndrome, heart attack or
stroke, contact your doctor immediately.
If you get an allergic reaction like phenomena
after taking rizatriptan, such as rash or itching,
you should contact your doctor immediately.
Reporting of side effects
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.
5 How to store rizatriptan
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 carton after EXP. The expiry
date refers to the last day of that month.

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

Do not store above 30°C.

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

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.

4 Possible side effects

6 Contents of the pack and other
information

In studies in adults, the most commonly reported
adverse events were dizziness, sleepiness and
fatigue.
The following side effects may happen with this
medicine
Common (occurring in less than 1 in 10 users)
! tingling (paraesthesia), headache, decreased
skin sensitivity (hypoesthesia) decreased
sharpness of mind, lack of sleep (insomnia)
! heart beat (palpitations)
! flushing (transient redness of the face)
! throat symptoms
! feeling sick (nausea), dry mouth, vomiting,
diarrhea, indigestion (dyspepsia)
! regional heaviness, neck pain, stiffness
! abdominal pain, chest pain.
Uncommon (affecting less than 1 in 100 users)
! bad taste in the mouth
! feeling of being out of balance when walking
(ataxia), dizziness (vertigo), blurred vision,
trembling, fainting (syncope)
! confusion, nervousness
! high blood pressure (hypertension), thirst, hot
flashes, sweating
! rash, itching, hives, swelling of the face, lips,
tongue and / or throat which may cause
difficulty in breathing and / or swallowing can
cause (angioedema), shortness of breath
(dyspnoea)
! regional tightness, muscle weakness
! changes in the rhythm or rate of the
heartbeat (arrhythmia), derogations from the
electrocardiogram (a test that measures the
electrical activity of your heart), fast heart rate
(tachycardia)
! facial pain, muscle pain.

What Rizatriptan orodispersible tablet
contains
- The active substance is Rizatriptan. One
orodispersible tablet contains 5 mg of
rizatriptan as 7.265 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 contents of the pack
Rizatriptan 5 mg orodispersible tablets are white,
round, flat faced beveled edge tablets, debossed
with “HP” on one side and ''238'' on the other side.
Pack size: Blister pack of 3 and 6 orodispersible
tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd
220 Butterfield
Great Marlings
Luton, LU2 8DL
United Kingdom
Manufacturer
Tillomed Laboratories Ltd
220 Butterfield
Great Marlings
Luton, LU2 8DL
United Kingdom
This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom
Germany

Rare (occurring in less than 1 in 1,000 users)
! wheezing
! allergic reaction (hypersensitivity), sudden
life-threatening allergic reaction (anaphylaxis)
! stroke (this is especially common in patients
with risk factors for cardiovascular disease
[high blood pressure, diabetes, smoking,
use of nicotine replacement, heart disease
or stroke in the family, arrhythmia (bundle),
or if you are a man over 40 or a menopausal
woman])
! slow heart rate (bradycardia).
Not known (based on the available data, the
frequency can not be determined)
! heart attack, spasm of blood vessels of the
heart (this is especially common in patients
with [high blood pressure risk factors for
5 mm

Back

Italy

Rizatriptan 5 mg
Orodispersible Tablets
Rizatriptan Tillomed 5 mg
Schmelztabletten
ECUHEAD

This leaflet was last revised in September
2017.

1956

510009306GB02

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

450 mm

!
!

cardiovascular disease, diabetes, smoking, use
of nicotine replacement, heart disease or
stroke in the family, arrhythmia (bundle), or if
you are a man over 40 or a woman in
menopause])
a syndrome 'serotonin syndrome' with side
effects such as coma, fluctuations in blood
pressure, extremely high body temperature,
lack of muscle coordination, can cause
agitation and hallucinations
severe blisters on the skin / peeling of the skin
with or without fever (toxic epidermal
necrolysis)
seizures (convulsions / fits)
constriction of blood vessels in the hands and
feet, with coldness and numbness
contraction of the blood vessels in the colon,
which may cause abdominal pain.

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