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RIZATRIPTAN TILLOMED 5 MG TABLETS

Active substance(s): RIZATRIPTAN BENZOATE / RIZATRIPTAN BENZOATE

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148 mm
5 mm

64 mm

5 mm

5 mm

5 mm

64 mm

5 mm

5 mm

Rizatriptan 5 mg and 10 mg Tablets
rizatriptan

If you take this medicine 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 this medicine.

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 of the side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet,
please tell your doctor or pharmacist. See
section 4.

Tell your doctor or pharmacist about your
symptoms. Your doctor will decide if you have
migraine. You should take this medicine only for a
migraine attack. This medicine should not be
used to treat headaches that might be caused by
other, more serious conditions.
Tell your doctor or pharmacist if you are taking or
have recently taken, or might 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 Tablets can affect the way
some medicines work. Also, other medicines can
affect this medicine.

What is in this leaflet:
1 What Rizatriptan Tablet is and what it

is used for
2 What you need to know before you

Other medicines and Rizatriptan Tablets
Do not take this medicine
! 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.

take Rizatriptan Tablets
How to take Rizatriptan Tablets
Possible side effects
How to store Rizatriptan Tablets
Contents of the pack and other
information

1 What Rizatriptan Tablet is and what it is

used for
Rizatriptan belongs to a class of medicines called
selective serotonin 5-HT1B/1Dreceptor agonists.
Rizatriptan is used to treat the headache phase of
the migraine attack in adults.

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

Treatment with Rizatriptan reduces swelling of
blood vessels surrounding the brain. This swelling
results in the headache pain of a migraine attack.
Do not use it to prevent an attack.

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

2 What you need to know before you

take Rizatriptan Tablets

You should wait at least 24 hours after taking
ergotamine-type medications before taking this
medicine

Do not take this medicine if:
! you are allergic to rizatriptan benzoate or any of
the other ingredients in 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 dihydroergotamine 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 Tablets below)

Ask your doctor for instructions and the risks
about taking Rizatriptan Tablets
! if you are taking propranolol (see section 3:
How to take Rizatriptan Tablets).
! if you are taking SSRIs such as sertraline,
escitalopram oxalate, and fluoxetine or SNRIs
such as venlafaxine, and duloxetine for
depression.
Children and adolescents
The use of this medicine in children under 18
years of age is not recommended.
Rizatriptan Tablets with food and drink
This medicine 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
may be pregnant or planning to have a baby, ask
your doctor or pharmacist for advice before
taking this medicine.
It is not known whether Rizatriptan Tablets is
harmful to an unborn baby when taken by a
pregnant woman. Breastfeeding should be
avoided for 24 hours after treatment.
Use in patients older than 65 years
There have been no full studies to look at how safe
and effective Rizatriptan Tablets is amongst
patients older than 65 years.

If you are not sure if any of the above apply to you
talk to your doctor or pharmacist before taking
this medicine

Driving or using machines
You may feel sleepy or dizzy while taking
Rizatriptan Tablets. If this happens, do not drive or
use any tools or machines.

Warnings and precautions:
Talk to your doctor or pharmacist before you take
Rizatriptan Tablets. 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 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 ser traline,
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.

R i z at r i p t a n Ta b l e t s co nt a i n s l a c to s e
monohydrate
The 5 mg tablet contains 47.435 mg of lactose
monohydrate and the 10 mg tablet contains
94.870 mg of lactose monohydrate. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
3 How to take Rizatriptan Tablets
Rizatriptan Tablets is used to treat migraine
attacks. Take this medicine as soon as possible
after your migraine headache has started.
Always take this medicine 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 Tablets. You should leave at
least 2 hours between taking propranolol and
Rizatriptan Tablets up to a maximum of 2 doses in
a 24-hour period.
Rizatriptan Tablets should be taken by mouth and
swallowed whole with liquid.

5 mm
V2G
210317

Front

480 mm

3
4
5
6

Pharma
Code

30 mm

Package Leaflet: Information for the User

5 mm

64 mm

5 mm

64 mm

5 mm

5 mm

148 mm

5 mm

5 mm

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
www.mhra.gov.uk/yellowcard. By reporting side
affects you can help provide more information on
the safety of this medicine.

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 Tablets. 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 Tablets during an attack, you should
not take a second dose of this medicine for
treatment of the same attack. It is still likely,
however, that you will respond to this medicine
during the next attack.

5 How to store Rizatriptan 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 carton/blister after "EXP".
The expiry date refers to the last day of the month.

Do not take more than 2 doses of this medicine in
a 24-hour period, (for example, do not take more
than two 10 mg or 5 mg tablets in a 24-hour
period). You should always wait at least 2 hours
between doses.

This medicinal product does not require any
special storage conditions.

If your condition worsens, seek medical attention.

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 take more Rizatriptan Tablets than you
should:
If you take more of this medicine than you should,
talk to your doctor or pharmacist straight away.
Take the medicine pack with you.

6 Contents of the pack and other

information

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

What Rizatriptan Tablets contains
- The active substance of Rizatriptan Tablets is
rizatriptan. One tablet contains 5 mg or 10 mg
rizatriptan as 7.265 or 14.53 mg of rizatriptan
benzoate.
- The other ingredients are: lactose
monohydrate, cellulose microcrystalline
(E460), starch, pregelatinised (E1401), iron
oxide red (E172), magnesium stearate (E572)

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.

What Rizatriptan Tablets looks like and
contents of the pack
Rizatriptan 5 mg Tablets are pale pink colored,
capsule shaped tablet debossed with 'HP' on one
side and “244” on other side
Rizatriptan 10 mg Tablets are pale pink colored,
capsule shaped tablet debossed with 'HP' on one
side and “245” on other side

Common (affects 1 to 10 people in 100)
! dizziness, tingling sensations (paraesthesia),
headache, decreased sensitivity of skin
(hypoaesthesia), decreased mental sharpness,
difficulty sleeping, sleepiness or tiredness,
! feeling your 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.

Rizatriptan Tablets are supplied inblisters
consisting of Aluminium forming (OPA/Alu/PVC)
and Aluminium lidding (PAP/PET/AL) containing
6 tablets.

Uncommon (affects 1 to 10 people in 1000)
! bad taste in your mouth.
! unsteadiness when walking (ataxia), loss of
balance, feeling giddy or dizzy (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.

480 mm

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Tillomed Laboratories Limited,
3 Howard Road,
Eaton Socon, St. Neots
Cambridgeshire
PE19 8ET
United Kingdom
Manufacturer1:
Tillomed laboratories Limited
3 Howard Road,
Eaton Socon, St. Neots
Cambridgeshire
PE19 8ET
United Kingdom
Emcure Pharma UK Ltd,
Basepoint Business Centre
110 Butterfield
Great Marlings, Luton
LU2 8DL
United Kingdom
1

Only actual manufacturer will be listed on
printed leaflet

Rare (affects 1 to 10 people in 10,000)
! wheezing,
! allergic reactions (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,
post-menopausal women, particular problem
with the way your heart beats [bundle branch
block]),
! Slow heartbeat (bradycardia).

This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom
Germany
Spain
Italy
Netherlands

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.

Rizatriptan 5 mg /10 mg
Tablets
Rizatriptan Tillomed 5 mg/
10 mg Tabletten
Rizatriptán Tillomed 10 mg
comprimidos EFG
Rizatriptan Tillomed
Rizatriptan Tillomed 5 mg /
10 mg Tabletten

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 this medicine

Pharma Code

5 mm

Back

SAPCODE

This leaflet was last updated on 02/2017

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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