TERRY

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS RIZATRIPTAN rizatriptan (as benzoate) 5 mg orally disintegrating tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS RIZATRIPTAN rizatriptan (as benzoate) 5 mg orally disintegrating tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222338
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222338

TERRY WHITE CHEMISTS RIZATRIPTAN rizatriptan (as benzoate) 5 mg orally disintegrating tablets

blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

9/02/2016

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. TERRY WHITE CHEMISTS RIZATRIPTAN rizatriptan (as benzoate) 5 mg orally disintegrating tablets blister

pack

Product Type

Single Medicine Product

Effective date

7/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Rizatriptan is indicated for the acute treatment of migraine attacks with or without aura.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. TERRY WHITE CHEMISTS RIZATRIPTAN rizatriptan (as benzoate) 5 mg orally disintegrating tablets blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

White to off-white coloured, round-shaped tablets with "APO" engraved on

one side and "RZ" over "5" on the other side.

Active Ingredients

rizatriptan benzoate

7.265 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:36:15 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Terry White Chemists

Rizatriptan

Orally Disintegrating Tablets

Contains the active ingredient Rizatriptan benzoate

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about Rizatriptan Orally

Disintegrating Tablets. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is Terry

White Chemists Rizatriptan Orally

Disintegrating Tablets. It contains the

active ingredient rizatriptan benzoate.

It is used to relieve the headache pain

and other symptoms of migraine

attacks.

Rizatriptan Orally Disintegrating

Tablets do not work for other types

of headaches.

Migraine is an intense, throbbing,

typically one-sided headache. It often

includes nausea, vomiting, sensitivity

to light, and sensitivity to sound.

Some people may have visual

symptoms before the headache,

called an aura. An aura can include

flashing lights or wavy lines.

Migraine attacks last anything from

two hours to two days and they can

return frequently. The severity and

frequency of migraine attacks may

vary.

Migraine occurs in about one out

every 10 people. It is three times

more common in women than men.

Six out of ten migraine sufferers their

first attack before the age of 20.

There is no single cause of migraine.

It tends to run in families. Certain

things, singly or in combination,

trigger migraine attacks in some

people. Some of these triggers are:

Certain foods or drinks, for

example, cheese and other dairy

products, chocolate, citrus fruit,

caffeine, alcohol (especially red

wine)

Stress, anger, worry

Changes in routine, for example,

under or over sleeping, missing

meal, change in diet

Bright light or loud noises

Hormonal changes in women,

example, during menstrual

periods

If you understand what triggers your

attacks, you may be able to prevent

migraine attacks or reduce their

frequency. Keeping a headache diary

will help you identify and monitor of

the possible migraine triggers

encounter. Once the triggers are

identified, you and your doctor can

modify your treatment and lifestyle

appropriately.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

During a migraine attack, blood

vessels in the brain dilate, or widen,

resulting in a throbbing pain.

TERRY WHITE CHEMISTS RIZATRIPTAN

Rizatriptan decreases this widening,

returning the blood vessels to their

normal size, and therefore helps to

relieve the pain. Rizatriptan also

blocks the release of certain

chemicals from nerve endings that

cause more pain and other symptoms

of migraine.

There is no evidence that this

medicine is addictive

Use in children

This medicine should not be used in

children.

The safety and effectiveness of

rizatriptan in children under 18 years

have not been established.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

Concurrent administration of

monoamine oxidase inhibitors

(MAOIs) for depression, or use

within 2 weeks of

discontinuation of MAOIs

therapy. MAOIs include

moclobemide, phenelzine,

tranylcypromine and pargyline.

Uncontrolled hypertension

Established coronary artery

disease, including ischemic

heart disease (angina pectoris,

history of myocardial

infarction, or documented silent

ischemia), signs and symptoms

of ischemic heart disease, or

Prinzmetal's angina

History of stroke or transient

ischemic attack (TIA)

Peripheral vascular disease,

including (but not limited to)

ischemic bowel disease

You are hypersensitive to, or

have had an allergic reaction to,

rizatriptan or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

If you are not sure whether you

should start taking rizatriptan,

talk to your doctor.

Do not give rizatriptan to children

under 18 years of age.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

Like most medicines, rizatriptan

is not recommended for use

during pregnancy. If there is need

to consider rizatriptan during

pregnancy, your doctor will

discuss with you the risks and

benefits of taking them during

pregnancy

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding.

It is not known whether

rizatriptan pass into breast milk.

Your doctor will discuss with you

the risks and benefits of taking

them while breast-feeding.

You have any risks factors for

heart or blood vessel disease,

including:

high blood pressure

diabetes

smoking

a high cholesterol level

a family history of heart or blood

vessel disease

Your headache is more severe

than your 'usual' migraine, or it

behaves differently

You have, or have had, any other

medical conditions

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

10. You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines should not be taken

with rizatriptan. These include:

monoamine oxidase inhibitors

(MAOIs) used to treat depression,

including moclobemide,

tranylcypromine, phenelzine,

pargyline

sumatriptan, another similar

medicine used to treat migraine

Some medicines, herbal products, or

dietary supplements may interact

with rizatriptan. These include:

propranolol, a medicine used to

treat high blood pressure

ergotamine, dihydroergotamine,

other medicines used to treat

migraine

TERRY WHITE CHEMISTS RIZATRIPTAN

methysergide, a medicine used to

prevent migraine

St. John's wort (Hypericum

perforatum), a herbal product sold

as a dietary supplement, or

products containing St. John's

wort

These medicines, herbal products, or

dietary supplements may be affected

by rizatriptan, or may affect how

well it works. If you are taking any

of these you may need a different

dose or you may need to take

different medicines or you may need

to be careful of the timing of some of

these medicines.

Ask your doctor for instructions

about taking rizatriptan if you are

also 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.

Other medicines not listed above

may also interact with rizatriptan.

Your doctor has more information on

medicines to be careful with or avoid

while taking rizatriptan.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

The usual dose to treat a migraine is

one 10 mg.

If the first rizatriptan tablet does help

your migraine, but it comes back

later, you may take another tablet.

Take the second tablet at least 2

hours after the first. Do not take more

than 30 mg (three 10 mg tablets) in a

24 hour period.

If the first rizatriptan tablet does not

help your migraine, do not take

another tablet for the same attack as

it is unlikely to help. It is still likely,

however, that you will respond to

rizatriptan during your next attack.

You should not take rizatriptan10mg

while you are taking propranolol.

If you do not understand the

instructions on the box, ask your

doctor for help.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

With dry hands place the tablet on

your tongue.

When to take it

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

your next dose at the usual time.

Otherwise, take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too many tablets, you

may feel sleepy, dizzy, faint or have

a slow heartbeat.

While you are taking

this medicine

Things you must do

If your headache is more severe than

your 'usual' migraine or behaves

differently, tell your doctor.

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

TERRY WHITE CHEMISTS RIZATRIPTAN

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Migraine or treatment with

rizatriptan may cause sleepiness or

dizziness in some people. Make sure

you know how you react to

rizatriptan before you drive a car,

operate machinery, or do anything

else that could be dangerous if you

are sleepy or dizzy. If you drink

alcohol, sleepiness or dizziness may

be worse.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking rizatriptan or if you have any

questions or concerns.

Rizatriptan helps most people with

migraine headaches, but they may

have unwanted side effects in a few

people. You may need medical

treatment if you get some of the side

effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

difficulty thinking or working

because of:

sleepiness, tiredness

dizziness

inability to sleep

decreased mental sharpness

nervousness

agitation

seeing/ feeling/ hearing things

that are not there

headache not relieved by

rizatriptan

stomach or bowel problems

feeling sick (nausea),

vomiting

stomach upset or pain

diarrhoea

changes in your sight or taste

such as:

blurred vision

dry mouth

thirst

bad taste

throat discomfort

tongue swelling

skin problems

skin rash, itching

redness or flushing of the face

hot flushes, sweating

changes in the way your body

feels, such as:

feelings of heaviness or tightness

on parts of the body

muscle weakness

muscle pain

tingling or numbness of the

hands or feet

tremor, unsteadiness when

walking

spinning sensation, also called

vertigo

very high temperature

unusually increased reflexes or

lack of coordination

fast, slow or irregular heartbeats,

palpitations

neck pain or facial pain

Dizziness, sleepiness and tiredness

are the most common side effects of

rizatriptan. For the most part, these

have been mild.

Abnormalities of the

electrocardiogram (a test that records

the electrical activity of your heart)

have also been reported.

If you take rizatriptan too often, you

may get chronic headaches. Contact

your doctor as you may have to stop

taking rizatriptan.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are serious side effects and

you may need urgent medical

attention or hospitalisation. Serious

side effects are rare:

fainting, coma

pinkish, itchy swellings on the

skin, also called hives or

nettlerash

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

shortness of breath, wheezing

pain or tightness in chest (which

may be symptoms of heart attack

or angina)

collapse, numbness or weakness

of the arms or legs, headache,

dizziness and confusion, visual

Other side effects not listed above

may occur in some patients.

disturbance, difficulty

swallowing, slurred speech and

loss of speech (which may be

symptoms of stroke)

severe skin reaction which starts

with painful red areas, then large

blisters and ends with peeling of

layers of skin. This is

accompanied by fever and chills,

aching muscles and generally

feeling unwell.

seizures, fits or convulsions

persistent purple discolouration,

and/or pain in the fingers, toes,

ears, nose or jaw

pain or spasms in the lower

stomach, bloody diarrhoea and

fever

As with other medicines in the same

class as rizatriptan, heart attack,

angina and stroke have been reported

very rarely, and generally occurred

TERRY WHITE CHEMISTS RIZATRIPTAN

people with risk factors for heart or

blood vessel disease (including high

blood pressure, diabetes, smoking,

family history of heart or blood

vessel disease e.g. stroke).

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice any

other effects.

Allergic reactions

If you think you are having an

allergic reaction to rizatriptan, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 30°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What Terry White Chemists

Rizatriptan orally

disintegrating tablets looks

like

Rizatriptan orally disintegrating

tablets are available in two strengths:

5mg: White to off-white coloured,

round-shaped tablets with "APO"

engraved on one side and "RZ" over

"5" on the other side.

Blister Pack of 2 tablets.

10mg: White to off-white coloured,

round-shaped tablets with "APO"

engraved on one side and "RZ" over

"10" on the other side.

Blister Pack of 2 tablets.

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each tablet contains rizatriptan

benzoate (equivalent to 5 mg or 10

mg of rizatriptan, respectively).

It also contains the following inactive

ingredients:

Cellulose-microcrystalline

Mannitol

Crospovidone

Sucralose

Magnesium stearate

Peppermint flavour.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Terry White Chemists Rizatriptan

5mg orally disintegrating tablets

(blister pack): AUST R 222338

Terry White Chemists Rizatriptan

10mg orally disintegrating tablets

(blister pack): AUST R 222329

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in:

March 2016

TERRY WHITE CHEMISTS RIZATRIPTAN

There are no safety alerts related to this product.

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency