RIZATRIPTAN

Main information

  • Trade name:
  • RIZATRIPTAN AN ODT rizatriptan (as benzoate) 10 mg orally disintegrating tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RIZATRIPTAN AN ODT rizatriptan (as benzoate) 10 mg orally disintegrating tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220024
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220024

RIZATRIPTAN AN ODT rizatriptan (as benzoate) 10 mg orally disintegrating tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

19/02/2015

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. RIZATRIPTAN AN ODT rizatriptan (as benzoate) 10 mg orally disintegrating tablet blister pack

Product Type

Single Medicine Product

Effective date

6/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

RIZATRIPTAN AN ODT 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

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. RIZATRIPTAN AN ODT rizatriptan (as benzoate) 10 mg orally disintegrating tablet blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

White, round, flat, bevel-edged tablet embossed with "IZ 10" on one side

and plain on the other side

Active Ingredients

rizatriptan benzoate

14.53 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 03:01:18 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

Rizatriptan AN ODT CMI v1.0

Rizatriptan AN ODT

orally

disintegrating tablets

Rizatriptan benzoate

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before

you start using Rizatriptan AN ODT.

This leaflet answers some common

questions about Rizatriptan AN ODT.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking Rizatriptan AN ODT

against the benefits they expect it will

have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Rizatriptan AN

ODT is used for

Rizatriptan AN ODT is used to relieve

the headache pain and other symptoms

of migraine attacks. Rizatriptan AN

ODT does 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 of

every 10 people. It is three times more

common in women than men.

Six out of ten migraine sufferers have

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, can 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 a

meal, change in diet

bright light or loud noises

hormonal changes in women, for

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 all

of the possible migraine triggers you

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 Rizatriptan AN

ODT has been prescribed for you.

How Rizatriptan AN ODT

works

During a migraine attack, blood

vessels in the brain dilate, or widen,

resulting in a throbbing pain.

Rizatriptan AN ODT decreases this

widening, returning the blood vessels

to their normal size, and therefore

helps to relieve the pain. Rizatriptan

AN ODT also blocks the release of

certain chemicals from nerve endings

that cause more pain and other

symptoms of migraine.

Before you take

Rizatriptan AN ODT

When you must not use it

Do not take Rizatriptan AN ODT

if you have an allergy to

Rizatriptan AN ODT or any of the

ingredients listed at the end of this

leaflet.

Do not take Rizatriptan AN ODT if

you have or had:

high blood pressure that is not

being treated

some heart diseases, including

angina, or a previous heart attack

a stroke or transient ischaemic

attack (TIA)

blood vessel problems, including

ischaemic bowel disease

Do not take Rizatriptan AN ODT if

you are currently taking monoamine

oxidase inhibitors (MAOIs) for

depression, or have taken them

within the last two weeks.

MAOIs include moclobemide,

phenelzine, tranylcypromine and

pargyline.

Do not take Rizatriptan AN ODT if

the packaging is torn or shows signs

of tampering.

Do not take Rizatriptan AN ODT if

the expiry date on the pack has

passed.

If you take this medicine after the

expiry date has passed, it may not

work.

If you are not sure whether you

should start taking Rizatriptan AN

ODT, talk to your doctor.

Do not give Rizatriptan AN ODT to

children under 18 years of age.

The safety and effectiveness of

Rizatriptan AN ODT in children under

18 years have not been established.

Before you start to take it

Tell your doctor if:

1. you are pregnant or intend to

become pregnant

Like most medicines, Rizatriptan AN

ODT are not recommended for use

during pregnancy. If there is a need to

consider Rizatriptan AN ODT during

pregnancy, your doctor will discuss

Rizatriptan AN ODT CMI v1.0

with you the risks and benefits of

taking them during pregnancy.

2. you are breast-feeding or plan to

breast-feed

It is not known whether Rizatriptan

AN ODT pass into breast milk. Your

doctor will discuss with you the risks

and benefits of taking them while

breast-feeding.

3. 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

4. your headache is more severe

than your 'usual' migraine, or it

behaves differently

5. you have a condition called

phenylketonuria

The 5mg orally disintegrating tablet

contains 4.4mg phenylalanine (a

component of aspartame) and the

10mg orally disintegrating tablet

contains 8.8mg phenylalanine.

6. you have, or have had, any other

medical conditions

7. you have any allergies to any

other medicines or any other

substances, such as foods,

preservatives or dyes.

If you have not told your doctor

about any of the above, tell them

before you take any Rizatriptan AN

ODT.

Taking other medicines

Tell your doctor if you are taking

any other medicines, herbal

products, or dietary supplements,

including those that you buy without

a prescription from your pharmacy,

supermarket or health food shop.

Some medicines should not be taken

with Rizatriptan AN ODT. 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, and

Rizatriptan AN ODT may

interfere with each other. These

include:

propranolol, a medicine used to

treat high blood pressure

ergotamine, dihydroergotamine,

other medicines used to treat

migraine

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 AN ODT, or may

affect how well it works. You may

need different amounts of your

medicine, 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 AN ODT 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.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

Rizatriptan AN ODT.

How to take

Rizatriptan AN ODT

How much to take

Take Rizatriptan AN ODT only

when prescribed by your doctor.

The usual dose to treat a migraine is

one 10 mg orally disintegrating

tablet.

If the first Rizatriptan AN ODT

orally disintegrating tablet does help

your migraine, but it comes back

later, you may take another orally

disintegrating tablet.

Take the second orally

disintegrating tablet at least 2

hours after the first. Do not take

more than 30 mg (three 10 mg

orally disintegrating tablets) in a

24 hour period.

If the first Rizatriptan AN ODT

orally disintegrating tablet does not

help your migraine, do not take

another orally disintegrating tablet for

the same attack as it is unlikely to

help. It is still likely, however, that you

will respond to Rizatriptan AN ODT

during your next attack.

You should not take Rizatriptan AN

ODT 10mg while you are taking

propranolol.

Follow all directions given to you by

your doctor carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How to take it

Do not to remove the orally

disintegrating tablet from the blister

until just prior to dosing.

With dry hands push the orally

disintegrating tablet through the foil

and place the orally disintegrating

tablet on your tongue.

The orally disintegrating tablet will

dissolve rapidly and be swallowed

with your saliva. No water is needed

for taking the orally disintegrating

tablet.

It does not matter if you take

Rizatriptan AN ODT before or after

food.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) for advice, or go

to accident and emergency at your

nearest hospital, if you think that

you or anyone else may have taken

too many Rizatriptan AN ODT. Do

this even if there are no signs of

discomfort or poisoning.

If you take too many orally

disintegrating tablets, you may feel

sleepy, dizzy, faint or have a slow

heart beat.

While you are using

Rizatriptan AN ODT

Things you must do

If your headache is more severe than

your 'usual' migraine or it behaves

differently, tell your doctor.

If you are about to be started on any

new medicine, tell your doctor and

Rizatriptan AN ODT CMI v1.0

pharmacist that you take

Rizatriptan AN ODT for migraines.

If you become pregnant while taking

Rizatriptan AN ODT, tell your

doctor immediately.

Things you must not do

Do not give Rizatriptan AN ODT to

anyone else, even if they have the

same condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

Rizatriptan AN ODT affect you.

Migraine or treatment with Rizatriptan

AN ODT may cause sleepiness or

dizziness in some people. Make sure

you know how you react to Rizatriptan

AN ODT 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.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Rizatriptan AN ODT.

Rizatriptan AN ODT help most people

with migraine headaches, but they may

have unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not.

You may need medical treatment if

you get some of the side effects.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor if you notice any of

the following and they worry you:

1. 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 AN ODT

2. stomach or bowel problems

feeling sick (nausea), vomiting

stomach upset or pain

diarrhoea

3. changes in your sight or taste

such as:

blurred vision

dry mouth

thirst

bad taste

throat discomfort

tongue swelling

4. skin problems

skin rash, itching

redness or flushing of the face

hot flushes, sweating

5. 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 reflexesor

lack of coordination

6. fast, slow or irregular heart

beats, palpitations

7. neck pain or facial pain

Dizziness, sleepiness and tiredness

are the most common side effects of

Rizatriptan AN ODT. 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 AN ODT too

often, you may get chronic

headaches. Contact your doctor as

you may have to stop taking

Rizatriptan AN ODT.

Tell your doctor immediately or go

to accident and emergency at your

nearest hospital if you notice any

of the following:

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

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

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

As with other medicines in the same

class as Rizatriptan AN ODT, heart

attack, angina and stroke have been

reported very rarely, and generally

occurred in 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.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After using Rizatriptan

AN ODT

Storage

Keep Rizatriptan AN ODT in a cool

dry place where the temperature

stays below 30°C. Do not store them

or any other medicine in the

bathroom or near a sink.

Do not leave them in the car or on

window sills.

Heat and dampness can destroy some

medicines.

Keep them where children cannot

reach them.

Rizatriptan AN ODT CMI v1.0

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

the orally disintegrating tablets, or the

orally disintegrating tablets have

passed their expiry date, ask your

pharmacist what to do with any that

are left over.

Product description

What it looks like

Rizatriptan AN ODT orally

disintegrating tablets are available in

two strengths:

Rizatriptan AN ODT orally

disintegrating tablets 5mg* - White,

round, flat, bevel-edged tablet

embossed with “IZ 5” on one side and

plain on the other side.

A pack contains 2, 3 or 6 orally

disintegrating tablets*.

Rizatriptan AN ODT orally

disintegrating tablets 10mg - White,

round, flat, bevel-edged tablet

embossed with “IZ 10” on one side

and plain on the other side.

A pack contains 2, 3* or 6* orally

disintegrating tablets.

Ingredients

Active ingredient:

Rizatriptan AN ODT orally

disintegrating tablets 5mg* -

7.265mg rizatriptan benzoate per

wafer, equivalent to 5 mg

rizatriptan

Rizatriptan AN ODT orally

disintegrating tablets 10mg -

14.53mg rizatriptan benzoate per

wafer, equivalent to 10mg

rizatriptan

Inactive ingredients:

Mannitol

microcrystalline cellulose

calcium silicate

crospovidone

aspartame

silica colloidal anhydrous

peppermint flavour

magnesium stearate

Rizatriptan AN ODT orally

disintegrating tablets do not contain

gluten, lactose, sucrose, tartrazine or

any other azo dyes.

Supplier

Rizatriptan AN ODT orally

disintegrating tablets are supplied in

Australia by:

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra VIC 3141

This leaflet was prepared in

September 2015.

Australian Register Number:

5 mg - AUST R 220034*

10 mg - AUST R 220024

* Not currently marketed.

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