RILUZOLE

Main information

  • Trade name:
  • RILUZOLE WINTHROP riluzole 50mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RILUZOLE WINTHROP riluzole 50mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215851
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215851

RILUZOLE WINTHROP riluzole 50mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

26/09/2014

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. RILUZOLE WINTHROP riluzole 50mg tablet blister pack

Product Type

Single Medicine Product

Effective date

31/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Riluzole is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

56 tablets

(S4) Prescription Only Medicine

Components

1. RILUZOLE WINTHROP riluzole 50mg tablet blister packt

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Capsule-shaped tablet engraved with the text "RPR202".

Active Ingredients

Riluzole

50 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 07:59:38 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

RILUZOLE WINTHROP

®

riluzole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Riluzole Winthrop.

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 this medicine

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 this

medicine.

You may need to read it again.

What Riluzole

Winthrop is used for

The brand name of your medicine is

Riluzole Winthrop. The active

ingredient in the medicine is called

riluzole.

Riluzole Winthrop is used to treat

people with amyotrophic lateral

sclerosis, which can cause muscle

degeneration leading to muscle

weakness. It is a form of Motor

Neurone Disease.

Your doctor may have prescribed this

medicine for another reason.

Ask your doctor or pharmacist if

you have any questions about why

this medicine has been prescribed

for you.

This medicine is only available with

a doctor's prescription.

It is important to remember that you

may not feel any different when you

take Riluzole Winthrop. The benefits

of using Riluzole Winthrop may not

be noticeable to you. You should not

stop taking Riluzole Winthrop

without speaking to your doctor first.

Before you take it

When you must not take it

Do not take Riluzole Winthrop if

you:

have liver disease

are pregnant or intend to

become pregnant

are breastfeeding or intend to

breastfeed

Do not take this medicine if you

are allergic to riluzole or any of the

ingredients listed at the end of this

leaflet.

Do not give this medicine to a

child.

There is no experience with the use

of this medicine in children.

Do not take this medicine after the

expiry date (EXP) printed on the

pack.

If you take it after the expiry date has

passed, it may not work as well.

Do not use it if the packaging is

damaged or shows signs of

tampering.

Before you start to take it

Tell your doctor if you are allergic

to any of the ingredients listed at

the end of this leaflet.

Tell your doctor if you are

pregnant or intend to become

pregnant.

This medicine is not recommended to

be used during pregnancy.

Tell your doctor if you are

breastfeeding or planning to

breastfeed.

It is not known whether it passes into

breast milk. Your doctor will discuss

the risks and benefits of taking it if

you are breastfeeding or planning to

breastfeed.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

liver disease

kidney disease

lung disease

Tell your doctor if you plan to have

surgery.

If you have not told your doctor

about any of the above, tell them

before you take this medicine.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food store.

Some medicines and Riluzole

Winthrop may interfere with each

other. These include:

theophylline - a medicine used to

treat asthma.

amitriptyline - a medicine used to

treat depression

tacrine - a medicine used in

patients with Alzheimer's Disease

RILUZOLE WINTHROP

some types of antibiotics eg.

rifampicin and quinolones

omeprazole - a medicine used to

treat gastric ulcers.

some medicines used to treat

depression eg. Clomipramine and

fluvoxamine

diazepam - a medicine for

sedation.

diclofenac - a medicine used to

reduce pain and inflammation.

These medicines may be affected by

Riluzole Winthrop, or may affect

how well it works. You may need to

use different amounts of your

medicine or you may need to take

different medicines. Your doctor or

pharmacist will advise you.

Tell your doctor if you smoke and

how much coffee you drink.

Nicotine and caffeine may affect

the amount of Riluzole Winthrop

in your body.

How to take Riluzole

Winthrop

How much to take

Your doctor or pharmacist will tell

you how many Riluzole Winthrop

tablets you should take, and when to

take them.

The recommended dose is usually

one tablet two times a day.

Do not take more than the dose

your doctor has directed.

Talk to your doctor or pharmacist

if you are unsure what dose to

take.

You should not change the dosage

without speaking to your doctor first.

How to take it

Swallow Riluzole Winthrop tablets

with a full glass of water or other

liquid.

Do not chew the tablets.

When to take it

Riluzole Winthrop should not be

taken immediately before or after

meals, especially meals which may

contain food high in fat.

Riluzole Winthrop may not work as

well if it is taken at the same time as

your meals.

Take your prescribed dose at

about the same time each day.

How long to take it

Do not stop taking Riluzole

Winthrop unless your doctor tells

you to, even if you feel better.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Do not take a double dose to make

up for the dose that you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If you take too much

(overdose)

Immediately telephone your

doctor, or the Poisons Information

Centre (telephone Australia 13 11

26 or New Zealand 0800 POISON

or 0800 764 766), or go to Accident

and Emergency at your nearest

hospital, if you think you or

anyone else may have taken too

much Riluzole Winthrop. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

Riluzole Winthrop

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking Riluzole

Winthrop. If you are about to be

started on any new medicine, tell

your doctor and pharmacist that

you are taking Riluzole Winthrop.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you are

taking this medicine.

If you become pregnant while you

are taking this medicine tell your

doctor immediately.

During your treatment with Riluzole

Winthrop your doctor will do some

blood tests from time to time to

check for any possible signs of liver

damage.

Things you must not do

Do not take more than the

recommended dose unless your

doctor tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not stop taking this medicine,

or lower the dosage, without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how this

medicine affects you.

This medicine may cause drowsiness

or dizziness in some people. Make

sure you know how you react to it

before you drive a car, operate

machinery, or do anything else that

could be dangerous if you are dizzy.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Riluzole

Winthrop.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

RILUZOLE WINTHROP

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:

stomach ache, nausea or vomiting

headache

joint stiffness

skin problems eg. rash, flaking

skin

dizziness

sleepiness

weakness or loss of strength

These are the most common side

effects of this medicine.

Tell your doctor immediately, or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

irregular or fast heartbeat

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

swelling of the hands, feet or legs

tingling sensations around the

mouth

shortness of breath or difficulty

breathing

These may be serious side effects of

Riluzole Winthrop. You may need

urgent medical attention. Serious side

effects are rare.

If any of the following happen, stop

taking this medicine and tell your

doctor immediately, or go to

Accident and Emergency at your

nearest hospital:

Severe upper stomach pain, often

with nausea and vomiting

If your skin becomes itchy or

yellow or if you start to bleed or

bruise easily. You may be

developing a liver problem.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation. All of

these side effects are very rare.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After taking Riluzole

Winthrop

Storage

Keep your tablets in the blister

pack until it is time to take/use

them.

If you take the tablets out of the box

or blister pack they may not keep

well.

Keep it in a cool, dry place where

the temperature stays below 25°C.

Do not store it or any other

medicine in the bathroom or near a

sink.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy some

medicines.

Keep it 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 Riluzole Winthrop, or it has

passed its expiry date, ask your

pharmacist what to do with any

that are left over.

Product description

What it looks like

Riluzole Winthrop tablets are white

and capsule-shaped. Each tablet is

engraved with the text RPR 202:

Each pack contains 56 tablets.

Ingredients

Each tablet contains 50 milligrams of

riluzole.

The tablets also contain

anhydrous calcium hydrogen

phosphate

microcrystalline cellulose

anhydrous colloidal silica

magnesium stearate

croscarmellose sodium

hypromellose

macrogol 6000

titanium dioxide

purified water

Manufacturer/Sponsor

Riluzole Winthrop is supplied in

Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

This leaflet was prepared in

September 2014.

Australian Registration Number

AUST R 215851

® Registered Trademark

riluzole-winthrop-ccdsv6-

cmiv1-26sep14

RILUZOLE WINTHROP

15-5-2018

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