RILUKEM

Main information

  • Trade name:
  • RILUKEM riluzole 50mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RILUKEM riluzole 50mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207453
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207453

RILUKEM riluzole 50mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

4/06/2014

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. RILUKEM riluzole 50mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

3/03/2015

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

24 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

56's blister pack (4 x 14's blister)

(S4) Prescription Only Medicine

14's blister pack (1 x 14's blister)

(S4) Prescription Only Medicine

Components

1. RILUKEM riluzole 50mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white coloured, capsule shaped film coated tablet, debossed

with 'RIL' on one side and '50' on other side.

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 28.11.2017 at 12:28:38 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

Rilukem

Rilukem

riluzole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Rilukem.

It does not contain all the available

information.

It does not take the place of talking

to your doctor or pharmacist.

medicines

have

risks

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 Rilukem is

used for

The brand name of your medicine is

Rilukem. The active ingredient in

the medicine is called riluzole.

Rilukem is used to treat people with

amyotrophic lateral sclerosis, which

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 Rilukem. The benefits of using

Rilukem

noticeable

you.

should

stop

taking

Rilukem

without

speaking

your

doctor first.

Before you take it

When you must not take it

Do not take Rilukem 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 Rilukem may

interfere

with

each

other.

These

include:

* theophylline - a medicine used to

treat asthma.

* amitriptyline - a medicine used to

treat depression

tacrine

medicine

used

patients

with

Alzheimer's

Disease

Rilukem

* 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

Rilukem, or may affect how well it

works.

need

different amounts of your medicine

or you may need to take different

medicines.

Your

doctor

pharmacist will advise you.

Tell your doctor if you smoke and

how

much

coffee

you

drink.

Nicotine and caffeine may affect

the amount of Rilukem

in your

body.

How to take Rilukem

How much to take

Your doctor or pharmacist will tell

you how many Rilukem 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

Rilukem

tablets

with

a

full glass of water or other liquid.

Do not chew the tablets.

When to take it

Rilukem

should

not

be

taken

immediately before or after meals,

especially

meals

which

may

contain food high in fat.

Rilukem 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 Rilukem 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

go

to

Accident

and

Emergency

at

your

nearest

hospital, if you think you or

anyone

else

may

have

taken

too

much

Rilukem.

Do

this

even

if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are taking

Rilukem

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking Rilukem.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are taking

Rilukem.

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 Rilukem

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

drive

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 Rilukem.

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.

Rilukem

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

Rilukem.

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

alarmed

this

list

possible

side

effects.

experience any of them.

After taking Rilukem

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

not keep

well.

Keep it in a cool, dry place where

the

temperature

stays

below

30

degrees 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

ground

good

place

store

medicines.

Disposal

If

your

doctor

tells

you

to

stop

taking Rilukem, or it has passed its

expiry

date,

ask

your

pharmacist

what to do with any that are left

over.

Ingredients

Each tablet contains 50 milligrams of

riluzole.

The tablets also contain

Dibasic

calcium

phosphate

dihydrate

* Crocarmellose sodium

* Hypromellose

* Microcrystalline cellulose

* Magnesium stearate

* Colloidal silicon dioxide

* Opadry Y-1-7000H

* Purified water

Manufacturer/Sponsor

Rilukem is supplied in Australia by:

Pharmacor Pty Limited

Suite 401, 7 Oaks Avenue

Dee Why, NSW, 2099

Australia

This leaflet was prepared in 07/2014

Australian Registration Number

AUST R 207453

bruise easily. You may be

developing

liver

problem.

These are very serious side effects.

You may need urgent medical

attention

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.

Product description

What it looks like

Rilukem tablets are white to off white

coloured

capsule-shaped

film-coated

tablets, debossed with “

RIL

” on one

side and “

50

” on other side :

Each pack contains 14 or 56 tablets.

15-5-2018

Riluzole Zentiva (Zentiva k.s.)

Riluzole Zentiva (Zentiva k.s.)

Riluzole Zentiva (Active substance: Riluzole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3055 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2622/T/23

Europe -DG Health and Food Safety