LINEZOLID

Main information

  • Trade name:
  • LINEZOLID APOTEX linezolid 600 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LINEZOLID APOTEX linezolid 600 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207475
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207475

LINEZOLID APOTEX linezolid 600 mg tablet 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

31/01/2014

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. LINEZOLID APOTEX linezolid 600 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

12/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Linezolid (intravenous or oral) is indicated for the treatment of suspected or proven infections due to Gram positive organisms resistant to multiple

classes of antibiotics, including methicillin resistant Staphylococcus species and vancomycin resistant Enterococcus species.

It is active against Gram-positive bacteria only and has no clinical activity against Gram-negative pathogens. Specific Gram-negative therapy is required

if a concomitant Gram-negative pathogen is documented or suspected.

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

(S4) Prescription Only Medicine

Components

1. LINEZOLID APOTEX linezolid 600 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White coloured, oval shaped, biconvex, film-coated tablet with "APO"

engraved on one side and "LIN600" on the other side.

Active Ingredients

Linezolid

600 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 12:26:57 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

Linezolid

APOTEX-600mg

Tablets

Contains the active linezolid

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 linezolid. 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

Linezolid APOTEX. It contains the

active ingredient linezolid. Linezolid

is an antibiotic (an agent used to

destroy certain types of bacteria). It

is used in the treatment of bacterial

infections such as pneumonia, skin

infections or blood infections.

Depending on the type of bacteria,

you may be given additional

medicines.

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.

There is no evidence that this

medicine is addictive.

Before you take this

medicine

When you must not take it

Do not take this medicine if you:

are allergic to linezolid or any of

the other ingredients listed at the

end of this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath, wheezing or

difficulty breathing, swelling of

the face, lips, tongue or other

parts of the body, rash, itching or

hives on the skin.

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.

have uncontrolled high blood

pressure

have pheochromocytoma (a type

of tumour of the adrenal gland)

have thyrotoxicosis (an

overactive thyroid gland)

have flushing or other symptoms

caused by a carcinoid tumour

are taking or have taken in the

last two weeks any medicine that

is a monoamine oxidase inhibitor

(e.g., moclobemide, phenelzine or

tranylcypromine to treat

depression or selegiline to treat

Parkinson's disease)

any cold or flu medicine

containing pseudoephedrine

adrenaline, a medicine used to

treat severe allergic reactions

any other medicine that increases

blood pressure (e.g.,

noradrenaline, dopamine,

dobutamine)

LINEZOLID APOTEX - 600MG TABLETS

are taking any medicine that is an

SSRI or serotonin re-uptake

inhibitor, which are types of

medicine to treat depression,

anxiety, panic attacks, obsessive

compulsive disorders or obesity

(e.g., citalopram,

scitalopram,fluoxetine,

fluvoxamine, paroxetine,

sertraline, duloxetine,

sibutramine, venlafaxine)

tricyclic antidepressants, which

are medicines to treat depression

(e.g., amitriptyline,

clomipramine, dothiepin,

doxepin, imipramine,

nortriptyline, trimipramine)

some medicines to treat migraine

(e.g.naratriptan, sumatriptan,

zolmitriptan)

pethidine, a medicine to treat

pain.

buspirone, a medicine to treat

anxiety

Do not take this medicine if

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 have any concerns about you

taking this medicine speak to your

doctor or pharmacist.

Before you start to take it

Tell your doctor if you:

have diarrhoea

have allergies to any other

medicines or substances, such as

foods, preservatives or dyes.

are anaemic or have had any

abnormal blood test results (e.g.,

low haemoglobin or platelets).

Tell your doctor if you:

are currently pregnant or you plan

to become pregnant.

are currently breastfeeding or you

plan to breast-feed.

If you are pregnant or

breastfeeding, the doctor may

decide not to prescribe linezolid.

Tell your doctor if 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.

In particular, tell the doctor if you

have been treated with or are taking:

any medicine that inhibits

monoamine oxidase,

(e.g.moclobemide, phenelzine or

tranylcypromine to treat

depression or selegiline to treat

Parkinson's disease)

any cold or flu medicine

containing pseudoephedrine

adrenaline, a medicine used to

treat severe allergic reactions

any other medicine that increases

blood pressure (e.g.,

noradrenaline, dopamine,

dobutamine)

are taking any medicine that is an

SSRI or serotonin re-uptake

inhibitor, which are types of

medicine to treat depression,

anxiety, panic attacks, obsessive

compulsive disorders or obesity

(e.g., citalopram, escitalopram,

fluoxetine, fluvoxamine,

paroxetine, sertraline, duloxetine,

sibutramine, venlafaxine)

tricyclic antidepressants, which

are medicines to treat depression

(e.g., amitriptyline,

clomipramine, dothiepin,

doxepin, imipramine,

nortriptyline, trimipramine)

some medicines to treat migraine

(e.g., naratriptan, sumatriptan,

zolmitriptan)

pethidine, a medicine to treat

pain.

buspirone, a medicine to treat

anxiety

rifampicin, a medicine to treat

tuberculosis and some other

infections

any medicine that could reduce

the levels of haemoglobin (the

pigment in red blood cells which

carries oxygen) or platelets

(blood cells which help blood to

clot)

Ask the doctor or pharmacist if

you are not sure about this list of

medicines.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with linezolid.

Also tell the doctor if your diet

contains a lot of mature cheese,

yeast extracts, meat extracts, soya

bean extracts (e.g., soy sauce),

draught beers or wine.

Linezolid may react with a substance

which is naturally present in these

foods.

How to take this

medicine

It is recommended that treatment

with linezolid begin in a hospital.

Follow all directions given by your

doctor.

These instructions may be different

to the information in this leaflet.

If you do not understand the

instructions on the box, ask the

doctor for help.

How much to take

The recommended dose for adults

and adolescents 12 years and older is

one 600mg tablet twice daily (every

12 hours).

Ask your doctor if you want more

information about the dose of

linezolid and how it is given.

When to take it

Take the dose as prescribed by

your doctor.

Linezolid can be taken before, during

or after meals.

LINEZOLID APOTEX - 600MG TABLETS

How long to take it for

Continue taking linezolid until you

finish the tablets unless your

doctor recommends otherwise.

Do not stop taking linezolid unless

your doctor tells you to, even if you

feel better.

If you do not complete the full course

prescribed by the doctor, the bacteria

causing the infection may continue to

grow and multiply. The infection

may not clear completely or it may

return.

A course of treatment usually lasts 10

to 14 days, but may be up to 28 days

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.

The possible effects of overdose are

vomiting, tremors (shaking),

unsteadiness or lack of coordination.

While you are taking

this medicine

Things you must do

Follow all instructions given by

your doctor. In some cases,

additional blood tests may be

required.

If the symptoms of the infection do

not improve within a few days, or

if they become worse, tell your

doctor.

As part of the treatment, you may be

given other medicines including

other antibiotics. It is important to

keep taking these medicines as well

as linezolid unless you are told

otherwise by your doctor or

pharmacist.

It is important to tell your doctor if

you develop diarrhoea during or

after treatment with linezolid. Do

this even if it occurs several weeks

after linezolid has been stopped.

Do not take any medicine to treat

diarrhoea without first checking

with the doctor.

Diarrhoea may be caused by a

serious condition affecting the bowel.

You may need urgent medical care.

If you get a sore white mouth or

tongue while taking or soon after

stopping linezolid tell the doctor.

Tell the doctor if you get vaginal

itching or discharge.

This may mean you have a fungal

infection called thrush.

Sometimes the use of linezolid

allows fungi to grow which causes

the symptoms described above.

Linezolid does not work against

fungi.

Tell your doctor immediately if

you become pregnant while you

are taking linezolid.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking linezolid.

Things you must not do

Do not start taking any other

medicines, prescription or not,

without first telling your doctor or

pharmacist.

Do not take any medicine to treat

diarrhoea without first checking

with the doctor.

Diarrhoea may be caused by a

serious condition affecting the bowel.

You may need urgent medical care.

Avoid eating too much mature

cheese, yeast extracts, meat

extracts or soya bean extracts (e.g.,

soy sauce). Avoid drinking alcohol,

especially draught beers and wine.

This is because linezolid may react

with a substance which is naturally

present in these foods.

If you develop a throbbing

headache after eating, tell your

doctor or health care professional.

Do not give this medicine to anyone

else, even if they seem to have the

same condition as you.

Do not take linezolid to treat any

other complaint unless your doctor

tells you to do so.

Things to be careful of

Be careful driving or operating

machinery, until you know how l

affects you.

No effects on the ability to drive or

use machines have been seen with

linezolid. However, as with many

other medicines, linezolid may cause

dizziness or tiredness in some people.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while taking linezolid.

This medicine helps most people, but

it may have unwanted side effects in

a few people. All medicines can have

side effects. If they occur, most are

likely to be minor and temporary.

However, some may be serious and

need medical attention.

Do not be alarmed by the following

lists of side effects.

You may not experience any of them.

LINEZOLID APOTEX - 600MG TABLETS

While taking it

Tell your doctor if you notice any of

the following and they worry you:

headache

sore, white mouth or tongue oral

thrush)

vaginal itching or discharge

(vaginal thrush)

pain, cramping or "bloating" of

the abdomen

nausea or vomiting

metallic taste

change in the colour of the tongue

change in the colour of teeth. This

may be reversible.

See your doctor immediately and

before you or your child take the

next dose of linezolid if you notice

any of the following:

skin reactions (hives, rash or

itching)

visual disturbances or numbness

or weakness of the arms and legs

(rare side effects that have been

primarily reported in patients

treated for longer than 28 days)

tiredness, headaches, being short

of breath when exercising,

dizziness, looking pale, fever and

chills, sore throat or bruising

(these symptoms may indicate a

decrease in the level of your

blood cells)

sweating, feeling drunk and

dizzy, muscle twitching, fever

and shivering, confusion. These

may be symptoms of the

serotonin syndrome, which is a

rare but serious side effect.

If any of the following happen to

you or your child, tell your or your

child's doctor immediately or go to

Accident and Emergency at your

nearest hospital:

seizure

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, severe itching or hives or

blisters on the skin.

These may be signs of a serious

allergic reaction or side effect. You

or your child may need urgent

medical attention or hospitalisation.

These side effects are rare.

After finishing it

Tell your doctor or pharmacist if

you get any of the following side

effects, particularly if they occur

several weeks after stopping

treatment with linezolid:

severe stomach cramps

watery and severe diarrhoea

(which may be bloody), fever, in

combination with one or both of

the above.

Linezolid can cause some bacteria,

which are normally present in the

bowel and normally harmless, to

multiply and cause these symptoms.

You may need urgent medical

attention.

Tell your doctor if you notice any

other side effects.

Other side effects not listed above

may also occur in some people.

After using it

Storage

Keep your tablets in the original

container packaging, including

outer carton, until it is time to take

them.

If you take the medicine out of the

pack it may not keep well.

Keep this medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store this medicine or any

other medicines in a bathroom or

near a sink.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy some

medicines.

Keep linezolid 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 your medicine or the

medicine has passed its expiry

date, ask your pharmacist what to

do with any that is left over.

Product description

What Linezolid APOTEX-

looks like

White coloured, oval shaped,

biconvex, film coated tablets with

"APO" engraved on one side and

"LIN600" on the other side.

The tablets are available in blister

packs of 10 tablets.

Ingredients

Each tablet contains 600 mg of

linezolid as the active ingredient.

It also contains the following inactive

ingredients:

methyl cellulose

crospovidone

silicon dioxide

magnesium stearate

hypromellose

hydroxypropylcellulose

macrogol 8000

titanium dioxide

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Linezolid APOTEX 600mg tablets

Blister packs of 10 tablets:

AUST R 207475.

LINEZOLID APOTEX - 600MG TABLETS

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trademarks of Apotex Inc

This leaflet was prepared in:

October 2016

LINEZOLID APOTEX - 600MG TABLETS