Voriconazole

Main information

  • Trade name:
  • Voriconazole APOTEX voriconazole 50mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Voriconazole APOTEX voriconazole 50mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218362
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218362

Voriconazole APOTEX voriconazole 50mg 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

27/01/2016

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. Voriconazole APOTEX voriconazole 50mg tablet blister pack

Product Type

Single Medicine Product

Effective date

12/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Voriconazole is indicated for treatment of the following fungal infections:

·Invasive aspergillosis.

·Serious Candida infections (including C. krusei), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated

candidiasis, candidaemia).

·Serious fungal infections caused by Scedosporium spp and Fusarium spp.

·Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,Prophylaxis in patients who are at high risk of developing

invasive fungal infections. The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/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. Voriconazole APOTEX voriconazole 50mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White coloured, round-shaped, film-coated tablets, engraved "APO" on one

side and "VOR" over "50" on the other side.

Active Ingredients

Voriconazole

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 04:58:33 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

Voriconazole APOTEX

Tablets

Contains the active ingredient voriconazole

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 voriconazole. 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

Voriconazole APOTEX tablets. It

contains the active ingredient

voriconazole.

It is used to treat fungal and yeast

infections such as:

invasive aspergillosis (as-pur-

jilosis), a fungal infection caused

by a fungus called Aspergillus

(as-pur-jilus), which usually

begins in the respiratory tract (in

the nose, sinuses or lungs).

Aspergillus is harmless in most

healthy people; however, in

people with poor immune

systems (such as people who have

had organ transplants and people

with cancer or HIV/AIDS)

invasive aspergillosis can be

serious and spread to other tissues

and organs.

serious Candida (can-did-da)

infections, including Candida

infections of the oesophagus

(food pipe or gullet) and those

that have spread into the blood

stream or to other parts of the

body.

serious fungal infections caused

by Scedosporium (ski-doe-spore-

rium) species and Fusarium (few-

saa-rium) species.

other serious fungal infections in

patients who do not respond to, or

cannot tolerate, other antifungal

medicines.

Voriconazole is also used to prevent

invasive fungal infections in patients

who are at risk of developing such

infections.

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

This medicine belongs to a group of

medicines called triazole antifungals.

This medicine works by preventing

the growth of fungal and yeast

organisms causing your infection.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be given

to children under the age of 2

years.

Safety and effectiveness in children

younger than 2 years has not been

established.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You are taking any of the

following medicines:

VORICONAZOLE APOTEX TABLETS

pimozide, a medicine used to

treat mental illness

quinidine, a medicine used to

treat irregular heartbeat

rifampicin, a medicine used to

treat tuberculosis and other

infections

carbamazepine, a medicine used

to treat seizures

long-acting barbiturates such as

phenobarbitone, medicines used

to treat severe insomnia and

seizures

rifabutin, an antibiotic

ergotamine or dihydroergotamine,

medicines used to treat migraine

sirolimus, a medicine used in

transplant patients

efavirenz (a medicine used to

treat HIV infection) in doses of

400 mg or more once a day

ritonavir (a medicine used to treat

HIV infection) in doses of

400 mg or more twice a day

St John's Wort (a herbal

medicine)

You are hypersensitive to, or

have had an allergic reaction to,

voriconazole or any of the

ingredients listed at the end of

this leaflet or to any other

similar medicines.

Symptoms of an allergic reaction

may include:, 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.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines, especially

antifungal medicines such as

itraconazole , fluconazole ,

posaconazole or ketoconazole

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

heart problems

any problems affecting your

kidneys

any problems affecting your liver.

If you have liver disease, your

doctor may prescribe a lower

dose

recent chemotherapy or stem cell

transplant.

You are currently pregnant or you

plan to become pregnant.

This medicine should not be

taken during pregnancy, unless

indicated by your doctor.

Effective contraception should be

used in women of childbearing

potential. Your doctor can discuss

with you the risks and benefits

involved.

You are currently breastfeeding

or you plan to breast-feed.

This medicine should not be

taken whilst breastfeeding, unless

indicated by your doctor. It is not

known if the active ingredient

voriconazole passes into breast

milk.

Your doctor can discuss with you

the risks and benefits involved.

You are planning to have

surgery. .

You are currently receiving or are

planning to receive dental

treatment.

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.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you get without a prescription

from a pharmacy, supermarket or

health food shop.

Some medicines should not be

taken with voriconazole. Do not

take voriconazole if you are taking

the following:

pimozide, a medicine used to

treat mental illness.

quinidine, a medicine for

irregular heartbeat.

rifampicin, a medicine used to

treat tuberculosis and other

infections.

carbamazepine, a medicine used

to treat seizures.

long-acting barbiturates such as

phenobarbitone, medicines used

to treat severe insomnia and

seizures.

rifabutin, an antibiotic.

ergotamine or dihydroergotamine,

medicines used to treat migraine.

sirolimus, a medicine used in

transplant patients.

efavirenz (a medicine used to

treat HIV infection) in doses of

400 mg or more once a day.

ritonavir (a medicine used to treat

HIV infection) in doses of 400

mg or more twice a day.

St John's Wort (a herbal

medicine).

Other medicines may also interact

with voriconazole. These include:

efavirenz (a medicine used to

treat HIV infection) in doses

below 400 mg once a day

ritonavir (a medicine used to treat

HIV infection) in doses of

100 mg twice a day

VORICONAZOLE APOTEX TABLETS

warfarin, a medicine used to stop

blood clots

everolimus, a medicine used to

treat cancer

fluconazole, a medicine used to

treat fungal infections

phenytoin, a medicine used to

treat epilepsy

cyclosporin, a medicine used to

prevent organ transplant rejection

or to treat certain problems with

the immune system.

sulphonylureas, medicines used

to treat diabetes such as

glibenclamide, gliclazide and

glipizide

some antihistamines, medicines

used to treat hayfever, allergic

skin reactions, itching

benzodiazepines, medicines used

to treat insomnia or anxiety

statins, medicines used for

lowering cholesterol

tacrolimus, a medicine used in

patients who have had a liver or

kidney transplant

indinavir and some other

medicines used to treat HIV

infection

omeprazole, a medicine used to

treat indigestion, reflux and

stomach or duodenal ulcers

methadone (used to treat heroin

addiction)

oral contraceptives (the Pill)

vincristine, vinblastine or

vinorelbine, medicines used in

treating cancer

strong pain killers such as

alfentanil, fentanyl and

oxycodone

non-steroidal anti-inflammatory

drugs, medicines used to treat

pain and inflammation such as

ibuprofen and diclofenac

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 voriconazole.

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.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

Adults

Treatment of invasive fungal

infections

The usual dose of voriconazole

tablets in adults weighing 40 kg and

greater is 400 mg (two 200 mg

tablets every 12 hours twice a day)

for the first day and then 200 mg to

300 mg twice a day thereafter.

In adults weighing less than 40 kg

the dose of voriconazole tablets is

halved.

Prevention of invasive fungal

infections

The usual dose in adults weighing 40

kg and greater is one 200 mg to 300

mg tablet every 12 hours twice a day.

In adults weighing less than 40 kg

the dose of voriconazole tablets is

halved.

Children

Voriconazole should not be given to

a child under the age of 2 years.

Your doctor will determine the dose

of voriconazole required for your

child.

Depending on how serious the

infection is and how your child reacts

to the medicine, your doctor may

increase or decrease the dose.

Adolescents (12-16 years of age)

Adolescents aged 12-16 years of age

are usually given the same dose as

adults.

How to take it

Voriconazole needs to be taken

regularly to be effective.

Swallow the tablets whole with a full

glass of water.

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.

Take voriconazole tablets at least one

hour before or one hour after a meal.

How long to take it for

The length of time you take this

medicine will depend on the type of

infection you have.

If you have a weakened immune

system or a difficult infection, you

may need long-term treatment to

prevent the infection from returning.

Continue taking this medicine for as

long as your doctor or pharmacist

recommends. Do not stop taking this

medicine because you are feeling

better.

If you do not complete the full course

prescribed by your doctor, the

infection may not clear completely or

your symptoms may return.

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.

VORICONAZOLE APOTEX TABLETS

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.

Symptoms of an overdose may

include upset stomach, diarrhoea,

headache and sensitivity to light.

While you are taking

this medicine

Things you must do

While you are taking this medicine,

tell your doctor if:

you develop a rash or blisters

while taking voriconazole. If this

rash worsens, this medicine may

need to be stopped.

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are about to have any blood

tests. It may interfere with the

results of some tests

you are going to have surgery or

are going into hospital. It may

affect other medicines used

during surgery.

Avoid going out in the sun for long

periods of time while you are

taking this medicine.

Voriconazole can cause sensitivity to

sunlight.

Tell your doctor if you notice any

changes to your skin while you are

taking this medicine.

If the symptoms of your infection

do not improve within a few days,

or if they become worse, tell your

doctor.

Make sure you follow your

doctor's instructions and keep all

appointments, including blood

tests.

Your doctor should monitor the

function of your liver and kidneys

using blood tests. If you have liver

disease, your doctor might lower

your dose of this medicine or stop

your treatment. Your doctor might

also monitor the function of your

pancreas.

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.

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.

If you do not complete the full course

prescribed by your doctor, the

infection may not clear completely or

your symptoms may return.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Avoid going out in the sun for long

periods of time while you are taking

this medicine. This medicine can

cause sensitivity to sunlight.

Tell your doctor if you notice any

changes to your skin while you are

taking this medicine.

You may experience changes to your

vision, such as blurriness, colour

changes or uncomfortable sensitivity

to light. If you have any of these

symptoms, do not drive, operate

machinery or do anything else that

could be dangerous. Do not drive at

night.

Children should be careful when

riding bicycles or climbing.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking voriconazole or if you have

any questions or concerns.

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:

changes to your vision, such as

blurred vision, colour changes or

sensitivity to light

irregular heartbeat

nausea or feeling sick, vomiting

headache

stomach pain, indigestion,

diarrhoea

back pain in the middle or upper

back

swelling of the arms or legs

rash

changes to your skin, such as skin

eruptions or small lumps on the

skin.

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 very serious side effects

and you may need urgent medical

attention or hospitalisation:

swelling of the face, lips or

tongue which may cause

difficulty in swallowing or

breathing

asthma, wheezing, shortness of

breath

sudden or severe itching, skin

rash, hives or blisters

fainting, seizures or fits

VORICONAZOLE APOTEX TABLETS

flaking of the skin

yellowing of the skin or eyes, also

called jaundice

signs of frequent or worsening

infections such as fever, severe

chills, sore throat or mouth ulcers

blood in urine

signs of kidney failure such as

tiredness, lack of appetite and

reduced or greatly increased

amount of urine.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to voriconazole,

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:

, 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 Voriconazole APOTEX

looks like

50 mg tablet:

White coloured, round-shaped, film-

coated tablets, engraved with "APO"

on one side and "VOR" over "50" on

the other side.

200 mg tablet:

White coloured, modified oval-

shaped, biconvex film-coated tablets,

engraved with "APO" on one side

and "VOR 200" on the other side.

Blister pack of 56 tablets

* Not all strengths may be available.

Ingredients

Each tablet contains 50 mg or 200

mg of voriconazole as the active

ingredient.

It also contains the following inactive

ingredients:

Lactose monohydrate

Croscarmellose sodium

Magnesium stearate

Polyvinyl alcohol

Macrogol 8000

Talc

Titanium dioxide

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

Voriconazole APOTEX 50 mg

tablets (blister): AUST R 218362.

Voriconazole APOTEX 200 mg

tablets (blister): AUST R 218361.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trademarks of Apotex Inc.

This leaflet was last updated in

December 2016.

VORICONAZOLE APOTEX TABLETS

2-10-2018

Vfend (Pfizer Europe MA EEIG)

Vfend (Pfizer Europe MA EEIG)

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Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

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