VORICONAZOLE

Main information

  • Trade name:
  • VORICONAZOLE SANDOZ voriconazole 200mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VORICONAZOLE SANDOZ voriconazole 200mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207785
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207785

VORICONAZOLE SANDOZ voriconazole 200mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

17/03/2015

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. VORICONAZOLE SANDOZ voriconazole 200mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

4/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Voriconazole Sandoz 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.,- This brand is only available as tablets and therefore only indicated for adults and children 12 years or older

who can tolerate tablets. For dosing requirements for populations who require intravenous or oral suspension treatment see DOSAGE and

ADMINISTRATION.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. VORICONAZOLE SANDOZ voriconazole 200mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, biconvex, capsule shaped film coated tablets with '200'

debossed on one side and plain on other side.

Active Ingredients

Voriconazole

200 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 12:02:56 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 SANDOZ

VORICONAZOLE SANDOZ

®

Voriconazole Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions

about

VORICONAZOLE

SANDOZ.

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 the medicine.

You may need to read it again.

What

VORICONAZOLE

SANDOZ is used for

This medicine is used to treat fungal

and yeast infections such as:

invasive aspergillosis, a fungal

infection caused by a fungus

called Aspergillus, 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 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 species and

Fusarium species.

other serious fungal infections in

patients who do not respond to, or

cannot tolerate, other antifungal

medicines.

Voriconazole Sandoz is also used to

prevent invasive fungal infections in

patients who are at risk of developing

such infections.

It contains the active ingredient

voriconazole. Voriconazole belongs

to a group of medicines called

triazole antifungals.

It works by preventing the growth of

fungal and yeast organisms causing

your infection.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

Before you take

VORICONAZOLE

SANDOZ

When you must not use it

Do

not

take

VORICONAZOLE

SANDOZ if you have an allergy to:

voriconazole, the active

ingredient, or to any of the other

ingredients listed at the end of

this leaflet under Product

Description

any other similar medicines such

as itraconazole (Sporanox),

fluconazole (Diflucan),

posaconazole (Noxafil) or

ketoconazole (Nizoral) (not all

brands given).

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.

Do not take VORICONAZOLE

SANDOZ if you are taking any of

the following medicines:

pimozide (e.g. Orap), a medicine

used to treat mental illness

quinidine (e.g. Kinidin Durules),

a medicine used to treat irregular

heartbeat

rifampicin (e.g. Rifadin,

Rimycin), a medicine used to

treat tuberculosis and other

infections

carbamazepine (e.g. Tegretol,

Teril), a medicine used to treat

seizures

long-acting barbiturates such as

phenobarbitone, medicines used

to treat severe insomnia and

seizures

rifabutin (e.g. Mycobutin) an

antibiotic

ergotamine (e.g. Cafergot) or

dihydroergotamine (e.g.

Dihydergot), medicines used to

treat migraine

VORICONAZOLE SANDOZ

sirolimus (e.g. Rapamune), a

medicine used in transplant

patients

efavirenz (e.g. Stocrin) (a

medicine used to treat HIV

infection) in doses of 400mg or

more once a day

ritonavir (e.g. Norvir, Kaletra) (a

medicine used to treat HIV

infection) in doses of 400mg or

more twice a day

St John's Wort (a herbal

medicine).

VORICONAZOLE SANDOZ

should not be given to a child

under the age of 2 years.

Safety and effectiveness in children

younger than 2 years has not been

established.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor first.

Before you start to take it

Tell your doctor if you have

allergies to any foods,

preservatives or dyes or any other

medicines, especially antifungal

medicines such as itraconazole

(Sporanox), fluconazole (Diflucan),

posaconazole (Noxafil) or

ketoconazole (Nizoral) (not all

brands given).

Tell your doctor if you have or

have had any of the following

medical conditions:

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.

Tell your doctor if you are

pregnant or plan to become

pregnant.

VORICONAZOLE SANDOZ should

not be taken during pregnancy, unless

indicated by your doctor. Effective

contraception

should

used

women

childbearing

potential.

Your doctor can discuss with you the

risks and benefits involved.

Tell your doctor if you are breast-

feeding.

VORICONAZOLE SANDOZ 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.

If you have not told your doctor

about any of the above, tell him/her

before you start taking

VORICONAZOLE SANDOZ.

Taking other medicines

Tell your doctor or pharmacist 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

SANDOZ.

These include (not all brands given):

pimozide (e.g. Orap), a medicine

used to treat mental illness

quinidine (e.g. Kinidin Durules),

a medicine for irregular heartbeat

rifampicin (e.g. Rifadin,

Rimycin), a medicine used to

treat tuberculosis and other

infections

carbamazepine (e.g. Tegretol,

Teril), a medicine used to treat

seizures

long-acting barbiturates such as

phenobarbitone, medicines used

to treat severe insomnia and

seizures

rifabutin (e.g. Mycobutin) an

antibiotic

ergotamine (e.g. Cafergot) or

dihydroergotamine (e.g.

Dihydergot), medicines used to

treat migraine

sirolimus (e.g. Rapamune) a

medicine used in transplant

patients

efavirenz (Stocrin) (a medicine

used to treat HIV infection) in

doses of 400mg or more once a

ritonavir (e.g. Norvir, Kaletra) (a

medicine used to treat HIV

infection) in doses of 400mg or

more twice a day

St John's Wort, (a herbal

medicine).

Some medicines and

VORICONAZOLE SANDOZ may

interfere with each other. These

include (not all brands given):

efavirenz (Stocrin) (a medicine

used to treat HIV infection) in

doses below 400mg once a day

ritonavir (Norvir, Kaletra) (a

medicine used to treat HIV

infection) in doses of 100mg

twice a day

warfarin (e.g. Marevan,

Coumadin), a medicine used to

stop blood clots

everolimus (e.g. Afinitor,

Certican), a medicine used to

treat cancer

fluconazole (e.g. Diflucan), a

medicine used to treat fungal

infections

phenytoin (e.g. Dilantin), a

medicine used to treat epilepsy

cyclosporin (e.g. Sandimmun,

Neoral), 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 (e.g. Daonil, Diamicron,

Minidiab)

VORICONAZOLE SANDOZ

some antihistamines, medicines

used to treat hayfever, allergic

skin reactions, itching

theophylline (e.g. Nuelin), a

medicine used to treat asthma

benzodiazepines (e.g. Valium),

medicines used to treat insomnia

or anxiety

statins (e.g. Zocor, Lipitor,

Crestor), medicines used for

lowering cholesterol

tacrolimus (e.g. Prograf), a

medicine used in patients who

have had a liver or kidney

transplant

indinavir (e.g. Crixivan) and

some other medicines used to

treat HIV infection

omeprazole (e.g. Losec), 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 (e.g.Vepesid)

strong pain killers such as

alfentanil (e.g. Rapifen), fentanyl

(e.g. Durogesic, Actiq,

Sublimaze) and oxycodone (e.g.

Endone, Proladone)

non-steroidal anti-inflammatory

drugs, medicines used to treat

pain and inflammation such as

ibuprofen and diclofenac (e.g.

Nurofen, Advil, Voltaren).

These medicines may be affected by

VORICONAZOLE SANDOZ or

may affect how well it works. You

may need different amounts of your

medicines or you may need to take

different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take

VORICONAZOLE

SANDOZ

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions, ask your doctor or

pharmacist for help.

How much to take

Your doctor will tell you how much

to take depending on your weight.

Adults

Treatment of invasive fungal

infections

The usual dose of

VORICONAZOLE SANDOZ tablets

in adults weighing 40kg and greater

is 400mg (two 200mg tablets twice a

day) for the first day and then 200mg

to 300mg twice a day thereafter.

In adults weighing less than 40kg the

dose of VORICONAZOLE

SANDOZ tablets is halved.

Prevention of invasive fungal

infections

The usual dose is 6mg/kg every 12

hours for the first day, given by

injection*. The dose is then adjusted

to 4mg/kg every 12 hours by

injection* or, in adults weighing

40kg and greater, one 200mg tablet

twice a day.

In adults weighing less than 40kg the

dose of VORICONAZOLE

SANDOZ tablets is halved.

Children

VORICONAZOLE SANDOZ should

not be given to a child under the age

of 2 years.

Your doctor will determine the dose

of VORICONAZOLE SANDOZ

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 SANDOZ needs

to be taken regularly to be effective.

Take VORICONAZOLE

SANDOZ tablets at least one

hour before or one hour after a

meal.

Swallow the tablets whole with a

full glass of water.

When to take it

Take your medicine regularly at

about the same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

How long to take it

The length of time you take

VORICONAZOLE SANDOZ 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

VORICONAZOLE SANDOZ for

as long as your doctor tells you. Do

not stop taking

VORICONAZOLE SANDOZ

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 you forget to take one 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.

This may increase the chance of you

getting an unwanted side effect.

VORICONAZOLE SANDOZ

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

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) for advice, or go to

Accident and Emergency at your

nearest hospital, if you think you

or anyone else may have taken too

much VORICONAZOLE

SANDOZ. 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 using

VORICONAZOLE

SANDOZ

Things you must do

Tell your doctor immediately if

you develop a rash or blisters while

taking VORICONAZOLE

SANDOZ.

If this rash worsens,

VORICONAZOLE SANDOZ may

need to be stopped.

Avoid going out in the sun for long

periods of time while you are

taking VORICONAZOLE

SANDOZ.

VORICONAZOLE SANDOZ can

cause sensitivity to light.

Tell your doctor if you notice any

changes to your skin while you are

taking Voriconazole Sandoz.

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 VORICONAZOLE

SANDOZ or stop your

VORICONAZOLE SANDOZ

treatment. Your doctor might also

monitor the function of your

pancreas.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking VORICONAZOLE

SANDOZ.

Tell any other doctors, dentists, and

pharmacists who treat you that you

are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

If you are a woman of child-

bearing age, you should avoid

becoming pregnant while taking

VORICONAZOLE SANDOZ. If

you become pregnant while taking

VORICONAZOLE SANDOZ, tell

your doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

Things you must not do

Do not take VORICONAZOLE

SANDOZ to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else even if they have the

same condition as you.

Do not stop taking your medicine

or lower the dosage without

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 driving or operating

machinery until you know how

VORICONAZOLE SANDOZ

affects you.

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.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well

while

you

are

taking

VORICONAZOLE SANDOZ.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

changes to your vision, such as

blurred vision, colour changes or

sensitivity to light

irregular heartbeat

nausea or feeling sick, vomiting

VORICONAZOLE SANDOZ

headache

stomach pain, indigestion,

diarrhoea

back pain in middle or upper back

swelling of the arms or legs

soreness at the injection site.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

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

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

convulsions, fits.

These may be signs of a serious

allergic reaction or side effect. You

may need urgent medical attention or

hospitalisation. These side effects are

rare.

Tell your doctor if you notice any

other side effects.

Other side effects not listed above

may also occur in some people.

After using

VORICONAZOLE

SANDOZ

Storage

Keep your medicine in the original

container.

If you take it out of the original

container it may not keep well.

Keep your medicine in a cool dry

place where the temperature stays

below 30°C.

Do not store VORICONAZOLE

SANDOZ 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 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

this medicine or the expiry date has

passed, ask your pharmacist what to

do with any medicine that is left

over.

Product description

What it looks like

VORICONAZOLE SANDOZ comes

in two types of tablets:

VORICONAZOLE SANDOZ 50mg

- White to off-white, round,

biconvex, film coated tablets with

‘50’ debossed on one side and plain

on other side.

VORICONAZOLE SANDOZ

200mg - White to off-white,

biconvex, capsule shaped film coated

tablets with ‘200’ debossed on one

side and plain on other side.

Available in blister packs and bottles

of 30, 56, 100 tablets.

All strengths and presentations may

not be marketed.

Ingredients

Active Ingredients:

VORICONAZOLE SANDOZ 50mg

- 50mg voriconazole

VORICONAZOLE

SANDOZ

200mg - 200mg voriconazole

Inactive Ingredients:

lactose

maize starch (pregelatinised)

croscarmellose sodium

povidone

magnesium stearate

hypromellose

titanium dioxide

glycerol triacetate

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park, NSW 2113

Australia

Tel: 1800 634 500

Novartis New Zealand Ltd

PO Box 99102

Newmarket, Auckland 1149

New Zealand

Tel: 0800 354 335

This leaflet was prepared in May

2015.

Australian Registration

Numbers

VORICONAZOLE SANDOZ 50mg

tablets: AUST R 207786 (blisters)

VORICONAZOLE SANDOZ

200mg tablets: AUST R 207785

(blisters)

*Available from other brand (s).

2-10-2018

Vfend (Pfizer Europe MA EEIG)

Vfend (Pfizer Europe MA EEIG)

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25-9-2018

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

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

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