VTTACK

Main information

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

Documents

Localization

  • Available in:
  • VTTACK voriconazole 200mg film coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 206985
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

206985

VTTACK voriconazole 200mg film coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

9/09/2015

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. VTTACK voriconazole 200mg film coated tablet blister pack

Product Type

Single Medicine Product

Effective date

13/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

VTTACK 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/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. VTTACK voriconazole 200mg film coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A white to off-white film-coated, capsule shaped, bivonvex tablet debossed

with M164 on one side of the tablet and blank on the other side

Active Ingredients

Public Summary

Page 1 of

Produced at 20.10.2017 at 05:46:12 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

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 2 of

Produced at 20.10.2017 at 05:46:12 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

VTTACK™

Tablets

contains the active ingredient Voriconazole (vori-con-a-zole)

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about VTTACK.

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 VTTACK

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your doctor

or pharmacist.

Read this leaflet carefully before

taking VTTACK and keep this

leaflet.

You may need to read it again.

What VTTACK is used

for

VTTACK is used to treat fungal and

yeast infections such as:

invasive aspergillosis (as-pur-ji-

losis), 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.

VTTACK is also used to prevent

invasive fungal infections in patients

who are at risk of developing such

infections.

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.

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 start to

use it

When you must not take it

Do not take VTTACK if you have

ever had an allergy to:

any medicine containing

voriconazole.

any of the ingredients listed at the

end of this leaflet.

any other similar medicines.

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; skin rash,

itching or hives.

Do not take VTTACK 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.

VTTACK™

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 (e.g. Stocrin) (a

medicine used to treat HIV

infection) in doses of 400 mg or

more once a day.

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

medicine used to treat HIV

infection) in doses of 400 mg or

more twice a day.

St John's Wort (a herbal

medicine).

VTTACK 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.

VTTACK 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.

Tell your doctor if you are breast-

feeding.

VTTACK 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 your

doctor before you start taking

VTTACK.

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 VTTACK. 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 400 mg or more once a

day.

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

medicine used to treat HIV

infection) in doses of 400 mg or

more twice a day.

St John's Wort, (a herbal

medicine).

Some medicines and VTTACK may

interfere with each other. These

include (not all brands given):

efavirenz (Stocrin) (a medicine

used to treat HIV infection) in

doses below 400 mg once a day.

ritonavir (Norvir, Kaletra) (a

medicine used to treat HIV

infection) in doses of 100 mg

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).

some antihistamines, medicines

used to treat hayfever, allergic

skin reactions, itching.

theophylline (e.g. Nuelin), a

medicine used to treat asthma.

VTTACK™

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

VTTACK 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 VTTACK

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 on the box or bottle,

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 VTTACK Tablets

in adults weighing 40 kg and greater

is 400 mg (two 200 mg tablets 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 VTTACK Tablets is

halved.

Children

VTTACK should not be given to a

child under the age of 2 years.

Your doctor will determine the dose

of VTTACK 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

VTTACK needs to be taken regularly

to be effective.

VTTACK Tablets

Take VTTACK 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

VTTACK 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.

You may be switched from the

injection to VTTACK Tablets or

Oral suspension once your condition

improves.

Continue taking VTTACK for as

long as your doctor or pharmacist

recommends. Do not stop taking

VTTACK 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.

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.

However, tell your doctor or

pharmacist if you think that a dose

has been forgotten.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(Phone Australia 13 11 26) for

advice or go to Accident and

Emergency at your nearest

hospital, if you think you or

anyone else may have taken too

much VTTACK. Do this even if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

VTTACK™

Symptoms of an overdose may

include upset stomach, diarrhoea,

headache and sensitivity to light.

While you are using

VTTACK

Things you must do

Tell your doctor immediately if

you develop a rash or blisters while

taking VTTACK.

If this rash worsens, VTTACK

may need to be stopped.

Avoid going out in the sun for long

periods of time while you are

taking VTTACK.

VTTACK can cause sensitivity to

light

Tell your doctor if you notice any

changes to your skin while you are

taking VTTACK.

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 VTTACK or stop your

VTTACK 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 VTTACK.

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

VTTACK. If you become pregnant

while taking VTTACK, 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 VTTACK 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 or if their

symptoms seem similar to yours.

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, operating

Be careful driving or operating

machinery until you know how

VTTACK 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

VTTACK.

This medicine helps most people

with fungal infections, but it may

have unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not. 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 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

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

VTTACK™

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 VTTACK

Storage

VTTACK Tablets

Keep your tablets in the pack until

it is time to use them.

If you take the tablets out of the

blister pack they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store VTTACK 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 your 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 the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

VTTACK Tablets

VTTACK Tablets come in two

strengths, 50 mg and 200 mg.

VTTACK 50 mg Tablets are white to

off white, oval tablets marked V26

on one side and blank on the other.

VTTACK 200 mg Tablets are white

to off white, capsule shaped tablets

marked M164 on one side and blank

on the other.

Each blister pack contains 2, 10, 14,

20, 28, 30, 50 or 56* and 100 tablets.

*Indicated the pack is marketed.

Ingredients

Active Ingredients

VTTACK 50 mg Tablets contain 50

mg of voriconazole as the active

ingredient.

VTTACK 200 mg Tablets contain

200 mg of voriconazole as the active

ingredient.

Inactive Ingredients

The 50 mg and 200 mg tablets

contain the following other

ingredients:

lactose

croscarmellose sodium

pregelatinised maize starch

povidone

magnesium stearate

OPADRY II complete film

coating system 31K58902

WHITE (ARTG no. 108791)

[50mg/200mg tablets].

VTTACK contains lactose.

VTTACK does not contain gluten,

sucrose, tartrazide or any other azo

dyes.

Sponsor

VTTACK is supplied in Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian Registration

Numbers:

50 mg (Blister pack):

AUST R 206983

200 mg (Blister pack):

AUST R 206985

Date of preparation

This leaflet was prepared on

27 September 2013

VTTACK_cmi\0913

VTTACK™

2-10-2018

Vfend (Pfizer Europe MA EEIG)

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