NOXAFIL

Main information

  • Trade name:
  • NOXAFIL posaconazole 100mg modified release tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOXAFIL posaconazole 100mg modified release tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216283
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216283

NOXAFIL posaconazole 100mg modified release tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

27/11/2014

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. NOXAFIL posaconazole 100mg modified release tablets blister pack

Product Type

Single Medicine Product

Effective date

5/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

NOXAFIL (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older; Invasive

aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy; Fusariosis, zygomycosis, coccidioidomycosis,

chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. NOXAFIL is also indicated for the:

Treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole.

Prophylaxis of invasive fungal infections, among patients 13 years of age and older, who are at high risk of developing these infections, such as patients

with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

24 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

24 tablets

(S4) Prescription Only Medicine

96 tablets

(S4) Prescription Only Medicine

Components

1. NOXAFIL posaconazole 100mg modified release tablets blister pack

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

Yellow coated, capsule shaped tablets with "100" debossed on one side of

the tablet.

Active Ingredients

Posaconazole

100 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 07:28:52 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

NOXAFIL

®

Modified

Release Tablets and

Oral Suspension

Posaconazole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about NOXAFIL. 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 NOXAFIL

against the benefits this medicine is

expected to have for you.

If you have any concerns about

taking NOXAFIL, ask your doctor

or pharmacist.

Read this leaflet carefully before

taking NOXAFIL.

Keep this leaflet with the medicine.

You may need to read it again.

What NOXAFIL is

used for

NOXAFIL contains the active

ingredient, posaconazole.

Posaconazole is a medicine that

belongs to the triazole group of

antifungal medicines.

NOXAFIL works by killing or

stopping the growth of the fungi

causing these infections.

NOXAFIL Modified Release Tablets

and Oral Suspension are used for:

The treatment of invasive

aspergillosis, a fungal infection

caused by a fungus called

aspergillus

The treatment of other serious

fungal infections called

fusariosis, zygomycosis,

chromoblastomycosis and

mycetoma.

NOXAFIL Oral Suspension is also

used to treat superficial fungal

infections of the mouth and throat

called oropharyngeal candidiasis.

These types of fungal infections

usually occur in some patients who

may have lowered resistance to

infection due to poor immunity.

Treatment of these serious fungal

infections with NOXAFIL is usually

reserved for patients who do not

respond to or cannot tolerate other

medicines used to treat these types of

fungal infections.

NOXAFIL is also used to treat

coccidioidomycosis, a rare and

serious fungal infection.

NOXAFIL is also used to prevent

fungal infections, such as yeasts and

moulds, from occurring in patients

who are at high-risk of developing

these infections.

Your doctor may have prescribed

NOXAFIL for another reason.

Ask your doctor if you have any

questions about why NOXAFIL

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

Before you take

NOXAFIL

When you must not take it

Do not take NOXAFIL if:

1.

you have an allergy to:

posaconazole or any other

triazole antifungal medicines

any of the ingredients listed at

the end of this leaflet (See

Product Description)

Symptoms of an allergic reaction

may include skin rash, itching, hives,

shortness of breath, difficulty

breathing, swelling of the face,

tongue or other parts of the body.

2.

you are pregnant or may

become pregnant.

Do not take NOXAFIL if you are

taking any of the following

medicines:

certain medicines used to treat

allergy or hay fever (terfenadine

or astemizole)

cisapride, a medicine used to treat

certain stomach problems

pimozide, a medicine used to

treat certain mental disorders

quinidine, a medicine used to

treat irregular heart beat

ergotamine and

dihydroergotamine, which are

medicines used to treat migraine

halofantrine, a medicine used to

treat malaria

simvastatin, lovastatin,

atorvastatin or similar medicines

NOXAFIL

(called HMG-CoA reductase

inhibitors or statins) that are used

to treat high cholesterol levels.

NOXAFIL is not recommended for

children below the age of 13 years.

Do not take NOXAFIL if the

packaging is torn or shows signs of

tampering.

Do not take NOXAFIL if the

expiry date (EXP) printed on the

pack has passed.

If you take NOXAFIL after the

expiry date has passed, it may not

work (as well). Return this medicine

to your pharmacist for disposal if it

has expired or is damaged.

If you are not sure whether you

should start taking NOXAFIL, talk

to your doctor.

Before you start to take it

Tell your doctor if:

1.

you have any allergies to any

other medicines, especially

other antifungal medicines such

as itraconazole (Sporanox

®

),

fluconazole (Diflucan

®

),

voriconazole (Vfend

®

),

ketoconazole (Nizoral

®

) or any

other substances such as foods,

preservatives or dyes.

2.

you have or have ever had any

other health problems/ medical

conditions including:

any kidney problems

any liver problems

any heart problems

any problems with potassium,

magnesium or calcium levels

in your blood.

Follow your doctor's advice if

any blood tests to check on your

kidney or liver are recommended.

3.

you are pregnant or plan to

become pregnant

NOXAFIL should not be taken

during pregnancy unless indicated

by your doctor. Women who are

of childbearing potential should

use effective contraception while

taking NOXAFIL and for 2

weeks after completing treatment.

Your doctor will discuss the

possible risks and benefits to you

and your unborn baby.

4.

You are breastfeeding

NOXAFIL should not be taken by

breastfeeding women. It is

possible that the active ingredient,

posaconazole, may be passed into

the breast milk. Your doctor can

discuss the risks and benefits

involved.

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

NOXAFIL.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may increase the

risk of side effects of NOXAFIL by

increasing the amount of

posaconazole in the blood. Similarly,

some medicines may decrease the

effectiveness of NOXAFIL by

decreasing the amount of

posaconazole in the blood.

Medicines that can decrease the

effectiveness of NOXAFIL are:

rifabutin, used to treat

tuberculosis

phenytoin, used to treat fits or

convulsions

efavirenz and fosamprenavir,

used to treat HIV infection

medicines used to decrease

stomach acid such as cimetidine,

ranitidine and omeprazole

NOXAFIL may possibly increase

the risk of side effects of some

medicines by increasing the

amount of these medicines in the

blood. These are:

vincristine, vinblastine and other

vinca alkaloids, used to treat

cancer

cyclosporine, tacrolimus and

sirolimus, used to treat certain

immune system problems or to

prevent organ transplant rejection

rifabutin, used to treat certain

infections

midazolam and other

benzodiazepine medicines used as

sedatives or muscle relaxants

calcium channel blockers, such as

diltiazem, nifedipine and

verapamil, used in certain heart

conditions and to treat high blood

pressure

digoxin, used to treat certain heart

conditions

sulfonylureas such as glipizide

(used to treat diabetes)

medicines used to treat HIV

called protease inhibitors

(including atazanavir which is

given with ritonavir) and non-

nucleoside reverse transcriptase

inhibitors

These medicines may be affected by

NOXAFIL or may affect how well it

works. You may need different

amounts of your medicine or you

may need to take different medicines.

Your doctor will advise you.

Taking NOXAFIL

Do not switch between taking

NOXAFIL Modified Release

Tablets and NOXAFIL Oral

Suspension without talking to your

doctor.

Follow all directions given to you

by your doctor and pharmacist

carefully.

This information may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box / bottle label,

ask your doctor or pharmacist for

help.

Children

NOXAFIL is not recommended for

children below the age of 13 years.

NOXAFIL Oral Suspension

Shake the bottle well before use.

NOXAFIL

How much to take

Treatment of invasive fungal

infections (aspergillosis,

coccidioidomycosis, fusariosis,

zygomycosis chromoblastomycosis

and mycetoma):

The usual dose for adults is 10 mL

twice a day.

Treatment of oropharyngeal

candidiasis:

The usual dose for adults is 5 mL

once on the first day, then take

2.5mL once daily for 13 days.

Prevention of invasive fungal

infections:

The usual dose for adults is 5 mL

three times a day.

A measuring spoon is supplied with

the medicine.

The dose may vary from one patient

to another. Your doctor may

recommend a different dose

depending on your condition.

How to take NOXAFIL Oral

Suspension

You should take NOXAFIL Oral

Suspension with a meal or a

nutritional supplement. Taking this

medication with food containing fat

will improve absorption.

Directions for opening the

bottle

NOXAFIL Oral Suspension comes

with a child-resistant cap. It can be

opened by pushing down on the

plastic screw cap while turning it

anti-clockwise.

NOXAFIL Modified Release

Tablets

How much to take

For treatment and prevention of

invasive fungal infections:

The usual dose is three tablets twice

a day on the first day, then three

tablets once a day, thereafter.

The dose may vary from one patient

to another. Your doctor may

recommend a different dose

depending on your condition.

How to take NOXAFIL

Modified Release Tablets

Swallow the tablet whole with

some water.

Do not crush, chew, break or

dissolve the tablet.

NOXAFIL modified release

tablets may be taken with or

without food.

How long to take NOXAFIL

Your doctor will advise how long

you should take NOXAFIL.

Continue taking NOXAFIL for the

length of time that your doctor

recommends.

If you forget to take

NOXAFIL

Take the dose you missed as soon as

you remember, then continue to take

it as you normally would.

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 you have missed.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

If you have taken too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre or

go to Accident and Emergency at

your nearest hospital, if you think

you or anyone else may have taken

too much NOXAFIL. Do this even

if there are no signs of discomfort

or poisoning. You may need urgent

medical attention.

Keep these telephone numbers

handy:

Poisons Information Centres:

Australia: 13 11 26

New Zealand: 0800 POISON or

0800 764 766

While you are taking

NOXAFIL

Things you must do

Always follow your doctor's

instructions carefully.

If you are a woman of

childbearing age, talk to your

doctor about the need for

effective contraception. Once you

have finished taking NOXAFIL,

continue using contraception until

your next period.

If you become pregnant while

you are taking NOXAFIL, tell

your doctor immediately.

If you are about to start any other

new medicine, tell your doctor

that you are taking NOXAFIL.

If you need to have any blood

tests, tell your doctor you are

taking NOXAFIL. NOXAFIL

may affect the results of some

laboratory tests.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking NOXAFIL.

Things you must not do

Do not give NOXAFIL to anyone

else, even if they have the same

condition as you.

Do not use NOXAFIL to treat

any other medical complaints

unless your doctor tells you to.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

NOXAFIL.

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.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

NOXAFIL

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you experience

any of the following:

Loss of appetite

Sleeplessness

Headache, dizziness, sleepiness

Tingling in fingers or toes

Hot flushes

Upset stomach, nausea, vomiting,

stomach pain, diarrhoea, gas from

stomach or bowel, dry mouth,

altered sense of taste.

Dry skin, rash, itchiness

Back pain

Fever.

If any of the following happen, stop

taking NOXAFIL and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital:

rash, itchiness, hives

swelling of the face, lips, mouth,

throat or neck which may cause

difficulty swallowing or

breathing

tingling or numbness of the

hands or feet, or muscle

weakness.

These are very serious side effects.

You may need urgent medical

attention. These side effects are 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.

After taking NOXAFIL

Storage

NOXAFIL Oral Suspension

Keep NOXAFIL Oral Suspension

in the bottle until it is time to take

Keep NOXAFIL Oral Suspension

in a cool dry place where the

temperature stays below 25°C.

Do not freeze NOXAFIL Oral

Suspension.

Protect NOXAFIL Oral

Suspension from light.

NOXAFIL Modified Release

Tablets

Store NOXAFIL Modified

Release Tablets below 30°C.

Store in original container.

Do not store NOXAFIL 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 NOXAFIL and all other

medicines where children cannot

reach them.

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 NOXAFIL, or if it has

passed the expiry date, ask your

pharmacist what to do with any

left over medicine.

Product description

What it looks like

NOXAFIL Oral Suspension

NOXAFIL Oral Suspension is a

white liquid.

It is supplied in an amber glass bottle

with a child-resistant cap. Each bottle

contains 105 mL of suspension. A

measuring spoon graduated to

measure 2.5 mL and 5 mL is

included with each bottle.

NOXAFIL Modified Release

Tablets

NOXAFIL Tablets are yellow-

coated, capsule-shaped tablets with

"100" marking on one side.

NOXAFIL tablets are available in

blister packs of 24 or 96 tablets.

Ingredients

NOXAFIL Oral Suspension

NOXAFIL Oral Suspension contains

40 mg posaconazole (the active

ingredient) per mL of suspension.

Other inactive ingredients are

polysorbate 80, simethicone, sodium

benzoate, sodium citrate dihydrate,

citric acid monohydrate, glycerol,

xanthan gum, liquid glucose,

titanium dioxide, artificial cherry

flavouring, and purified water.

NOXAFIL Oral Suspension does not

contain lactose, gluten, tartrazine or

any other azo dyes.

NOXAFIL Modified Oral Release

Tablets

Each tablet contains 100 mg of

posaconazole.

Other inactive ingredients are:

hypromellose acetate succinate,

microcrystalline cellulose,

hydroxypropylcellulose, silicon

dioxide, croscarmellose sodium,

magnesium stearate, polyvinyl

alcohol, Macrogol 3350, titanium

dioxide, purified talc, iron oxide

yellow.

Sponsor

Merck Sharp & Dohme (Australia)

Pty Limited

Level 1, Building A, 26 Talavera Rd

Macquarie Park NSW 2113

Australia

Australian Registration Number:

Oral suspension AUST R 115556

Modified Release Tablet AUST R

216283

This leaflet was prepared in

September 2017.

Based on PI dated 29 September

2017.

NOXAFIL

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

10-7-2018

Noxafil (Merck Sharp and Dohme B.V.)

Noxafil (Merck Sharp and Dohme B.V.)

Noxafil (Active substance: Posaconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4476 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/610/T/54

Europe -DG Health and Food Safety