DIFICID fidaxomicin 200 mg tablets in bottles

Main information

  • Trade name:
  • DIFICID fidaxomicin 200 mg tablets in bottles
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIFICID fidaxomicin 200 mg tablets in bottles
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195623
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195623

DIFICID fidaxomicin 200 mg tablets in bottles

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

23/04/2013

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. DIFICID fidaxomicin 200 mg tablets in bottles

Product Type

Single Medicine Product

Effective date

2/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

DIFICID (fidaxomicin) is indicated for the treatment of confirmed Clostridium difficile infection (CDI) in adults.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

36 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

60 tablets

(S4) Prescription Only Medicine

20 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Tablets are white to off-white, film coated, capsule-shaped tablets

debossed with "FDX" on one side and "200" on the other side.

Active Ingredients

Fidaxomicin

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 03:46:33 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

DIFICID

®

fidaxomicin tablets

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about fidaxomicin tablets.

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 DIFICID

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 DIFICID is used

for

This medicine is used to treat

infections of the lining of the colon

(large intestine) with certain bacteria

called Clostridium difficile. This

serious illness can result in painful,

severe diarrhoea.

DIFICID contains the active

ingredient fidaxomicin.

Fidaxomicin is an antibiotic that

belongs to a new group of medicines

called macrocyclic antibiotics.

It works by killing the bacteria which

cause Clostridium difficile infections.

DIFICID will not work against viral

infections such as colds or flu or

against infections with other types of

bacteria.

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 only available

with a doctor’s prescription.

There is no evidence that this

medicine is addictive.

Before you take

DIFICID

When you must not take it

Do not take this medicine if you

have an allergy to:

Fidaxomicin

Any of the other ingredients of

DIFICID 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.

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.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or plan to become

pregnant.

Your doctor can discuss with you the

risks and benefits involved.

Tell your doctor if you are

breastfeeding or are planning to

breastfeed.

It is not known whether fidaxomicin

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

DIFICID.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

How to take DIFICID

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 bottle, ask your

doctor or pharmacist for help.

Follow the instructions they give

you.

DIFICID

If you take the wrong dose, DIFICID

may not work as well and your

problem may not improve.

How much to take

The usual dose is one tablet (200 mg)

twice daily (one tablet every 12

hours) for 10 days.

How to take it

Swallow the tablets whole with a

glass of water.

When to take it

This medicine may be taken with or

without food.

How long to take it

Continue taking your medicine

until you finish the pack or for as

long as your doctor tells you.

If you do not complete the full course

prescribed by your doctor, the

infection may not clear completely or

your symptoms may return.

Do not stop taking it because you

are feeling better.

If you forget to take it

Take the tablet as soon as you

remember. However, if it is nearly

time for the next dose, skip the

missed dose.

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.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

in Australia (telephone 13 11 26)

for advice, or go to Accident and

Emergency at the nearest hospital,

if you think that you or anyone else

may have taken too much

DIFICID. Do this even if there are

no signs of discomfort or

poisoning.

You may need urgent medical

attention.

While you are taking

DIFICID

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking DIFICID.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If the symptoms of your infection

do not improve within a few days,

or if they become worse, tell your

doctor.

Things you must not do

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, all the

organisms causing your infection

may not be killed. These organisms

may continue to grow and multiply

so that your infection may not clear

completely or may return.

Do not take DIFICID to treat any

other complaints unless your

doctor tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

DIFICID affects you.

DIFICID is not expected to affect

your ability to drive, use tools or

machines.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking DIFICID.

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 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:

nausea

vomiting

constipation

headache

dizziness

These are mild side effects of the

medicine, and are short-lived.

Tell your doctor immediately or go

to Accident & Emergency at your

nearest hospital if you notice any of

the following:

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

These are signs of a serious allergic

reaction, which may require medical

attention. Serious side effects are

rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

DIFICID

After taking DIFICID

Storage

Keep your medicine in the original

container.

If you take it out of its original

container it may not keep well.

Keep your medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store DIFICID 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 (about 5 feet) 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

DIFICID 200mg are white, oblong

tablets; each tablet is marked with

"FDX" on one side and "200" on the

other side. They are available in

bottles of 20 or 60 tablets and blister

packs of 20 or 100 tablets. Not all

packs may be marketed.

Ingredients

Active ingredient:

Fidaxomicin 200 mg

Inactive ingredients:

Microcrystalline Cellulose

pregelatinised maize starch

hydroxypropylcellulose

Butylated Hydroxytoluene

Sodium Starch Glycollate

Magnesium Stearate

Coating:

Polyvinyl Alcohol

Titanium Dioxide

Talc

Macrogol 3350

Lecithin (Soy)

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Sponsor

Merck Sharp & Dohme (Australia)

Pty Limited

Level 1, Building A,

26 Talavera Road

Macquarie Park NSW 2113

This leaflet was prepared in May

2019

Australian Register Number

200 mg film-coated tablet (bottle):

AUST R 195623

200 mg film-coated tablet (blister

pack): AUST R 195622

Based on PI dated 16 May 2019.

DIFICID