XIFAXAN

Main information

  • Trade name:
  • XIFAXAN rifaximin 200 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XIFAXAN rifaximin 200 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222643
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222643

XIFAXAN rifaximin 200 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Norgine Pty Ltd

Postal Address

PO Box 6100,FRENCHS FOREST DC, NSW, 2086

Australia

ARTG Start Date

26/05/2015

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. XIFAXAN rifaximin 200 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

22/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

XIFAXAN is indicated for the treatment of patients ( > = 12 years of age) with travellers' diarrhoea caused by non-invasive strains of Escherichia coli (see

'PRECAUTIONS', and 'CLINICAL TRIALS' ). Travellers' diarrhoea describes a clinical picture predominantly observed in subjects travelling from

developed to developing countries. It is most frequently caused by enterotoxigenic Escherichia coli (ETEC), enteroaggregative E. coli (EAEC) and other

non-invasive pathogens.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

9 tablets

(S4) Prescription Only Medicine

Components

1. XIFAXAN rifaximin 200 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, circular, biconvex film-coated tablets

Active Ingredients

Rifaximin

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 26.11.2017 at 10:59:29 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

Xifaxan 200 mg CMI February 2017

- 1 -

XIFAXAN 200 mg Tablets

Rifaximin

Consumer Medicine Information

What is in this Leaflet

This leaflet answers some common questions about

XIFAXAN 200 mg 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.

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 XIFAXAN 200 mg is used for:

XIFAXAN

antibiotic

that

passes

through

gastrointestinal tract and very little is absorbed. XIFAXAN

200 mg is used to treat travellers’ diarrhoea that is caused by

bacteria that do not invade the gut wall, in people aged 12

years and older. XIFAXAN is not effective for diarrhoea

caused by bacteria that invade the gut wall. There is no

experience using XIFAXAN to treat travellers’ diarrhoea in

children under 12 years of age. XIFAXAN may be prescribed

for you before you travel overseas, so you have it with you if

you need to treat an episode of diarrhoea.

Before you travel overseas, ask your doctor or

pharmacist if you have any questions about why

XIFAXAN has been prescribed for you, or how to use it.

Your doctor may have recommended XIFAXAN tablets for

another reason.

Before you take XIFAXAN 200 mg

When you must not take it

Do not take XIFAXAN tablets if:

You have an allergy to rifaximin or any of the rifamycin

antibiotics

(rifampicin,

rifabutin)

other

ingredient contained in this medicine, 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, itchiness or hives on the

skin.

You have bowel obstruction (a blocked bowel)

You also have a fever, or blood in your stools. These

are signs that the diarrhoea may be caused by an

invasive bacteria that will not be effectively treated by

XIFAXAN.

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, see medical advice.

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 you doctor if you are breastfeeding.

It is not known if your baby can absorb rifaximin from breast

milk if you are breastfeeding.

If you have not told your doctor about any of the above,

tell him/her before you start taking XIFAXAN tablets.

Taking other medicines

Tell you 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.

There is a possibility that XIFAXAN can interact with

other medicines, including ciclosporin, oral

contraceptives and warfarin.

Your doctor and pharmacist have more information on which

medicines to be careful with or avoid while taking this

medicine.

How to take XIFAXAN 200 mg tablets

How much to take

The recommended dosage of XIFAXAN tablets is one

200 mg tablet three times a day for three days

(a total of 9 doses).

How to take it

Swallow the tablet whole with a glass of water. You can

take XIFAXAN tablets with or without food.

If you forget to take it

If it is nearly time for your next dose, skip the dose you

missed and take the next dose when you are meant to.

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 the dose that

you missed.

If you have trouble remembering to take your medicine, ask

your pharmacist for some hints.

If you take too much (overdose)

If in Australia, immediately telephone your doctor or the

Poisons

Information

Centre

(telephone

advice, or go to the Accident and Emergency department at

the nearest hospital, if you think that you or anyone else may

have taken too many XIFAXAN tablets. If overseas, seek

medical

advice.

this

even

there

signs

discomfort or poisoning.

While you are using XIFAXAN tablets

Things you must do

Tell any other doctors, dentists, and pharmacists who

treat you that you are taking this medicine.

If you experience fever, if your diarrhoea becomes

worse, you have blood in your stools, or if symptoms

have not resolved after 3 days of treatment, then contact

a doctor for assessment. Do not take a second course of

XIFAXAN.

Things you must not do

Do not take XIFAXAN tablets to treat any other

conditions 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.

Xifaxan 200 mg CMI February 2017

- 2 -

If you stop taking it suddenly, your condition may worsen or

you may have unwanted side effects.

Side effects

Tell a doctor or pharmacist as soon as possible if you

do not feel well while you are using XIFAXAN.

All medicines can have unwanted effects. Sometimes they

are serious, most of the time they are not. Do not be alarmed

by this list of possible side effects. You may not experience

any of them.

Ask a doctor or pharmacist to answer any questions

that you may have.

Tell your doctor or pharmacist if you notice any of the

following common side effects and they worry you:

dizziness, headache

wind, abdominal bloating, abdominal pain, constipation,

diarrhoea

involuntary, painful, or ineffective straining on the toilet

nausea, vomiting

fever

The above list includes the more common side effects of

your medicine reported in adults being treated for traveller’s

diarrhoea. They are usually mild and short-lived.

Less common side effects include:

Thrush, cold sore, swollen throat, inflammation or

infection of the nose or throat

Loss of appetite, dehydration

Depressed mood, sleeplessness, nervousness

Earache

Cough, dry or sore throat, runny nose, shortness of

breath, blocked nose

Muscle cramps, muscle pain, back or neck pain

Chills, cold sweats, perspiration, flu-like illness

Rash, blotchy skin, hot flushes.

Tell your doctor as soon as possible if you notice any of

the following:

Diarrhoea. XIFAXAN, like nearly all antibiotics, can alter

the mix of bacteria in the intestine. This can lead to an

overgrowth of a bacteria called Clostridium difficile

(C. difficile). If you take XIFAXAN, there is a small risk

that you could experience diarrhoea caused by C.

difficile. If you develop severe diarrhoea after you have

stopped XIFAXAN, contact your doctor immediately.

As with other medicines there is a small risk of serious

allergic reactions. Consult your doctor immediately or

go to the Accident & Emergency department of your

nearest hospital if you notice any of the following:

swelling of the face, lips or tongue which may make

swallowing or breathing difficult

asthma, wheezing, shortness of breath

sudden or severe itching, skin rash, hives

Tell your doctor or pharmacist if you notice anything

that is making you feel unwell.

Other side effects not listed above may also occur in some

people.

After using XIFAXAN tablets

Storage

Keep your tablets in the blister packaging until it is time

to take them

If you take the tablets out of the packaging they will not keep

well.

Keep

your

tablets

in

a

cool

dry

place

where

the

temperature stays below 25˚C.

Do not store XIFAXAN tablets or any other medicines 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 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

XIFAXAN 200 mg tablets are pink, round, biconvex, film-

coated tablets.

Ingredients

XIFAXAN tablets contains 200 mg of rifaximin as the active

ingredient. The tablets also contain:

Microcrystalline cellulose

Glyceryl diisostearate

Sodium starch glycolate Type A

Colloidal anhydrous silica

Purified talc

The film coating contains

Hypromellose

Titanium dioxide

Disodium edetate

Propylene glycol

Iron oxide red

Supplier

XIFAXAN tablets are supplied in Australia by:

Norgine Pty Ltd

3/14 Rodborough Road

Frenchs Forest NSW 2086

AUSTRALIA

Phone: 1800 766 936

www.norgine.com.au

This Leaflet was prepared in February 2017

Australian Registration No. AUST R 222643