XIFAXAN rifaximin 200 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rifaximin, Quantity: 200 mg

Available from:

Norgine Pty Ltd

INN (International Name):

Rifaximin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; glyceryl isostearate; sodium starch glycollate type A; colloidal anhydrous silica; purified talc; hypromellose; titanium dioxide; disodium edetate; propylene glycol; iron oxide red

Administration route:

Oral

Units in package:

9 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: Pink, circular, biconvex film-coated tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-05-26

Patient Information leaflet

Xifaxan 200 mg CMI April 2020
- 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
is
an
antibiotic
that
passes
through
the
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)
or
to
any
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.

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
XIFAXAN
®
200 mg AUST R 222643
April 2020
Page 1 of 15
XIFAXAN
® (RIFAXIMIN) 200 MG FILM COATED TABLETS
1
NAME OF THE MEDICINE
Rifaximin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
XIFAXAN 200 mg tablets are pink, circular, biconvex film-coated
tablets.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
XIFAXAN
®
200 mg is a pink, circular, biconvex film-coated tablet. The tablets
are
packaged in PVC/PE/PVDC/Aluminium blisters in cartons containing 9
tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 Section 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE, and Section 5.1
PHARMACODYNAMIC PROPERTIES - 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose of XIFAXAN is one 200 mg tablet taken orally
three times a
day for 3 days (total 9 doses). It can be taken with or without food.
XIFAXAN should
not be used for more than 3 days even if symptoms continue. A second
course of
treatment must not be taken.
AUSTRALIAN PRODUCT INFORMATION
XIFAXAN
®
200 mg AUST R 222643
April 2020
Page 2 of 15
4.3
C
ONTRAINDICATIONS
XIFAXAN is contraindicated in patients with a hypersensitivity to
rifaximin, any of the
rifamycin antimicrobial agents, or to any of the excipients.
Hypersensitivity reactions
have included exfoliative dermatitis, angioneurotic oedema, and
anaphylaxis.
Cases of intestinal obstruction.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
XIFAXAN SHOULD NOT BE USED IN PATIENTS WITH DIARRHOEA COMPLICATED BY
FEVER OR
BLOOD IN THE STOOL OR DIARRHOEA DUE TO PATH