XIFAXAN rifaximin 550 mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

rifaximin, Quantity: 550 mg

Tilgængelig fra:

Norgine Pty Ltd

INN (International Name):

Rifaximin

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

56, 14, 30, 28, 60

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Prevention of the recurrence of hepatic encephalopathy where other treatments have failed or are contraindicated.

Produkt oversigt:

Visual Identification: Pink oval biconvex film-coated tablet; 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

Autorisation status:

Registered

Autorisation dato:

2012-05-17

Indlægsseddel

XIFAXAN 550 CMI (ANZ) April 2020
- 1 -
XIFAXAN 550 MG TABLETS
_Rifaximin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
XIFAXAN 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 IS USED FOR:
XIFAXAN
is
an
antibiotic
that
passes
through
the
gastrointestinal tract and very little is absorbed. XIFAXAN is
used
to
help
prevent
a
condition
called
HEPATIC
ENCEPHALOPATHY (HE). HE is a disease of the brain that
occurs when the liver is not working properly. Symptoms are
caused by too much ammonia in the blood. XIFAXAN works
by killing bacteria in the gut that produce ammonia. This
means less ammonia is produced and less gets into the
blood.
XIFAXAN is intended to be used for preventing HE only in
those patients where HE is likely to occur again, and where it
cannot be managed with other treatments.
There
is
no
experience
using
XIFAXAN
to
prevent
the
recurrence of HE in children or adolescents.
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT WHY XIFAXAN HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have recommended XIFAXAN tablets for
another reason.
BEFORE YOU TAKE XIFAXAN
_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)
DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON
THE PACK OR IF THE PACKAGING IS TORN OR SHOWS

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
XIFAXAN
®
550 mg AUST R 183411
April 2020
Page 1 of 12
XIFAXAN
® (RIFAXIMIN) 550 MG FILM COATED TABLETS
1
N
AME OF THE MEDICINE
Rifaximin
2
Q
UALITATIVE AND QUANTITATIVE COMPOSITION
XIFAXAN tablets are oval biconvex pink film-coated tablets containing
rifaximin 550 mg,
marked RX on one side.
For the full list of excipients, see Section 6.1 List of excipients.
3
P
HARMACEUTICAL FORM
XIFAXAN® is a pink oval biconvex film-coated tablet marked RX on one
side, containing
550 mg of rifaximin. The tablets are packaged in PVC/PE/PVDC/Aluminium
blisters in
cartons containing 14, 28, 30, 56, or 60 tablets.
(Not all pack sizes may be marketed)
4
C
LINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prevention of the recurrence of hepatic encephalopathy where other
treatments have failed or
are contraindicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose of XIFAXAN is one 550 mg tablet taken orally
twice a day, with or
without food.
In the pivotal trial of XIFAXAN for HE, 91% of the patients were using
lactulose
concomitantly.
Because of the limited systemic absorption of rifaximin, no specific
dosing adjustment is
recommended for patients with hepatic insufficiency.
4.3
C
ONTRAINDICATIONS
XIFAXAN is contraindicated in patients with a hypersensitivity to
rifaximin, any of the
rifamycin antimicrobial agents, or any of the components in XIFAXAN.
Hypersensitivity
reactions have included exfoliative dermatitis, angioneurotic oedema,
and anaphylaxis.
Cases of intestinal obstruction.
AUSTRALIAN PRODUCT INFORMATION
XIFAXAN
®
550 mg AUST R 183411
April 2020
Page 2 of 12
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
_Clostridium difficile-Associated Diarrhoea _
_Clostridium difficile_
-associated diarrhoea (CDAD) has been reported with use of nearly all
antibacterial agents, including XIFAXAN, and may range in severity
from mild diarrhoea to
fatal colitis. Treatment with antibacterial agents alters the normal
flora of the colon which
may lead to overgrowth of
_C.