Xifaxan

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Rifaximin 550mg;  ;  ;  

Saatavilla:

CARSL Consulting

INN (Kansainvälinen yleisnimi):

Rifaximin 550 mg

Annos:

550 mg

Lääkemuoto:

Film coated tablet

Koostumus:

Active: Rifaximin 550mg       Excipient: Colloidal silicon dioxide Disodium edetate Glyceryl diisostearate Hypromellose Iron oxide red Microcrystalline cellulose Propylene glycol Purified talc Purified water Sodium starch glycolate Titanium dioxide

Kpl paketissa:

Blister pack, PVC/PE/PVDC/Aluminium, 14 tablets

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

ZaCh System S.p.A

Käyttöaiheet:

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

Tuoteyhteenveto:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Aluminium - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/Aluminium - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/Aluminium - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/Aluminium - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/Aluminium - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Valtuutus päivämäärä:

2013-01-24

Pakkausseloste

XIFAXAN® rifaximin 550 mg tablets
1
XIFAXAN®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING XIFAXAN?
XIFAXAN contains the active ingredient rifaximin. XIFAXAN is used to
help prevent a condition called hepatic encephalopathy
(HE).
For more information, see Section 1. Why am I taking XIFAXAN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE XIFAXAN?
Do not take if you have ever had an allergic reaction to XIFAXAN or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
XIFAXAN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XIFAXAN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE XIFAXAN?
•
The recommended dosage of XIFAXAN is one tablet twice daily.
•
Swallow the tablet whole with a glass of water. You can take XIFAXAN
with or without food.
More instructions can be found in Section 4. How do I take XIFAXAN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING XIFAXAN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
XIFAXAN.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how XIFAXAN affects you.
DRINKING
ALCOHOL
•
As with all medicines, drinking alcohol while taking medicines is not
recommended
LOOKING AFTER
YOUR MEDICINE
•
Keep your tablets in a cool dry place where the temperature stays
below 25˚C.
For more information, see Section 5. What should I know while taking
XIFAXAN? in the full CMI

Valmisteyhteenveto

XIFAXAN
®
550 mg Data Sheet February 2023
NEW ZEALAND DATASHEET
1 PRODUCT NAME
XIFAXAN
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifaximin 550 mg Film-coated Tablets
3 PHARMACEUTICAL FORM
XIFAXAN tablets are oval biconvex pink film-coated tablets containing
rifaximin 550 mg,
marked RX on one side.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Prevention of the recurrence of hepatic encephalopathy where other
treatments have failed or
are contraindicated.
4.2
Dose 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
Contraindications
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.
4.4
Special warnings and precautions for use
USE WITH P-GLYCOPROTEIN INHIBITORS
Caution should be exercised when concomitant use of rifaximin and a
P-glycoprotein inhibitor
such as ciclosporin is needed (see Interactions).
USE WITH WARFARIN
Both decreases and increases in international normalized ratio (in
some cases with bleeding
events) have been reported in patients maintained on warfarin and
prescribed rifaximin. If co-
administration is necessary, the international normalized ratio should
be carefully monitored
with the addition or withdrawal of rifaximin. Adjustments in the dose
of oral anticoagulants may
be necessary (see ‘INTERACTIONS WITH OTHER MEDICINES’).
PAEDIATRIC USE
The safety and effectiveness of XIFAXAN for the prevention of
recurrence of hepatic
encephalopathy have not been established in patients under 18 years of
age.
XIFAXAN
®
550 mg Data Sheet Fe