Xifaxanta 200mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Rifaximin

Mevcut itibaren:

Norgine Pharmaceuticals Ltd

ATC kodu:

A07AA11

INN (International Adı):

Rifaximin

Doz:

200mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 05010700; GTIN: 5012748004528

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
XIFAXANTA ® 200 MG FILM-COATED TABLETS
Rifaximin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Xifaxanta 200 mg film-coated tablets are and what they are
used for
2. What you need to know before you take Xifaxanta 200 mg film-coated
tablets
3. How to take Xifaxanta 200 mg film-coated tablets
4. Possible side effects
5. How to store Xifaxanta 200 mg film-coated tablets
6. Contents of the pack and other information
1.
WHAT XIFAXANTA 200 MG FILM-COATED TABLETS ARE AND WHAT
THEY ARE USED FOR
XIFAXANTA 200 MG FILM-COATED TABLETS ARE AN INTESTINAL ANTIBIOTIC AND
ARE USED TO TREAT

traveller´s diarrhoea in adults when the diarrhoea is not accompanied
by fever or blood
in the stools, or 8 or more unformed (soft or liquid) stools in the
last 24 hours.

Xifaxanta 200 mg film-coated tablets are not recommended for use in
children (aged
less than 18 years).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XIFAXANTA 200 MG
FILM-COATED TABLETS
2
DO NOT TAKE XIFAXANTA 200 MG FILM-COATED TABLETS

if you are allergic (hypersensitive) to rifaximin, to similar types of
antibiotics (such as
rifampicin or rifabutin) or to any of the other ingredients (see
section 6) of Xifaxanta
film coated tablets.

if you have a fever;

if you have blood in your stools;

if you passed 8 or more unformed stools in the last 24 hours.

If you have constipation, abdominal pain and vomiting caused by
blockage of the
bowel
WARNING AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING XIFAXANTA 200MG FILM
COA

Ürün özellikleri

OBJECT 1
XIFAXANTA 200 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 27-Jun-2017 | Norgine
Limited
1. Name of the medicinal product
XIFAXANTA 200 mg film-coated tablets
2. Qualitative and quantitative composition
One film-coated tablet contains:
Rifaximin 200 mg.
Excipients:
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink, circular biconvex film-coated tablets, with “AW” embossed on
one side.
4. Clinical particulars
4.1 Therapeutic indications
Xifaxanta 200mg film-coated tablets are indicated for the treatment of
travellers' diarrhoea that is not
associated with any of :
Fever
Bloody diarrhoea
Eight or more unformed stools in the previous 24 h
Occult blood or leucocytes in the stool.
Xifaxanta 200mg film-coated tablets may shorten the duration of
diarrhoea when this is associated with
non-invasive strains of _E.coli _(see sections 4.4 and 5.1).
4.2 Posology and method of administration
Posology
200 mg every 8 hours for three days (total 9 doses).
Rifaximin must not be used for more than 3 days even if symptoms
continue and a second course of
treatment must not be taken (see section 4.4).
Rifaximin can be administered with or without food
_Paediatric population_
The safety and efficacy of Xifaxanta 200 mg film-coated tablets in
children (aged less than 18 years) have
not been established
Elderly
No dosage adjustment is necessary as the safety and efficacy data of
Xifaxanta 200 mg film-coated tablets
showed no differences between the elderly and the younger patients.
Hepatic impairment
A dosage adjustment for patients with hepatic insufficiency is not
necessary (see section 5.2).
Renal impairment
Although dosing change is not anticipated, caution should be used in
patients with impaired renal
function (see section 5.2).
Method of administration
Orally with a glass of water.
4.3 Contraindications
Hypersensitivity to the active substance, to any rifamycin (e.g
rifampicin or rifabutin) or to any of the
excipients (listed in section 6.1).
Cases o