TARGAXAN 550 Milligram Film Coated Tablet

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

RIFAXIMIN

Beschikbaar vanaf:

Norgine Limited

ATC-code:

A07AA11

INN (Algemene Internationale Benaming):

RIFAXIMIN

Dosering:

550 Milligram

farmaceutische vorm:

Film Coated Tablet

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

Antibiotics

Autorisatie-status:

Authorised

Autorisatie datum:

2013-02-22

Bijsluiter

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TARGAXAN® 550 MG FILM-COATED TABLETS
RIFAXIMIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 Targaxan is and what it is used for
2. What you need to know before you take Targaxan
3. How to take Targaxan
4. Possible side effects
5. How to store Targaxan
6. Contents of the pack and other information
1. WHAT TARGAXAN IS AND WHAT IT IS USED FOR
Targaxan contains the active substance rifaximin. Targaxan is an
antibiotic that destroys
bacteria, which can cause a disease called hepatic encephalopathy
(symptoms include
agitation, confusion, muscle problems, difficulty in speaking and in
some cases coma).
Targaxan is used in adults with liver disease to reduce the recurrence
of episodes of overt
hepatic encephalopathy.
Targaxan can either be used alone or more commonly together with
medicines containing
lactulose (a laxative).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARGAXAN
Do not take Targaxan:

if you are allergic to:
-
rifaximin
-
similar types of antibiotics (such as rifampicin or rifabutin)
-
any of the other ingredients of this medicine (listed in section 6).

if you have a blockage in your intestine
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Targaxan.
While you are taking Targaxan your urine may turn a reddish colour.
This is quite normal.
Treatment with any antibiotic including rifaximin may cause severe
diarrhoea. This can
happen several months after you have finished taking the medicine. If
yo

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Targaxan 550 mg fiilm-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 550 mg rifaximin.
Excipients:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval biconvex 10 mm x 19 mm film-coated tablets embossed with
“RX” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Targaxan is indicated for the reduction in recurrence of episodes of
overt hepatic encephalopathy in patients
18 years
of age (see section 5.1).
In the pivotal study, 91% of the patients were using concomitant
lactulose.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: 550 mg twice a day. The clinical benefit was
established from a controlled study in which
subjects were treated for 6 months. Treatment beyond 6 months should
take into consideration the individual balance
between benefits and risks, including those associated with the
progression of hepatic dysfunction (see sections 4.4, 5.1
and 5.2).
Targaxan can be administered with or without food.
_Paediatric population_
The safety and efficacy of Targaxan in paediatric patients (aged less
than 18 years) have not been established.
_Elderly_
No dosage adjustment is necessary as the safety and efficacy data of
Targaxan showed no differences between the
elderly and the younger patients.
_Hepatic impairment_
No dosage adjustment is necessary for patients with hepatic
insufficiency (see section 4.4).
_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
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