Targaxan 550 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rifaximin

Available from:

Norgine B.V.

ATC code:

A07AA; A07AA11

INN (International Name):

Rifaximin

Dosage:

550 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Antibiotics; rifaximin

Authorization status:

Marketed

Authorization date:

2013-02-22

Patient Information leaflet

Page 1 of 2
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Profile
Technical Info
PRE-PRINTED (AS PART OF ARTWORK)
PRINTED ON-LINE
33314102
2
38430, 44174
24/03/2021
Ireland
-
-
PIL (Alanno)
Alfasigma
N/A
165 x 440mm
TBC
TBC
N/A
105246346 / 402300325 0020
Targaxan 550mg
Black
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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 you have severe diarrhoea during or
after using Targaxan you should stop
taking
Targaxan
and
contact
your
doctor immediately.
If
your
liver
problems
are
severe
your doctor will need to o

Summary of Product characteristics

Health Products Regulatory Authority
19 September 2022
CRN00D00C
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Targaxan 550 mg film-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).
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 as long term treatment for the
reduction in recurrence of episodes of overt hepatic
encephalopathy (see sections 4.4, 5.1 and 5.2).
In the pivotal study, 91% of the patients were using concomitant
lactulose (see also section 5.1).
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
Orally with a glass of water.
4.3 CONTRAINDICATIONS

Hypersensitivity to rifaximin, rifamycin-derivatives or to any of the
excipients listed in section 6.1.

Cases of intestinal obstruction.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
19 September 2022
CRN00D00C
Page 2 of 8
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