RIFAXIMIN ALFA WASSERMAN 550 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RIFAXIMIN

Available from:

Alfa Wassermann S.p.A.

ATC code:

A07AA11

INN (International Name):

RIFAXIMIN

Dosage:

550 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Antibiotics

Authorization status:

Authorised

Authorization date:

2012-12-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

RIFAXIMIN ALFA WASSERMANN 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 RIFAXIMIN ALFA WASSERMANN is and what it is used for 
2. 
What you need to know before you
take RIFAXIMIN ALFA WASSERMANN  
3. 
How to take RIFAXIMIN ALFA WASSERMANN 
4. 
Possible side effects 
5. 
How to store RIFAXIMIN ALFA WASSERMANN  
6. 
Contents of the pack and other information 

1.  WHAT RIFAXIMIN ALFA WASSERMANN IS AND WHAT IT IS
USED FOR 

RIFAXIMIN ALFA WASSERMANN contains the active
substance rifaximin. Rifaximin 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).  

RIFAXIMIN ALFA WASSERMANN is used in adults
with liver disease to reduce the recurrence of 
episodes of overt hepatic encephalopathy. 

RIFAXIMIN ALFA WASSERMANN can either be used alone or more
commonly together with 
medicines containing lactulose (a laxative). 

2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFAXIMIN
ALFA WASSERMANN  

DO NOT TAKE RIFAXIMIN ALFA WASSERMANN: 


if you are allergic to:  

  rifaximin  

  similar types of antibioti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rifaximin Alfa Wasserman 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 10mm x 19 mm film-coated tablets embossed with
"RX" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rifaximin Alfa Wasserman 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).
Rifaximin Alfa Wasserman can be administered with or without food.
_Paediatric population_
The safety and efficacy of Rifaximin Alfa Wasserman 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
Rifaximin Alfa Wasserman 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).
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