Rifaximin Alfasigma 550 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rifaximin

Available from:

Alfasigma S.p.A

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:

Not marketed

Authorization date:

2012-12-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIFAXIMIN ALFASIGMA 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 ALFASIGMA is and what it is used for
2.
What you need to know before you take RIFAXIMIN ALFASIGMA
3.
How to take RIFAXIMIN ALFASIGMA
4.
Possible side effects
5.
How to store RIFAXIMIN ALFASIGMA
6.
Contents of the pack and other information
1.
WHAT RIFAXIMIN ALFASIGMA IS AND WHAT IT IS USED FOR
RIFAXIMIN ALFASIGMA 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 ALFASIGMA is used in adults with liver disease to reduce the
recurrence of episodes of
overt hepatic encephalopathy.
RIFAXIMIN ALFASIGMA 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 ALFASIGMA
DO NOT TAKE RIFAXIMIN ALFASIGMA:

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 RIFAXIMIN ALFASIGMA.
While you are taking RIFAXIMIN ALFASIGMA your urine may turn a reddish
colour. This is quite
normal.
Treatment with any antibio

Summary of Product characteristics

Health Products Regulatory Authority
30 August 2022
CRN00CZGK
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rifaximin Alfasigma 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 ALFASIGMA 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).
RIFAXIMIN ALFASIGMA can be administered with or without food.
_Paediatric population_
The safety and efficacy of RIFAXIMIN ALFASIGMA 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 ALFASIGMA 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.
Health Products Regulatory Authority
30 August 2022
CRN00CZGK
Page 2 of 9
4.4 SPECIAL WARNINGS AN