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XIFAXANTA 200 MG FILM-COATED TABLETS

Active substance(s): RIFAXIMIN / RIFAXIMIN / RIFAXIMIN

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CLIENTE

CORPO

ALFA WASSERMANN S.p.A.

TESTO: 9
INTERLINEA: 11

ARTICOLO

PRODOTTO

Prospetto

Proof Number:
Date

22217403

XIFAXANTA 200 mg Film-coated tablets - UK - CCDS 7.0

Steso

Piegato

Con microforatura

Three

GRAMMATURA CARTA

20/07/2017

00 g

Change Control

Stylegraph
Via Garbagnate, 61
20020 Lainate (MI)
 +39 02 9371446

Cod. 04739/4

Artwork Approval Signature
Regulatory
Commercial
Trademark
Artwork Coodinator

LAYOUT DI RIFERIMENTO

390 /195x140 mm

DIS. 000

CODICE CLIENTE

00000000

5525, 7411, 7474 & 6006

1

Booklet

Senza microforatura

FORMATO

CODICE AW

Bobina
% DI COPERTURA TESTI/SUPERFICIE

2

Edizione
0

SCALA

100 %

IMPORTANTE! Per ogni comunicazione si prega
di considerare sempre l’astuccio aperto e steso,
dalla parte stampata e con la linguetta d’incollatura a sinistra. La sequenza delle facciate parte
quindi dalla linguetta d’incollatura nell’ordine:

3

4

Data allestimento
13.04.2017

1:1

RIF. PRATICA

22217403

SENSO DI
SVOLGIMENTO
N.

RIF. LAETUS
MASTER DI
RIFERIMENTO
NOTE / RIF. IMPIANTO PRECEDENTE

SOLO PER PROSPETTI
IN BOBINA

COLORI

DATE AND SIGNATURE FOR PRINTING APPROVAL VISTO SI STAMPI

NERO
FORMATO

CUSTOMER

L’impianto stampa non deve assolutamente essere modificato o danneggiato

· near fainting
· giant hives
· skin roughness, skin redness, itching, wheals, skin with little
purple-coloured spots.
Treatment with any antibiotic may cause Clostridium difficile
associated diarrhoea (CDAD).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5. HOW TO STORE XIFAXANTA 200 MG FILM-COATED
TABLETS
Keep out of the sight and reach of children.
Xifaxanta 200 mg film-coated tablets do not require any special
storage conditions.
Do not use Xifaxanta 200 mg film-coated tablets after the expiry
date which is stated on the carton and the blister. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Xifaxanta 200 mg film-coated tablets contain
· The active substance is: Rifaximin. Each film-coated tablet
contains: 200 mg of Rifaximin. The other ingredients are: Tablet

ALFA WASSERMANN S.p.A.
Bar prints 100mm @ 100%

core: sodium starch glycolate type A, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose. Tablet
coating: hypromellose, titanium dioxide, disodium edetate,
propylene glycol, red iron oxide E172.
What Xifaxanta 200 mg film-coated tablets look like and
contents of the pack
· Xifaxanta 200 mg film-coated tablets are pink circular biconvex
coated tablets, with “AW” embossed on one side.
· They are provided in a blister pack containing 9 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Norgine Pharmaceuticals Ltd.
Moorhall Rd, Harefield, Middx, UB9 6NS, U.K.

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.

Manufacturer:
Alfasigma S.p.A.
Via E. Fermi, 1 - 65020 Alanno (PE), ITALY

This includes any possible side effects not listed in this leaflet.
See section 4.

This leaflet was last revised in August 2017

What is in this leaflet:

Product under licence from Alfasigma S.p.A. XIFAXANTA is a
registered trademark of the
Alfasigma group of companies,
licensed to the Norgine group of companies.
NORGINE and the sail logo are registered trademarks of the
Norgine group of companies.

22217403

Item Number:

FONTS

Helv. Neue Lt Std
Roman, Bold, Italic

00000000

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

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
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;

4. Possible side effects

· if you passed 8 or more unformed stools in the last 24 hours.

5. How to store Xifaxanta 200 mg film-coated tablets

· If you have constipation, abdominal pain and vomiting caused

6. Contents of the pack and other information

by blockage of the bowel

CLIENTE

CORPO

ALFA WASSERMANN S.p.A.

TESTO: 9
INTERLINEA: 11

ARTICOLO

PRODOTTO

Prospetto

Item Number:
Proof Number:
Date

22217403

XIFAXANTA 200 mg Film-coated tablets - UK - CCDS 7.0

Steso

Piegato

Con microforatura

Three

GRAMMATURA CARTA

20/07/2017

00 g

Stylegraph
Via Garbagnate, 61
20020 Lainate (MI)
 +39 02 9371446

Cod. 04739/4

Artwork Approval Signature
Regulatory
Commercial
Trademark
Artwork Coodinator

LAYOUT DI RIFERIMENTO

390 /195x140 mm

DIS. 000

CODICE CLIENTE

00000000

5525, 7411, 7474 & 6006

Bobina
% DI COPERTURA TESTI/SUPERFICIE

2

Edizione
0

SCALA

100 %

IMPORTANTE! Per ogni comunicazione si prega
di considerare sempre l’astuccio aperto e steso,
dalla parte stampata e con la linguetta d’incollatura a sinistra. La sequenza delle facciate parte
quindi dalla linguetta d’incollatura nell’ordine:

1

Booklet

Senza microforatura

FORMATO

CODICE AW

Change Control

FONTS

Helv. Neue Lt Std
Roman, Bold, Italic

3

4

Data allestimento
13.04.2017

1:1

RIF. PRATICA

22217403

SENSO DI
SVOLGIMENTO
N.

RIF. LAETUS
MASTER DI
RIFERIMENTO
NOTE / RIF. IMPIANTO PRECEDENTE

SOLO PER PROSPETTI
IN BOBINA

COLORI

DATE AND SIGNATURE FOR PRINTING APPROVAL VISTO SI STAMPI

NERO
FORMATO

CUSTOMER

L’impianto stampa non deve assolutamente essere modificato o danneggiato

Warning and Precautions
Talk to your doctor or pharmacist before taking Xifaxanta
200 mg film coated tablets and take special care;
· if, after 3 days of treatment, your symptoms continue or re-appear
shortly afterwards do not take a second course of Xifaxanta
200 mg film-coated tablets, see a doctor
· if your symptoms get worse during treatment stop taking
Xifaxanta 200 mg film-coated tablets and consult a doctor.
Other medicines and Xifaxanta 200 mg film coated tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
- Please tell your doctor if you are taking ciclosporin (immunosuppressor), warfarin (medicine to prevent blood clotting) or
oral contraceptives
If you are using activated charcoal (for example to treat wind or
diarrhoea) please take Xifaxanta 200 mg film-coated tablets at
least 2 hours after taking charcoal.
Xifaxanta 200 mg film-coated tablets with food and drink
Xifaxanta 200 mg film-coated tablets can be taken with or without
food. Orally with a glass of water.
Taking this medicine may cause a reddish discolouration of your urine
Pregnancy, breast-feeding and fertility
Xifaxanta 200 mg film-coated tablets are not recommended during
pregnancy or in fertile women not using contraception.

ALFA WASSERMANN S.p.A.
Bar prints 100mm @ 100%

Inform your doctor
· if you are pregnant or think you may be pregnant or are thinking
of becoming pregnant
· if you are breast-feeding or planning to start breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Xifaxanta 200 mg film-coated tablets are unlikely to affect your
reactions when driving or using machines.
If you feel dizzy or drowsy you should not drive or operate machinery
3. HOW TO TAKE XIFAXANTA 200 MG FILM-COATED TABLETS
Always take Xifaxanta 200 mg film-coated tablets exactly as
your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
· Unless otherwise prescribed by the doctor, the usual dose is 1
tablet every 8 hours (600 mg/day). You should continue taking
Xifaxanta 200 mg film-coated tablets for three days even if your
symptoms have improved.
· Unless otherwise prescribed, the duration of the treatment
should not exceed three days. If your symptoms persist for
more than three days please see a doctor.
If you take more Xifaxanta 200 mg film-coated tablets than
you should
If you take more than the recommended number of tablets,
please contact a doctor.

If you forget to take Xifaxanta 200 mg film-coated tablets
· take the missed dose as soon as you remember and take the
next scheduled dose at its regular time.
If you stop taking Xifaxanta 200 mg film-coated tablets
If you do not complete the three days of treatment recommended,
your symptoms may worsen.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Xifaxanta 200 mg film-coated tablets can
cause side effects, although not everybody gets them.

·
·
·
·
·
·
·

·
·
·

numbness, migraine, pins and needles, sinus headache, drowsiness
double vision
earache, sensation of the room going round (vertigo)
heart racing
increased blood pressure, hot flushes
cough, dry throat, shortness of breath, blocked nose, sore
throat, runny nose
upper abdominal pain, indigestion, intestinal movement disorder,
dry lips, hard stools, blood in the stools, mucus in stools, taste
disorders
blood test results: increased liver enzyme values (aspartate-aminotransferase)
rashes, blotchy skin, sunburn
back pain, muscle cramps, muscle weakness, muscle pain,
neck pain
urinalysis results: blood in urine, protein in urine, sugar in urine
frequent urination, excessive urination (polyuria)
frequent periods
loss of strength, chills, cold sweat, increased perspiration, flulike illness, swollen arm, pain.

Common (may affect up to 1 in 10 people):
· Dizziness, headache
· wind, abdominal distension, abdominal pain, constipation,
diarrhoea, urgency to evacuate faeces, nausea, involuntary
and painful or ineffective straining, vomiting
· fever.

·
·
·
·

Uncommon (may affect up to 1 in 100 people):
· Thrush, cold sore, swollen throat, inflammation or infection of
the nose and throat
· abnormal blood test results (increased lymphocytes, increased
monocytes, reduced neutrophilic granulocytes)
· loss of appetite, loss of body fluid (dehydration)
· abnormal dreams, depressed mood, sleeplessness, nervousness

The following side effects have been reported, however their
frequency cannot be estimated from the available data:
· bacterial infections (Clostridial infections)
· abnormal blood tests (reduced platelets, liver function tests out
of normal range, changes in international normalised ratio - INR)
· severe acute reactions to the drug (anaphylactic reactions),
allergic reactions to the drug

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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