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XIFAXANTA 200 MG FILM-COATED TABLETS

Active substance(s): RIFAXIMIN

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CLIENTE

CORPO

ALFA WASSERMANN S.p.A.

TESTO: 9
INTERLINEA: 12

ARTICOLO

Proof Number:

22217402

Change Control

22/03/2016
1975

Commercial
Trademark
Artwork Coodinator

292,5 x 195 mm
Tacca 18 mm

REG.07/16

Cod. 04303/3

Bobina

1
Booklet

Senza microforatura
LAYOUT DI RIFERIMENTO

% DI COPERTURA TESTI/SUPERFICIE

100 %

CODICE CLIENTE

SCALA

2

3

4

Edizione

Data allestimento

1

11.03.2016

1:1

RIF. PRATICA

22217402

SENSO DI
SVOLGIMENTO
N.

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

Artwork Approval Signature
Regulatory

FORMATO

CODICE AW

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

Piegato

Con microforatura
GRAMMATURA CARTA

Date

XIFAXANTA 200 mg Film-coated tablets - UK

Steso

One

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:

PRODOTTO

Prospetto

Item Number:

FONTS

Helv. Neue Lt Std
Roman, Bold

SOLO PER PROSPETTI
IN BOBINA

COLORI

DATE AND SIGNATURE FOR PRINTING APPROVAL VISTO SI STAMPI

NERO
FORMATO
L’impianto stampa non deve assolutamente
essere modificato o danneggiato

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.
This includes any possible side effects not listed in this
leaflet. See section 4.
In this leaflet:
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
4. Possible side effects
5. How to store Xifaxanta 200 mg film-coated tablets
6. Contents of the pack and other information
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;
● if you passed 8 or more unformed stools in the last 24 hours;
● If you have constipation, abdominal pain and vomiting
caused by blockage of the bowel.
Take special care with Xifaxanta 200 mg film-coated tablets
● 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.

CUSTOMER

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

Please tell your doctor if you are taking ciclosporin
(immunosuppressor) or warfarin (medicine to prevent blood
clotting).
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.
Taking 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.
It is recommended that you take additional contraceptive
precautions, in particular if the oestrogen content of oral
contraceptives is less than 50µg , as the effectiveness of your
oral contraceptive can decrease whilst taking this medicine.
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.

22217402

CLIENTE

CORPO

ALFA WASSERMANN S.p.A.

TESTO: 9
INTERLINEA: 12

ARTICOLO

Steso

Change Control

One
22/03/2016
1975

Commercial

Cod. 04303/3

Bobina

1
Booklet

Senza microforatura
LAYOUT DI RIFERIMENTO

% DI COPERTURA TESTI/SUPERFICIE

100 %

CODICE CLIENTE

SCALA

2

3

4

Edizione

Data allestimento

1

11.03.2016

1:1

RIF. PRATICA

22217402

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

Trademark
Artwork Coodinator

292,5 x 195 mm
Tacca 18 mm

REG.07/16

Artwork Approval Signature
Regulatory

FORMATO

CODICE AW

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

Piegato

Con microforatura
GRAMMATURA CARTA

Date

XIFAXANTA 200 mg Film-coated tablets - UK

FORMATO

Bar prints 100mm @ 100%

L’impianto stampa non deve assolutamente
essere modificato o danneggiato

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.
Common (may affect up to 1 in 10 people):
● Dizziness, headache
● wind, abdominal bloating, 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
● 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 (aspartateaminotransferase)
● rashes, purplish discolouration of the skin caused by
bleeding into the skin (purpura), blotchy skin, sunburn
● back pain, muscle cramps, muscle weakness, muscle pain,
neck pain
● urinalysis results: blood in urine (haematuria), protein in
urine (proteinuria), sugar in urine (glycosuria),
● frequent urination, excessive urination (polyuria),
● frequent periods (polymenorrhoea)
● loss of strength, chills, cold sweat, increased perspiration,
flu-like illness, swollen arm, pain.
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, international normalised ratio
abnormalities)
● severe acute reactions to the drug, allergic reactions to the drug
● near fainting
● giant hives
● skin roughness, skin redness, itching, wheals.
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

ALFA WASSERMANN S.p.A.

CUSTOMER

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 reach and sight 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 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” printed on both sides.
● 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, UK
Manufacturer:
Alfa Wassermann S.p.A.
Via E. Fermi, 1
65020 Alanno (PE), ITALY
This leaflet was last revised in March 2016
Product under licence from Alfa Wassermann S.p.A.
XIFAXANTA is a registered trademark of the
Alfa Wassermann group of companies,
licensed to the Norgine group of companies.
REG. 07/16

Proof Number:

22217402

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:

PRODOTTO

Prospetto

Item Number:

FONTS

Helv. Neue Lt Std
Roman, Bold

22217402

Expand view ⇕

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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