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TARGAXAN 550 MG FILM-COATED TABLETS

Active substance(s): RIFAXIMIN

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Item Number:

22223401

Proof Number:

two

Date

15/12/2015

Stylegraph

Cod. 02941/10

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

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Bar prints 100mm @ 100%

Change Control: CR/15/0137

Regulatory _______________________________
Commercial ______________________________
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Package Leaflet: Information for the user

TARGAXAN® 550 mg film-coated tablets
rifaximin
70

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

70

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

Please tell your doctor if you are taking
any of the following medicines:
- antibiotics (medicines to treat infections)
- warfarin (medicine to prevent blood
clotting)
- antiepileptics (medicines for the
treatment of epilepsy)
- antiarrhythmics (medicines to treat
abnormal heart beat)
- ciclosporin (immunosuppressor)
- oral contraceptives
Pregnancy and breast-feeding

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 observe you carefully.
Children and adolescents
Targaxan is not recommended for
children and adolescents aged under
18 years. This medicine has not been
studied in children and adolescents.
Other medicines and Targaxan
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.

If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
any medicine.
It is not known if Targaxan can harm your
unborn baby. Targaxan is therefore not
to be used if you are pregnant.
It is not known if rifaximin may be passed
to your baby in breast milk. Targaxan
is therefore not to be used if you are
breast-feeding.
Driving and using machines
Targaxan does not normally affect the
ability to drive and use machines, but
may cause dizziness in some patients.
If you feel dizzy you should not drive or
operate machinery.

3. How to take Targaxan
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
The recommended dose is 1 tablet twice
a day taken with a glass of water. Your
doctor will assess the need for you to
continue treatment after 6 months.
If you take more Targaxan than you
should
If you take more than the recommended
number of tablets, even if you do not
notice any problems, please contact
your doctor.

If you forget to take Targaxan
Take the next dose at its normal time.
Do not take a double dose to make up
for a forgotten tablet.
If you stop taking Targaxan
Do not stop taking Targaxan without
talking to your doctor first because your
symptoms may return.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
70

Like all medicines, this medicine can
cause side effects, although not everybody gets them.
Stop taking Targaxan and tell your
doctor IMMEDIATELY if you have any
of the following side effects:

Uncommon: may affect up to 1 in
100 people
• If you have bleeding from swollen blood
vessels in your throat (oesophageal
varices).
• If you have severe diarrhoea during
or after using this medicine. This may
be due to an infection of the intestine.

70

Not known (frequency cannot be
estimated from the available data
• If you get an allergic reaction, hypersensitivity or angioedema. Symptoms
include:
- swelling of the face, tongue or throat
- swallowing difficulties
- hives and breathing difficulties.
• If you have any unexpected or unusual
bleeding or bruising. This may be due to
a decrease in the platelets in your blood
which increases the risk of bleeding.
Frequency is not known (cannot be
estimated from the available data).
Other side effects that may occur
Common (may affect up to 1 in 10
people):
• Depressed mood
• Dizziness
• Headache
• Shortness of breath
• Feeling or being sick
• Stomach ache or bloating/swelling
• Diarrhoea
• Accumulation of fluid in the abdominal
cavity (ascites)
• Rash or itching
• Muscle cramps
• Joint pain
• Swelling of ankles, feet or fingers
Uncommon (may affect up to 1 in
100 people):
• Yeast infections (such as thrush)
• Urinary infection (such as cystitis)
• Anaemia (reduction in red blood cells
which can make the skin pale and
cause weakness or breathlessness)
• Loss of appetite
• Hyperkalaemia (high level of potassium
in the blood)
• Confusion
• Anxiety
• Feeling sleepy
• Difficulty sleeping
• Feeling unsteady
• Loss of or poor memory
• Loss of concentration
• Reduced sense of touch
• Convulsions (fits)
• Hot flushes
• Fluid around the lungs (pleural effusion)
• Abdominal pain
• Dry mouth
• Muscle pain

• Needing to pass urine more often than
usual
• Difficulty or pain passing urine
• Fever
• Oedema (swelling due to too much
fluid in the body)
• Falls
Rare (may affect up to 1 in 1,000
people):
• Chest infections including pneumonia
• Cellulitis (inflammation of tissue under
skin)
• Upper respiratory tract infections
(nose, mouth, throat)
• Rhinitis (inflammation inside the nose)
• Dehydration (body water loss)
• Changes in blood pressure
• Constant breathing problems (such
as chronic bronchitis)
• Constipation
• Back pain
• Protein in the urine
• Feeling weak
• Bruising
• Pain following surgery
Not known (frequency cannot be
estimated from the available data):
• Fainting or feeling faint
• Skin irritation, eczema (itchy, red, dry skin)
• Reduction in platelets (seen in the blood)
• Changes in the way the liver is working
(seen in blood test)
• Changes in blood coagulation (International Normalised Ratio seen in blood
test)
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet.
United Kingdom: You can also report
side effects directly via Yellow Card
Scheme Website:
www.mhra.gov.uk/yellowcard.
Ireland: You can also report side effects
directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
By reporting side effects you can help
provide more information on the safety
of this medicine.

5. How to store Targaxan
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and
the blister after EXP. The expiry date
refers to the last day of that month.
Targaxan does not require any special
storage conditions.

Do not throw away any medicine via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use.
These measures will help to protect the
environment.

6. Contents of the pack and other information
Manufacturer:
Alfa Wassermann S.p.A.
Via E. Fermi, 1 - 65020 Alanno (PE), ITALY
Product under license from Alfa
Wassermann S.p.A. TARGAXAN
is a registered trademark of the Alfa
Wassermann group of companies,
licensed to the Norgine group of
companies.
NORGINE and the sail logo are regis­
tered trademarks of the Norgine group
of companies.
This medicinal product is authorised
in the Member States of the EEA
under the following names:
TARGAXAN®: Belgium, Finland, Ireland,
Luxembourg, United
Kingdom
XIFAXAN ® : Denmark, Germany,
Netherlands, Norway,
Sweden.
This leaflet was last revised in 10/2015.
22223401

What Targaxan contains
The active substance is rifaximin. Each
tablet contains 550 mg rifaximin.
The other ingredients are:
- Tablet core: sodium starch glycolate
(Type A), glycerol distearate, colloidal
anhydrous silica, talc, microcrystalline
cellulose.
- Tablet coat (opadry oy-s-34907):
hypromellose, titanium dioxide (E171),
disodium edetate, propylene glycol,
red iron oxide (E172).
What Targaxan looks like and
contents of the pack
Pink oval curved film-coated tablets
marked with “RX” on one side.
Targaxan is available in cartons of 14,
28, 42, 56 and 98 tablets.
Not all pack-sizes may be marketed.
Marketing Authorisation Holder (UK):
Norgine Pharmaceuticals Ltd.
Norgine House - Widewater Place Moorhall Road - Harefield - Middlesex
UB9 6NS - United Kingdom
Marketing Authorisation Holder (IE):
Norgine Limited
Norgine House - Widewater Place Moorhall Road - Harefield - Middlesex
UB9 6NS - United Kingdom

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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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