Norgine Item No.

: 33314102
Proof No.: 2
Change Control No.: 38430, 44174
Product Name (including flavour): Targaxan 550mg

Date: 24/03/2021
Market: Ireland
Package Leaflet: Information for the user
Component Type: PIL (Alanno)
Manufacturing Site: Alfasigma TARGAXAN® 550 mg film-coated tablets
Technical Drawing No.: N/A
Dimensions (mm): 165 x 440mm rifaximin
Pharmacode: TBC
Material Number: TBC Read all of this leaflet carefully before you start taking this medicine
Variable data prompts information: N/A
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
Pre-printed (as part of artwork) - - If you have any further questions, ask your doctor or pharmacist.
Printed on-line - - This medicine has been prescribed for you only. Do not pass it on to others.
Schawk Job No.: 105246346 / 402300325 0020 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
Black
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
Technical Info Profile
3. How to take Targaxan
4. Possible side effects
5. How to store Targaxan
6. Contents of the pack and other information
SGK is a Matthews International Corporation
1. What Targaxan is and what it is used for
Fonts used:
Page 1 of 2 Targaxan contains the active Targaxan is used in adults with liver
Helvetica Neue LT Std-55 Roman substance rifaximin. Targaxan is an disease to reduce the recurrence
Helvetica Neue LT Std-56 Italic antibiotic that destroys bacteria, of episodes of overt hepatic
Helvetica Neue LT Std-75 Bold
which can cause a disease called encephalopathy.
Helvetica Neue LT Std-76 Bold Italic
hepatic encephalopathy (symptoms Targaxan can either be used alone
Average Text Size (Body Text): include agitation, confusion, muscle or more commonly together with
12.0 pt
problems, difficulty in speaking and in medicines containing lactulose (a
some cases coma). laxative).
2. What you need to know before you take Targaxan
Do not take Targaxan: Other medicines and Targaxan
• if you are allergic to: Tell your doctor or pharmacist if you
- rifaximin are taking, have recently taken or
- similar types of antibiotics (such might take any other medicines.
as rifampicin or rifabutin) Please tell your doctor if you are
- any of the other ingredients of this taking any of the following medicines:
medicine (listed in section 6). - antibiotics (medicines to treat
• if you have a blockage in your intestine infections)
Warnings and precautions - warfarin (medicine to prevent blood
Talk to your doctor or pharmacist clotting)
before taking Targaxan. - antiepileptics (medicines for the
While you are taking Targaxan your treatment of epilepsy)
urine may turn a reddish colour. This - antiarrhythmics (medicines to treat
is quite normal. abnormal heart beat)
Treatment with any antibiotic including - ciclosporin (immunosuppressor)
- oral contraceptives
rifaximin may cause severe diarrhoea.
This can happen several months after Pregnancy and breast-feeding
you have finished taking the medicine. If you are pregnant or breast-feeding,
If you have severe diarrhoea during or think you may be pregnant or are
after using Targaxan you should stop planning to have a baby, ask your
taking Targaxan and contact your doctor or pharmacist for advice
doctor immediately. before taking any medicine.
If your liver problems are severe It is not known if Targaxan can harm
your doctor will need to observe you your unborn baby. Targaxan is therefore
carefully. not to be used if you are pregnant.
Targaxan contains sodium It is not known if rifaximin may be
This medicine contains less than passed to your baby in breast milk.
1 mmol sodium (23 mg) per tablet, Targaxan is therefore not to be used
that is to say essentially ‘sodium-free’. if you are breast-feeding.
Children and adolescents Driving and using machines
Targaxan does not normally affect
Targaxan is not recommended for
the ability to drive and use machines,
children and adolescents aged under
but may cause dizziness in some
18 years. This medicine has not been
patients. If you feel dizzy you should
studied in children and adolescents.
not drive or operate machinery.
3. How to take Targaxan
Always take this medicine exactly as your If you forget to take Targaxan
doctor has told you. Check with your Take the next dose at its normal time.
doctor or pharmacist if you are not sure. Do not take a double dose to make up
The recommended dose is 1 tablet for a forgotten tablet.
twice a day taken with a glass of water.
Continue taking Targaxan until your If you stop taking Targaxan
doctor tells you to stop. Do not stop taking Targaxan without
If you take more Targaxan than you talking to your doctor first because
should your symptoms may return.
If you take more than the recommended If you have any further questions on
number of tablets, even if you do not the use of this medicine, ask your
notice any problems, please contact doctor or pharmacist.
your doctor.
4. Possible side effects
Like all medicines, this medicine • If you have bleeding from swollen
can cause side effects, although not blood vessels in your throat
everybody gets them. (oesophageal varices).
Stop taking Targaxan and tell your • If you have severe diarrhoea during
doctor IMMEDIATELY if you have
or after using this medicine. This
any of the following side effects:
Uncommon (may affect up to 1 in may be due to an infection of the
100 people): intestine.
Norgine Item No.: 33314102
Proof No.: 2
Change Control No.: 38430, 44174
Product Name (including flavour): Targaxan 550mg

Date: 24/03/2021
Market: Ireland
Component Type: PIL (Alanno) Not known (frequency cannot be • Fluid around the lungs (pleural
Manufacturing Site: Alfasigma estimated from the available data): effusion)
Technical Drawing No.: N/A • If you get an allergic reaction, • Abdominal pain
Dimensions (mm): 165 x 440mm hypersensitivity or angioedema. • Dry mouth
Pharmacode: TBC
Material Number: TBC
Symptoms include: • Muscle pain
Variable data prompts information: N/A - swelling of the face, tongue or throat • Needing to pass urine more often
- swallowing difficulties than usual
- hives and breathing difficulties. • Difficulty or pain passing urine
Pre-printed (as part of artwork) - • If you have any unexpected or • Fever
Printed on-line - unusual bleeding or bruising. • Oedema (swelling due to too much
Schawk Job No.: 105246346 / 402300325 0020
This may be due to a decrease in fluid in the body)
the platelets in your blood which • Falls
Black increases the risk of bleeding. Rare (may affect up to 1 in 1,000 people):
Frequency is not known (cannot be • Chest infections including pneumonia
estimated from the available data). • Cellulitis (inflammation of tissue
Other side effects that may occur under skin)
Common (may affect up to 1 in • Upper respiratory tract infections
Technical Info Profile 10 people): (nose, mouth, throat)
• Depressed mood • Rhinitis (inflammation inside the nose)
• Dizziness • Dehydration (body water loss)
• Headache • Changes in blood pressure
SGK is a Matthews International Corporation
• Shortness of breath • Constant breathing problems (such
Fonts used:
Page 2 of 2 • Feeling or being sick as chronic bronchitis)
Helvetica Neue LT Std-55 Roman
• Stomach ache or bloating/swelling • Constipation
Helvetica Neue LT Std-56 Italic • Diarrhoea • Back pain
Helvetica Neue LT Std-75 Bold • Accumulation of fluid in the • Protein in the urine
Helvetica Neue LT Std-76 Bold Italic abdominal cavity (ascites) • Feeling weak
Average Text Size (Body Text): • Rash or itching • Bruising
12.0 pt • Muscle cramps • Pain following surgery
• Joint pain Not known (frequency cannot be
• Swelling of ankles, feet or fingers estimated from the available data):
Uncommon (may affect up to 1 in • Fainting or feeling faint
100 people): • Skin irritation, eczema (itchy, red,
• Yeast infections (such as thrush) dry skin)
• Urinary infection (such as cystitis) • Reduction in platelets (seen in the
• Anaemia (reduction in red blood cells blood)
which can make the skin pale and • Changes in the way the liver is
cause weakness or breathlessness) working (seen in blood test)
• Loss of appetite • Changes in blood coagulation
• Hyperkalaemia (high level of (International Normalised Ratio
potassium in the blood) seen in blood test)
• Confusion Reporting of side effects
• Anxiety If you get any side effects, talk to your
• Feeling sleepy doctor, pharmacist or nurse. This includes
• Difficulty sleeping any possible side effects not listed in this
• Feeling unsteady leaflet. You can also report side effects
• Loss of or poor memory directly via HPRA Pharmacovigilance
• Loss of concentration Website: www.hpra.ie.
• Reduced sense of touch By reporting side effects, you can
• Convulsions (fits) help provide more information on the
• Hot flushes safety of this medicine.
5. How to store Targaxan
Keep this medicine out of the sight Targaxan does not require any special
and reach of children. storage conditions.
Do not use this medicine after the Do not throw away any medicine via
expiry date which is stated on the wastewater or household waste. Ask your
carton and the blister after EXP. The pharmacist how to throw away medicines
expiry date refers to the last day of you no longer use. These measures will
that month. help to protect the environment.
6. Contents of the pack and other information
What Targaxan contains This medicinal product is
The active substance is rifaximin. authorised in the Member States
Each tablet contains 550 mg rifaximin. of the EEA under the following
The other ingredients are: names:
- Tablet core: sodium starch glycolate TARGAXAN®: Belgium, Finland,
(Type A), glycerol distearate, Ireland, Luxembourg, United
colloidal anhydrous silica, talc, Kingdom.
microcrystalline cellulose. XIFAXAN®: Denmark, Germany,
- Tablet coat (opadry oy-s-34907): Netherlands, Norway, Sweden.
hypromellose, titanium dioxide Other sources of information
(E171), disodium edetate, propylene If you need the information on this
glycol, red iron oxide (E172). leaflet in an alternative format,
What Targaxan looks like and such as large print, please ring
contents of the pack 00 44 1895 826 606.
Pink oval curved film-coated tablets Product under license from Alfasigma
marked with “RX” on one side. S.p.A. TARGAXAN is a registered
Targaxan is available in cartons of 14, trademark of the Alfasigma group of
28, 42, 56 and 98 tablets. companies, licensed to the Norgine
Not all pack-sizes may be marketed. group of companies.
Marketing Authorisation Holder: NORGINE and the sail logo are
Norgine B.V. registered trademarks of the Norgine
Antonio Vivaldistraat 150, group of companies.
1083HP Amsterdam
Netherlands
Manufacturer:
Alfasigma S.p.A.
33314102

Via E. Fermi, 1 - 65020 Alanno (PE),

ITALY
This leaflet was last revised in
03/2021. 00000000