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RIFAXIMIN 550 MG FILM-COATED TABLETS

Active substance(s): RIFAXIMIN

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Targaxan® 550 mg film-coated tablets

2791
15.04.16[2]

(rifaximin)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using the above name but will be referred to as
Targaxan throughout this leaflet.
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 further 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
Do not take Targaxan:
- if you are allergic to:
- rifaximin
- similar type of antibiotics (such as rifampicin or rifabutin)
- any 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
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.
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
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
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.
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. You can also
report side effects directly via the Yellow Card Scheme at:
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 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.
If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.
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 FURTHER INFORMATION
What Targaxan contains
The active substance is rifaximin.
Each film-coated 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 biconvex film-coated tablets embossed with “RX” on one side and
plain on the other side.
Targaxan is available in blister pack size of 56 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Targaxan is manufactured by Alfa Wasserman S.p.A., Via Enrico Fermi, 165020 Alanno (PE), Italy. Procured from within the EU by Product Licence
holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2791

Leaflet revision and issue date (Ref) 15.04.16[2]
Targaxan is a trademark of Alfa Wassermann S.p.A.

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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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