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REFERO 550MG FILM-COATED TABLETS

Active substance(s): RIFAXIMIN

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Package leaflet: Information for the user

REFERO® 550 mg film-coated tablets
rifaximin
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 REFERO is and what it is used for
2. What you need to know before you take REFERO
3. How to take REFERO
4. Possible side effects
5. How to store REFERO
6. Contents of the pack and other information
1. What REFERO is and what it is used for
REFERO contains the active substance rifaximin. Rifaximin 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).
REFERO is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic
encephalopathy.
REFERO can either be used alone or more commonly together with medicines containing lactulose (a laxative).
2. What you need to know before you take REFERO
Do not take REFERO:
· 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 REFERO.
While you are taking REFERO 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 REFERO you
should stop taking REFERO and contact your doctor immediately.
If your liver problems are severe your doctor will need to observe you carefully.
Children and adolescents
REFERO is not recommended for children and adolescents aged under 18 years. This medicine has not
been studied in children and adolescents.
Other medicines and REFERO
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 REFERO can harm your unborn baby. REFERO 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. REFERO is therefore not to be used
if you are breast-feeding.
Driving and using machines
REFERO 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 REFERO
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 REFERO 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 REFERO
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 REFERO
Do not stop taking REFERO 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 REFERO 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.
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 fluid retention 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 or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via 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 REFERO
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.
REFERO 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
What REFERO 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 REFERO looks like and contents of the pack
Pink oval curved film-coated tablets marked with “RX” on one side.
REFERO is available in cartons of 14, 28, 42, 56 and 98 tablets.
Not all pack-sizes may be marketed.
Marketing Authorisation Holder
ALFA WASSERMANN S.p.A.
Via E. Fermi 1, 65020 Alanno (PE)
Manufacturer
ALFA WASSERMANN S.p.A.
Via E. Fermi 1, 65020 Alanno (PE)
This medicinal product is authorised in the Member States of the EEA under the following names:
Refero®: Austria, Denmark, Finland, Hungary, Luxembourg, Norway, Portugal, Slovakia, United Kingdom
Tixteller®: Belgium, Czech Republic, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain, Sweden
Tixtar®: France, Greece, Italy, Spain
Rifaximin Alfa Wassermann: Ireland

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This leaflet was last revised in October 2015

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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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