550 mg film-coated tablets
rifaximin
What Xifaxan is and what it is used for
Xifaxan contains the active substance rifaximin. Rifaximin is an antibiotic that destroys bacteria that can cause a disease called hepatic encephalopathy (symptoms include agitation, confusion, muscle problems, difficulty speaking, and, in some cases, unconsciousness).
Xifaxan is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy.
Xifaxan can either be used alone or, more commonly, together with medicines containing lactulose (a laxative ).
What you need to know before you take Xifaxan
Do not take Xifaxan:
- if you are allergic to:
- rifaximin
- similar types of antibiotics (such as rifampicin or rifabutin)
- any other ingredient in this medicine (listed in section 6).
- if your bowel is blocked.
Warnings and precautions
Talk to your doctor or pharmacist before taking Xifaxan.
While taking Xifaxan, your urine may turn a reddish color. It is completely normal.
Treatment with antibiotics, including rifaximin, can cause severe diarrhea. This may occur several months after you stop taking the medicine. If you develop severe diarrhea while using or after using Xifaxan, stop taking Xifaxan and contact your doctor immediately.
If your liver problems are severe, your doctor will need to observe you closely.
Xifaxan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. is almost “sodium-free”.
Children and young people
Xifaxan is not recommended for children and adolescents under 18 years of age. This medicine has not been studied in children and adolescents.
Other medicines and Xifaxan
Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking other medicines, including over-the-counter medicines, herbal medicines, or other natural products.
Tell your doctor if you are taking any of the following medicines:
- antibiotics (medicines that treat infections )
- warfarin (medicines that prevent the formation of blood clots)
- antiepileptics (drugs for the treatment of epilepsy )
- antiarrhythmics (medicines to treat abnormal heart rhythms)
- ciclosporin (drugs that suppress the immune system)
- birth control pills
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
It is not known whether Xifaxan can harm your unborn baby. Xifaxan should therefore not be used if you are pregnant.
It is not known whether rifaximin can be passed to the baby through breast milk. Xifaxan should therefore not be used if you are breastfeeding.
Driving ability and use of machinery
Xifaxan does not normally affect the ability to drive or use machines but may cause dizziness in some patients. If you feel dizzy, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to take Xifaxan
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet taken twice a day with a glass of water.
Keep taking Xifaxan until your doctor tells you to stop.
If you have taken too much Xifaxan
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have taken more than the recommended number of tablets, contact your doctor, even if you do not notice any problems.
If you forget to take Xifaxan
Take the next dose at the normal time. Do not take a double dose to make up for a missed tablet.
If you stop taking Xifaxan
Do not stop taking Xifaxan without first talking to your doctor, as your symptoms may return.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Xifaxan and talk to your doctor IMMEDIATELY if you experience any of the following side effects:
Uncommon (may affect up to 1 in 100 users)
• If you bleed from swollen blood vessels in the throat ( esophageal varices ).
• If you get severe diarrhea while using or after using this medicine. This may be due to an infection in the intestine.
Has been reported (occurring in an unknown number of users)
• If you have an allergic reaction, develop hypersensitivity or angioedema.
The symptoms can be
– swelling of the face, tongue, or throat,
– difficulty swallowing,
– hives and difficulty breathing.
• If you experience unexpected or unusual bleeding or bruising. This may be due to a reduced number of platelets in the 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
• Nausea or vomiting
• Stomach pain or bloating/swelling
• Diarrhea
• Accumulation of fluid in the abdominal cavity ( ascites )
• Rash or itching
• Muscle cramps
• Joint pain
• Swollen ankles, feet, or fingers
Uncommon (may affect up to 1 in 100 people)
• Yeast infections (such as thrush)
• Urinary tract infections (such as cystitis )
• Anemia (reduced number of red blood cells, which can cause pale skin and cause weakness or shortness of breath)
• Loss of appetite
• Hyperkalemia (high level of potassium in the blood)
• Confusion
• Anxiety
• Feeling sleepy
• Difficulty sleeping
• Feeling unsteady
• Memory loss or poor memory
• Decreased ability to concentrate
• Decreased sensation
• Convulsions (seizures)
• Hot flashes
• Fluid around the lungs
• Abdominal pain
• Dry mouth
• Muscle pain
• Need to urinate more often than usual
• Difficulty or pain when urinating
• Fever
• Edema (swelling due to too much fluid in the body)
• Falling accidents
Rare (may affect up to 1 in 1,000 people)
• Infection in the lower respiratory tract, including pneumonia
• Cellulitis ( inflammation of tissue under the skin)
• Infection in the upper respiratory tract (nose, mouth, throat)
• Rhinitis ( inflammation inside the nose)
• Dehydration (dehydration)
• Blood pressure changes
• Persistent breathing problems (such as chronic bronchitis )
• Constipation
• Back pain
• Protein in the urine
• Feeling of weakness
• Bruises
• Pain after surgery
Has been reported (occurring in an unknown number of users)
• Fainting or feeling faint
• Skin irritation, eczema (itchy, red, dry skin)
• Reduction in the number of platelets (in the blood)
• Altered liver function (seen with a blood test)
• Changes in blood coagulation (liver ring) (international normalized ratio, seen with a blood test)
How to store Xifaxan
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is rifaximin. Each tablet contains 550 mg of rifaximin.
Other ingredients are:
- Tablet core: sodium starch glycolate (type A), glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose.
- Tablet coating (paddy oy-s-34907): hypromellose, titanium dioxide (E171), disodium edetate, propylene glycol, red iron oxide (E172)
Appearance and package sizes of the medicine
Pink, oval, curved, film-coated tablets marked with “RX” on one side.
Xifaxan is available in boxes of 14, 28, 42, 56, and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Norgine BV
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands
Manufacturer:
Alfasigma SpA
Via Enrico Fermi, 1
65020 Alanno (PE)
Italy
and
Alfasigma S.p.A
Via Pontina Km 30,400
00071 Pomezia (RM)
Italy
| This medicine is approved in the European Economic Area under the names: | |
| Belgium | TARGAXAN |
| Denmark | THE XIFAXAN |
| Finland | TARGAXAN |
| Germany | THE XIFAXAN |
| Ireland | TARGAXAN |
| Luxembourg | TARGAXAN |
| Netherlands | THE XIFAXAN |
| Norway | THE XIFAXAN |
| Sweden | THE XIFAXAN |
| UK | TARGAXAN |