Xifaxanta 200 mg film coated tablets are an intestinal antibiotic and are used to treat: travellers diarrhoea in adults when the diarrhoea is not accompanied by fever or blood in the stools, or 8 or more unformed (soft or liquid) stools in the last 24 hours. Xifaxanta 200 mg film coated tablets are not recommended for use in children (aged less than 18 years).
Always take Xifaxanta 200 mg film coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the usual dose is 1 tablet every 8 hours (600 mg/day). You should continue taking Xifaxanta 200 mg film coated tablets for three days even if your symptoms have improved. Unless otherwise prescribed, the duration of the treatment should not exceed three days. If your symptoms persist for more than three days please see a doctor.
If you take more than the recommended number of tablets, please contact a doctor. If you forget to take Xifaxanta 200 mg film coated tablets take the missed dose as soon as you remember and take the next scheduled dose at its regular time. If you stop taking Xifaxanta 200 mg film coated tablets. If you do not complete the three days of treatment recommended, your symptoms may worsen. If you have any further questions on the use of this product,
ask your doctor or pharmacist.
The active substance is: Rifaximin. Each film coated tablet contains: 200 mg of Rifaximin. The other ingredients are:
Tablet core: Sodium Starch Glycolate Type A, Glycerol Distearate, Colloidal Anhydrous Silica, Talc, Microcrystalline
Cellulose. Tablet coating:Hhypromellose, Titanium Dioxide, Disodium Edetate, Propylene Glycol, Red Iron Oxide E172.
Do not take Xifaxanta 200 mg tablets if you are allergic (hypersensitive) to rifaximin, to similar types of antibiotics (such as rifampicin or rifabutin) or to any of the other ingredients of Xifaxanta; if you have a fever; if you have blood in your stools; if you passed 8 or more unformed stools in the last 24 hours. Take special care with Xifaxanta 200 mg fi lm-coated tablets if, after 3 days of treatment, your symptoms continue or re-appear shortly afterwards do not take a second course of Xifaxanta tablets, see a doctor; if your symptoms get worse during treatment stop taking Xifaxanta tablets and consult a doctor. Taking other medicines please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are using activated charcoal (for example to treat wind or diarrhoea) please take Xifaxanta at least 2 hours after taking charcoal. Taking Xifaxanta with food and drink Xifaxanta tablets can be taken with or without food. Pregnancy and breast-feeding Xifaxanta are not recommended during pregnancy or in fertile women not using contraception.
Inform your doctor, if you are pregnant or think you may be pregnant or are thinking of becoming pregnant; if you are breast-feeding or planning to start breast-feeding. Ask your doctor or pharmacist for advice before taking any
medicine. Driving and using machines Xifaxanta are unlikely to affect your reactions when driving or using machines. Like all medicines, Xifaxanta can cause side effects, although not everybody gets them.
Common side effects (1 in 10 - 100 patients): Dizziness, headache, wind, abdominal bloating, abdominal pain, constipation, diarrhoea, urgency to evacuate faeces, nausea, involuntary and painful or ineffective straining, vomiting, fever. Uncommon side effects (1 in 100 - 1,000 patients): Thrush, cold sore, swollen throat, inflammation or infection of the nose and throat, abnormal blood test results (increased lymphocytes, increased monocytes, reduced neutrophilic granulocytes), loss of appetite, loss of body fluid (dehydration), abnormal dreams, depressed mood, sleeplessness, nervousness, numbness, migraine, pins and needles, sinus headache, drowsiness, double vision, earache, sensation of the room going round (vertigo), heart racing, increased blood pressure, hot flushes, cough, dry throat, shortness of breath, blocked nose, sore, throat, runny nose, upper abdominal pain, indigestion, intestinal movement, disorder, dry lips, hard stools, blood in the stools, mucus, in stools, taste disorders, increased liver enzyme values (aspartate-aminotransferase), rashes, blotchy skin, sunburn, back pain, muscle cramps, muscle weakness, muscle pain, neck pain, blood in urine, sugar in urine (glycosuria), frequent urination, excessive urination (polyuria), protein in urine, frequent periods (polymenorrhoea), loss of strength, chills, cold sweat, increased perspiration, fl u-like illness, swollen arm, pain. The following side effects have been reported, however
their frequency cannot be estimated from the available data: Bacterial infections (Clostridial infections), abnormal blood tests (reduced platelets, liver function, tests out of normal range, international normalised ratio
abnormalities), severe acute reactions to the drug, allergic reactions to the drug, near fainting, giant hives, skin roughness, skin redness, itching, wheals. Treatment with any antibiotic may cause Clostridium difficile associated diarrhoea (CDAD). If any of the side effects get serious, or if you notice any side effects not listed in this leafl et, please tell your doctor or pharmacist.