XIFAXAN RIFAXIMIN 12 FILM-CO

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XIFAXAN RIFAXIMIN 12 FILM-CO is a new member of the class of drugs called rifamycins, but unlike other rifamycins it is poorly absorbed from the intestine (less than 1% of the administered dose), so it acts only against intestinal microorganisms. Xifaxan is active against most pathogenic microorganisms responsible for acute infectious diarrhoea.



Xifaxan is used for the treatment of acute infectious diarrhea caused by microorganisms sensitive to rifaximin and for the symptomatic treatment of uncomplicated diverticular disease of the colon when combined with dietary fiber therapy.


In the treatment of acute infectious diarrhea, if you do not feel better or have worsened after 3 days, you should see your doctor.

Rifaximin is indicated for adults and children over 12 years of age. Please read this leaflet carefully before you start taking this medicine because it contains important information for you.


Keep this handout. You may need to read it again.

- If you have further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. You should not pass it on to others. The medicine can harm them even if they have the same signs of illness.

- If you get any side effects, talk to your doctor, pharmacist or nurse, this includes any possible side effects not mentioned in this leaflet. See Section 4.

Xifaxan One is an enteric antimicrobial.


2. What you need to know before taking Xifaxan

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Do not take Xifaxan:


- if you are allergic (hypersensitive) to rifaximin, any other rifamycins, or any of the other ingredients of this medicine (listed in section 6).


- In case of intestinal obstruction and severe ulcerative lesions of the intestine.



Warnings and precautions:


Talk to your doctor, pharmacist or nurse before taking Xifaxan or if:


- If you develop a fever and/or blood in your stool, you should consult your doctor.


- If redness appears in your urine, after taking Xifaxan, you should inform your doctor. This is because the active substance (rifaximin), like most antimicrobials in the rifamycin family, is orange-red. In cases of prolonged treatment, or if the intestinal mucosa is damaged, a small amount of rifaximin may be absorbed (less than 1%), which may cause the urine to turn red.


Taking oral contraceptives. Xifaxan may decrease the effectiveness of estrogen-containing oral contraceptives. It is recommended to use additional contraceptives.


Xifaxan should be discontinued if diarrhea symptoms worsen. Other medicines and Xifaxan


Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.



Xifaxan may reduce the effectiveness of estrogen-containing oral contraceptives. It is recommended to use additional contraceptives.



Xifaxan with food


Xifaxan film-coated tablets can be taken with or without food.



Pregnancy, lactation and fertility


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 taking this medicine.



In case of pregnancy, as a precaution, it is preferable to avoid the use of Xifaxan.



The use of Xifaxan in nursing mothers should be under the strict supervision of your physician.



Driving and using machines


Xifaxan has no effect on the ability to drive and use machines.


3. How to take Xifaxan

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Always take this medication exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure.



acute infectious diarrhea


600 mg (one tablet three times a day) or 800 mg (two tablets twice a day). Treatment should not exceed 3 days. If symptoms persist, consult your doctor. Xifaxan film-coated tablets should be swallowed with juice or water.



Symptomatic treatment of uncomplicated diverticular disease of the colon with the addition of dietary fiber.


800 mg (2 tablets twice daily) for 7 days/month in long-term cycles.



Use in children and adolescents


The safety and efficacy of rifaximin in children under 12 years of age have not been established. It is not possible to make a dosage recommendation.



If you take more Xifaxan than you should


If you accidentally take a dose two or three times more than what your doctor told you to do, most likely nothing will happen.


If you accidentally take several tablets, contact your doctor or pharmacist. If possible, take the Xifaxan packages with you to see your doctor or pharmacist.



If you forget to take Xifaxan


Do not take a double dose to make up for a forgotten dose. Continue treatment as planned.



If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.


4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.



The following side effects have been observed in some cases:


Common (affects less than 1 in 10 and more than 1 in 100)


Dizziness and headache


Unwanted mild to moderate gastrointestinal symptoms such as: nausea, vomiting, abdominal pain/cambria, flatulence, constipation, flatulence and diarrhoea.


It usually goes away on its own without the need to change the dose or stop treatment.



Uncommon (affects less than 1 in 100 but more than 1 in 1,000)


Lack of appetite and dehydration.


Insomnia and nervousness.


Migraine, decreased sensitivity and drowsiness.


Hot flashes, high blood pressure, palpitations and drowsiness.


Respiratory effects: cough, dry throat, difficulty breathing, sore throat.


Undesirable mild to moderate gastrointestinal effects such as: upper abdominal pain,


Indigestion, lack of taste and altered gastrointestinal motility.


Urticaria-like reactions.


Muscle pain, including back pain, muscle weakness.



Report side effects


If you have any side effects, including possible non-inflammatory side effects.


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