Xifaxan

Package Leaflet: Information for the User

Xifaxan, 200 mg, Film-Coated Tablets

Rifaximin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Xifaxan and what is it used for
• 2. Important information before taking Xifaxan
• 3. How to take Xifaxan
• 4. Possible side effects
• 5. How to store Xifaxan
• 6. Contents of the pack and other information

1. What is Xifaxan and what is it used for

Xifaxan is an oral antibiotic. It contains rifaximin, an antibiotic belonging to the class of rifamycin antibiotics, but unlike other rifamycins, it is only slightly absorbed into the bloodstream (the alpha polymorphic form is absorbed at less than 1% of the administered dose), so it only acts on microorganisms in the intestine. Xifaxan is active against most bacteria responsible for intestinal infections.

Indications for Use

In adults and children over 12 years old

• intestinal infections with bacteria sensitive to rifaximin, exceptfor diarrhea with fever and/or blood in the stool and also when the number of unformed stools is equal to or exceeds 8 per day
• traveler's diarrhea, exceptfor diarrhea with fever and/or blood in the stool and also when the number of unformed stools is equal to or exceeds 8 per day,

In adults:

• hepatic encephalopathy,
• symptomatic, uncomplicated diverticular disease of the colon in adult patients on a high-fiber diet.

2. Important Information Before Taking Xifaxan

When Not to Take Xifaxan:

• -if you are allergic to rifaximin or other rifamycins or any of the other ingredients of this medicine (listed in section 6).
• -if you have intestinal obstruction, even partial (intestinal blockage that prevents the passage of food through the intestines) and severe ulcerative intestinal damage.

Warnings and Precautions

Before starting treatment, discuss with your doctor or pharmacist:

• If you have ever had a severe skin rash or skin peeling after taking rifaximin.
• if you have diarrhea with fever or blood in the stool, or frequent bowel movements (8 times or more per day) - such symptoms are usually a sign of significant involvement of the intestinal mucosa by invasive intestinal pathogens (such as Campylobacter, Salmonellaand Shigella) and Xifaxan, with minimal absorption in the gastrointestinal tract, was not effective in these cases and therefore should not be used
• if you have kidney function disorders, as there are no studies in this patient group

Particular caution should be exercised when using rifaximin. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with rifaximin treatment. Most of these cases were reported in patients with liver disease (such as cirrhosis or hepatitis). If any severe skin reaction occurs, as described in section 4, rifaximin should be discontinued immediately and a doctor consulted.
If the symptoms of diarrhea worsen or persist for more than 24-48 hours, Xifaxan should be discontinued, and the doctor will consider alternative therapy.
Diarrhea caused by Clostridium difficileinfection (causing a disease called pseudomembranous colitis) has been reported with the use of almost all antibacterial drugs. The most common symptoms of this infection are frequent, watery stools, sometimes with blood, severe abdominal cramps or pain, fever. A potential link between rifaximin treatment and the occurrence of this infection cannot be ruled out. If symptoms of this disease occur, a doctor should be consulted.
A doctor should be consulted if a reddish discoloration of the urine is noticed after taking Xifaxan. This is due to the active substance, which, like most antibiotics in the same family (rifamycins), has a reddish-orange color.

Children

Xifaxan should not be given to children under 12 years of age.

Xifaxan and Other Medicines

Tell your doctor about all the medicines you have taken recently, even those that are available without a prescription.
In particular, tell your doctor if you are taking any of the following medicines: another rifamycin antibiotic for the treatment of systemic bacterial infections, warfarin, antiepileptic drugs, antiarrhythmic drugs, and cyclosporine.
When taking activated charcoal, Xifaxan should be taken at least 2 hours after taking the charcoal.
In patients treated with warfarin who have been prescribed Xifaxan, cases of both decreased and increased international normalized ratio (INR) values have been observed. If concomitant administration of both drugs is necessary, INR should be carefully monitored, at the start and end of Xifaxan treatment. The doctor may consider it necessary to adjust the dose of oral anticoagulant drugs belonging to the group of vitamin K antagonists.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
As a precautionary measure, it is recommended to avoid the use of rifaximin during pregnancy.
In the case of Xifaxan treatment in breastfeeding women, the doctor will discuss with the patient whether to stop breastfeeding or discontinue Xifaxan treatment.
Animal studies have not shown any direct or indirect harmful effects on the fertility of males and females.

Driving and Using Machines

Xifaxan has a negligible influence on the ability to drive and use machines.
Caution should be exercised, and if symptoms such as dizziness, double vision, or drowsiness occur, you should not drive or operate machinery.
Xifaxan contains less than 1 mmol (23 mg) of sodium per 2 tablets, i.e., the medicine is considered "sodium-free".

3. How to Take Xifaxan

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Xifaxan is:
Intestinal infections with bacteria sensitive to rifaximin:
Patient over 12 years old: 200 mg (1 tablet) every 8 hours to 400 mg (2 tablets) every 8-12 hours
Traveler's diarrhea:
Patient over 12 years old: 200 mg (1 tablet) every 8 hours for 3 days. Do not take for more than 3 days. Do not restart therapy if symptoms of diarrhea return after a short period of recovery (see "Warnings and Precautions").
Hepatic Encephalopathy:
Adult patient: 400 mg (2 tablets) every 8 hours.
Treatment duration should not exceed 7 days.
Symptomatic Uncomplicated Diverticular Disease of the Colon
Adult patient on a high-fiber diet: 400 mg (2 tablets of 200 mg) every 12 hours for 7 days. If necessary, the doctor will recommend repeating the therapy every month for the next 11 months, i.e., a maximum of 12 cycles of 7 days. After complete disappearance of symptoms, the administration of the medicine should be stopped.
A single treatment period with rifaximin should not exceed 7 days.
Any re-treatment with rifaximin should be preceded by a 30-day period without taking the medicine. If during this period the symptoms worsen or recur, the patient should immediately consult a doctor.
Patient with renal impairment: although dose adjustment is not recommended, caution should be exercised in this patient group.
Patient with hepatic impairment: no dose adjustment is necessary in this patient group.
Elderly patient: no dose adjustment is required as the safety and efficacy data of Xifaxan did not show any differences between elderly and younger patients.
Children: the efficacy and safety of rifaximin in children under 12 years of age have not been established.
Method of Administration
The medicine can be taken with or without food. Take orally, with a glass of water.

Overdose of Xifaxan

If you take more than the recommended dose of Xifaxan, contact your doctor or pharmacist immediately.
Take Xifaxan (medicine and packaging) with you to show to your doctor or pharmacist.

Missed Dose of Xifaxan

If you miss a dose, take it as soon as you remember.
However, if it is almost time for your next dose, do not take the missed dose, but take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

4. Possible Side Effects

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

Stop Taking Rifaximin and Contact Your Doctor or the Emergency Department of Your Nearest Hospital Immediately if You

notice any of the following symptoms:

• red, non-raised, target-like or round patches on the torso, often with a central blister, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions can be preceded by fever and flu-like symptoms.
• fever or severe generalized allergic reaction usually involving: cardiovascular system, lungs, skin (anaphylactoid reaction), allergic reaction with skin swelling (dermatitis, exfoliative dermatitis, eczema, rash, hives, itching, blisters) and (or) mucous membranes (angioedema), anaphylactoid syndrome

See also "Warnings and Precautions" in section 2.
Common side effects (affect 1 to 10 patients in 100): abdominal pain, constipation, sudden need to have a bowel movement, diarrhea, bloating with gas, abdominal distension, nausea, painful defecation, vomiting, fever, headache, dizziness.
Uncommon side effects (affect 1 to 10 patients in 1000): abdominal pain, fluid in the abdominal cavity (ascites), indigestion, dry mouth, disorders of gastrointestinal motility, blood in the stool, hard stools, stools with mucus, taste disorders, abnormal blood test results (increased white blood cell count, i.e., lymphocytes, increased monocyte count, decreased neutrophil count), palpitations, dizziness, ear pain, double vision, weakness, pain and discomfort, chills, cold sweats, excessive sweating, flu-like illness, swelling of the legs and (or) arms, increased aspartate aminotransferase activity, thrush (candidiasis), vaginal yeast infection, Herpes simplex, rhinitis, pharyngitis, upper respiratory tract infections, decreased appetite, dehydration, back pain, muscle spasms, muscle weakness, neck pain, paresthesia (sensory disturbances), migraine, tingling in the limbs, sinusitis, drowsiness, sleep disorders, low mood, insomnia, nervousness, blood in the urine, sugar in the urine, frequent urination, excessive urination, protein in the urine, excessive menstrual bleeding, cough, dry throat, shortness of breath (dyspnea), stuffy nose, sore throat and larynx, runny nose, skin rashes, skin eruptions, eczema (skin changes), photoallergic reactions, sudden flushing of the face, increased blood pressure.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Xifaxan

Keep this medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use Xifaxan after the expiry date stated on the blister and carton, after: Expiry Date (EXP). The expiry date refers to the last day of that month.

6. Contents of the Pack and Other Information

What Xifaxan Contains

• The active substance is rifaximin. One film-coated tablet contains 200 mg of rifaximin
• The other ingredients are: sodium starch glycolate, glycerol distearate, colloidal silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide (E171), sodium edetate, propylene glycol, iron oxide red (E172).

What Xifaxan Looks Like and Contents of the Pack

Xifaxan is a pink, round, biconvex film-coated tablet with AW embossed on one side.
Xifaxan tablets are packaged in PVC/PE/PVDC/Al blisters in a carton.
Pack of 9 tablets: 1 blister packaged in a carton.
Pack of 12 tablets: 1 blister packaged in a carton.
Pack of 14 tablets: 1 blister packaged in a carton.
Pack of 28 tablets: 2 blisters packaged in a carton.
Pack of 42 tablets: 3 blisters packaged in a carton.

Marketing Authorization Holder

Alfasigma S.p.A.
Via Ragazzi del ’99, n. 5
40133 Bologna (BO), Italy

Manufacturer

Alfasigma S.p.A.
Via Enrico Fermi 1
65020 Alanno (PE)
Italy
Date of Last Revision of the Package Leaflet:15.04.2024
For more detailed information, please contact the representative of the marketing authorization holder.
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807, Warsaw
Tel. +48 22 824 03 64
Fax: +48 22 822 97 71
e-mail: [email protected]
{Logo of the marketing authorization holder Alfasigma}