Xifaxan

Package Leaflet: Information for the User

Xifaxan, 100 mg/5 ml, Granules for Oral Suspension

Rifaximin

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

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

Contents of the Package Leaflet:

• 1. What Xifaxan is and what it is 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 XIFAXAN IS AND WHAT IT IS USED FOR

Xifaxan is an oral antibacterial medicine. 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 acts only 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:

• 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 more than 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 more than 8 per day,

In adults:

• irritable bowel syndrome, diarrhea-predominant form,
• 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 to take the medicine, discuss it with your doctor or pharmacist

• If you have ever had a severe skin rash or skin peeling, blisters on the skin, mouth sores, or oral ulcers after taking rifaximin.
• if you have diarrhea with fever or blood in the stool, or frequent bowel movements (8 times or more per day) - see below
• if you have kidney function disorders, as there are no studies in this patient group

Particular caution should be exercised when taking 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 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.
Xifaxan should not be taken by patients with diarrhea complicated by fever or blood in the stool, or with a high frequency of stools (8 or more per day) - such symptoms are usually a sign of significant involvement of the intestinal mucosa by invasive intestinal pathogens, such as Campylobacter, Salmonella, and Shigella, and Xifaxan, with minimal absorption in the gastrointestinal tract, was not effective in these cases.
Diarrhea caused by Clostridium difficileinfection (causing pseudomembranous colitis) has been reported with the use of almost all antibacterial agents. 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. A doctor should be consulted if symptoms of this disease occur.
A doctor should be consulted if a red 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 are also 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

In pregnancy and breastfeeding, or if you think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
As a precaution, rifaximin should be avoided 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 fertility in 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 the following undesirable effects occur, such as dizziness, double vision, or drowsiness, do not drive or operate machinery.

Xifaxan contains sucrose, sodium benzoate, sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking the medicine.
The medicine contains about 5.8 g of sucrose in 20 ml of suspension, which should be taken into account in patients with diabetes.
Xifaxan contains 12 mg of sodium benzoate in each 20 ml of suspension.
Xifaxan contains less than 1 mmol (23 mg) of sodium per 20 ml of suspension, i.e., the medicine is considered "sodium-free".

3. HOW TO TAKE XIFAXAN

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The recommended dose of Xifaxan is:
Intestinal infections with bacteria sensitive to rifaximin:
Patient over 12 years: 200 mg (10 ml suspension) every 8 hours to 400 mg (20 ml suspension) every 8-12 hours
Traveler's diarrhea:
Patient over 12 years: 200 mg (10 ml suspension) every 8 hours for 3 days
Do not take for more than 3 days.
Do not restart treatment if the symptoms of diarrhea return after a short period of recovery (see "Warnings and precautions").
Irritable bowel syndrome, diarrhea-predominant form:
Adult patients: 550 mg (27.5 ml suspension, i.e., measure 15 ml and then 12.5 ml) every 8 hours for 14 days.
The following shows how to measure 27.5 ml of suspension.

Hepatic encephalopathy:
Adult patients: 400 mg (20 ml suspension) every 8 hours.
Treatment duration should not exceed 7 days.
Symptomatic, uncomplicated diverticular disease of the colon:
Adult patients on a high-fiber diet: 400 mg (20 ml suspension) 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 worsening or recurrence of symptoms occurs during this period, the patient should contact the doctor immediately.
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 patients: no dose adjustment is required, as the data on the safety and efficacy 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. Before each administration, the suspension should be shaken vigorously. A calibrated measuring cup is attached to the bottle containing the granules. Take orally, followed by a glass of water.

Instructions for preparing the medicine for use

The granules for oral suspension are in a tightly closed bottle. Open the bottle, add potable water to the arrow and shake vigorously. Then refill with water to the arrow.
The concentration of rifaximin in the resulting suspension is 100 mg/5 ml.

Overdose of Xifaxan

In case of overdose, contact your doctor or pharmacist immediately.
If possible, bring Xifaxan (medicine and packaging) with you to show to the doctor or pharmacist.

Missed dose of Xifaxan

If you miss a dose, take it as soon as possible. However, if it is almost time for the 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 the missed dose of the suspension.

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 sores, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms:

• fever or severe generalized allergic reaction involving: the circulatory system, lungs, skin (anaphylactoid reaction), allergic reaction with skin swelling (angioedema), and/or mucous membranes.

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, nasal and throat inflammation, pharyngitis, upper respiratory tract infections, decreased appetite, dehydration, back pain, muscle spasms, muscle weakness, neck pain, numbness (sensory disturbances), migraine, tingling in the limbs, sinus pain, drowsiness, sleep disturbances, low mood, insomnia, nervousness, blood in the urine, sugar in the urine, frequent urination, excessive urination, protein in the urine, excessive menstrual bleeding, cough, throat dryness, shortness of breath (dyspnea), stuffy nose, sore throat and larynx, runny watery nose, rashes, skin eruptions, eczema (skin changes), photoallergic reactions, sudden flushing of the face, increased blood pressure.

Unknown frequency (frequency cannot be estimated from the available data): abnormal blood test results (decreased platelet count, abnormal liver function tests, disorders of international normalized ratio), infections with Clostridiumbacteria (C. difficile), anaphylactic reactions, hypersensitivity, anaphylactoid reaction, angioedema (allergic reaction with skin and/or mucous membrane swelling), skin inflammation, peeling skin inflammation, eczema, redness of the skin, itching, hives.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE XIFAXAN

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use Xifaxan, granules for oral suspension, after the expiry date stated on the bottle and carton, after: Expiry date. The expiry date is the last day of the given month.
Note!
The suspension prepared and ready for use by the patient in the above manner remains stable for 7 days at a temperature up to 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Xifaxan contains

• The active substance is rifaximin.
• The granules for oral suspension contain 100 mg of rifaximin in each 5 ml of the prepared suspension.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, pectin, kaolin, sodium saccharin, sodium benzoate, sucrose, black cherry flavor.

What Xifaxan looks like and contents of the pack

Xifaxan is a medicine in the form of granules for oral suspension. The packaging of the medicine is a cardboard box containing a tightly closed, yellowish-brown glass bottle of 60 ml, with an aluminum screw cap. A calibrated measuring cup is attached to the bottle.

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 leaflet:15.04.2024
To obtain more detailed information, 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
e-mail: [email protected]
{Logo of the marketing authorization holder Alfasigma}