PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Xifaxan (Normix 200 mg)
200 mg, film-coated tablets
Rifaximinum
Xifaxan and Normix 200 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Xifaxan is and what it is used for
Important information before taking Xifaxan
How to take Xifaxan
Possible side effects
How to store Xifaxan
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 a class of medicines called rifamycins. However, unlike other rifamycins, it is only minimally absorbed from the intestine into the bloodstream (the α polymorphic form is absorbed at less than 1% of the administered dose), thus acting exclusively on microorganisms present in the intestine. Xifaxan is active against most bacteria responsible for intestinal infections.
Indications

In adults and children over 12 years of age:

intestinal infections caused by bacteria sensitive to rifaximin, excluding diarrhoea associated with fever and/or blood in the stool, and also when the number of unformed stools is equal to or exceeds 8 per day;
travellers' diarrhoea, excluding diarrhoea associated 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-residue diet.

2. Important information before using Xifaxan

When not to use Xifaxan:

if the patient is allergic to rifaximin or other rifamycins, or to any of the other ingredients of this medicine (listed in section 6).
if the patient has intestinal obstruction, even partial (a blockage in the intestine that prevents the passage of intestinal contents), or severe ulcerative intestinal damage.

Warnings and precautions
Before taking this medicine, discuss with your doctor or pharmacist:

if the patient has ever experienced severe skin rash, skin peeling, blisters, mouth sores, and/or oral ulcers after taking rifaximin,
if the patient has diarrhoea accompanied by fever or blood in the stool, or frequent bowel movements (8 times or more per day) – these symptoms are usually signs of significant intestinal mucosal involvement by invasive intestinal pathogens (such as Campylobacter, Salmonella and Shigella). Due to minimal absorption of Xifaxan in the gastrointestinal tract, it is not effective in such cases, and therefore should not be used,
if the patient has kidney function disorders, as there are no studies available in this patient group. Extreme caution should be exercised when using rifaximin. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with rifaximin. Most of these cases were reported in patients with liver disease (such as cirrhosis or hepatitis). If any severe skin reaction described in section 4 occurs, rifaximin should be discontinued immediately and the patient should contact their doctor. If diarrhoea symptoms worsen or persist longer than 24–48 hours, Xifaxan should be discontinued and the doctor will consider alternative therapy.

Diarrhoea caused by Clostridium difficile infection (leading to a condition called pseudomembranous colitis) has been reported with nearly all antibacterial agents. The most common symptoms of this infection include frequent watery stools, sometimes with blood, severe cramps or abdominal pain, and fever. A potential association between rifaximin treatment and the occurrence of this infection cannot be excluded. Contact your doctor if symptoms of this disease occur.
Contact your doctor if reddish discoloration of urine occurs after taking Xifaxan. This is due to the active substance, which, like most antibiotics in the same family (rifamycins), has a red-orange colour.

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

Xifaxan and other medicines
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
In particular, inform your doctor if you are taking any of the following medicines: another antibiotic from the rifamycin group used to treat systemic bacterial infection, warfarin, antiepileptic medicines, antiarrhythmic medicines, or cyclosporine.
If you are taking activated charcoal, Xifaxan should be taken at least 2 hours after the charcoal.
In patients receiving warfarin who were also prescribed Xifaxan, both decreased and increased values of the International Normalized Ratio (INR) have been observed. If concomitant administration of both medicines is necessary, INR should be carefully monitored at the start and after completion of Xifaxan treatment. Your doctor may consider adjusting the dose of oral vitamin K antagonist anticoagulants.

Pregnancy, breastfeeding and fertility

During pregnancy or breastfeeding, or if pregnancy is suspected or planned, consult your doctor before using this medicine.
As a precautionary measure, the use of rifaximin during pregnancy is not recommended.
If Xifaxan is used in breastfeeding women, the doctor will discuss with the patient the need to discontinue breastfeeding or to stop treatment with Xifaxan.
Animal studies have not shown any direct or indirect harmful effects on male or female fertility.

Driving and operating machinery
The effect of Xifaxan on the ability to drive vehicles or operate machinery is negligible.
However, caution is advised. If adverse effects such as dizziness, double vision, or drowsiness occur, the patient 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 use Xifaxan

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose of Xifaxan is:
Bacterial intestinal infections sensitive to rifaximin:
Patients over 12 years of age: from 200 mg (1 tablet) every 8 hours to 400 mg (2 tablets) every 8–12 hours
Traveler's diarrhea:
Patients over 12 years of age: 200 mg (1 tablet) every 8 hours for 3 days. Do not use for longer than 3 days. Do not reinitiate therapy if diarrhea symptoms recur after a short period following recovery (see "Warnings and precautions").
Hepatic encephalopathy:
Adult patients: 400 mg (2 tablets) every 8 hours.
The treatment period should not exceed 7 days.
Symptomatic uncomplicated diverticular disease of the colon
Adult patients on a high-fiber diet: 400 mg (2 tablets of 200 mg) every 12 hours for 7 days. If necessary, your doctor may recommend repeating the therapy once per month for the next 11 months, for a maximum of 12 cycles of 7 days each. After complete resolution of symptoms, treatment should be discontinued.
A single course of treatment with rifaximin should not exceed 7 days.
Each new course of treatment with rifaximin should be preceded by a 30-day treatment-free period. If symptoms worsen or recur during this period, the patient should contact their doctor immediately.
Patients with renal impairment: although dose adjustment is not recommended, caution should be exercised in this patient group.
Patients with hepatic impairment: no dose adjustment is necessary in this patient group.
Elderly patients: no dose adjustment is required, as safety and efficacy data for Xifaxan have not shown any differences between elderly and younger patients.
Children: the efficacy and safety of rifaximin have not yet been established in children under 12 years of age.
Method of administration
This medicine may be taken with or without food. Administer orally, with a glass of water.
Use of a higher than recommended dose of Xifaxan
If an overdose is taken, seek immediate medical advice from your doctor or pharmacist.
If possible, bring the Xifaxan medicine (both the medicine and its packaging) with you to show to the doctor or pharmacist.
Missed dose of Xifaxan
If a dose is missed, take it as soon as possible. However, if it is nearly time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed tablet.

4. Possible adverse reactions

Like all medicines, Xifaxan may cause adverse reactions, although not everyone experiences them.
Rifaximin must be discontinued immediately and a doctor or the nearest hospital emergency department must be contacted if the patient notices any of the following symptoms:

Reddish, flat, target-like or circular skin lesions on the trunk, often with a central blister, skin peeling, and ulceration of the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms.
Fever or severe generalized allergic reaction usually affecting: the circulatory system, lungs, skin (anaphylactoid reaction), or allergic reaction manifesting as skin swelling (dermatitis, exfoliative dermatitis, purpura, rash, rough skin, redness of the skin, itching, blisters) and (or) mucous membranes (angioedema), pre-syncopal state.

See also "Warnings and precautions" in section 2.

Common adverse reactions (affecting 1 to 10 patients out of 100): upper abdominal pain, constipation, sudden need for bowel movement, diarrhea, bloating with gas passage, increased abdominal wall tension, nausea, painful urge to defecate, vomiting, fever, headache, dizziness.

Uncommon adverse reactions (affecting 1 to 10 patients out of 1,000): upper abdominal pain, fluid in the abdominal cavity (ascites), dyspepsia, dry mouth, disturbances in gastrointestinal transit, presence of blood in stool, hard stools, stools with mucus, taste disturbances, abnormal blood test results (increased white blood cells, i.e. lymphocytes, increased monocytes, decreased neutrophils), palpitations, dizziness, ear pain, double vision, weakness, pain and discomfort, chills, cold sweats, excessive sweating, influenza-like illness, swelling of legs and (or) hands, increased aspartate aminotransferase activity, oral candidiasis (thrush), vaginal yeast infection, Herpes simplex, rhinitis, pharyngitis, upper respiratory tract infections, decreased appetite, dehydration, back pain, muscle cramps, decreased muscle strength, muscle pain, neck pain, hypoesthesia (sensory disturbances), migraine, tingling in limbs, sinus pain, somnolence, sleep disturbances, low mood, insomnia, nervousness, presence of blood in urine, glucose in urine, frequent urination, excessive urination, protein in urine, abnormally frequent menstruation, cough, dry throat, shortness of breath (dyspnea), stuffy nose, sore throat and larynx, watery nasal discharge, rash, skin eruptions, exanthema (skin changes), photoallergic reactions, sudden facial flushing, increased blood pressure.

Frequency not known (frequency cannot be estimated from available data): abnormal blood test results (decreased platelet count, abnormal liver function tests, disturbances in international normalized ratio), infections with Clostridium bacteria (C. difficile), anaphylactic reactions, hypersensitivity, pre-syncopal state, angioedema (allergic reaction manifesting as swelling of the skin and (or) mucous membranes), dermatitis, exfoliative dermatitis, rash, erythema, pruritus, petechiae, urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to gather more information on the safety of this medicine.

5. How to store the medicine Xifaxan

Keep the medicine out of the sight and reach of children.
There are no special requirements for the storage of this medicinal product.
Do not use the medicine Xifaxan after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the packaging and other information

What Xifaxan contains

The active substance is rifaximin. One coated tablet contains 200 mg of rifaximin.
The other ingredients are: sodium carboxymethyl starch (type A), glyceryl distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, and coating: hypromellose, titanium dioxide (E 171), disodium edetate, propylene glycol, iron oxide red (E 172).

What Xifaxan looks like and contents of the pack
Xifaxan is a pink, round, biconvex coated tablet.
Xifaxan tablets are packed in PVC-PE-PVDC/Aluminium blisters, placed in a cardboard box.
The pack contains either 12 or 24 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Italy, the country of export:
Alfasigma S.p.A.
Via Ragazzi del '99, n. 5
40133 Bologna (BO)
Italy
Manufacturer:
Alfasigma S.p.A.
Via E. Fermi, n. 1
65020 Alanno (PE)
Italy
Alfasigma S.p.A.
Via Pontina Km 30
400-00071 Pomezia (RM)
Italy
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Italy, the country of export: 025300029
Parallel Import Licence Number: 232/20