Package leaflet: Information for the user

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

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

Table of contents:

What Xifaxan is and what it is used for
What you need to know 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 the class of drugs known as 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 for use
In adults and children above 12 years of age:

intestinal infections caused by bacteria sensitive to rifaximin, excluding diarrhoea accompanied by fever and/or blood in the stool, as well as cases where the number of unformed stools is equal to or exceeds 8 per day;
travellers' diarrhoea, excluding diarrhoea accompanied by fever and/or blood in the stool, as well as cases where 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. 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 starting treatment, discuss the following issues with your doctor:

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 indicative 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, the medicine has not been effective in such cases and therefore should not be used.
if the patient has impaired kidney function, as there are no studies available in this patient group.
in patients with liver cirrhosis (a type of liver disease), a severe, potentially life-threatening skin reaction may occur, characterized by painful rash or formation of blisters on the skin, mouth, eyes, and genitals.

If a severe skin reaction or any other hypersensitivity reaction occurs, the drug 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 during treatment 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 class (rifamycins), has a red-orange color.

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 obtained without a prescription.
In particular, inform your doctor if you are taking any of the following medicines: another antibiotic from the rifamycin group for the treatment of systemic bacterial infection, warfarin, antiepileptic drugs, antiarrhythmics, 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 it necessary to adjust the dose of oral anticoagulants belonging to the vitamin K antagonist group.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, 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 option of discontinuing breastfeeding or stopping treatment with Xifaxan.
Animal studies have not shown any direct or indirect harmful effects on fertility in men or women.

Driving and operating machinery
The influence of Xifaxan on the ability to drive and 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 taken exactly as directed by your doctor. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Xifaxan is:
Intestinal infections caused by bacteria sensitive to rifaximin
Patients over 12 years of age: 200 mg (1 tablet) every 8 hours up to 400 mg (2 tablets) every 8–12 hours.
Travellers' diarrhoea
Patients over 12 years of age: 200 mg (1 tablet) every 8 hours for 3 days. Do not use for longer than 3
days. Repeating the treatment is not recommended if diarrhoea symptoms return 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-residue diet: 400 mg (2 tablets of 200 mg) every 12 hours for 7
days. If necessary, your doctor may recommend repeating the treatment once a month for the following 11 months, i.e. up to 12 cycles of 7 days each. After complete resolution of symptoms, the medicine should be discontinued.
A single treatment course 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 modification is necessary in this patient group.
Elderly patients: no dose adjustment is required, as safety and efficacy data for Xifaxan have shown
no differences between elderly and younger patients.
Children: efficacy and safety of rifaximin have not been established in children under 12 years of age.
Method of administration
The medicine can be taken with or without food. Administer orally, swallow with a glass of water.
Taking more Xifaxan than recommended
If you take more Xifaxan than you should, contact your doctor or pharmacist immediately.
If possible, take the medicine (both the medicine and its packaging) with you to show to the doctor or pharmacist.
Missing a dose of Xifaxan
If you miss a dose at the scheduled time, take it as soon as possible. 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 adverse reactions

Like all medicines, Xifaxan may cause adverse reactions, although not everyone experiences them.
You should contact a doctor or the emergency department of the nearest hospital immediately if the patient experiences:

fever or severe generalized allergic reaction usually affecting: the circulatory system, lungs, skin (pseudoanaphylactic reaction), 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
life-threatening reaction with influenza-like symptoms and painful rash appearing on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)*
life-threatening reaction with influenza-like symptoms and formation of blisters on the skin, mouth, eyes, and genitals*.
* These reactions have been observed in patients with liver cirrhosis. 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 defecation, diarrhoea, bloating with flatulence, 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 motility, presence of blood in stool, hard stools, stools containing mucus, taste disturbances, abnormal blood test results (increased number of white blood cells, i.e. lymphocytes, increased number of monocytes, decreased number of neutrophil granulocytes), palpitations, dizziness, ear pain, double vision, asthenia, pain and discomfort, chills, cold sweats, excessive sweating, influenza-like illness, swelling of legs and (or) hands, increased activity of aspartate aminotransferase, candidiasis, candidal vaginal infection, Herpes simplex, rhinitis and pharyngitis, pharyngitis, upper respiratory tract infections, decreased appetite, dehydration, back pain, muscle cramps, decreased muscle strength, muscle pain, neck pain, hypoesthesia (sensory disturbances), migraine, paresthesia in limbs, sinus pain, somnolence, sleep disorders, depressed 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), nasal congestion, sore throat and larynx, watery nasal discharge, skin rash, skin eruptions, exanthema (skin changes), photoallergic reactions, sudden facial flushing, increased blood pressure.

Frequency unknown (frequency cannot be estimated from available data): abnormal blood test results (decreased platelet count, abnormal liver function tests, abnormalities 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, skin redness, pruritus, petechiae, urticaria.

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

5. How to store the medicine Xifaxan

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
Do not use 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. This 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.
Other components of the medicine are: Core: sodium carboxymethyl starch (type A), glyceryl distearate, colloidal anhydrous silica, talc, microcrystalline cellulose; Coating: hypromellose (E 464), titanium dioxide (E 171), disodium edetate, propylene glycol, iron oxide red (E 172).

What Xifaxan looks like and contents of the packaging
Xifaxan is a medicine in the form of pink, round, biconvex coated tablets.
Xifaxan tablets are packed in PVC-PE-PVDC/Al blisters in cardboard boxes.
The 12-tablet pack contains 1 blister packed in a cardboard box.
The 14-tablet pack contains 1 blister packed in a cardboard box.
The 24-tablet pack contains 2 blisters packed in a cardboard box.
The 28-tablet pack contains 2 blisters packed in a cardboard box.
The 42-tablet pack contains 3 blisters packed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.

Responsible party in Romania, country of export:
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 Scalo (Pescara)
Italy
Alfasigma S.p.A.
Via Pontina Km 30,400
00071 Pomezia (Rome)
Italy

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing authorization number in Romania, country of export: 12333/2019/01
12333/2019/02
12333/2019/03
12333/2019/04

Parallel import authorization number: 96/19