Xifaxan

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Xifaxan (Normix 200 mg)

200 mg, film-coated tablets

Rifaximin
Xifaxan and Normix 200 mg are different trade names for the same medicine.

Important information to be read before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the 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 antibacterial medicine. It contains rifaximin, an antibiotic from the class of rifamycin antibiotics, but unlike other rifamycins, it is only slightly absorbed into the bloodstream from the gut (the alpha-polymorphic form is absorbed at less than 1% of the administered dose), so it only acts on microorganisms in the gut. 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 the patient is allergic to rifaximin or other rifamycins or any of the other ingredients of this medicine (listed in section 6).
• if the patient has 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, the following problems should be discussed with the doctor

• if the patient has 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, Salmonella, and Shigella) and Xifaxan, with minimal absorption in the gastrointestinal tract, was not effective in these cases and therefore should not be used
• if renal impairment has been detected in the patient, as there are no studies in this patient group
• in patients with liver cirrhosis (a type of liver disease), a severe skin reaction may occur, which can be life-threatening, with painful rash or blistering on the skin, mouth, eyes, and genitals.

If a severe skin reaction or other hypersensitivity reaction occurs, the medicine should be discontinued immediately and a doctor should be 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 pseudomembranous colitis) has been reported with the use of almost all antibacterial medicines. 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 reddish discoloration of the urine is noticed after taking Xifaxan. This is caused by 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 old.

Xifaxan and other medicines

The doctor should be told about all medicines taken recently, even those that are available without a prescription.
In particular, the doctor should be told about the use 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 at the same time, cases of both decreased and increased INR values have been observed. If concomitant administration of both medicines 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 medicines belonging to the group of vitamin K antagonists.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, a doctor should be consulted before taking this medicine.
As a precaution, the use of rifaximin is not recommended 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

The effect of Xifaxan on the ability to drive and use machines is negligible.
Care should be taken and if symptoms such as dizziness, double vision, or drowsiness occur, vehicles should not be driven and machines should not be operated.
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 according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted.
The recommended dose of Xifaxan is:

Intestinal infections with bacteria sensitive to rifaximin

Patients over 12 years old: 200 mg (1 tablet) every 8 hours to 400 mg (2 tablets) every 8-12 hours.

Traveler's diarrhea

Patients over 12 years old: 200 mg (1 tablet) every 8 hours for 3 days. It should not be taken for more than 3 days. Therapy should not be restarted if the symptoms of diarrhea return after a short period of recovery (see "Warnings and precautions").

Hepatic encephalopathy

Adult patients: 400 mg (2 tablets) every 8 hours.
The treatment period should not be longer than 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, 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 discontinued.
A single treatment period with rifaximin should not be longer than 7 days.
Each re-treatment with rifaximin should be preceded by a period without taking the medicine lasting 30 days. If during this period the symptoms worsen or recur, the patient should immediately consult a doctor.
Patients with renal impairment: although dose adjustment is not recommended, caution should be exercised in this patient group.
Patients with hepatic impairment: there is no need to modify the dose in this patient group.
Elderly patients: no dose adjustment is required, as the safety and efficacy data for Xifaxan did not show any differences between elderly and younger patients.
Children: the efficacy and safety of rifaximin treatment have not been established in children under 12 years old.
Method of administration
The medicine can be taken with or without food. It should be taken orally, with a glass of water.

Use of a higher than recommended dose of Xifaxan

In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.
If possible, the medicine (medicine and packaging) should be taken to show it to the doctor or pharmacist.

Missing a dose of Xifaxan

In case of missing a dose at the right time, it should be taken as soon as possible. However, if it is close to the time of taking the next dose, the missed dose should not be taken, but the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed tablet.

4. Possible side effects

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

Immediate medical attention should be sought if the patient experiences:

ifthe patient experiences:

• fever or severe generalized allergic reaction usually involving: the circulatory system, lungs, skin (anaphylactoid reaction), allergic reaction with skin swelling (dermatitis, exfoliative dermatitis, eczema, rash, erythema, pruritus, urticaria) and (or) mucous membranes (angioedema), anaphylactoid reaction
• life-threatening reaction with flu-like symptoms and painful rash on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)*
• life-threatening reaction with flu-like symptoms and blistering 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 side effects (affect 1 to 10 patients in 100): abdominal pain, constipation, sudden need to defecate, diarrhea, bloating with gas, increased abdominal tension, 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 food transport in the intestines, 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, Herpessimplex, 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, exanthema (skin changes), photoallergic reactions, sudden flushing of the face, increased blood pressure.
Frequency not known (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), dermatitis, exfoliative dermatitis, eczema, erythema, pruritus, urticaria.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department for the Monitoring of Adverse Reactions to Medicinal Products, the 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Xifaxan

The medicine should be stored out of sight and reach of children.
It should be stored at a temperature below 25°C, in the original packaging.
Xifaxan should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Xifaxan contains

• The active substance of the medicine is rifaximin.
• One film-coated tablet contains 200 mg of rifaximin.
• The other ingredients of the medicine are: core:sodium carboxymethylcellulose (type A), glycerol distearate, silica colloidal anhydrous, 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 pack

Xifaxan is a medicine in the form of pink, round, biconvex film-coated tablets.
Xifaxan tablets are packaged in PVC-PE-PVDC/Al blisters in a cardboard box.
The pack of 12 tablets contains 1 blister packaged in a cardboard box.
The pack of 14 tablets contains 1 blister packaged in a cardboard box.
The pack of 24 tablets contains 2 blisters packaged in a cardboard box.
The pack of 28 tablets contains 2 blisters packaged in a cardboard box.
The pack of 42 tablets contains 3 blisters packaged in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export:
12333/2019/01
12333/2019/02
12333/2019/03
12333/2019/04

Parallel import authorization number: 96/19

Date of leaflet approval: 04.03.2024

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