Xifaxan

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, information on the immediate packaging in a foreign language.

XIFAXAN (NORMIX), 200 mg, film-coated tablets

Rifaximin
XIFAXAN NORMIXare different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 antibiotic that works against bacteria. It contains rifaximin, an antibiotic belonging to 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 effective against most bacteria that cause 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:

Warnings and precautions

Before starting to take the medicine, the following problems should be discussed with the doctor

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 the symptoms of diarrhea worsen or persist for more than 24-48 hours, Xifaxan should be discontinued, and the doctor will consider using another 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. The doctor should be contacted if symptoms of this disease occur.
The doctor should be contacted in case of noticing a reddish discoloration of the urine after taking Xifaxan. This is caused by the active substance, which, like most antibiotics from 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 taking 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 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 after the 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 during breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, the doctor should be consulted before taking this medicine.
Xifaxan should not be used during pregnancy.
In the case of using Xifaxan in breastfeeding women, the doctor will consider with the patient either stopping breastfeeding or discontinuing 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 vehicles and operate machinery is negligible.
Care should be taken and in case of such side effects as dizziness, double vision, or drowsiness, vehicles should not be driven or machines 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: from 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 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, 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 the complete disappearance of symptoms, the treatment should be discontinued.
A single treatment period with rifaximin should not exceed 7 days.
Each subsequent rifaximin treatment should be preceded by a 30-day period without taking the medicine. If the symptoms worsen or recur during this period, the patient should contact the doctor immediately.
Patients with renal impairment: although dose adjustment is not recommended, caution should be exercised in this group of patients.
Patients with hepatic impairment: there is no need to modify the dose in this group of patients.
Older patients: no dose adjustment is required, as the data on the safety and efficacy of Xifaxan did not show any differences between older and younger patients.
Children: the efficacy and safety of rifaximin in children under 12 years old have not been established.
Method of administration
The medicine can be taken with or without food. Take orally, with a glass of water.

Taking a higher dose of Xifaxan than recommended

In case of taking a higher dose of Xifaxan than recommended, the doctor or pharmacist should be contacted immediately.
If possible, Xifaxan (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.

You should contact your doctor or the emergency department of the nearest hospital immediately if

you experiencefever or severe generalized allergic reaction usually affecting: the circulatory system, lungs, skin (anaphylactoid reaction), allergic reaction manifested by skin swelling (dermatitis, exfoliative dermatitis, rash, eruption, rough skin, redness of the skin, itching, blisters) and (or) mucous membranes (angioedema), pre-shock state.
See also "Warnings and precautions" in section 2.
Common side effects (affect 1 to 10 patients out of 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 out of 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 lymphocyte count, 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 cramps, muscle weakness, neck pain, numbness (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 reddening of the face, increased blood pressure.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help 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.
There are no special recommendations for storage.
Xifaxan should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The 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 Xifaxan is rifaximin. One film-coated tablet contains 200 mg of rifaximin.
• The other ingredients of the medicine are: sodium carboxymethylcellulose (type A), glycerol distearate, silicon dioxide, talc, microcrystalline cellulose
• 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 medicine in the form of pink, round, biconvex film-coated tablets.
Xifaxan tablets are packaged in PVC-PE-PVDC/Aluminum blisters.
The pack of 12 tablets contains: 1 blister of 12 pieces packaged in a cardboard box.
The pack of 24 tablets contains: 2 blisters of 12 pieces packaged in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Italy, in the country of export:

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

Manufacturer:

Alfasigma S.p.A., Via Pontina Km 30, 400 – 00071 Pomezia (RM), Italy

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND JOINT-STOCK COMPANY, ul. Beskidzka 190, 91-610 Łódź
Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Authorization number in Italy, in the country of export:025300029
Parallel import authorization number:458/12
Date of leaflet approval: 25.07.2022