Xifaxan 400 mg

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Xifaxan 400 mg (Normix 400 mg), 400 mg, film-coated tablets

Rifaximin
Xifaxan 400 mg and Normix 400 mg are 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 you need to.
• If you have 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 their symptoms 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 400 mg and what is it used for
• 2. Important information before taking Xifaxan 400 mg
• 3. How to take Xifaxan 400 mg
• 4. Possible side effects
• 5. How to store Xifaxan 400 mg
• 6. Contents of the pack and other information

1. What is Xifaxan 400 mg and what is it used for

Pharmaceutical form and active substance content

Xifaxan 400 mg is in the form of film-coated tablets. Each film-coated tablet of Xifaxan 400 mg contains 400 mg of rifaximin.

Mode of action

Xifaxan 400 mg is an oral antibiotic with antibacterial action, belonging to the class of rifamycin antibiotics. Unlike other rifamycins, it is only slightly absorbed into the bloodstream (less than 1% of the administered dose), so it acts only on microorganisms in the gut.

Indications for use

Xifaxan 400 mg is used to treat symptomatic uncomplicated diverticular disease of the colon in adult patients on a high-fiber diet.
If no improvement occurs or the patient feels worse within 7 days of taking the medicine, they should consult a doctor.

2. Important information before taking Xifaxan 400 mg

When not to take Xifaxan 400 mg:

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their doctor or pharmacist:

• If the patient has ever had a severe skin rash or skin peeling, blisters on the skin, sores on the mouth and (or) ulcers in the mouth after taking rifaximin.
• The patient should contact their doctor if they notice a reddish color of the urine after taking Xifaxan 400 mg. This is caused by the active substance, which, like most antibiotics in the same family (rifamycins), has a red-orange color. During long-term treatment with high doses or in the event of intestinal mucosal damage, a small amount of rifaximin (however, less than 1% of the administered dose) may be absorbed, which may lead to a reddish color of the urine.
• The medicine should not be given to children under 18 years of age.
• Use of Xifaxan 400 mg in patients with liver function disorders: no dose adjustment is necessary in this patient group.
• Use of Xifaxan 400 mg in elderly patients: the patient should inform their doctor if they are over 65 years old.
• Use of Xifaxan 400 mg in patients with kidney function disorders: the patient should inform their doctor if they have kidney function disorders.
• In case of diarrhea with fever or blood in the stool, the patient should ask their doctor about the possibility of using Xifaxan 400 mg.

The patient should be particularly careful 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 immediately and the patient should contact their doctor.

Xifaxan 400 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they have taken recently or plan to take.
In particular, the patient should tell their doctor about taking the following medicines: another rifamycin antibiotic taken to treat systemic bacterial infection, warfarin, antiepileptic drugs, antiarrhythmic drugs, and cyclosporine.
When taking activated charcoal, Xifaxan 400 mg should be taken at least 2 hours after taking the charcoal.

Xifaxan 400 mg with food and drink

Xifaxan 400 mg can be taken with or without food. The patient should swallow it with a glass of water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Xifaxan 400 mg should be avoided during pregnancy.
In the case of Xifaxan 400 mg treatment in breastfeeding women, a decision should be made to either discontinue breastfeeding or discontinue Xifaxan 400 mg treatment.

Driving and using machines

If the patient experiences side effects such as dizziness or drowsiness, they should not drive or operate machinery.
Otherwise, the patient should be cautious.
Xifaxan 400 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Xifaxan 400 mg

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Xifaxan 400 mg is:
Symptomatic uncomplicated diverticular disease of the colon:
Adult patients on a high-fiber diet: 400 mg (1 tablet of 400 mg) every 12 hours.
To achieve the best results in treating symptoms of the disease, the patient should take the medicine for 7 days. It may be necessary to repeat the therapy every month for up to a year, i.e., 12 cycles of 7 days each.
After the symptoms have completely disappeared, the patient should stop taking the medicine. If the symptoms do not improve within 7 days of therapy, the patient should contact their doctor immediately.
During long-term therapy, the patient should remain under close medical supervision.
If the medicine has not been prescribed otherwise, a single treatment period should not exceed 7 days.
In the case of symptomatic uncomplicated diverticular disease of the colon, if retreatment is necessary, each subsequent treatment period should be preceded by a 30-day break in treatment. If the symptoms worsen or recur during this period, the patient should contact their doctor immediately.
Use in children and adolescents:
Xifaxan 400 mg is intended for use only in adult patients.
Patients with renal impairment: 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.
Xifaxan 400 mg film-coated tablets should be swallowed with water.

Taking a higher dose of Xifaxan 400 mg than recommended:

If the patient takes a higher dose of the medicine than recommended, they should immediately consult their doctor or pharmacist.
The patient should take the medicine (and packaging) with them to show the doctor or pharmacist.

Missing a dose of Xifaxan 400 mg

If the patient misses a dose at the scheduled time, they should take it as soon as possible. However, if it is almost time for the next dose, the patient should not take the missed dose but take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Xifaxan 400 mg can cause side effects, although not everybody gets them.

The patient should immediately discontinue rifaximin and contact their doctor or the emergency department of the nearest hospital if they notice any of the following symptoms:

The patient should immediately discontinue rifaximin and contact their doctor or the emergency department of the nearest hospital if they notice any of the following symptoms:

• red, flat, target-like or round patches on the torso, often with a centrally located blister, skin peeling, mouth ulcers, 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 involving: the circulatory system, lungs, skin (anaphylactoid reaction), allergic reaction with symptoms such as: skin swelling (dermatitis, exfoliative dermatitis, rash, eruption, rough skin, redness of the skin, itching, blisters) and (or) mucous membranes (angioedema), anaphylactoid reaction. See also "Warnings and precautions" in section 2.

Common side effects (affecting 1 to 10 patients in 100): bloating, abdominal pain, constipation, sudden need to defecate, diarrhea, bloating with gas, nausea, painful defecation, vomiting, fever, dizziness, headache.
Uncommon side effects (affecting 1 to 10 patients in 1,000): upper abdominal pain, fluid in the abdominal cavity (ascites), indigestion, dry mouth, disorders of food transport in the intestines, presence of fresh blood in the stool, stool 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, lack of efficacy of the medicine, fatigue, flu-like illness, swelling of the legs and (or) arms, fungal infection (candidiasis), vaginal yeast infection, nasal and throat inflammation, throat inflammation, upper respiratory tract infections, increased liver enzyme activity (elevated aspartate aminotransferase activity), increased blood pressure, presence of blood and red blood cells in the urine, loss of appetite (anorexia), dehydration, back pain, muscle spasms, muscle weakness, neck pain, muscle pain, loss of taste, numbness, migraine, tingling and burning sensation, sinus pain, drowsiness, sleep disorders, insomnia, nervousness, blood in the urine, sugar in the urine, frequent urination, excessive urination, excessive menstrual bleeding, cough, throat dryness, shortness of breath, nasal congestion, sore throat and larynx, runny nose, cold sweats, rash, exanthema (skin changes), sensitivity to light, sudden flushing of the face.
Frequency not known (frequency cannot be estimated from the available data): abnormal blood test results (decreased platelet count, abnormal liver test results, hypersensitivity, disorders of international normalized ratio (INR), infections with bacteria of the genus Clostridium (C. difficile), generalized reaction, resembling a severe allergic reaction, affecting several organs, usually the circulatory system, lungs, skin (anaphylactoid reaction), allergic reaction with symptoms such as skin and (or) mucous membrane swelling (angioedema), facial swelling, skin inflammation, rash, redness of the skin, itching, hives, rash, anaphylactoid reaction.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Xifaxan 400 mg

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Xifaxan 400 mg should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Xifaxan 400 mg contains

• The active substance of the medicine is rifaximin.
• One film-coated tablet contains 400 mg of rifaximin.
• The other ingredients of the medicine are: Tablet core:sodium carboxymethylcellulose (type A), glycerol distearate, silicon dioxide, anhydrous, talc, microcrystalline cellulose; Coating:hypromellose 2910, titanium dioxide (E 171), disodium edetate, propylene glycol, iron oxide red (E 172).

What Xifaxan 400 mg looks like and contents of the pack

Xifaxan 400 mg is a pink, round, biconvex film-coated tablet.
Xifaxan 400 mg film-coated tablets are packaged in PVC/PE/PVDC/Al blisters in a cardboard box.
A pack of 14 film-coated tablets contains: 1 blister in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, 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 (PE)
Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:15/159/17-C

Parallel import authorization number: 445/24

Date of leaflet approval: 20.12.2024

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