Xifaxan 400 mg

Package leaflet: Information for the user

XIFAXAN 400 mg, 400 mg, coated tablets
Rifaximinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What XIFAXAN 400 mg is and what it is used for
2. Before you take 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 XIFAXAN 400 mg is and what it is used for

Pharmaceutical form and active substance content
XIFAXAN 400 mg is in the form of coated tablets. Each coated tablet of XIFAXAN 400 mg contains 400 mg of rifaximin.
Mechanism of action
XIFAXAN 400 mg is an oral antibacterial agent belonging to a class of drugs known as rifamycins. Unlike other rifamycins, it is only minimally absorbed from the intestine into the bloodstream (less than 1% of the administered dose), thus acting exclusively on microorganisms present in the intestine.
Indications
XIFAXAN 400 mg is indicated for the treatment of symptomatic uncomplicated diverticular disease of the colon in adult patients following a high-residue diet.
If there is no improvement within 7 days of treatment, or if the patient's condition worsens, medical advice should be sought.

2. Important information before using XIFAXAN 400 mg

When not to use XIFAXAN 400 mg:

• 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 (blockage of the intestine causing food to stop moving through the intestines), or severe ulcerative colitis.

Warnings and precautions
Before starting treatment, discuss the following with your doctor or pharmacist:

• If the patient has ever experienced severe skin rash, skin peeling, blisters on the skin, or mouth sores (and/or oral ulcers) after taking rifaximin.
• Contact your doctor if you notice reddish discoloration of 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 presence of intestinal mucosal damage, a small amount of rifaximin (however, less than 1% of the administered dose) may be absorbed, potentially leading to reddish discoloration of urine.
• Do not administer this medicine to children under 18 years of age.
• Use of XIFAXAN 400 mg in patients with liver function disorders: dose adjustment is not required in this patient group.
• Use of XIFAXAN 400 mg in elderly patients: Inform your doctor if the patient is 65 years of age or older.
• Use of XIFAXAN 400 mg in patients with kidney function disorders: Inform your doctor if the patient has been diagnosed with impaired kidney function.
• In case of diarrhea with fever or presence of blood in stool, consult your doctor regarding the possibility of using XIFAXAN 400 mg.

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 diseases (such as cirrhosis or hepatitis). If any severe skin reaction described in section 4 occurs, rifaximin should be discontinued immediately and medical advice should be sought.

XIFAXAN 400 mg with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines: another rifamycin antibiotic used for systemic treatment of bacterial infection, warfarin, antiepileptic drugs, antiarrhythmic drugs, or cyclosporine.
If taking activated charcoal, XIFAXAN 400 mg should be taken at least 2 hours after the charcoal.

XIFAXAN 400 mg with food and drink
XIFAXAN 400 mg may be taken with or without food. It should be taken with a glass of water.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Use of XIFAXAN 400 mg during pregnancy is not recommended.
If XIFAXAN 400 mg is used in breastfeeding women, a decision should be made whether to discontinue breastfeeding or to stop treatment with XIFAXAN 400 mg.

Driving and operating machinery
If adverse effects such as dizziness or drowsiness occur, the patient should not drive or operate machinery.
Otherwise, exercise caution.

Xifaxan 400 mg contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use XIFAXAN 400 mg

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of XIFAXAN 400 mg is:
Symptomatic uncomplicated diverticular disease of the colon:
Adult patients on a high-residue diet: 400 mg (1 tablet of 400 mg) every 12 hours.
To achieve optimal treatment results for symptom relief, the medicine should be taken for
7 days. Repeating the therapy once a month for up to one year, i.e. 12 cycles of 7-day treatment, may be necessary.
After complete resolution of symptoms, treatment should be discontinued. If there is no improvement in symptoms within 7 days of therapy, the patient should contact the doctor immediately. During long-term therapy, the patient should remain under close medical supervision.
Unless otherwise prescribed, a single treatment course should not exceed 7 days.
In the case of symptomatic uncomplicated diverticular disease of the colon, if repeated treatment is necessary, each subsequent treatment period should be preceded by a 30-day break from the medicine. If symptoms worsen or recur during this period, the patient should contact the doctor immediately.
Use in children and adolescents:
XIFAXAN 400 mg is intended for use in adults only.
Patients with renal impairment: Exercise caution in this patient group.
Patients with hepatic impairment: Dose adjustment is not required in this patient group.
Elderly patients: Dose adjustment is not required.
XIFAXAN 400 mg coated tablets should be swallowed with water.
Use of a higher than recommended dose of XIFAXAN 400 mg:
If a higher than recommended dose is taken, consult your doctor or pharmacist immediately.
Bring XIFAXAN 400 mg (the medicine and its packaging) with you to show the doctor or pharmacist.
Missed dose of XIFAXAN 400 mg
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Take the next dose at the regular time. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, XIFAXAN 400 mg may cause adverse reactions, although not
everyone will experience them.
Rifaximin should be discontinued immediately and the patient should contact a doctor or the
emergency department of the nearest hospital if any of the following symptoms occur:

• Reddish, flat, disc-shaped or round spots on the trunk, often with a centrally located 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 (pseudo-anaphylactic reaction), allergic reaction manifested by: 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 (occur in 1 to 10 patients out of 100): abdominal distension, abdominal pain,
constipation, sudden need for bowel movement, diarrhea, flatulence, nausea,
straining at stool, vomiting, fever, dizziness, headache.
Uncommon adverse reactions (occur in 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 fresh blood in stool, mucus in stool, taste disturbances, abnormal blood test results (increased white blood cell count, i.e. lymphocytes, increased monocyte count, decreased neutrophil granulocyte count), palpitations, dizziness, ear pain, double vision, weakness, pain and discomfort, chills, lack of drug efficacy, fatigue, flu-like illness, swelling of legs and (or) hands, fungal infection (candidiasis), yeast infection of the vagina, inflammation of nose and throat, pharyngitis, upper respiratory tract infections, increased liver enzyme activity (elevated aspartate aminotransferase activity), increased blood pressure, presence of blood cells and blood in urine, loss of appetite (anorexia), dehydration, back pain, muscle cramps, decreased muscle strength, neck pain, muscle pain, loss of taste, hypogeusia, migraine, tingling and burning sensation, sinus pain, somnolence, sleep disturbances, insomnia, nervousness, blood in urine, glucose in urine, frequent urination, polyuria, abnormally frequent menstruation, cough, dry throat, dyspnea, rhinitis, sore throat and larynx, watery nasal discharge, cold sweats, rash, urticaria (skin lesions), photosensitivity reactions, sudden flushing of the face.
Frequency unknown (frequency cannot be estimated from available data):
abnormal blood test results (reduced platelet count, abnormal liver function tests), hypersensitivity, disturbances in international normalized ratio (INR), infections caused by Clostridium bacteria (C. difficile), generalized reaction resembling a severe allergic reaction affecting several organs simultaneously, usually the circulatory system, lungs, skin (pseudo-anaphylactic reaction), allergic reaction manifested by swelling of the skin and (or) mucous membranes (angioedema), facial swelling, skin inflammation, rash, redness of the skin, itching, petechiae, urticaria, purpura, pre-syncopal state.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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. Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store XIFAXAN 400 mg

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicinal product.
Do not use XIFAXAN 400 mg after the expiry date stated on the blister and carton: EXP. 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. These measures help protect the environment.

6. Contents of the pack and other information

What XIFAXAN 400 mg contains

• The active substance is rifaximin.
• One coated tablet contains 400 mg of rifaximin.
• The other ingredients are: sodium carboxymethyl starch (type A), glyceryl distearate (type I), colloidal anhydrous silica, talc, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E 171), talc, Macrogol 4000 (polyethylene glycol), iron oxide red (E 172).

What XIFAXAN 400 mg looks like and contents of the pack
XIFAXAN 400 mg is a medicine in the form of pink, round, biconvex coated tablets.
XIFAXAN 400 mg tablets are packed in blisters made of PVC/PE/PVDC/Aluminium,
contained in a cardboard box.
Pack size of 14 tablets: 1 blister in a cardboard box.

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

For further information, please contact the representative of the Marketing Authorisation Holder.
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807 Warsaw
Tel. +48 22 824 03 64
e-mail: [email protected]
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