Xifaxan 400 mg

Package Leaflet: User Information

XIFAXAN 400 mg, 400 mg, film-coated tablets

Rifaximin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 contains 400 mg of rifaximin.

Mode of action

XIFAXAN 400 mg is an oral antibacterial medicine, belonging to a class of medicines called rifamycins. 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 there is no improvement or the patient feels worse after 7 days of treatment, they should consult a doctor.

2. Important information before taking XIFAXAN 400 mg

When not to take XIFAXAN 400 mg:

• -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 movement of food through the intestines) and severe ulcerative colitis.

Warnings and precautions

Before starting treatment with this 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, mouth sores, and (or) oral ulcers after taking rifaximin.
• The patient should contact their doctor if they notice a reddish discoloration 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 reddish-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, which may lead to the appearance of a reddish discoloration 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: there is no need to modify the dose in this group of patients.
• 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 cautious 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 for the treatment of systemic bacterial infections, warfarin, antiepileptic medicines, antiarrhythmic medicines, 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 the tablet 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 baby, they should consult their doctor or pharmacist before taking this medicine.
XIFAXAN 400 mg should be avoided during pregnancy.
In case of treatment with XIFAXAN 400 mg in breastfeeding women, a decision should be made to either discontinue breastfeeding or discontinue XIFAXAN 400 mg treatment.

Driving and using machines

In case of side effects such as dizziness or drowsiness, the patient 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 essentially 'sodium-free'.

3. How to take XIFAXAN 400 mg

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient 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 there is no improvement in symptoms within 7 days of treatment, the patient should contact their doctor immediately. During long-term therapy, the patient should remain under close medical supervision.
If the medicine was not prescribed otherwise, a single treatment period should not exceed 7 days.
In case of symptomatic uncomplicated diverticular disease of the colon, if retreatment is necessary, each subsequent treatment period should be preceded by a 30-day interval. 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 group of patients.
Patients with hepatic impairment: there is no need to modify the dose in this group of patients.
Patients of advanced age: no dose adjustment is required.
XIFAXAN 400 mg film-coated tablets should be swallowed with water.

Overdose of XIFAXAN 400 mg:

In case of taking a higher dose than recommended, the patient should immediately consult their doctor or pharmacist.
The patient should take XIFAXAN 400 mg (the medicine and packaging) to show to their doctor or pharmacist.

Missed dose of XIFAXAN 400 mg:

In case of missing a dose at the right time, the patient should take it as soon as possible.
However, if it is close to the 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:

immediatelyif the patient notices any of the following symptoms:

• red, flat, target-like, or round patches on the torso, often with a central blister, skin peeling, mouth sores, 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, eczema, rash, rough skin, redness, 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, 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 (increased aspartate aminotransferase activity), increased blood pressure, presence of blood 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 inflammation, sore throat and larynx, runny nose, cold sweats, rash, skin eruption (skin changes), sensitivity to light, sudden facial flushing.
Frequency not known (frequency cannot be estimated from the available data): abnormal blood test results (decreased platelet count, abnormal liver function tests, hypersensitivity, disorders of international normalized ratio (INR), bacterial infections with Clostridium( C. difficile), generalized reaction, resembling a severe allergic reaction, affecting multiple organs, usually the circulatory system, lungs, skin (anaphylactoid reaction), allergic reaction with symptoms such as: skin swelling and (or) mucous membranes (angioedema), facial swelling, skin inflammation, rash, redness, itching, hives, eczema, skin eruption, anaphylactoid reaction.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help 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 of the medicinal product.
XIFAXAN 400 mg should not be used after the expiry date stated on the blister and carton, after: Expiry date (EXP). The expiry date refers to the last day of the 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: sodium carboxymethylcellulose (type A), glycerol distearate (type I), silicon dioxide, talc, microcrystalline cellulose, hypromellose 5 cP, hypromellose 15 cP, 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 tablets are packaged in PVC/PE/PVDC/Aluminum blisters in a carton.
A pack of 14 tablets contains: 1 blister in a carton.

Marketing authorization 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
Date of last revision of the leaflet:15.04.2024
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807, Warsaw
Phone: +48 22 824 03 64
e-mail: [email protected]
{Logo of the marketing authorization holder Alfasigma}