TIXTELLER 550 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

TIXTELLER 550 mg film-coated tablets

rifaximin

Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is TIXTELLER and what is it used for
2. What you need to know before you take TIXTELLER
3. How to take TIXTELLER
4. Possible side effects
5. Storage of TIXTELLER
6. Contents of the pack and other information

1. What is TIXTELLER and what is it used for

TIXTELLER contains the active substance rifaximin. Rifaximin is an antibiotic that eliminates bacteria that can cause a disease called hepatic encephalopathy (symptoms include agitation, confusion, muscle problems, difficulty speaking, and in some cases, coma).

TIXTELLER is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy.

TIXTELLER may be used alone or, more commonly, in combination with medications containing lactulose (a laxative).

2. What you need to know before you take TIXTELLER

Do not take TIXTELLER:

• if you are allergic to:

-rifaximin

-similar antibiotics (such as rifampicin or rifabutin)

-any of the other components of this medicine (listed in section 6)

• if you have an intestinal obstruction

Warnings and precautions

Consult your doctor or pharmacist before starting to take TIXTELLER if you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rifaximin.

Be careful with rifaximin:

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with rifaximin treatment. Stop using rifaximin and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

While taking TIXTELLER, your urine may turn reddish. This is normal.

Treatment with any antibiotic, including rifaximin, can cause severe diarrhea. This can happen several months after you have finished taking the medicine. If you have severe diarrhea during or after using TIXTELLER, you should stop taking TIXTELLER and contact your doctor immediately.

If your liver problems are severe, your doctor should keep you under close observation.

TIXTELLER contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

Children and adolescents

TIXTELLER is not recommended for children and adolescents under 18 years of age. This medicine has not been studied in children and adolescents.

Other medicines and TIXTELLER

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• antibiotics (medicines to treat infections)
• warfarin (medicine to prevent blood clotting)
• antiepileptics (medicines to treat epilepsy)
• antiarrhythmics (medicines to treat abnormal heart rhythm)
• cyclosporin (immunosuppressant)
• oral contraceptives

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if TIXTELLER can harm the fetus. Therefore, TIXTELLER should not be used if you are pregnant.

It is not known if rifaximin can pass into breast milk. Therefore, TIXTELLER should not be used if you are breastfeeding.

Driving and using machines

TIXTELLER normally does not affect your ability to drive or use machines, but it can cause dizziness in some patients. If you feel dizzy, do not drive or operate machinery.

3. How to take TIXTELLER

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet twice a day taken with a glass of water.

Continue taking TIXTELLER until your doctor tells you to stop.

If you take more TIXTELLER than you should

If you have taken more tablets than you should, even if you do not notice any problems, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medicine and the amount taken.

If you forget to take TIXTELLER

Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking TIXTELLER

Do not stop taking TIXTELLER without consulting your doctor first, because the symptoms may come back.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop using rifaximin and seek immediate medical attention if you notice any of the following symptoms:

Uncommon(may affect up to 1 in 100 people)

• If you have bleeding from swollen blood vessels in the throat (esophageal varices).
• If you have severe diarrhea during or after using this medicine. This can be due to an intestinal infection.

Frequency not known(cannot be estimated from the available data)

• Reddish, non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, mouth ulcers, and/or sores in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms.
• If you experience an allergic reaction, hypersensitivity, or angioedema. Symptoms include:
  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty swallowing.
• If you have any unexpected or unusual bleeding or bruising. This can be due to a decrease in platelets in the blood, which increases the risk of bleeding.

Other side effects that may occur:

Common(may affect up to 1 in 10 people)

• Depressed mood
• Dizziness
• Headache
• Breathing difficulties
• Feeling sick or vomiting
• Stomach pain or bloating
• Diarrhea
• Fluid accumulation in the abdominal cavity (ascites)
• Skin rash or itching
• Muscle cramps
• Joint pain
• Swelling of the ankles, feet, or fingers

Uncommon(may affect up to 1 in 100 people)

• Fungal infections (such as candidiasis)
• Urinary tract infection (such as cystitis)
• Anemia (decrease in red blood cells that can make the skin pale and cause weakness or breathing difficulties)
• Loss of appetite
• High potassium levels in the blood (hyperkalemia)
• Confusion
• Anxiety
• Numbness
• Difficulty sleeping
• Feeling unsteady
• Memory loss or poor memory
• Decreased concentration
• Decreased sense of touch
• Seizures (epileptic fits)
• Hot flashes
• Fluid around the lungs (pleural effusion)
• Abdominal pain
• Dry mouth
• Muscle pain
• Need to urinate more frequently than usual
• Difficulty or pain when urinating
• Fever
• Edema (swelling due to fluid accumulation in the body)
• Falls

Rare(may affect up to 1 in 1,000 people)

• Chest infections, including pneumonia
• Cellulitis (inflammation of the tissue under the skin)
• Infections of the upper respiratory tract (nose, mouth, throat)
• Rhinitis (inflammation inside the nose)
• Dehydration (loss of body water)
• Changes in blood pressure
• Chronic respiratory problems (such as chronic bronchitis)
• Constipation
• Back pain
• Protein in the urine
• Feeling weak
• Bruising
• Pain after an operation

Frequency not known(cannot be estimated from the available data)

• Fainting or feeling faint
• Skin irritation, eczema (dry, red, and itchy skin)
• Decrease in platelets (seen in blood tests)
• Changes in liver function (seen in blood tests)
• Changes in blood clotting (International Normalized Ratio, seen in blood tests)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TIXTELLER

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

TIXTELLER does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of TIXTELLER

The active substance is rifaximin. Each tablet contains 550 mg of rifaximin.

The other ingredients are:

• Core of the tablet: sodium carboxymethyl starch type A (potato), glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose.
• Tablet coating (opadry oy-s-34907): hypromellose, titanium dioxide (E171), disodium edetate, propylene glycol, iron oxide red (E172)

Appearance of the product and pack contents

Film-coated tablets, oval, convex, and pink, with "RX" engraved on one side.

TIXTELLER is available in packs of 14, 28, 42, 56, and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Alfasigma Spain, S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, SPAIN

Manufacturer:

Alfasigma, S.p.A.

Via Enrico Fermi, 1

65020 Alanno, Pescara, ITALY

ALFASIGMA, S.p.A.

Via Pontina Km 30,400

00071 Pomezia, Rome, ITALY

This medicine is authorized in the Member States of the European Economic Area under the following names:

REFERO: Austria, Hungary, Luxembourg, Portugal, Slovak Republic

TIXTELLER: Belgium, Germany, Italy, Netherlands, Poland, Romania, Spain

TIXTAR: France

RIFAXIMIN ALFASIGMA: Ireland

Date of last revision of this leaflet: April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/