Leaflet: information for the user

TIXTELLER 550 mg film-coated tablets

rifaximina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What TIXTELLER is and what it is used for

2. What you need to know before you start taking TIXTELLER

3. How to take TIXTELLER

4. Possible side effects

5.Storage of TIXTELLER

6.Contents of the pack and additional information

TIXTELLER contains the active ingredient rifaximin. Rifaximin is an antibiotic that eliminates bacteria that can cause a disease called hepatic encephalopathy (among the symptoms are 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).

Do not take TIXTELLER:

• if you are allergic to:

- rifaximin

- similar antibiotics (such as rifampicin or rifabutin)

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

• if you have an intestinal obstruction

Warnings and precautions

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

Be especially 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 medical attention immediately 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 in color. This is normal.

Treatment with any antibiotic, including rifaximin, may cause severe diarrhea. This can occur several months after you have stopped taking the medication. If you have severe diarrhea during or after using TIXTELLER, stop taking TIXTELLER and contact your doctor immediately.

If you have severe liver problems, your doctor will need to closely monitor you.

TIXTELLER contains sodium

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

Children and adolescents

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

Other medications and TIXTELLER

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you are taking any of the following medications:

- antibiotics (infection medications)

- warfarin (blood clot prevention medication)

- antiepileptics (epilepsy medications)

- antiarrhythmics (abnormal heart rhythm medications)

- ciclosporin (immunosuppressant)

- oral contraceptives

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of TIXTELLER for use during pregnancy is unknown. Therefore, TIXTELLER should not be used if you are pregnant.

The safety of rifaximin for use during breastfeeding is unknown. Therefore, TIXTELLER should not be used if you are breastfeeding.

Driving and operating machinery

TIXTELLER usually does not affect your ability to drive and operate machinery, but it may cause dizziness in some patients. If you feel dizzy, do not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet taken twice a day 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 Toxicological Information Service, phone 91-562 04 20, indicating the medication 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 the missed doses.

If you interrupt treatment with TIXTELLER

Do not stop taking TIXTELLER without first consulting your doctor, as symptoms may return.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Rare(may affect up to 1 in 100 people)

• If you have a bleeding of swollen blood vessels in the throat (esophageal varices).

• If you have severe diarrhea during or after taking this medicine. This may be due to an intestinal infection.

Frequency unknown(cannot be estimated from available data)

•Flat, red, non-elevated spots or circular patches on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may 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

- Urticaria and difficulty swallowing.

• If you have any unexpected or unusual bleeding or hematoma. This may be due to a decrease in platelets in the blood, which increases the risk of bleeding.

Other side effects that may occur:

Frequent(may affect up to 1 in 10 people)

• Depressed mood

• Dizziness

• Headache

• Difficulty breathing

• Nausea or vomiting sensation

• Abdominal pain or meteorism/ bloating

• Diarrhea

• Ascites (fluid accumulation in the abdominal cavity)

• Skin rash or itching

• Muscle cramps

• Joint pain

• Swelling of the ankles, feet, or hands

Rare(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 may cause pale skin and weakness or difficulty breathing)

• Loss of appetite

• Hyperkalemia (elevated potassium levels in the blood)

• Confusion

• Anxiety

• Numbness sensation

• Difficulty sleeping

• Feeling of instability

• Memory loss or poor memory

• Difficulty concentrating

• Decreased sense of touch

• Seizures (epileptic crises)

• Hot flashes

• Fluid around the lungs (pleural effusion)

• Abdominal pain

• Dry mouth

• Muscle pain

• Frequent need to urinate

• Difficulty or pain while urinating

• Fever

• Edema (swelling due to fluid accumulation in the body)

• Falls

Very rare(may affect up to 1 in 1,000 people)

• Thoracic infections, including pneumonia

• Cellulitis (inflammation of the tissue under the skin)

• Upper respiratory tract infections (nose, mouth, throat)

• Rhinitis (inflammation inside the nose)

• Dehydration (loss of body water)

• Blood pressure changes

• Chronic respiratory problems (such as chronic bronchitis)

• Constipation

• Back pain

• Protein in the urine

• Feeling of weakness

• Hematoma

• Pain after an intervention

Frequency unknown(cannot be estimated from available data)

• Fainting or feeling of fainting

• Skin irritation, eczema (dry, red skin that itches)

• Decreased 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

TIXTELLER does not require special conditions for conservation.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition of TIXTELLER

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

The other components are:

-Tablet core:carboxymethylcellulose sodium type A (from potato), diestearoyl glycerol, anhydrous colloidal 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 contents of the packaging

Film-coated, oval, convex tablets, pink in color, with “RX” engraved on one side.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona. SPAIN

Manufacturer responsible:

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 medicinal product is authorized in the member states of the European Economic Area with the following names:

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

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

TIXTAR: France

RIFAXIMIN ALFASIGMA: Ireland

Last review date of this leaflet: April 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/