Tixteller

Leaflet attached to the packaging: Information for the user

TIXTELLER 550 mg film-coated tablets

Rifaximin

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section
• 4.

Table of contents of the leaflet

• 1. What is TIXTELLER and what is it used for
• 2. Important information before taking TIXTELLER
• 3. How to take TIXTELLER
• 4. Possible side effects
• 5. How to store 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 destroys bacteria that can cause a disease called hepatic encephalopathy (whose symptoms include restlessness, confusion, muscle problems, speech difficulties, and in some cases coma). The medicine TIXTELLER is used in adults with liver disease to reduce the recurrence of episodes of overt hepatic encephalopathy. TIXTELLER may be used alone or in combination with lactulose-containing medicines (laxatives).

2. Important information before taking TIXTELLER

When not to take TIXTELLER:

• rifaximin
• similar types of antibiotics (such as rifampicin or rifabutin)
• any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with TIXTELLER, discuss it with your doctor or pharmacist if you have ever had a severe skin rash or skin peeling, blisters on the skin and (or) mouth ulcers after taking rifaximin. Particular caution should be exercised when using rifaximin. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with rifaximin treatment. If any severe skin reaction described in section 4 occurs, rifaximin should be discontinued immediately and a doctor consulted. While taking TIXTELLER, urine may be colored red. This is a normal reaction. Treatment with any antibiotic, including rifaximin, may cause severe diarrhea. This can happen several months after the end of treatment with TIXTELLER. If you experience severe diarrhea during or after treatment with TIXTELLER, discontinue TIXTELLER and consult your doctor immediately. If liver problems are severe, the patient will be under close supervision.

TIXTELLER contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

Children and adolescents

TIXTELLER is not recommended for use in children and adolescents below 18 years. This medicine has not been studied in children and adolescents.

TIXTELLER and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. Tell your doctor if you are taking any of the following medicines:

• antibiotics (medicines used to treat infections)
• warfarin (a medicine that prevents blood clotting)
• antiepileptic medicines (medicines used to treat epilepsy)
• antiarrhythmic medicines (medicines used to treat heart rhythm disorders)
• cyclosporin (an immunosuppressive medicine)
• oral contraceptives

Pregnancy and breastfeeding

If you are pregnant, 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 whether TIXTELLER may harm your unborn child. Therefore, do not take TIXTELLER if you are pregnant. It is not known whether rifaximin passes into breast milk. Do not take TIXTELLER if you are breastfeeding.

Driving and using machines

TIXTELLER usually does not affect the ability to drive or use machines, but it may cause dizziness in some patients. If you experience dizziness, do not drive or use machines.

3. How to take TIXTELLER

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one tablet taken twice a day, swallowed with a glass of water. Continue treatment until your doctor tells you to stop.

Take more TIXTELLER than recommended

If you have taken more tablets than recommended, even if you do not have any symptoms, contact your doctor.

Miss a dose of TIXTELLER

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

Stop taking TIXTELLER

Do not stop taking TIXTELLER without consulting your doctor first, as your symptoms may return. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking rifaximin and contact your doctor immediately if you notice any of the following:

Uncommon: may affect up to 1 in 100 people

• If you have bleeding from an enlarged blood vessel in the throat (esophageal varices).
• If you have had severe diarrhea during or after taking this medicine. This may be due to a gut infection. Frequency not known (cannot be estimated from the available data)
• Red, non-raised, target-like or circular patches on the torso, often with a central blister, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin reactions 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, and throat
• difficulty swallowing
• rash and difficulty breathing.
• If you experience unexplained or unusual bleeding or bruising. This may be due to a decrease in platelet count and may increase the risk of bleeding.

Other side effects may include
Commonside effects (may affect up to 1 in 10 people) include

• Worsening of mood
• Dizziness
• Headache
• Shortness of breath
• Nausea or vomiting
• Stomach pain or bloating
• Diarrhea
• Fluid accumulation in the abdominal cavity (ascites)
• Rash or itching
• Muscle cramps
• Joint pain
• Swelling of the ankles, feet, or toes

Uncommonside effects (may affect up to 1 in 100 people) include

• Fungal infections (such as thrush)
• Urinary tract infections (such as cystitis)
• Anemia (a condition where the number of red blood cells is reduced, which can cause pale skin, weakness, or shortness of breath)
• Loss of appetite
• Hyperkalemia (high potassium levels in the blood)
• Confusion
• Anxiety
• Drowsiness
• Sleep disturbances
• Loss of balance
• Memory loss or memory problems
• Lack of concentration
• Decreased sensation of touch
• Seizures
• Sudden flushing of the face
• Fluid accumulation around the lungs
• Abdominal pain
• Dry mouth
• Muscle pain
• Need to urinate more frequently than usual
• Difficulty or pain when urinating
• Fever
• Swelling (swelling caused by excess fluid in the body)
• Falls

Rareside effects (may affect up to 1 in 1,000 people) include

• Chest infections, including pneumonia
• Cellulitis (inflammation of the connective tissue)
• Upper respiratory tract infections (such as nose, mouth, throat)
• Nasal passage inflammation
• Dehydration (loss of water from the body)
• Changes in blood pressure
• Chronic breathing difficulties (such as chronic bronchitis)
• Constipation
• Back pain
• Protein in the urine
• Feeling of weakness
• Bruises
• Pain after surgery

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

• Fainting or feeling faint
• Skin irritation, eczema (itching, redness, dry skin)
• Decreased platelet count (visible in blood tests)
• Changes in liver function (visible in blood tests)
• Changes in blood clotting (Normalized Prothrombin Time - INR, visible in blood tests)

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month. There are no special storage instructions for TIXTELLER. 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

What TIXTELLER contains

The active substance is rifaximin. One tablet contains 550 mg of rifaximin. The other ingredients are:

• Tablet core: Carboxymethylcellulose sodium, glycerol distearate, silica colloidal anhydrous, talc, microcrystalline cellulose.
• Tablet coating (opadry oy-s-34907): Hypromellose, titanium dioxide (E171), disodium edetate, propylene glycol, iron oxide red (E172)

What TIXTELLER looks like and contents of the pack

Pink, oval, biconvex film-coated tablets with "RX" engraved on one side. TIXTELLER is available in cartons of 14, 28, 42, 56, and 98 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

ALFASIGMA S.p.A.
Via Ragazzi del ’99, n. 5
40133 Bologna (BO)
Italy

Manufacturer

ALFASIGMA S.p.A.Via E. Fermi, 1 65020 - Alanno (PE) Italy
ALFASIGMA S.p.A.Via Pontina Km 30,400 - 00071 Pomezia (RM) Italy
To obtain further information, contact the marketing authorization holder. Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807, Warsaw
Tel. +48 22 824 03 64
e-mail: [email protected]

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

Refero:Austria, Hungary, Luxembourg, Portugal, Slovakia, Tixteller:Belgium, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain
Tixtar:France, Greece, Italy, Spain
Rifaximin Alfasigma: Ireland
Date of last revision of the leaflet:15.04.2024