Tixteller 550 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
TIXTELLER 550 mg film-coated tablets
rifaximin
Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What TIXTELLER is and what it is used for
- What you need to know before taking TIXTELLER
- How to take TIXTELLER
- Possible side effects
- How to store TIXTELLER
- Contents of the pack and other information
1. What TIXTELLER is and what it is used for
TIXTELLER contains the active substance rifaximin. Rifaximin is an antibiotic that kills bacteria which may cause a condition 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 recurrence of episodes of overt hepatic encephalopathy.
TIXTELLER may be used alone or, more commonly, together with medications containing lactulose (a laxative).
2. What you need to know before taking TIXTELLER
Do not take TIXTELLER:
- if you are allergic to:
-rifaximin
-antibiotics similar to rifaximin (such as rifampicin or rifabutin)
-any of the other ingredients of this medicine (listed in section 6)
- if you have intestinal obstruction
Warnings and precautions
Consult your doctor or pharmacist before taking TIXTELLER if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking rifaximin.
Exercise special caution with rifaximin:
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with rifaximin treatment. Stop taking rifaximin and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.
While taking TIXTELLER, your urine may become reddish in color. This is normal.
Treatment with any antibiotic, including rifaximin, may cause severe diarrhea. This may occur several months after you have finished taking the medicine. If you develop severe diarrhea during or after treatment with TIXTELLER, you must stop taking TIXTELLER and contact your doctor immediately.
If you have severe liver problems, your doctor should monitor you closely.
TIXTELLER contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".
Children and adolescents
TIXTELLER is not recommended for children or 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 need to take any other medicines.
Inform 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)
- ciclosporin (immunosuppressant)
- oral contraceptives
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether TIXTELLER may harm the unborn baby. Therefore, TIXTELLER must not be used if you are pregnant.
It is unknown whether rifaximin passes into breast milk. Therefore, TIXTELLER must not be used if you are breastfeeding.
Driving and using machines
TIXTELLER normally does not affect the ability to drive or operate machinery, but it may cause dizziness in some patients. If you feel dizzy, you should not drive or operate machinery.
3. How to take TIXTELLER
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 1 tablet twice daily, 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 notice no problems, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91-562 04 20, indicating the medicine and the amount taken.
If you forget to take TIXTELLER
Take the next dose at your usual time. Do not take a double dose to make up for missed doses.
If you stop taking TIXTELLER
Do not stop taking TIXTELLER without first consulting your doctor, as symptoms may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop taking rifaximin and seek medical attention immediately if you notice any of the following symptoms:
Uncommon (can 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 taking this medicine. This may be due to an intestinal infection.
Frequency not known (cannot be estimated from available data)
- Reddish, non-elevated, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes 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
- hives and difficulty breathing.
- If you experience unexpected or unusual bleeding or bruising. This may be due to a decrease in platelets in the blood, increasing the risk of bleeding.
Other adverse effects that may occur:
Common (can affect up to 1 in 10 people)
- Depressed mood
- Dizziness
- Headache
- Difficulty breathing
- Nausea 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 (can affect up to 1 in 100 people)
- Yeast infections (such as candidiasis)
- Urinary tract infection (such as cystitis)
- Anaemia (reduction in red blood cells which may cause paleness, weakness, or shortness of breath)
- Loss of appetite
- Hyperkalaemia (high potassium levels in the blood)
- Confusion
- Anxiety
- Numbness
- Difficulty sleeping
- Feeling unsteady
- Memory loss or poor memory
- Difficulty concentrating
- Reduced sense of touch
- Seizures (epileptic fits)
- Hot flushes
- 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
- Oedema (swelling due to fluid accumulation in the body)
- Falls
Rare (can affect up to 1 in 1,000 people)
- Chest infections, including pneumonia
- Cellulitis (inflammation of tissue under the skin)
- Upper respiratory tract infections (nose, mouth, throat)
- Rhinitis (inflammation inside the nose)
- Dehydration (loss of body water)
- Changes in blood pressure
- Persistent breathing problems (such as chronic bronchitis)
- Constipation
- Back pain
- Protein in the urine
- Feeling of weakness
- Bruising
- Pain after a procedure
Frequency not known (cannot be estimated from available data)
- Fainting or feeling faint
- Skin irritation, eczema (dry, red, itchy skin)
- Decrease in platelets (seen in blood tests)
- Changes in liver function (seen in blood tests)
- Changes in blood clotting (International Normalised Ratio, seen in blood tests)
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of TIXTELLER
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date is the last day of the month indicated.
TIXTELLER does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are:
- Tablet core: sodium carboxymethylstarch type A (from potato), glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose.
- Tablet film-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 pack
Film-coated oval-shaped, convex, pink tablets, with "RX" engraved on one side.
TIXTELLER is available in boxes containing 14, 28, 42, 56 and 98 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder:
Alfasigma España, S.L.
C/ Aribau 195, 4º
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 medicinal product is authorized in the European Economic Area member states 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 the most recent revision of this leaflet: April 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/