Tixteller

Package leaflet: Information for the user

TIXTELLER 550 mg coated tablets
rifaximin
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What TIXTELLER is and what it is used for
2. What you need to know 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 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 restlessness, confusion, muscle problems, difficulty speaking, and in some cases coma).
TIXTELLER is used in adults with liver disease to reduce recurrences 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 use TIXTELLER:

• if the patient is allergic to:
  • rifaximin
  • similar types of antibiotics (such as rifampicin or rifabutin)
  • any of the other ingredients of this medicine (listed in section 6)
• if the patient has intestinal obstruction

Warnings and precautions
Before starting treatment with TIXTELLER, consult a doctor or pharmacist if the patient has ever experienced severe skin rash, skin peeling, skin blisters and/or oral mucosal ulcers after taking rifaximin.
Extreme 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 medical advice should be sought.
During treatment with TIXTELLER, urine may turn red. This is a normal reaction.
Treatment with any antibiotic, including rifaximin, may cause severe diarrhoea, which may occur several months after completion of treatment. If the patient develops severe diarrhoea during or after treatment with TIXTELLER, the medication should be stopped immediately and a doctor should be consulted without delay.
If liver problems are severe, the patient will require close monitoring.

TIXTELLER contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

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

TIXTELLER and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform your doctor if the patient is taking any of the following medicines:

• antibiotics (medicines used to treat infections)
• warfarin (a medicine used to prevent blood clots)
• antiepileptic medicines (medicines used to treat epilepsy)
• antiarrhythmic medicines (medicines used to treat heart rhythm disorders)
• cyclosporine (an immunosuppressant medicine)
• oral contraceptives

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is planning to become pregnant, or is breastfeeding, consult a doctor or pharmacist before taking this medicine.
It is unknown whether TIXTELLER may harm the unborn child. Therefore, TIXTELLER should not be used during pregnancy.
It is not known whether rifaximin passes into breast milk and reaches the infant. TIXTELLER must not be used during breastfeeding.

Driving and operating machinery
TIXTELLER generally does not affect the ability to drive or operate machinery. However, in some patients it may cause dizziness. If dizziness occurs, the patient should not drive or operate machinery.

3. How to take Tixteller

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet taken twice daily, swallowed with a glass of water.
Continue treatment for as long as your doctor recommends.
Taking more Tixteller than prescribed
If you take more tablets than recommended, even if there are no disturbing symptoms, you should contact your doctor.
Missing a dose of Tixteller
Take the next dose at your usual time. Do not take a double dose to make up for a missed tablet.
Stopping Tixteller
Do not stop taking Tixteller without consulting your doctor first, as symptoms of the disease may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rifaximin must be discontinued immediately and a doctor should be contacted if the patient
experiences any of the following symptoms:
Uncommon: may affect up to 1 in 100 patients

• If the patient has bleeding from dilated blood vessels in the throat (oesophageal varices).
• If the patient develops severe diarrhoea during or after treatment with this medicine. This may be due to an intestinal infection. Frequency is unknown (cannot be estimated from available data)
• Reddish, flat, target-like or round skin lesions on the trunk, often with a centrally located blister, skin peeling, and ulceration of the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms.
• If an allergic reaction, hypersensitivity, or angioedema occurs. Symptoms include:
  • swelling of the face, tongue, and throat
  • difficulty swallowing
  • rash and breathing difficulties.
• If unexplained or unusual bleeding or bruising occurs. This may be due to a reduced number of platelets in the blood and may increase the risk of bleeding.

Other adverse reactions may include
The following are common adverse reactions (may affect up to 1 in 10 patients):

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

The following are uncommon adverse reactions (may affect up to 1 in 100 patients):

• Fungal infection (such as candidiasis)
• Urinary tract infection (such as cystitis)
• Anaemia (a condition in which there is a reduced number of red blood cells, which may cause pale skin, weakness, or breathlessness)
• Loss of appetite
• Hyperkalaemia (high potassium levels in the blood)
• Confusion
• Anxiety
• Drowsiness
• Sleep disturbances
• Feeling of imbalance
• Memory loss or memory problems
• Difficulty concentrating
• Reduced sense 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
• Oedema (swelling caused by excess fluid in the body)
• Falls

The following are rare adverse reactions (may affect up to 1 in 1,000 patients):

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

Frequency is unknown (cannot be estimated from available data):

• Fainting or feeling faint
• Skin irritation, eczema (itching, redness, dry skin)
• Decreased platelet count (observed in blood tests)
• Changes in liver function (observed in blood tests)
• Changes in blood coagulation (elevated International Normalized Ratio – INR, observed in blood tests)

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine TIXTELLER

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date". The expiry date refers to the last day of the stated month.
There are no special storage requirements for the medicine TIXTELLER.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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.
Other components of the medicine are:

• Tablet core: Sodium carboxymethyl starch type A, glyceryl 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).

What TIXTELLER looks like and contents of the pack
Pink, oval, biconvex coated tablets with "RX" debossed on one side.
TIXTELLER is available in cardboard boxes containing 14, 28, 42, 56, and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, please contact the representative of the Marketing Authorisation 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 authorised in the European Economic Area countries under the following trade names:
Refero: Austria, Hungary, Luxembourg, Portugal, Slovakia
Tixteller: Belgium, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain
Tixtar: France, Greece, Italy, Spain
Rifaximin Alfasigma: Ireland