Texibax

Package leaflet: Information for the user

Texibax, 20 mg, enteric-coated tablets
Texibax, 40 mg, enteric-coated tablets
Esomeprazole magnesium, amorphous
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Texibax is and what it is used for
2. Important information before taking Texibax
3. How to take Texibax
4. Possible side effects
5. How to store Texibax
6. Contents of the pack and other information

1. What Texibax is and what it is used for

Texibax contains the active substance called esomeprazole, which belongs to a group of medicines known as proton pump inhibitors. These medicines work by reducing the amount of acid produced by the stomach.
Texibax is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This is a condition where acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers associated with infection by bacteria called Helicobacter pylori. If you have these conditions, your doctor may prescribe antibiotics to treat the infection and help heal the ulcers.
• Stomach ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Texibax may also be used to prevent stomach or duodenal ulcers in patients who are taking NSAIDs.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).
• Continuing treatment to prevent re-bleeding after intravenous esomeprazole therapy for peptic ulcer bleeding.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This is a condition where acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers associated with infection by bacteria called Helicobacter pylori. If you have these conditions, your doctor may prescribe antibiotics to treat the infection and help heal the ulcers.

2. Important information before using Texibax

When not to use Texibax

• if the patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other medicines from the group of proton pump inhibitors (e.g.: pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infections).

Do not take Texibax if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before taking Texibax.

Warnings and precautions

Before starting to take Texibax, discuss with your doctor or pharmacist if:

• the patient has severe liver disease,
• the patient has severe kidney function disorders,
• the patient has ever had a skin reaction after taking a medicine similar to Texibax that reduces gastric acid secretion, a specific blood test (chromogranin A level) may be planned.

Texibax may mask symptoms of other diseases. Therefore, if the patient experiences any of the
following symptoms before starting or while taking Texibax, contact a doctor immediately:
significant, unintentional weight loss without reason and difficulty swallowing,
abdominal pain or indigestion,
vomiting food or blood,
passing black stools (containing blood).

If Texibax has been prescribed for short-term use, contact a doctor if symptoms do not improve or change in nature.

Taking proton pump inhibitors such as Texibax, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if osteoporosis has been diagnosed or if the patient is taking corticosteroids (which may increase the risk of osteoporosis).

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as it may be necessary to discontinue treatment with Texibax. Also report any other adverse reactions such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4).
Severe skin rashes may cause ulceration of the mouth, throat, nose, and genital organs, as well as conjunctivitis (red and swollen eyes). Severe skin rashes often appear after flu-like symptoms such as fever, headache, and limb pain. The rash may affect large areas of the body and is accompanied by blistering and peeling of the skin. If a skin rash or any skin-related symptoms occur at any time during treatment (even after several weeks), stop taking this medicine and contact a doctor immediately.

Children under 12 years of age
Texibax enteric-coated tablets are not recommended for use in children under 12 years of age.

Texibax and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, or those the patient plans to take. This includes medicines taken without a prescription.

Texibax may affect how some medicines work, and some medicines may affect how Texibax works.

Do not take Texibax if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infections).

Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• atazanavir (used in the treatment of HIV infections),
• clopidogrel (used to prevent blood clots),
• ketoconazole, itraconazole, or voriconazole (used to treat fungal infections),
• erlotinib (used in cancer treatment),
• citalopram, imipramine, or clomipramine (used in the treatment of depression),
• diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy),
• phenytoin (used in the treatment of epilepsy). If the patient is taking phenytoin, the doctor will monitor the patient's condition when starting and stopping Texibax,
• anticoagulants such as warfarin. The doctor will monitor the patient's condition when starting and stopping Texibax,
• cilostazol (used in the treatment of intermittent claudication – leg pain during walking caused by poor blood supply),
• cisapride (used in the treatment of indigestion and heartburn),
• digoxin (used in the treatment of heart disorders),
• methotrexate (a medicine used in chemotherapy, at high doses in cancer treatment) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue treatment with Texibax,
• tacrolimus (used after organ transplants),
• rifampicin (used in the treatment of tuberculosis),
• St John's wort (Hypericum perforatum) (used in the treatment of depression).

If the doctor has prescribed antibiotics: amoxicillin, clarithromycin, and Texibax for the treatment of ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about all other medicines the patient is taking.

Texibax with food and drink
The tablets can be taken with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether she can take Texibax during this time.

It is not known whether esomeprazole passes into human milk. For this reason, Texibax should not be used during breastfeeding.

Driving and operating machinery
It is unlikely that esomeprazole affects the ability to drive or operate tools or machinery. However, dizziness or blurred vision may occur not very commonly or rarely (see section 4). In such cases, do not drive or operate machinery.

Texibax contains sucrose
Texibax contains sucrose – a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Texibax contains sodium
Texibax contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Texibax

This medicine should always be used exactly as instructed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.

• If this medicine is taken for a long time, medical monitoring may be necessary (especially if the patient takes the medicine for longer than one year).
• If the doctor has advised the patient to take this medicine on an as-needed basis, any changes in symptoms should be reported to the doctor.

Dosage

• The doctor will inform the patient how much and for how long to take the tablets. This depends on the patient's condition, age, and liver function.
• Recommended doses are given below.

Adults aged 18 years and over
Treatment of heartburn caused by gastroesophageal reflux disease:

• If the doctor has diagnosed minor esophageal damage, the recommended dose is one 40 mg enteric-coated tablet of Texibax once daily for 4 weeks. If healing of the esophagus has not occurred, the doctor may recommend continuing the same dose for another 4 weeks.
• The recommended dose after healing of the esophagus is one 20 mg tablet of Texibax once daily.
• If the esophagus was not damaged, the recommended dose is one 20 mg tablet of Texibax once daily. After symptom control is achieved, the doctor may recommend taking the medicine on an as-needed basis, up to a maximum of one 20 mg tablet of Texibax once daily.
• If the patient has severe liver disease, the doctor may prescribe a lower dose.

Treatment of peptic ulcer caused by Helicobacter pylori infection and prevention of
disease recurrence:

• The recommended dose is one 20 mg tablet of Texibax twice daily for one week.
• The doctor will also advise the patient to take antibiotics, such as amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by use of NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg tablet of Texibax once daily for 4 to 8 weeks.

Prevention of gastric or upper intestinal ulcers during use of NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg tablet of Texibax once daily.

Treatment of excess stomach acid caused by a pancreatic tumour (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg tablet of Texibax twice daily.
• The doctor will adjust the dose according to the patient's needs and determine how long the patient should continue taking the medicine. The maximum dose is 80 mg twice daily.

Continuation of treatment to prevent re-bleeding from peptic ulcers following intravenous administration of esomeprazole:

• The recommended dose is one 40 mg tablet of Texibax once daily for 4 weeks.

Adolescents aged 12 years and older
Treatment of heartburn caused by gastroesophageal reflux disease:

• If the doctor has diagnosed minor esophageal damage, the usual dose is one 40 mg enteric-coated tablet of Texibax once daily for 4 weeks. If healing of the esophagus has not occurred, the doctor may recommend continuing the same dose for another 4 weeks.
• The recommended dose after healing of the esophagus is one 20 mg tablet of Texibax once daily.
• If the esophagus was not damaged, the recommended dose is one 20 mg tablet of Texibax once daily.
• If the patient has severe liver disease, the doctor may prescribe a lower dose.

Treatment of peptic ulcer caused by Helicobacter pylori infection and prevention of
disease recurrence:

• The recommended dose is one 20 mg tablet of Texibax twice daily for one week.
• The doctor will also advise the patient to take antibiotics, such as amoxicillin and clarithromycin.

Method and route of administration

• Tablets may be taken at any time of day.
• Tablets may be taken with or without food.
• Swallow the tablets whole with water. Do not chew or crush the tablets, as they contain coated pellets designed to prevent the medicine from breaking down in the acidic environment of the stomach. It is important not to damage the pellets.

In case of difficulty swallowing

• If the patient has difficulty swallowing the tablets:
  • Place them in a glass of still water. Do not use any other liquid.
  • Stir until the tablets disintegrate (the mixture will not be clear). Drink the mixture immediately or within 30 minutes. Stir well just before drinking.
  • To ensure the patient receives the full dose, thoroughly rinse the glass with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush them.
• If the patient cannot swallow independently, the tablet may be mixed with a small amount of water and transferred to a syringe. It can then be administered via a tube (gastric feeding tube) directly into the stomach.

Use in children under 12 years of age
Texibax should not be used in children under 12 years of age. Other pharmaceutical forms of this medicine may be more suitable for this age group.
Elderly patients
No dose adjustment is necessary in elderly patients.
Use of a higher than recommended dose of Texibax
If a dose higher than recommended by the doctor is taken, consult a doctor or pharmacist immediately.
Missed dose of Texibax
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose.
Do not take a double dose to make up for a missed tablet.
If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking Texibax and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Blisters and bleeding of the lips, eyes, mouth, nose and genital organs may also occur. These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine and fatigue, which may be signs of liver disease.

These adverse reactions are rare and may occur in 1 out of 1,000 people.
Other adverse reactions include:
Common (may occur in 1 out of 10 people)

• headache,
• effects on stomach or intestines: diarrhoea, abdominal pain, constipation, bloating,
• nausea or vomiting,
• mild gastric polyps.

Uncommon (may occur in 1 out of 100 people)

• swelling of feet and ankles,
• sleep disturbances (insomnia),
• dizziness, tingling sensation, drowsiness,
• sensation of spinning (vertigo),
• dry mouth,
• changes in blood test results indicating liver function,
• rash, raised itchy rash (urticaria) and itching of the skin,
• fractures of the hip, wrist or spine (if Texibax is used at high doses and for a prolonged period).

Rare (may occur in 1 out of 1,000 people)

• blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, easy bruising or increased susceptibility to infections,
• low sodium levels in the blood. This may cause weakness, vomiting and muscle cramps,
• feeling agitated, confused or depressed,
• taste disturbances,
• visual disturbances such as blurred vision,
• sudden wheezing or shortness of breath (bronchospasm),
• inflammation of the mucous membrane of the mouth,
• fungal infection called candidiasis, which may affect the intestines and is caused by fungi,
• liver diseases, including jaundice, which may cause yellowing of the skin, dark urine and fatigue,
• hair loss (alopecia),
• rash occurring during exposure to sunlight,
• joint pain or muscle pain,
• malaise and lack of energy,
• increased sweating.

Very rare (may occur in 1 out of 10,000 people)

• blood cell disorders, including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling or hearing things that are not real (hallucinations),
• severe liver dysfunction leading to liver failure and encephalopathy,
• sudden onset of severe rash or blisters, or skin peeling. This may be accompanied by high fever and joint pain [erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)],
• muscle weakness,
• severe kidney dysfunction,
• breast enlargement in males.

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

• if the patient has been taking Texibax for longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, the doctor should be informed immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• inflammation of the intestine (leading to diarrhoea);
• rash which may be associated with joint pain.

Texibax may very rarely affect white blood cells, leading to weakened immunity. If the patient develops an infection with symptoms such as fever with very poor general condition or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, contact the doctor immediately for blood tests to rule out white blood cell deficiency (agranulocytosis). It is very important to inform the doctor about all currently used medicines.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Texibax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Store below 30°C.
Keep in the original packaging (blister) to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Texibax contains
The active substance is esomeprazole.
20 mg: Each tablet contains 20 mg of esomeprazole (as amorphous esomeprazole magnesium).
40 mg: Each tablet contains 40 mg of esomeprazole (as amorphous esomeprazole magnesium).

The other ingredients are:
Tablet core: sucrose, granules (sucrose, corn starch), hydroxypropylcellulose, crospovidone (Type B), povidone (K30), polyethylene glycol 400, talc, hypromellose phthalate (HP-55S), hypromellose phthalate (HP-50), diethyl phthalate, polyethylene glycol 6000, microcrystalline cellulose PH 101, microcrystalline cellulose PH 112, crospovidone (Type A), sodium stearyl fumarate.
Coating: Opadry 03B86651 Brown (HPMC 2910/Hypromellose 6cP, titanium dioxide (E 171), polyethylene glycol / PEG 400, talc, iron oxide red (E 172)), polyethylene glycol 4000.

What Texibax looks like and contents of the pack
Texibax enteric-coated tablets, 20 mg are light brick-red to brown, oval, biconvex, coated tablets, with the imprint "E5" on one side and smooth on the other.
Texibax enteric-coated tablets, 40 mg are light brick-red to brown, oval, biconvex, coated tablets, with the imprint "E6" on one side and smooth on the other.

The product is available in packs of:
20 mg and 40 mg: OPA/Aluminium/PE/moisture-absorbing agent/HDPE/Aluminium blisters containing 28 tablets.
20 mg and 40 mg: OPA/Aluminium/PVC/Aluminium blisters containing 28 tablets.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw, Poland

Manufacturer
Terapia SA, 124 Fabricii Street, 400 632 Cluj Napoca, Romania
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, The Netherlands