TEXIBAX 40 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Texibax, 20 mg, gastro-resistant tablets
3. Texibax, 40 mg, gastro-resistant tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Texibax and what is it used for
5. Important information before taking Texibax
   1. When not to take Texibax
   2. Warnings and precautions
   3. Texibax and other medicines
   4. Texibax with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Texibax contains sucrose
   8. Texibax contains sodium
6. How to take Texibax
   1. Dosage
   2. Adults aged 18 years and older
   3. Treatment of heartburn caused by gastroesophageal reflux disease:
   4. Treatment of stomach ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs):
   5. Prevention of stomach ulcers or duodenal ulcers when taking non-steroidal anti-inflammatory drugs (NSAIDs):
   6. Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):
   7. After intravenous administration of esomeprazole, continuation of prevention of rebleeding from peptic ulcers:
   8. Adolescents aged 12 years and older
   9. Treatment of heartburn caused by gastroesophageal reflux disease:
   10. Method and route of administration
   11. In case of swallowing difficulties
   12. Use in children under 12 years of age
   13. Elderly patients
   14. Overdose of Texibax
   15. Missed dose of Texibax
7. Possible side effects
   1. If you experience any of the following serious side effects, stop taking Texibax and contact your doctor immediately:
   2. Common (may affect up to 1 in 10 people)
   3. Uncommon (may affect up to 1 in 100 people)
   4. Rare (may affect up to 1 in 1,000 people)
   5. Very rare (may affect up to 1 in 10,000 people)
   6. Frequency not known (cannot be estimated from the available data)
   7. Reporting side effects
8. How to store Texibax
9. Contents of the packaging and other information
   1. What Texibax contains
   2. What Texibax looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet accompanying the packaging: patient information

Texibax, 20 mg, gastro-resistant tablets

Texibax, 40 mg, gastro-resistant tablets

Ezomeprazole magnesium, amorphous

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Texibax and what is it 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 packaging and other information

1. What is Texibax and what is it used for

Texibax contains the active substance ezomeprazole, which belongs to a group of medicines called proton pump inhibitors. Their action involves reducing the amount of acid produced by the stomach.

Texibax is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease. This is when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or duodenal ulcers with Helicobacter pylori infection. If these conditions occur, the doctor may prescribe antibiotics to treat the infection and heal the ulcers.
• Stomach ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Texibax can also be used to prevent stomach ulcers or duodenal ulcers when taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• After intravenous administration of esomeprazole, continuation of prevention of rebleeding from peptic ulcers.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease. This is when stomach acid flows back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or duodenal ulcers with Helicobacter pylori infection. If these conditions occur, the doctor may prescribe antibiotics to treat the infection and heal the ulcers.

2. Important information before taking Texibax

When not to take Texibax

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

Warnings and precautions

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

• the patient has severe liver disease,
• the patient has severe kidney problems,
• the patient has ever had a skin reaction after taking a medicine that reduces stomach acid (e.g., lansoprazole, omeprazole, pantoprazole, rabeprazole), a specific blood test (chromogranin A levels) is planned.

Texibax may mask the symptoms of other diseases. Therefore, if the patient experiences any of the following symptoms before starting or during treatment with Texibax, they should contact their doctor immediately:
significant, unintentional weight loss without cause and difficulty swallowing,
abdominal pain or indigestion,
vomiting blood or food,
passing black stools (with blood).
If Texibax is prescribed for on-demand treatment, the patient should contact their doctor if the symptoms do not improve or change.
Taking proton pump inhibitors like Texibax, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Texibax. The patient should also report any other side effects, such as joint pain.
Severe skin reactions have occurred in patients taking esomeprazole (see also section 4).
A rash may cause mouth sores, throat, nose, genital, and eye inflammation (red and swollen eyes). Severe skin reactions often occur after flu-like symptoms, such as fever, headache, and limb pain. The rash may cover large areas of the body and is accompanied by blistering and peeling of the skin. If a skin rash or any skin symptoms occur at any time during treatment (even after several weeks), the patient should stop taking the medicine and contact their doctor immediately.
Children under 12 years of age
The gastro-resistant tablets of Texibax are not recommended for use in children under 12 years of age.

Texibax and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Texibax may affect the way some medicines work, and some medicines may affect the way Texibax works.
Do not take Texibax if you are taking a medicine containing nelfinavir (used to treat HIV infections).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• atazanavir (used to treat HIV infections),
• clopidogrel (used to prevent blood clots),
• ketokonazole, itraconazole, or voriconazole (used to treat fungal infections),
• erlotinib (used to treat cancer),
• citalopram, imipramine, or clomipramine (used to treat depression),
• diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy),
• phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will monitor you when starting or stopping Texibax,
• blood-thinning medicines, such as warfarin. Your doctor will monitor you when starting or stopping Texibax,
• cilostazol (used to treat intermittent claudication - leg pain when walking, which is caused by poor blood circulation),
• cisapride (used to treat indigestion and heartburn),
• digoxin (used to treat heart rhythm disorders),
• methotrexate (a chemotherapy medicine, used in high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop Texibax therapy,
• tacrolimus (used after organ transplants),
• rifampicin (used to treat tuberculosis),
• St. John's Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed antibiotics, such as amoxicillin and clarithromycin, and Texibax to treat ulcers caused by Helicobacter pylori infection, it is very important to tell your doctor about all other medicines you are taking.

Texibax with food and drink

The tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take Texibax during this time.
It is not known whether esomeprazole passes into breast milk. Therefore, you should not take this medicine during breastfeeding.

Driving and using machines

It is unlikely that esomeprazole will affect your ability to drive or use machines. However, it is possible to experience side effects such as dizziness or blurred vision (see section 4). If this happens, do not drive or use machines.

Texibax contains sucrose

Texibax contains sucrose, a type of sugar. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Texibax contains sodium

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

3. How to take Texibax

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• If you are taking this medicine for a long time, you may need to have regular check-ups with your doctor (especially if you are taking it for more than a year).
• If your doctor has told you to take this medicine on demand, you should tell them about any changes in your symptoms.

Dosage

• Your doctor will tell you how many tablets to take and for how long. This depends on your condition, age, and liver function.
• The recommended doses are given below.

Adults aged 18 years and older

Treatment of heartburn caused by gastroesophageal reflux disease:

• If your doctor has found minimal esophageal damage, the recommended dose is one 40 mg gastro-resistant tablet of Texibax once a day for 4 weeks. If the esophagus has not healed, your doctor may prescribe the same dose for another 4 weeks.
• The recommended dose after esophageal healing is one 20 mg tablet of Texibax once a day.
• If the esophagus was not damaged, the recommended dose is one 20 mg tablet of Texibax once a day. After symptom control has been achieved, your doctor may prescribe on-demand treatment, up to one 20 mg tablet of Texibax once a day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

Treatment of duodenal ulcers caused by Helicobacter pylori infection and prevention of recurrence:

• The recommended dose is one 20 mg tablet of Texibax twice a day for 1 week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Treatment of stomach ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of stomach ulcers or duodenal ulcers when taking non-steroidal anti-inflammatory drugs (NSAIDs):

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

Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg tablet of Texibax twice a day.
• Your doctor will adjust the dose according to your needs and decide how long you should take this medicine. The maximum dose is 80 mg twice a day.

After intravenous administration of esomeprazole, continuation of prevention of rebleeding from peptic ulcers:

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

Adolescents aged 12 years and older

Treatment of heartburn caused by gastroesophageal reflux disease:

• If your doctor has found minimal esophageal damage, the usual dose is one 40 mg gastro-resistant tablet of Texibax once a day for 4 weeks. If the esophagus has not healed, your doctor may prescribe the same dose for another 4 weeks.
• The recommended dose after esophageal healing is one 20 mg tablet of Texibax once a day.
• If the esophagus was not damaged, the recommended dose is one 20 mg tablet of Texibax once a day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

Treatment of duodenal ulcers caused by Helicobacter pylori infection and prevention of recurrence:

• The recommended dose is one 20 mg tablet of Texibax twice a day for 1 week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

Method and route of administration

• The tablets can be taken at any time of the day.
• The tablets can be taken with or without food.
• Swallow the tablets whole with water. Do not chew or crush the tablets, as they contain enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is essential not to damage the pellets.

In case of swallowing difficulties

• If you have difficulty swallowing the tablets:
• Put them in a glass of non-carbonated water. Do not use any other liquids.
• Stir until the tablets break up (the mixture will not be clear). Drink the mixture immediately or within 30 minutes. Stir well before drinking.
• To ensure you take all the medicine, rinse the glass with half a glass of water and drink. The solid pieces contain the medicine - do not chew or crush them.
• If you cannot swallow, the tablet can be mixed with a small amount of water and given through a tube (nasogastric 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.

Overdose of Texibax

If you have taken more than the prescribed dose of Texibax, contact your doctor or pharmacist immediately.

Missed dose of Texibax

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for a missed tablet.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Texibax and contact your doctor immediately:

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

These side effects are rare and may affect up to 1 in 1,000 people.
Other side effects include:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• swelling of the feet and ankles,
• sleep disturbances (insomnia),
• dizziness, feeling of tingling, drowsiness,
• feeling of spinning (vertigo),
• dry mouth,
• changes in blood test results showing liver function,
• rash, hives, and itching of the skin,
• fractures of the hip, wrist, or spine (if Texibax is taken in high doses and for a long period).

Rare (may affect up to 1 in 1,000 people)

• blood disorders, such as a decrease in white blood cells or platelets. This can cause weakness, bruising, or increased susceptibility to infections,
• low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps,
• agitation, confusion, or depression,
• taste disturbances,
• vision disturbances, such as blurred vision,
• wheezing or shortness of breath (bronchospasm),
• mouth inflammation,
• a fungal infection that can affect the intestines and is caused by fungi,
• liver disease, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue,
• hair loss (alopecia),
• skin rash when exposed to sunlight,
• joint or muscle pain,
• general feeling of being unwell and lack of energy,
• increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• blood disorders, including agranulocytosis (a decrease in white blood cells),
• aggression,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• severe liver disease leading to liver failure and brain inflammation,
• sudden appearance of a severe rash or blisters, or peeling of the skin. This can 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 problems,
• breast enlargement in men.

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

Texibax can very rarely affect the white blood cells, leading to a weakened immune system. If you experience an infection with symptoms such as fever with a very bad general feeling, or fever with local infection symptoms such as sore throat, mouth, or urinary problems, you should contact your doctor as soon as possible to have a blood test to rule out a lack of white blood cells (agranulocytosis). It is essential to inform your doctor about all the medicines you are taking.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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.
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 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.
The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Store in the original packaging (blister) to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Texibax contains

The active substance is esomeprazole.
20 mg: Each tablet contains 20 mg of esomeprazole (as esomeprazole magnesium amorphous).
40 mg: Each tablet contains 40 mg of esomeprazole (as esomeprazole magnesium amorphous).
Other ingredients are:
Core:sucrose, sugar spheres (sucrose, corn starch), hydroxypropylcellulose, crospovidone (Type B), povidone (K30), macrogol 400, talc, hypromellose phthalate (HP-55S), hypromellose phthalate (HP-50), diethyl phthalate, macrogol 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),
macrogol / PEG 400, talc, iron oxide red (E 172)), macrogol 4000.

What Texibax looks like and contents of the pack

Texibax 20 mg gastro-resistant tabletsare light brown to brown, oval, biconvex, coated, with the inscription "E5" on one side and smooth on the other side.
Texibax 40 mg gastro-resistant tabletsare light brown to brown, oval, biconvex, coated, with the inscription "E6" on one side and smooth on the other side.
The product is available in packs of:
20 mg and 40 mg: OPA/Aluminum/PE/moisture-absorbing agent/HDPE/Aluminum blisters of 28 tablets.
20 mg and 40 mg: OPA/Aluminum/PVC/Aluminum blisters of 28 tablets.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer

Terapia SA, 124 Fabricii Street, 400 632 Cluj Napoca, Romania
Sun Pharmaceutical Industries Europe B.V.,Polarisavenue 87 2132JH, Hoofddorp, Netherlands
Date of last revision of the leaflet:24.11.2023