TEXIBAX 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Texibax, 20 mg, Gastro-Resistant Tablets
3. Texibax, 40 mg, Gastro-Resistant Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
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 Medications
   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 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):
   5. Prevention of Stomach or Duodenal Ulcers in Patients 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 Ezomeprazole, Prolonged Treatment to Prevent 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 Difficulty Swallowing
   12. Use in Children Under 12 Years of Age
   13. Elderly Patients
   14. Overdose of Texibax
   15. Missed Dose of Texibax
7. Possible Undesirable Effects
   1. In Case of any of the Following Serious Undesirable Effects, the Patient Should Stop Taking Texibax and Immediately Consult a Doctor:
   2. Common (may Occur in up to 1 in 10 Patients)
   3. Uncommon (may Occur in up to 1 in 100 Patients)
   4. Rare (may Occur in up to 1 in 1,000 Patients)
   5. Very Rare (may Occur in up to 1 in 10,000 Patients)
   6. Frequency Not Known (Frequency Cannot be Estimated from Available Data)
   7. Reporting Undesirable Effects
8. How to Store Texibax
9. Package Contents and Other Information
   1. What Texibax Contains
   2. What Texibax Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer

Package Leaflet: Information for the Patient

Texibax, 20 mg, Gastro-Resistant Tablets

Texibax, 40 mg, Gastro-Resistant Tablets

Ezomeprazole Magnesium, Amorphous

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, as You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed to a Specific Person. Do Not Pass it on to Others. The Medication may Harm Another Person, Even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Texibax and What is it Used for
• 2. Important Information Before Taking Texibax
• 3. How to Take Texibax
• 4. Possible Undesirable Effects
• 5. How to Store Texibax
• 6. Package Contents 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 Medications 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 Condition Involves Stomach Acid Flowing Back into the Esophagus (the Tube Connecting 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 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Texibax may also be Used to Prevent Stomach or Duodenal Ulcers in Patients Taking NSAIDs.
• Excessive Stomach Acid Caused by a Tumor in the Pancreas (Zollinger-Ellison Syndrome).
• After Intravenous Administration of Ezomeprazole, Prolonged Treatment to Prevent Rebleeding from Peptic Ulcers.

Adolescents Aged 12 Years and Older

• Gastroesophageal Reflux Disease. This Condition Involves Stomach Acid Flowing Back into the Esophagus (the Tube Connecting 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

• If the Patient is Allergic to Ezomeprazole or any of the Other Ingredients of this Medication (Listed in Section 6),
• If the Patient is Allergic to Other Proton Pump Inhibitors (e.g., Pantoprazole, Lansoprazole, Rabeprazole, Omeprazole),
• If the Patient is Taking a Medication Containing Nelfinavir (Used to Treat HIV Infection).

Do Not Take Texibax if any of the Above Conditions Apply to the Patient. In Case of Doubts, Consult a Doctor or Pharmacist Before Taking Texibax.

Warnings and Precautions

Before Starting Texibax, Discuss the Following with a Doctor or Pharmacist:

• Severe Liver Disease,
• Severe Kidney Problems,
• If the Patient has Ever Experienced a Skin Reaction After Taking a Medication that Reduces Stomach Acid, a Specific Blood Test (Chromogranin A) is Planned.

Texibax may Mask the Symptoms of Other Diseases. Therefore, if the Patient Experiences any of the Following Symptoms Before or During Treatment with Texibax, they Should Immediately Consult a Doctor:

Significant, Unintentional Weight Loss Without a Reason and Difficulty Swallowing,

Abdominal Pain or Nausea,

Vomiting Food or Blood,

Passing Black Stools (with Blood).

If Texibax is Prescribed for Short-Term Use, the Patient Should Consult a Doctor if the Symptoms do not Improve or Change.

Taking Proton Pump Inhibitors, such as 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 Osteoporosis or are Taking Corticosteroids (which may Increase the Risk of Osteoporosis).

If the Patient Experiences a Skin Rash, Especially in Areas Exposed to the Sun, they Should Immediately Inform their Doctor, as it may be Necessary to Discontinue Texibax. The Patient Should also Inform their Doctor about any Other Undesirable Effects, such as Joint Pain.

Severe Skin Rashes have Occurred in Patients Taking Ezomeprazole (see also Section 4).

The Rash may Cause Ulcers in the Mouth, Throat, Nose, Genital Area, and Eyes (red and Swollen Eyes). Severe Skin Rashes Often Appear with 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 of these Skin Symptoms Occur at any Time During Treatment (even after Several Weeks), the Patient Should Discontinue Texibax and Immediately Consult a Doctor.

Children Under 12 Years of Age

Texibax Gastro-Resistant Tablets are not Recommended for Use in Children Under 12 Years of Age.

Texibax and Other Medications

The Patient Should Inform their Doctor or Pharmacist about all Medications they are Currently Taking or Plan to Take, Including those Without a Prescription.

Texibax may Affect the Action of Certain Medications, and Certain Medications may Affect the Action of Texibax.

Do Not Take Texibax if the Patient is Taking a Medication Containing Nelfinavir (Used to Treat HIV Infection).

The Patient Should Inform their Doctor or Pharmacist about Taking any of the Following Medications:

• Atazanavir (Used to Treat HIV Infection),
• Clopidogrel (Used to Prevent Blood Clots),
• Ketoconazole, 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, Reduce Muscle Tension, or in Epilepsy),
• Phenytoin (Used to Treat Epilepsy). If the Patient is Taking Phenytoin, the Doctor will Monitor their Condition when Starting or Stopping Texibax,
• Blood-Thinning Medications, such as Warfarin. The Doctor will Monitor the Patient's Condition when Starting or Stopping Texibax,
• Cilostazol (Used to Treat Intermittent Claudication - Leg Pain when Walking, Caused by Poor Blood Circulation),
• Cisapride (Used to Treat Nausea and Heartburn),
• Digoxin (Used to Treat Heart Conditions),
• Methotrexate (a Chemotherapy Medication Used in High Doses to Treat Cancer) - if the Patient is Taking High Doses of Methotrexate, the Doctor may Temporarily Discontinue Texibax,
• Tacrolimus (Used After Organ Transplants),
• Rifampicin (Used to Treat Tuberculosis),
• St. John's Wort (Hypericum Perforatum) (Used to Treat Depression).

If the Doctor has Prescribed Antibiotics: Amoxicillin and Clarithromycin, and Texibax to Treat Ulcers Caused by Helicobacter pylori Infection, it is Very Important to Inform the Doctor about all Other Medications the Patient is Taking.

Texibax with Food and Drink

The Tablets can be Taken with or Without Food.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant, Breastfeeding, or Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication. The Doctor will Decide whether the Patient can Take Texibax at this Time.

It is not Known whether Ezomeprazole Passes into Breast Milk. Therefore, this Medication Should not be Used During Breastfeeding.

Driving and Using Machines

It is Unlikely that Ezomeprazole will Affect the Ability to Drive or Use Tools or Machines. However, it is Possible that Undesirable Effects such as Dizziness or Blurred Vision may Occur (see Section 4). In this Case, the Patient Should not Drive or Use Machines.

Texibax Contains Sucrose

Texibax Contains Sucrose, a Type of Sugar. If the Patient has been Diagnosed with Intolerance to some Sugars, they Should Consult a Doctor Before Taking this Medication.

Texibax Contains Sodium

Texibax Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which means the Medication is Considered "Sodium-Free".

3. How to Take Texibax

This Medication Should Always be Taken as Directed by a Doctor or Pharmacist. In Case of Doubts, the Patient Should Consult a Doctor or Pharmacist.

• In Case of Long-Term Use, Regular Medical Check-Ups may be Necessary (especially if the Patient is Taking the Medication for more than a Year).
• If the Doctor has Prescribed Texibax for Short-Term Use, the Patient Should Inform their Doctor about any Changes in Symptoms.

Dosage

• The Doctor will Inform the Patient about the Dosage and Duration of Treatment, which Depends on the Patient's Condition, Age, and Liver Function.
• Recommended Dosages are Listed Below.

Adults Aged 18 Years and Older

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease:

• If the Doctor has Diagnosed Minor Esophageal Damage, the Recommended Dosage is one 40 mg Gastro-Resistant Tablet of Texibax Once a Day for 4 Weeks. If the Esophagus has not Healed, the Doctor may Prescribe the Same Dosage for another 4 Weeks.
• The Recommended Dosage After Healing of the Esophagus is one 20 mg Tablet of Texibax Once a Day.
• If the Esophagus was not Damaged, the Recommended Dosage is one 20 mg Tablet of Texibax Once a Day. After Symptom Control has been Achieved, the Doctor may Prescribe the Medication for Short-Term Use, up to a Maximum of one 20 mg Tablet of Texibax Once a Day.
• If the Patient has Severe Liver Disease, the Doctor may Prescribe a Lower Dosage.

Treatment of Ulcers Caused by Helicobacter pylori Infection and Prevention of Recurrence:

• The Recommended Dosage is one 20 mg Tablet of Texibax Twice a Day for 1 Week.
• The Doctor will also Prescribe Antibiotics, such as Amoxicillin and Clarithromycin.

Treatment of Stomach Ulcers Caused by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• The Recommended Dosage is one 20 mg Tablet of Texibax Once a Day for 4 to 8 Weeks.

Prevention of Stomach or Duodenal Ulcers in Patients Taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• The Recommended Dosage 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 Dosage is one 40 mg Tablet of Texibax Twice a Day.
• The Doctor will Adjust the Dosage According to the Patient's Needs and Decide how Long the Patient Should Take the Medication. The Maximum Dosage is 80 mg Twice a Day.

After Intravenous Administration of Ezomeprazole, Prolonged Treatment to Prevent Rebleeding from Peptic Ulcers:

• The Recommended Dosage 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 the Doctor has Diagnosed Minor Esophageal Damage, the Usual Dosage is one 40 mg Gastro-Resistant Tablet of Texibax Once a Day for 4 Weeks. If the Esophagus has not Healed, the Doctor may Prescribe the Same Dosage for another 4 Weeks.
• The Recommended Dosage After Healing of the Esophagus is one 20 mg Tablet of Texibax Once a Day.
• If the Esophagus was not Damaged, the Recommended Dosage is one 20 mg Tablet of Texibax Once a Day.
• If the Patient has Severe Liver Disease, the Doctor may Prescribe a Lower Dosage.

Treatment of Ulcers Caused by Helicobacter pylori Infection and Prevention of Recurrence:

• The Recommended Dosage is one 20 mg Tablet of Texibax Twice a Day for 1 Week.
• The 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.
• The Tablets Should be Swallowed Whole with Water. The Tablets Should not be Chewed or Crushed, as they Contain Enteric-Coated Pellets that Prevent the Medication from Breaking Down in the Stomach due to Acid. It is Important not to Damage the Pellets.

In Case of Difficulty Swallowing

• If the Patient has Difficulty Swallowing:
• Put the Tablet in a Glass of Still Water. Do not Use any Other Liquids.
• Stir until the Tablet Breaks Down (the Mixture will not be Clear). Drink the Mixture Immediately or within 30 Minutes. Stir Well Before Drinking.
• To Ensure the Patient has Taken the Entire Medication, Rinse the Glass with Half a Glass of Water and Drink.
• If the Patient is Unable to Swallow, the Tablet can be Mixed with a Small Amount of Water and Administered through a Tube (Gastric 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 Medication may be More Suitable for this Age Group.

Elderly Patients

In Elderly Patients, there is no Need to Adjust the Dosage.

Overdose of Texibax

In Case of Overdose, the Patient Should Immediately Consult a Doctor or Pharmacist.

Missed Dose of Texibax

If a Dose is Missed, the Patient Should Take it as Soon as they Remember, unless it is Almost Time for the Next Dose.

Do not Take a Double Dose to Make up for a Missed Tablet.

In Case of Further Doubts about Taking this Medication, the Patient Should Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Texibax can Cause Undesirable Effects, although not Everybody will Experience them.

In Case of any of the Following Serious Undesirable Effects, the Patient Should Stop Taking Texibax and Immediately Consult a Doctor:

• 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 and Bleeding may also Occur on the Lips, Eyes, Mouth, Nose, and Genital Area. These may be Symptoms of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis.
• Yellowing of the Skin, Dark Urine, and Fatigue, which may be Symptoms of Liver Disease.

These Undesirable Effects are Rare and may Occur in 1 in 1,000 Patients.

Other Undesirable Effects Include:

Common (may Occur in up to 1 in 10 Patients)

• Headache,
• Effects on the Stomach or Intestines: Diarrhea, Abdominal Pain, Constipation, Bloating,
• Nausea or Vomiting,
• Mild Stomach Polyps.

Uncommon (may Occur in up to 1 in 100 Patients)

• 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 Indicating Liver Function,
• Rash, Pustular Rash (Hives) and Itching,
• Fractures of the Hip, Wrist, or Spine (if Texibax is Used in High Doses and for a Long Period).

Rare (may Occur in up to 1 in 1,000 Patients)

• Blood Disorders, such as Decreased White Blood Cell or Platelet Count. This may Cause Weakness, Bruising, or Increased Risk of Infection,
• Low Sodium Levels in the Blood. This may Cause Weakness, Vomiting, and Muscle Cramps,
• Feeling of Agitation, Confusion, or Depression,
• Taste Disorders,
• Vision Disorders, such as Blurred Vision,
• Sudden Wheezing or Shortness of Breath (Bronchospasm),
• Mouth Inflammation,
• Fungal Infections that may Affect the Intestines and are Caused by Fungi,
• Liver Diseases, Including Jaundice, which may Cause Yellowing of the Skin, Dark Urine, and Fatigue,
• Hair Loss (Alopecia),
• Skin Rash that may Occur with Sun Exposure,
• Joint or Muscle Pain,
• General Feeling of Illness and Lack of Energy,
• Increased Sweating.

Very Rare (may Occur in up to 1 in 10,000 Patients)

• Blood Disorders, Including Agranulocytosis (Low White Blood Cell Count),
• Aggression,
• Seeing, Feeling, or Hearing Things that do not Exist (Hallucinations),
• Severe Liver Dysfunction Leading to Liver Failure and Hepatic Encephalopathy,
• Sudden Onset of Severe Rash or Blisters, or Peeling of the Skin. This may be Accompanied by High Fever and Joint Pain [Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)],
• Muscle Weakness,
• Severe Kidney Problems,
• Enlargement of the Breasts in Men.

Frequency Not Known (Frequency Cannot be Estimated from Available Data)

• If the Patient has Taken Texibax for more than Three Months, there is a Possibility of Decreased Magnesium Levels in the Blood. Low Magnesium Levels may Cause Weakness, Involuntary Muscle Contractions, Disorientation, Seizures, Dizziness, and Rapid Heart Rate. If the Patient Experiences any of these Symptoms, they Should Immediately Inform their Doctor. 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.
• Intestinal Inflammation (Leading to Diarrhea);
• Rash that may Occur with Joint Pain.

Texibax may Rarely Affect the White Blood Cell Count, Leading to Decreased Immunity. If the Patient Experiences an Infection with Symptoms such as Fever with a Very Bad Feeling, or Fever with Local Infection Symptoms, such as Neck, Throat, or Mouth Pain, or Difficulty Urinating, they Should Immediately Consult a Doctor for Blood Tests to Rule out Agranulocytosis (Low White Blood Cell Count). It is Very Important to Inform the Doctor about all Medications the Patient is Currently Taking.

Reporting Undesirable Effects

If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, they Should Inform their Doctor or Pharmacist, or Nurse.

Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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.

Undesirable Effects can also be Reported to the Marketing Authorization Holder.

Reporting Undesirable Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Texibax

Store the Medication in a Place that is not Visible and not Accessible to Children.

Do not Use this Medication after the Expiration Date Stated on the Carton and Blister.

The Expiration Date refers to the Last Day of the Specified Month.

Store in a Temperature Below 30°C.

Store in the Original Packaging (Blister) to Protect from Moisture.

Medications Should not be Disposed of in Sewage or Household Waste. The Patient Should Ask their Pharmacist how to Dispose of Unused Medications. This will Help to Protect the Environment.

6. Package Contents and Other Information

What Texibax Contains

The Active Substance of Texibax is Ezomeprazole.

20 mg: Each Tablet Contains 20 mg of Ezomeprazole (in the Form of Ezomeprazole Magnesium Amorphous).

40 mg: Each Tablet Contains 40 mg of Ezomeprazole (in the Form of Ezomeprazole Magnesium Amorphous).

Other Ingredients are:

Core:Sucrose, Sugar Spheres (Sucrose, Corn Starch), Hydroxypropyl Cellulose, 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 Stearate 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 Package

Texibax 20 mg Gastro-Resistant Tabletsare Light Brown-Red to Brown, Oval, Convex, Coated, with the Imprint "E5" on one Side and Smooth on the Other Side.

Texibax 40 mg Gastro-Resistant Tabletsare Light Brown-Red to Brown, Oval, Convex, Coated, with the Imprint "E6" on one Side and Smooth on the Other Side.

The Product is Available in:

20 mg and 40 mg: Blisters OPA/Aluminum/PE/Moisture-Absorbing Agent/HDPE/Aluminum, each Containing 28 Tablets.

20 mg and 40 mg: Blisters OPA/Aluminum/PVC/Aluminum, each Containing 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 Package Leaflet:24.11.2023