MESOPRAL 20 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Mesopral, 20 mg, Gastro-Resistant Hard Capsules
3. Mesopral, 40 mg, Gastro-Resistant Hard Capsules
   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 Mesopral and what is it Used for
5. Important Information Before Taking Mesopral
   1. When not to Take Mesopral:
   2. Warnings and Precautions
   3. Mesopral and other Medications
   4. Mesopral with Food and Drink
   5. Pregnancy, Breastfeeding, and Fertility
   6. Driving and Using Machines
   7. Mesopral Contains Sugar, Benzoic Acid, and Sodium
6. How to Take Mesopral
   1. How to Take Mesopral
   2. Adults Aged 18 and Above
   3. Adolescents Aged 12 and Above
   4. How to Take Mesopral
   5. What to do if you have Difficulty Swallowing
   6. Children Under 12 Years
   7. Elderly Patients
   8. What to do if you Take more Mesopral than you Should
   9. What to do if you Miss a Dose of Mesopral
7. Possible Side Effects
   1. If you Experience any of the Following Serious Side Effects, Stop Taking Mesopral and Contact a Doctor Immediately:
   2. Reporting Side Effects
8. How to Store Mesopral
9. Package Contents and other Information
   1. What Mesopral Contains
   2. What Mesopral Looks Like and Package Contents
   3. Marketing Authorization Holder and Manufacturer

Package Leaflet: Information for the Patient

Mesopral, 20 mg, Gastro-Resistant Hard Capsules

Mesopral, 40 mg, Gastro-Resistant Hard Capsules

Esomeprazole

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

• Keep this Package Leaflet, so you can Read it Again if Necessary.
• If you have any Further Questions, Ask your Doctor or Pharmacist.
• This Medication has been Prescribed for a Specific Person. Do not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same.
• If the Patient Experiences any Side Effects, including any not Listed in this Package Leaflet, they should Tell their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Mesopral and what is it Used for
• 2. Important Information Before Taking Mesopral
• 3. How to Take Mesopral
• 4. Possible Side Effects
• 5. How to Store Mesopral
• 6. Package Contents and other Information

1. What is Mesopral and what is it Used for

Mesopral Contains the Active Substance Esomeprazole. It Belongs to a Group of Medications Called
“Proton Pump Inhibitors”. Their Action Involves Reducing the Amount of Acid Produced in the
Stomach.
Mesopral is Used to Treat the Following Conditions:
Adults

• Gastroesophageal Reflux Disease (GERD). This Occurs when Stomach Acid Flows back into the Esophagus (the Tube that Connects the Throat to the Stomach), Causing Pain, Inflammation, and Heartburn.
• Stomach Ulcers or Infection of the Upper Part of the Intestine with the Bacterium Helicobacter pylori. If one of these Conditions is Diagnosed, the Doctor may also Prescribe Antibiotics to Treat the Infection and Allow the Ulcer to Heal.
• Stomach Ulcers Caused by Non-Steroidal Anti-Inflammatory Drugs. Mesopral may also be Used to Prevent Stomach Ulcers from Forming while Taking Non-Steroidal Anti-Inflammatory Drugs.
• Excessive Stomach Acid Caused by a Tumor in the Pancreas (Zollinger-Ellison Syndrome).
• Prolonged Treatment after Preventing Recurrence of Bleeding using Esomeprazole Administered Intravenously.

Adolescents Aged 12 and Above

• Gastroesophageal Reflux Disease (GERD). This Occurs when Stomach Acid Flows back into the Esophagus (the Tube that Connects the Throat to the Stomach), Causing Pain, Inflammation, and Heartburn.
• Stomach Ulcers or Infection of the Upper Part of the Intestine with the Bacterium Helicobacter pylori. If one of these Conditions is Diagnosed, the Doctor may also Prescribe Antibiotics to Treat the Infection and Allow the Ulcer to Heal.

2. Important Information Before Taking Mesopral

When not to Take Mesopral:

• If the Patient is Allergic to Esomeprazole or any of the other Ingredients of this Medication (Listed in Section 6).
• If the Patient is Allergic to other Medications in the Proton Pump Inhibitor Group (e.g., Pantoprazole, Lansoprazole, Rabeprazole, Omeprazole).
• If the Patient has Ever Experienced a Severe Skin Rash, Blistering, or Peeling after Taking Mesopral or Similar Medications.
• If the Patient is Taking a Medication Containing Nelfinavir (Used to Treat HIV Infection). If any of these Situations Apply, do not Take Mesopral. If in Doubt, Consult a Doctor or Pharmacist Before Taking the Medication.

Warnings and Precautions

Before Starting Mesopral, Inform your Doctor or Pharmacist:

• If you have Severe Liver Disease,
• If you have Severe Kidney Disease,
• If you have Ever Experienced a Skin Reaction after Taking a Medication Similar to Mesopral that Reduces Stomach Acid,
• If you Experience a Skin Rash, especially in Areas Exposed to the Sun, you should Tell your Doctor Immediately, as you may Need to Stop Taking Mesopral. You should also Report any other Side Effects, such as Joint Pain.
• About any Planned Specific Blood Test (Chromogranin A Levels).

Taking Mesopral may Mask the Symptoms of other Conditions, so you should Immediately
Tell your Doctor if you Experience any of the Following Symptoms Before or During Treatment with Mesopral:

• Significant, Unintentional Weight Loss and Difficulty Swallowing,
• Abdominal Pain or Symptoms of Indigestion,
• Vomiting or Vomiting with Blood,
• Black, Tarry Stools (with Traces of Blood). If Mesopral is Taken as Needed, you should Consult a Doctor if Symptoms Persist or Change.

When Taking Proton Pump Inhibitors like Mesopral, especially for more than a Year, there may be a Slightly Increased Risk of Hip, Wrist, or Spine Fractures. Inform your Doctor if you have Osteoporosis or are Taking Corticosteroids (which can Increase the Risk of Osteoporosis).
Severe Skin Reactions, including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been Reported with Mesopral. The Patient should Stop Taking Mesopral and Consult a Doctor Immediately if they Notice any of the Symptoms of these Severe Skin Reactions Described in Section 4.

Mesopral and other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking, or have Recently Taken, and any Medications you Plan to Take. This Includes Medications Bought without a Prescription. This is Important because Mesopral may Affect the Action of other Medications, or the Action of Mesopral may be Affected if other Medications are Taken at the Same Time.
Do not Take Mesopral if you are Taking a Medication Containing Nelfinavir(Used to Treat HIV Infection).
Tell your Doctor or Pharmacist if you are Taking any of the Following Medications:

• Atazanavir (Used to Treat HIV Infection).
• Clopidogrel (Used to Prevent Blood Clots).
• Ketoconazole, Itraconazole, or Voriconazole (Medications Used to Treat Fungal Infections).
• Erlotinib (Used to Treat Cancer).
• Citalopram, Imipramine, or Clomipramine (Medications Used to Treat Depression).
• Diazepam (Used to Treat Anxiety, Epilepsy, or to Relax Muscles).
• Phenytoin (Used to Treat Epilepsy). If you are Taking Phenytoin, your Doctor may Recommend Additional Blood Tests at the Start and End of Treatment with Mesopral.
• Blood-Thinning Medications, such as Warfarin. Your Doctor may Recommend Additional Blood Tests at the Start and End of Treatment with Mesopral.
• Cilostazol (Used to Treat Intermittent Claudication - Pain in the Legs when Walking due to Poor Blood Flow).
• Cisapride (Used to Treat Indigestion or Heartburn).
• Digoxin (Used to Treat Heart Conditions).
• Methotrexate (a Chemotherapy Medication Used to Treat Cancer)
• If you are Taking High Doses of Methotrexate, your Doctor may Recommend Temporarily Stopping Mesopral.
• Tacrolimus (Used after Organ Transplantation).
• 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) to be Taken with Mesopral to Treat Stomach Ulcers Caused by Helicobacter pylori, it is Very Important to Tell your Doctor about any other Medications you are Taking.

Mesopral with Food and Drink

It is Recommended to Take Mesopral (Best in the Morning) 30-60 Minutes Before the First Meal.

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 Medication.
Your Doctor will Decide whether you can Take Mesopral during this Period. There is Limited Data on the Excretion of Esomeprazole in Breast Milk. Therefore, Mesopral should not be Taken by Breastfeeding Women.

Driving and Using Machines

Mesopral is Unlikely to Affect your Ability to Drive or Use Machines. However, Rare or Uncommon Side Effects such as Dizziness or Blurred Vision (See Section 4) may Affect your Ability to Drive or Use Machines. If you Experience these Side Effects, do not Drive or Use Machines.

Mesopral Contains Sugar, Benzoic Acid, and Sodium

Mesopral Contains Sugar (a Type of Sugar), Benzoic Acid (E210), and Sodium.

• If you have been Diagnosed with an Intolerance to some Sugars, you should Consult your Doctor Before Taking Mesopral.
• The Medication Contains 1.80 Micrograms of Benzoic Acid in each 20 mg Gastro-Resistant Hard Capsule or 3.50 Micrograms of Benzoic Acid in each 40 mg Gastro-Resistant Hard Capsule.
• The Medication Contains Less than 1 mmol (23 mg) of Sodium per Capsule, which Means it is Essentially ‘Sodium-Free’.

3. How to Take Mesopral

Always Take this Medication Exactly as your Doctor or Pharmacist has Told you. If you are not Sure, Ask your Doctor or Pharmacist.

• If you are Taking Mesopral for a Long Time, especially more than a Year, your Doctor may Recommend Additional Checks and/or Tests.
• If your Doctor has Prescribed Mesopral to be Taken as Needed, i.e., when you Need it, and your Symptoms Change, you should Tell your Doctor.

How to Take Mesopral

• Your Doctor will Tell you how Many Capsules to Take and for how Long. This Depends on your Condition, Age, and Liver Function.
• The Recommended Dose is Given Below.

Adults Aged 18 and Above

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease:

• If your Doctor has Diagnosed Mild Esophageal Damage, the Recommended Dose of Mesopral is 40 mg. The Capsule is Taken Once a Day for 4 Weeks. In Patients who do not Heal within this Time, or who still have Symptoms, the Doctor may Recommend the Same Dose for another 4 Weeks.
• For Healed Esophagitis, the Doctor may Recommend Taking one 20 mg Mesopral Capsule Once a Day.
• In Patients where Esophageal Damage has been Ruled Out, the Recommended Dose is 20 mg Once a Day. Once Symptoms are Under Control, the Doctor may Recommend Taking Mesopral as Needed, i.e., when Symptoms Occur, at a Dose of one 20 mg Capsule Once a Day.
• In Patients with Severe Liver Disease, the Doctor may Recommend Reducing the Dose.

Treatment of Ulcer Disease Caused by Helicobacter pyloriInfection and Prevention of Recurrence:

• The Recommended Dose of Mesopral is one 20 mg Capsule Twice a Day for 1 Week.
• The Doctor will also Recommend Taking Antibiotics, such as Amoxicillin and Clarithromycin.

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

• The Recommended Dose of Mesopral is one 20 mg Capsule Once a Day for 4 to 8 Weeks.

Prevention of Stomach Ulcers when Taking Non-Steroidal Anti-Inflammatory Drugs:

• The Recommended Dose of Mesopral is one 20 mg Capsule Once a Day.

Excessive Stomach Acid Caused by a Tumor in the Pancreas (Zollinger-Ellison Syndrome):

• The Recommended Dose of Mesopral is one 40 mg Capsule Twice a Day.
• The Doctor may Adjust the Dose and Duration of Treatment Based on the Patient's Needs. The Maximum Dose is 80 mg Twice a Day.

Prolonged Treatment after Preventing Recurrence of Bleeding using Esomeprazole Administered Intravenously:

• The Recommended Dose is one 40 mg Mesopral Capsule Once a Day for 4 Weeks.

Adolescents Aged 12 and Above

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease:

• If the Doctor has Diagnosed Mild Esophageal Damage, the Recommended Dose of Mesopral is 40 mg. The Capsule is Taken Once a Day for 4 Weeks. In Patients who do not Heal within this Time, or who still have Symptoms, the Doctor may Recommend the Same Dose for another 4 Weeks.
• For Healed Esophagitis, the Doctor may Recommend Taking one 20 mg Mesopral Capsule Once a Day.
• In Patients where Esophageal Damage has been Ruled Out, the Recommended Dose is 20 mg Once a Day.
• In Patients with Severe Liver Disease, the Doctor may Recommend Reducing the Dose.

Treatment of Ulcer Disease Caused by Helicobacter pyloriInfection and Prevention of Recurrence:

• The Recommended Dose of Mesopral is one 20 mg Capsule Twice a Day for 1 Week.
• The Doctor will also Recommend Taking Antibiotics, such as Amoxicillin and Clarithromycin.

How to Take Mesopral

• It is Recommended to Take the Capsules (Best in the Morning) 30-60 Minutes Before the First Meal.
• The Capsules should be Swallowed Whole with a Glass of Water. Do not Chew or Crush the Capsules or their Contents, as the Coating that Protects the Pellets from Stomach Acid may be Damaged. It is Important not to Damage the Pellets.

What to do if you have Difficulty Swallowing

• If you have Difficulty Swallowing the Capsule:
• 1) Carefully Open the Capsule over a Glass of Still Water and Pour the Contents into it (the Pellets). Do not Use any other Liquids.
• 2) Stir. The Solution should be Taken Immediately or Within 30 Minutes of Preparation. Always Stir the Solution Before Drinking it.
• 3) To Ensure that all the Medication is Taken, Fill the Glass with Water to the Halfway Mark, Stir, and Drink the Liquid. Undissolved Particles Contain the Medication, do not Chew or Crush them.
• If the Patient is Unable to Swallow, the Contents of the Capsule can be Dissolved in Water and Given through a Nasogastric Tube.

Children Under 12 Years

Mesopral should not be Used in Children Under 12 Years of Age.

Elderly Patients

No Dose Adjustment is Necessary in Elderly Patients.

What to do if you Take more Mesopral than you Should

If you Take more Mesopral than you Should, Contact a Doctor or Pharmacist Immediately.

What to do if you Miss a Dose of Mesopral

• Take the Missed Dose as Soon as Possible. However, if it is Almost Time for the Next Dose, do not Take the Missed Dose.
• Do not Take a Double Dose to Make up for the Missed Dose.

If you have any Further Questions on the Use of this Medication, Ask your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Mesopral can Cause Side Effects, although not Everybody gets them.

If you Experience any of the Following Serious Side Effects, Stop Taking Mesopral and Contact a Doctor Immediately:

• Sudden Onset of Wheezing, Swelling of the Face or Body, Rash, Fainting, or Difficulty Swallowing (Severe Allergic Reaction). These Symptoms are Rare and may Affect up to 1 in 1000 People.
• Redness of the Skin with Blisters or Peeling, which may also be Accompanied by Blisters or Bleeding in the Mouth, Eyes, Mouth, Nose, and Genitals. This may be a Sign of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis. These Symptoms are Very Rare and may Affect up to 1 in 10,000 People.
• Widespread Rash, High Fever, and Enlarged Lymph Nodes (DRESS or Hypersensitivity Syndrome). These Symptoms are Very Rare.
• Yellowing of the Skin, Dark Urine, and General Fatigue may be Signs of Liver Disease. These Symptoms are Rare.

Other Side Effects:
Common (affect up to 1 in 10 People)

• Headache.
• Gastrointestinal Symptoms: Abdominal Pain, Constipation, Diarrhea, Bloating (with Gas), Mild Gastric Polyps.
• Nausea, Vomiting.

Uncommon (affect up to 1 in 100 People)

• Swelling of the Feet and Ankles.
• Sleep Disturbances (Insomnia).
• Dizziness, Tingling, Numbness, and Drowsiness.
• Vertigo of Vestibular Origin.
• Dry Mouth.
• Changes in Liver Function Tests.
• Rash, Urticaria, and Itching.
• Fractures of the Hip, Wrist, or Spine (if Mesopral is Taken in High Doses and for a Long Time).

Rare (affect up to 1 in 1000 People)

• Blood Disorders, such as Reduced White Blood Cell or Platelet Count. These can Cause Weakness, Bruising, or Increased Risk of Infection.
• Low Sodium Levels in the Blood. Symptoms may Include Weakness, Nausea (Vomiting), and Muscle Cramps.
• Agitation, Disorientation, or Depression.
• Changes in Taste.
• Visual Disturbances, such as Blurred Vision.
• Sudden Onset of Shortness of Breath, Difficulty Breathing (Bronchospasm).
• Mouth Ulcers.
• Fungal Infections, such as Thrush, which can Affect the Intestines.
• Liver Disease, including Jaundice, which can Cause Yellowing of the Skin and Eyes, Dark Urine, and Fatigue.
• Hair Loss.
• Sun-Induced Rash.
• Joint or Muscle Pain.
• General Feeling of Illness, Lack of Energy.
• Increased Sweating.

Very Rare (affect up to 1 in 10,000 People)

• Changes in Blood Cell Count, including Agranulocytosis (Lack of White Blood Cells).
• Aggression.
• Seeing, Feeling, or Hearing Things that are not There (Hallucinations).
• Severe Liver Problems, Leading to Liver Failure and Encephalopathy.
• Sudden Onset of Severe Rash, Ulcers, or Skin Peeling. These may be Accompanied by High Fever and Muscle Pain (Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, DRESS).
• Muscle Weakness.
• Severe Kidney Disease.
• Breast Enlargement in Men.

Frequency Not Known (Cannot be Estimated from Available Data)

• If you have Taken Mesopral for more than Three Months, there is a Possibility of Reduced Magnesium Levels in the Blood. Symptoms of Low Magnesium may Include Fatigue, Involuntary Muscle Contractions, Disorientation, Seizures, Dizziness, and Rapid Heart Rate. If you Notice any of these Symptoms, Inform your Doctor Immediately. Low Magnesium can also Lead to Reduced Potassium or Calcium Levels in the Blood. Your Doctor may Recommend Regular Blood Tests to Monitor Magnesium Levels.
• Colitis (Leading to Diarrhea).
• Rash that may be Accompanied by Joint Pain.

Mesopral can Very Rarely Affect the White Blood Cells, Leading to Immune System Disorders.
If you Experience an Infection with Symptoms such as Fever with SevereGeneral Condition
or Fever with Symptoms of Local Infection, such as Neck, Throat, or Mouth Pain, as well as Difficulty Urinating, you should Immediately Consult a Doctor to Rule out the Possibility of Reduced White Blood Cell Count (Agranulocytosis) with a Blood Test. You must Provide your Doctor with Information about any Medications you are Currently Taking.

Reporting Side Effects

If you Experience any Side Effects, including any not Listed in this Package Leaflet, you should Tell your Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects can also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Mesopral

• Keep the Medication out of Sight and Reach of Children.
• Do not Store above 25°C.
• Store the Medication in its Original Packaging to Protect it from Moisture (Blisters) or Keep the Container Tightly Closed (Bottle) to Protect it from Moisture.
• Do not Take this Medication after the Expiration Date Shown on the Carton, Bottle, or Blister Pack. The Expiration Date Refers to the Last Day of the Specified Month.
• After Opening the Bottle, the Capsules should be Used Within 3 Months.
• The Marking on the Packaging after the Abbreviation EXP Indicates the Expiration Date, and after the Abbreviation Lot/LOT Indicates the Batch Number.
• Medications should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and other Information

What Mesopral Contains

• The Active Substance of Mesopral is Esomeprazole. Each Capsule Contains 20 mg or 40 mg of Esomeprazole (in the Form of Esomeprazole Magnesium Dihydrate).
• Other Ingredients are: Capsule Contents: Sugar, Pellets (Sugar and Corn Starch), Hypromellose 3 cP, Simethicone Emulsion 30% (Containing Simethicone, Polysorbate 65 (E436), Methylcellulose, Stearyl Glycolate, Glycerides, Xanthan Gum, Benzoic Acid (E210), Sorbic Acid (E200), Sulfuric Acid), Polysorbate 80, Mannitol, Diacetylated Monoglycerides, Talc, Methacrylic Acid and Ethyl Acrylate Copolymer (1:1), 30% Dispersion (Containing Methacrylic Acid and Ethyl Acrylate Copolymer, Sodium Lauryl Sulfate, and Polysorbate 80), Triethyl Citrate, and Stearyl Glycolate of Macrogol.

What Mesopral Looks Like and Package Contents

• 20 mg Mesopral Capsules are Yellow (Opaque) and have a White (Opaque) Body. The Marking "20 mg" is Embossed on both the Cap and Body. The Capsule Contains White or Grayish-White Spherical Pellets.
• 40 mg Mesopral Capsules are Yellow (Opaque) and have a Yellow (Opaque) Body. The Marking "40 mg" is Embossed on both the Cap and Body. The Capsule Contains White or Grayish-White Spherical Pellets.
• Capsules are Available in: Bottles Containing 28, 30, 90, or 98 Capsules. Blisters of 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100, or 140 Capsules. Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of Last Revision of the Package Leaflet:March 2025