MESOPRAL 40 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Mesopral, 20 mg, gastro-resistant hard capsules
3. Mesopral, 40 mg, gastro-resistant hard capsules
   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 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 medicines
   4. Mesopral with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Mesopral contains sucrose, benzoic acid, and sodium
6. How to take Mesopral
   1. How to take Mesopral
   2. Adults 18 years and older
   3. Adolescents 12 years and older
   4. How to take Mesopral
   5. What to do if there are difficulties with swallowing
   6. Children under 12 years
   7. Elderly patients
   8. What to do if a higher dose of Mesopral is taken than recommended
   9. What to do if a dose of Mesopral is missed
7. Possible side effects
   1. If any of the following serious side effects occur, stop taking Mesopral and contact a doctor immediately:
   2. Reporting side effects
8. How to store Mesopral
9. Contents of the packaging and other information
   1. What Mesopral contains
   2. What Mesopral looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Leaflet accompanying the packaging: patient information

Mesopral, 20 mg, gastro-resistant hard capsules

Mesopral, 40 mg, gastro-resistant hard capsules

Esomeprazole

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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. Contents of the packaging 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 medicines called
“proton pump inhibitors”. Their action is to reduce the amount of acid produced in the
stomach.
Mesopral is used to treat the following diseases:
Adults

• Gastroesophageal reflux disease (GERD). It occurs when stomach acid enters the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers or infection of the upper part of the intestine with Helicobacter pylori bacteria. If one of these diseases occurs, the doctor may also prescribe antibiotics to cure 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 during the use of non-steroidal anti-inflammatory drugs.
• Excessive stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome).
• Prolonged treatment after preventing recurrence of bleeding using intravenous esomeprazole.
  

Adolescents 12 years and older

• Gastroesophageal reflux disease (GERD). It occurs when stomach acid enters the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach ulcers or infection of the upper part of the intestine with Helicobacter pylori bacteria. If one of these diseases occurs, the doctor may also prescribe antibiotics to cure the infection and allow the ulcer to heal.

2. Important information before taking Mesopral

When not to take Mesopral:

Warnings and precautions

Before starting to take Mesopral, tell your doctor or pharmacist:

Taking Mesopral may mask the symptoms of other diseases, so it is essential to
tell the doctor immediately if, before or during treatment with Mesopral, any of the following symptoms occur:

• significant, unintended weight loss and swallowing disorders,
• abdominal pain or symptoms of indigestion,
• vomiting or vomiting with blood,
• black, tarry stools (with blood traces). If Mesopral is taken on demand, the patient should contact their doctor if the symptoms persist or change.

When taking proton pump inhibitors like Mesopral, especially for a period longer than one year,
the risk of hip, wrist, or spine fractures may increase slightly. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Mesopral treatment. The patient should stop taking Mesopral and seek medical advice immediately if they notice any of the symptoms associated with these severe skin reactions described in section 4.

Mesopral and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including those bought without a prescription. This is important because Mesopral may change the effect of other medicines, or the effect of Mesopral may change if other medicines are taken at the same time.
Do not take the medicine if the patient is taking a medicine containing nelfinavir(used to treat HIV infection).
Tell the doctor or pharmacist if the patient is taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, or clomipramine (medicines used to treat depression).
• Diazepam (a medicine used to treat anxiety, epilepsy, or to relax muscles).
• Phenytoin (a medicine used to treat epilepsy). If the patient is taking phenytoin, the doctor may recommend additional testing at the beginning and end of Mesopral treatment.
• Blood thinners, such as warfarin. The doctor may recommend additional testing at the beginning and end of Mesopral treatment.
• Cilostazol (used to treat intermittent claudication - leg pain when walking due to insufficient blood supply).
• Cisapride (a medicine used to treat indigestion or heartburn).
• Digoxin (a medicine used to treat heart conditions).
• Methotrexate (a chemotherapy medicine used to treat cancer in high doses)
• Tacrolimus (used after organ transplantation).
• Rifampicin (a medicine used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (a medicine used to treat depression).

If the doctor has prescribed antibiotics (amoxicillin and clarithromycin) together with Mesopral to treat stomach ulcers caused by Helicobacter pylori infection, it is essential to tell the doctor about other medicines being taken.

Mesopral with food and drink

It is recommended to take Mesopral (preferably in the morning) 30-60 minutes before the first meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
The doctor will decide whether the patient can take Mesopral during this period. There is no data on the excretion of esomeprazole into breast milk in nursing women. Therefore, Mesopral should not be given to nursing mothers.

Driving and using machines

Mesopral is unlikely to affect the ability to drive or use machines. However, dizziness or blurred vision (see section 4) may occur infrequently or rarely. If these side effects occur, the patient should not drive or operate machinery.

Mesopral contains sucrose, benzoic acid, and sodium

Mesopral contains sucrose (a type of sugar), benzoic acid (E210), and sodium.

• If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
• The medicine 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 medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Mesopral

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

• If the medicine is taken for a long time, especially for more than a year, the doctor may recommend additional checks and (or) tests.
• If the doctor has prescribed the medicine to be taken on demand, i.e., when the patient needs it, and the symptoms change, they should tell their doctor.

How to take Mesopral

• The doctor will inform the patient how many capsules to take and for how long. This depends on the patient's disease, age, and liver function.
• The recommended dose is given below.

Adults 18 years and older

Treatment of heartburn caused by gastroesophageal reflux disease:

• If the doctor has found minor esophageal damage, the recommended dose of Mesopral is 40 mg. The capsule is taken once a day for 4 weeks. In patients who have not healed their esophagus during this time or who still have symptoms, the doctor may recommend taking the same dose for another 4 weeks.
• In patients with healed esophagus, the doctor may recommend taking one Mesopral 20 mg capsule once a day.
• In patients who have been ruled out for esophageal damage, the recommended dose is 20 mg once a day. When symptoms are controlled, the doctor may recommend taking Mesopral on demand, i.e., when symptoms occur, in 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 stomach ulcers caused by Helicobacter pylori bacteria 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 during the use of non-steroidal anti-inflammatory drugs:

• The recommended dose of Mesopral is one 20 mg capsule once a day.

Excessive stomach acid caused by a pancreatic tumor (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 according to the patient's needs. The maximum dose is 80 mg twice a day.

Prolonged treatment after preventing recurrence of bleeding using intravenous esomeprazole:
The recommended dose is one Mesopral 40 mg capsule once a day for 4 weeks.

Adolescents 12 years and older

Treatment of heartburn caused by gastroesophageal reflux disease:

• If the doctor has found minor esophageal damage, the recommended dose of Mesopral is 40 mg. The capsule is taken once a day for 4 weeks. In patients who have not healed their esophagus during this time or who still have symptoms, the doctor may recommend taking the same dose for another 4 weeks.
• In patients with healed esophagus, the doctor may recommend taking one Mesopral 20 mg capsule once a day.
• In patients who have been ruled out for esophageal damage, the recommended dose is 20 mg once a day.
• In patients with severe liver disease, the doctor may recommend reducing the dose.

Treatment of stomach ulcers caused by Helicobacter pylori bacteria 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 (preferably 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 the acidic stomach environment may be damaged. It is essential not to damage the pellets.

What to do if there are difficulties with swallowing

• In case of difficulty swallowing the capsule:
• 1) Carefully open the capsule over a glass of still water and pour the contents into it (pellets). Do not use other liquids.
• 2) Stir. The solution should be drunk immediately or within 30 minutes of preparation. Always stir the solution before drinking.
• 3) To ensure that all the medicine is taken, fill the glass with water to the halfway point, stir, and drink the liquid. Undissolved particles contain the medicine, do not chew or crush them.
• If the patient cannot swallow, the contents of the capsule can be dissolved in water and given through a nasogastric tube.

Children under 12 years

Mesopral is not recommended for children under 12 years.

Elderly patients

No dose adjustment is necessary in elderly patients.

What to do if a higher dose of Mesopral is taken than recommended

In case of taking a higher dose of Mesopral than recommended, consult a doctor or pharmacist immediately.

What to do if a dose of Mesopral is missed

• Missed dose should be taken as soon as possible. However, if it is close to the time for the next dose, do not take the missed dose.
• Do not take a double dose to make up for the missed dose.

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If any of the following serious side effects occur, 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 occur in less than 1 in 1000 patients treated.
• Redness of the skin with blisters or peeling. Blisters and bleeding in the mouth, eyes, mouth, nose, and genitals may also occur. Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. These symptoms are very rare and may occur in less than 1 in 10,000 patients.
• Widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome). These symptoms are very rare.
• Yellow skin, dark urine, and general fatigue may be symptoms of liver disease. These symptoms are rare.

Other side effects:
Common (occurring in less than 1 in 10 patients)

• Headache.
• Gastrointestinal symptoms: abdominal pain, constipation, diarrhea, bloating (with gas), mild gastric polyps.
• Nausea, vomiting.

Uncommon (occurring in less than 1 in 100 patients)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, feeling of pins and needles, numbness, and tingling (paresthesia), drowsiness.
• Vertigo of labyrinthine origin.
• Dry mouth.
• Changes in liver function tests.
• Rash, papular rash (hives) and itchy skin.
• Fractures of the hip, wrist, or spine (if Mesopral is taken in high doses and for a long time).

Rare (occurring in less than 1 in 1000 patients)

• Blood disorders, such as decreased white blood cell count and platelet count. They may cause weakness, bruising, or increased susceptibility to infections.
• Low sodium levels in the blood. Symptoms may include: weakness, nausea (vomiting), and cramps.
• Restlessness, disorientation, or depression.
• Changes in taste.
• Visual disturbances, such as blurred vision.
• Sudden onset of shortness of breath, difficulty breathing (bronchospasm).
• Mouth ulcers.
• Fungal infection called thrush, which can affect the intestines.
• Liver disease, including jaundice, which can cause yellowing of the skin and whites of the eyes, dark urine, and fatigue.
• Hair loss.
• Sun-induced rash.
• Joint pain or muscle pain.
• General malaise, lack of energy.
• Increased sweating.

Very rare (occurring in less than 1 in 10,000 patients)

• 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. They may occur with 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 Mesopral is taken for more than three months, there is a possibility of decreased magnesium levels in the blood. Symptoms of low magnesium levels may include: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Colitis (leading to diarrhea).
• Rash that may be accompanied by joint pain.

Mesopral may very rarely affect the white blood cells, leading to immune system disorders.
If the patient has an infection with symptoms such as fever with very severegeneral condition
or fever with symptoms of local infection, such as neck, throat, or mouth pain, as well as difficulty urinating, they should consult their doctor immediately to rule out the possibility of decreased white blood cell count (agranulocytosis) with a blood test. It is essential to provide the doctor with information about currently taken medicines.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, 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
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 gather more information on the safety of this medicine.

5. How to store Mesopral

• The medicine should be stored out of sight and reach of children.
• Do not store above 25°C.
• Store the medicine in its original packaging to protect it from moisture (blister packs) or keep the container tightly closed (bottle) to protect it from moisture.
• Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack. The expiry date refers to the last day of the month stated.
• After opening the bottle, the capsules should be used within 3 months.
• The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mesopral contains

• The active substance of Mesopral is esomeprazole. Each capsule contains 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• Other ingredients are: Capsule contents: sucrose, pellets (sucrose and cornstarch), hypromellose 3 cP, simethicone emulsion 30% (containing simethicone, polyoxyethylene sorbitan tristearate (polysorbate 65) (E436), methylcellulose, polyethylene glycol stearate, 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 macrogol stearate. The capsule shell: Iron oxide black (E172), shellac, gelatin, iron oxide yellow (E172), and titanium dioxide (E171).

What Mesopral looks like and contents of the pack

• The 20 mg Mesopral capsules have a non-transparent (yellow) cap and a non-transparent (white) body. The inscription "20 mg" is embossed on both the cap and the body. The capsule contains white or grayish spherical pellets.
• The 40 mg Mesopral capsules have a non-transparent (yellow) cap and a non-transparent (yellow) body. The inscription "40 mg" is embossed on both the cap and the body. The capsule contains white or grayish spherical pellets.
• The capsules are available in packs of: Bottles containing 28, 30, 90, or 98 capsules. Blister packs 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 leaflet:March 2025