STOMEZUL 20 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Stomezul, 20 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:
3. What is Stomezul and what is it used for
4. Important information before taking Stomezul
   1. When not to take Stomezul
   2. Warnings and precautions
   3. Children
   4. Stomezul and other medicines
   5. Pregnancy and breastfeeding
   6. Pregnancy
   7. Breastfeeding
   8. Driving and using machines
   9. Stomezul contains glucose and sucrose
5. How to take Stomezul
   1. How much to take
   2. Treatment of heartburn caused by gastroesophageal reflux disease
   3. Treatment of stomach ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs)
   4. Prevention of stomach ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs)
   5. Treatment of excessive production of stomach acid caused by changes in the pancreas (Zollinger-Ellison syndrome)
   6. Long-term treatment after prevention of recurrent bleeding from gastrointestinal ulcers with esomeprazole in intravenous form
   7. Treatment of heartburn caused by gastroesophageal reflux disease
   8. How to take the medicine
   9. What to do in case of difficulty swallowing
   10. What to do in case of taking a higher dose of Stomezul than recommended
   11. What to do in case of missing a dose of Stomezul
   12. What to do in case of stopping Stomezul treatment
6. Possible side effects
   1. If the patient experiences any of the following serious side effects, they should stop taking the medicine and immediately consult a doctor:
   2. Reporting side effects
7. How to store Stomezul
8. Package contents and other information
   1. What Stomezul contains
   2. What the package contains
   3. Marketing authorization holder and manufacturer
   4. For more information about the medicine and its names in other European Economic Area countries, please contact:

Leaflet accompanying the packaging: patient information

Stomezul, 20 mg, gastro-resistant tablets

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 possible 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 Stomezul and what is it used for
• 2. Important information before taking Stomezul
• 3. How to take Stomezul
• 4. Possible side effects
• 5. How to store Stomezul
• 6. Package contents and other information

1. What is Stomezul and what is it used for

Stomezul contains the active substance esomeprazole, which belongs to a group of medicines called proton pump inhibitors. These medicines reduce the production of stomach acid. Stomezul is used to treat the following diseases: Adults Gastroesophageal reflux disease. This occurs when acidic stomach contents flow back into the esophagus (the section connecting the throat to the stomach), causing pain, inflammation, and heartburn. Stomach or duodenal ulcers caused by Helicobacter pylori infection. In such cases, the doctor may also prescribe antibiotics to treat the infection and heal the ulcer. Stomach ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Stomezul can also be used to prevent stomach ulcers in patients taking non-steroidal anti-inflammatory drugs. Excessive production of stomach acid caused by changes in the pancreas (Zollinger-Ellison syndrome). Long-term treatment after prevention of recurrent bleeding from gastrointestinal ulcers with esomeprazole in intravenous form. Adolescents (12 years and older) Gastroesophageal reflux disease. This occurs when acidic stomach contents flow back into the esophagus (the section connecting the throat to the stomach), causing pain, inflammation, and heartburn. Stomach or duodenal ulcers caused by Helicobacter pylori infection. In such cases, the doctor may also prescribe antibiotics to treat the infection and heal the ulcer.

2. Important information before taking Stomezul

When not to take Stomezul

if the patient is allergicto esomeprazole or any of the other ingredients of this medicine (listed in section 6); if the patient is allergicto similar medicines that contain active substances with the suffix -prazole (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole); if the patient is taking medicines containing the active substance nelfinavir, used to treat HIV infections. if the patient has ever had a severe skin rash or skin peeling, blistering, and (or) mouth sores after taking Stomezul or other similar medicines. If any of the above situations apply to the patient, they should not take Stomezul. In case of doubts before taking the medicine, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Stomezul, the patient should discuss it with their doctor if: they have severe liver problems; they have severe kidney problems; they are going to have a specific blood test (chromogranin A measurement); they have ever had a skin reaction after taking a medicine that reduces stomach acid production, similar to Stomezul. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in association with Stomezul treatment. The patient should stop taking Stomezul and consult a doctor immediately if they notice any of the symptoms related to these serious skin reactions described in section 4. If the patient develops 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 Stomezul. They should also tell their doctor about any other side effects, such as joint pain. Stomezul may mask the symptoms of other diseases. Therefore, the patient should immediately consult their doctor if, before or during Stomezul treatment, they experience any of the following symptoms:significant, unintentional weight loss and swallowing disorders,abdominal pain or indigestion,vomiting food or blood,black stools (discolored with blood).If the patient is taking the medicine on an as-needed basis, they should consult their doctor if the symptoms persist or change. Taking proton pump inhibitors (such as Stomezul), especially for more than a year, may slightly increase the risk of hip, wrist, or spine fractures. If the patient has been diagnosed with osteoporosis or is taking corticosteroids (which may increase the risk of developing osteoporosis), they should tell their doctor.

Children

The medicine is not recommended for children under 12 years of age due to insufficient data.

Stomezul and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Stomezul and other medicines may interact with each other. The patient should not take Stomezul if they are taking a medicine containing nelfinavir (used to treat HIV infection). The following medicines and Stomezul may interact with each other: atazanavir(a medicine used to treat HIV infections); ketoconazole, itraconazoleor voriconazole(medicines used to treat fungal infections); In case of necessity, the doctor will adjust the dose of Stomezul in patients taking the medicine continuously and in patients with severe liver problems. erlotinib(a medicine used to treat cancer); medicines metabolized by a specific enzyme, such as: - diazepam(a sedative and sleep aid) - citalopram, imipramine, clomipramine(medicines used to treat depression) - phenytoin(a medicine used to treat epilepsy and some pain conditions). In case of necessity, the doctor will reduce the dose of these medicines, especially if they are taken occasionally. In patients taking phenytoin, the doctor will monitor its blood levels, especially at the beginning and after stopping Stomezul. warfarin, phenprocoumon, acenocoumarol(medicines used to prevent physiological blood clotting). The doctor will monitor the blood clotting parameters, especially at the beginning and after stopping Stomezul. cilostazol(a medicine used to treat intermittent claudication - a disease characterized by leg pain when walking due to insufficient blood flow); cisapride(a medicine used to treat stomach and intestinal diseases); methotrexate(a medicine used in high doses in cancer chemotherapy). If the patient is receiving high doses of methotrexate, the doctor may recommend temporary discontinuation of Stomezul. rifampicin(an antibiotic used to treat tuberculosis); St. John's wort(a herbal medicine used to treat depression); digoxin(a medicine used to treat various heart diseases); clopidogrel(a medicine used to prevent events related to the formation of blood clots, such as heart attack or stroke); tacrolimus(a medicine used to prevent rejection of a transplanted organ).

If the doctor has prescribed, in addition to Stomezul, two antibiotics (amoxicillin and clarithromycin) to treat ulcers caused by Helicobacter pylori infection, it is very important to inform them about any other medicines being taken.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The doctor will decide whether it is advisable to take Stomezul during pregnancy.

Breastfeeding

It is not known whether Stomezul passes into breast milk. Therefore, this medicine should not be taken during breastfeeding.

Driving and using machines

It is unlikely that Stomezul will affect the ability to drive or use tools and machines. However, dizziness and blurred vision (see section 4) may occur rarely. In such cases, the patient should not drive or use machines.

Stomezul contains glucose and sucrose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Stomezul

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. It is not recommended to take Stomezul in children under 12 years of age. If the patient is taking this medicine for a long time (especially more than a year), the doctor will monitor the treatment. If the doctor has recommended taking the medicine on an as-needed basis (when necessary), the patient should report any changes in symptoms to their doctor.

How much to take

The doctor will inform the patient about the number of tablets to take and how long to take the medicine. This depends on the patient's disease, age, and liver function. The usual doses are listed below. Adults

Treatment of heartburn caused by gastroesophageal reflux disease

If the doctor has found minor damage to the esophageal mucosa, the usual dose of Stomezul is 40 mg. The medicine is taken once a day for 4 weeks. If the changes in the esophagus do not heal during this time, the doctor may recommend taking the medicine at the same dose for another 4 weeks. After healing the esophagus, the usual dose is one 20 mg tablet per day. If the esophageal mucosa is not damaged, the usual dose is one 20 mg tablet per day. After the symptoms of the disease have been brought under control, the doctor may recommend taking the medicine as needed (on demand), up to a maximum of one 20 mg tablet per day. If the patient has severe liver problems, the doctor may recommend a lower dose. Treatment of ulcers associated with Helicobacter pylori infection and prevention of their recurrenceThe usual dose is one 20 mg tablet twice a day for one week. The doctor will also recommend taking two antibiotics, such as amoxicillin and clarithromycin.

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

The usual dose is one 20 mg tablet per day for 4 to 8 weeks.

Prevention of stomach ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs)

The usual dose is one 20 mg tablet per day.

Treatment of excessive production of stomach acid caused by changes in the pancreas (Zollinger-Ellison syndrome)

The usual dose is one 40 mg tablet twice a day. The doctor will adjust the dose according to the patient's needs and determine how long to take the medicine. The maximum dose is 80 mg taken twice a day.

Long-term treatment after prevention of recurrent bleeding from gastrointestinal ulcers with esomeprazole in intravenous form

The usual dose is 40 mg 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 damage to the esophageal mucosa, the usual dose of Stomezul is one 40 mg tablet per day for 4 weeks. If the changes in the esophagus do not heal during this time, the doctor may recommend taking the medicine at the same dose for another 4 weeks. After healing the esophagus, the usual dose is one 20 mg tablet per day. If the esophageal mucosa is not damaged, the usual dose is one 20 mg tablet per day. After the symptoms of the disease have been brought under control, the doctor may recommend taking the medicine as needed (on demand), up to a maximum of one 20 mg tablet per day. If the patient has severe liver problems, the doctor may recommend a lower dose. Treatment of ulcers associated with Helicobacter pylori infection and prevention of their recurrenceThe usual dose is one 20 mg tablet twice a day for one week. The doctor will also recommend taking two antibiotics, such as amoxicillin and clarithromycin.

How to take the medicine

The medicine can be taken at any time of the day. The medicine 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, whose coating protects the medicine from stomach acid. It is essential not to damage the pellets.

What to do in case of difficulty swallowing

If the patient has difficulty swallowing the tablet:

• put the tablet in a glass of non-carbonated water. Do not use other liquids.
• stir until the tablet dissolves (the liquid will not be clear). Drink the liquid immediately or within 15 minutes of preparation. Stir the liquid before drinking.
• to ensure that the entire medicine is taken, fill the glass with water to half, stir, and drink the liquid. Undissolved particles contain the medicine - do not chew or crush them. if the patient cannot swallow on their own, the tablet can be mixed with a small amount of water and given through a syringe into the stomach through a nasogastric tube.

What to do in case of taking a higher dose of Stomezul than recommended

In case of taking a higher dose of Stomezul than recommended, the patient should immediately consult a doctor or pharmacist.

What to do in case of missing a dose of Stomezul

A missed dose should be taken 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.

What to do in case of stopping Stomezul treatment

The medicine should be taken for as long as the doctor has recommended. Stopping treatment or taking it intermittently without consulting a doctor may reduce the effectiveness of the therapy. In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking the medicine and immediately consult a doctor:

Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction) (rare: may occur less frequently than in 1 in 1000 patients). Redness of the skin with blistering or peeling. It is also possible to have blisters, bleeding in the mouth, eyes, mouth, nose, and genitals, or high fever and joint pain. This condition is called erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis (very rare: may occur less frequently than in 1 in 10,000 patients). Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which occurs very rarely. Yellowing of the skin, dark urine, and feeling tired - these may be symptoms of liver problems (very rare: may occur less frequently than in 1 in 10,000 patients). This medicine may very rarely affect the number of white blood cells, leading to a lack of immunity. If the patient has an infection with symptoms such as fever with a significant worsening of their general condition or fever with symptoms of a local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should immediately consult a doctor to have blood tests done to rule out a lack of white blood cells (agranulocytosis). It is essential to inform the doctor about the medicine being taken (very rare: may occur less frequently than in 1 in 10,000 patients). Other side effects: Common(may occur less frequently than in 1 in 10 patients):

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

Uncommon(may occur less frequently than in 1 in 100 patients):

• swelling of the hands, ankles, or feet
• insomnia
• dizziness
• tingling sensation
• drowsiness
• dry mouth
• changes in liver function test results
• itching
• skin rash
• hives
• fracture of the hip, wrist, or spine (if the medicine is taken in high doses or for a long time)
• vertigo (dizziness of labyrinthine origin)

Rare(may occur less frequently than in 1 in 1000 patients):

• blood disorders, such as a decreased number of white blood cells or platelets (which may cause weakness, bruising, or increased susceptibility to infections)
• low sodium levels in the blood (which may cause weakness, vomiting, and muscle cramps)
• feeling agitated, confused, or depressed
• changes in taste
• blurred vision
• sudden wheezing or shortness of breath (bronchospasm)
• mouth inflammation
• fungal infections of the digestive tract (thrush)
• hair loss
• skin rash after sun exposure
• joint pain or muscle pain
• general malaise
• increased sweating

Very rare(may occur less frequently than in 1 in 10,000 patients):

• lack of white and red blood cells and platelets
• aggression
• seeing, feeling, or hearing things that do not exist (hallucinations)
• muscle weakness
• severe kidney disease
• breast enlargement in men

Frequency not known(cannot be estimated from the available data) If the patient takes this medicine for more than three months, there is a possibility of a decrease in magnesium levels in the blood. Low magnesium levels may cause fatigue, 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 also lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

• inflammation of the colon (microscopic colitis) leading to diarrhea
• rash, which may be accompanied by joint pain.

Reporting side effects

If side effects occur, including any side effects not listed in the 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, tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Stomezul

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister or bottle after EXP. The expiry date refers to the last day of the month. Blisters: Do not store above 25°C. HDPE bottles: Before first opening: do not store above 30°C. After first opening: do not store above 30°C. Shelf life after first opening the bottle: 6 months. Store the bottle tightly closed 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. Package contents and other information

What Stomezul contains

• The active substance of the medicine is esomeprazole. Each gastro-resistant tablet contains 20 mg of esomeprazole (in the form of esomeprazole magnesium dihydrate).
• Other ingredients are: Tablet core: sucrose, pellets (sucrose, corn starch, liquid glucose), hydroxypropylcellulose, povidone, talc, titanium dioxide (E171), methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, glycerol monostearate, propylene glycol, stearic acid, polysorbate 80, simethicone, microcrystalline cellulose, macrogol 6000, crospovidone, silica colloidal anhydrous, magnesium stearate. Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide red and yellow (E172).

The medicine looks like pink, oval, film-coated tablets.

What the package contains

Stomezul is available in blisters containing 28, 30, and 60 gastro-resistant tablets and in HDPE bottles containing 28, 30, and 100 gastro-resistant tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria Manufacturer Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany Lek S.A. ul. Domaniewska 50 C 02-672 Warsaw Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia S.C. Sandoz S.R.L 4 and 7A Livezeni Street, 540472, Targu Mures, Mures County Romania Novartis Pharmaceutical Manufacturing LLC Verovškova ulica 57 1000 Ljubljana Slovenia Lek Pharmaceuticals d.d. Trimlini 2D 9220 Lendava Slovenia

For more information about the medicine and its names in other European Economic Area countries, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Sandoz logo Date of last revision of the leaflet:06/2025 Information intended for healthcare professionals only: Administration through a gastric tube If the patient cannot swallow, the tablets can be dissolved in non-carbonated water and administered through a gastric tube. It is essential to check that the correct syringe and tube have been chosen. Administration through a gastric tube

• 1. Put the tablet in the appropriate syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, it may be necessary to dissolve the tablet in 50 ml of water to avoid clogging the tube.
• 2. Immediately after adding water, shake the syringe for about 2 minutes until the tablet dissolves.
• 3. Holding the syringe with the tip up, check that the tip is not clogged.
• 4. Connect the syringe to the tube in the position described above.
• 5. Shake the syringe and turn it upside down. Immediately inject 5-10 ml of the contents into the tube. After administration, turn the syringe upside down and shake. Hold the syringe with the tip up to avoid clogging.
• 6. Turn the syringe upside down and immediately inject another 5-10 ml into the tube. Repeat these steps until the syringe is empty.
• 7. Fill the syringe with 25 ml of water and 5 ml of air. If necessary, repeat the steps described in point 5 to rinse any remaining sediment in the syringe. For some tubes, it may be necessary to add 50 ml of water.