Stomezul

Package Leaflet: Information for the Patient

Stomezul, 40 mg, Gastro-Resistant Tablets

Esomeprazole

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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. Contents of the Package 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 medications called proton pump inhibitors. These medications reduce the production of stomach acid. Stomezul is used to treat the following conditions: Adults Gastroesophageal reflux disease. This occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. Stomach or duodenal ulcers caused by Helicobacter pylori infection. In this case, your 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 injectable form. Adolescents (12 years and older) Gastroesophageal reflux disease. This occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. Stomach or duodenal ulcers caused by Helicobacter pylori infection. In this case, your 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 you are allergic to esomeprazole or any of the other ingredients of this medication (listed in section 6); if you are allergic to medications that contain a similar active substance (with the suffix -prazole, e.g., pantoprazole, lansoprazole, rabeprazole, omeprazole); if you are taking medications containing the active substance nelfinavir, used to treat HIV infections. if you have ever had a severe skin rash or blistering, or peeling and (or) mouth sores after taking Stomezul or other similar medications. If any of the above applies to you, do not take Stomezul. If in doubt, consult your doctor or pharmacist before taking the medication.

Warnings and Precautions

Before starting to take Stomezul, discuss it with your doctor if: you have severe liver problems. you have severe kidney problems. you are going to have a specific blood test (chromogranin A test). if you have ever had a skin reaction after taking a medication that reduces stomach acid production, similar to Stomezul. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Stomezul. You should stop taking Stomezul and consult your doctor immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4. If you get a rash on your skin, especially in areas exposed to sunlight, you should contact your doctor as soon as possible, as it may be necessary to stop taking Stomezul. You should also inform your doctor about any other side effects, such as joint pain. Stomezul may mask the symptoms of other diseases. Therefore, you should immediately consult your doctor if you experience any of the following symptoms before or during treatment with Stomezul: significant, unintentional weight loss and difficulty swallowing, abdominal pain or indigestion, vomiting blood or food, black stools (blood-stained). If you are taking the medication on demand, you should consult your 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 you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of developing osteoporosis), you should inform your doctor.

Children

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

Stomezul and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Stomezul and other medications may interact with each other. Do not take Stomezul if you are taking a medication containing nelfinavir (used to treat HIV infections). The following medications and Stomezul may interact with each other: atazanavir (a medication used to treat HIV infections); ketoconazole, itraconazole, or voriconazole (medications used to treat fungal infections); If necessary, your doctor will adjust the dose of Stomezul in patients taking the medication continuously and in patients with severe liver problems. erlotinib (a medication used to treat cancer); medications metabolized by a specific enzyme, such as: diazepam (a sedative and sleep aid); citalopram, imipramine, clomipramine (medications used to treat depression); phenytoin (a medication used to treat epilepsy and some types of pain). If necessary, your doctor will reduce the dose of these medications, especially if taken occasionally. In patients taking phenytoin, your doctor will monitor its blood levels, especially at the beginning and after stopping Stomezul. warfarin, phenprocoumon, acenocoumarol (medications used to prevent blood clotting). Your doctor will monitor blood clotting parameters, especially at the beginning and after stopping Stomezul. cilostazol (a medication used to treat intermittent claudication - a disease characterized by leg pain when walking due to insufficient blood flow); cisapride (a medication used to treat stomach and intestinal diseases); methotrexate (a medication used in high doses in cancer chemotherapy). If you are receiving high doses of methotrexate, your doctor may recommend temporary discontinuation of Stomezul. rifampicin (an antibiotic used to treat tuberculosis); St. John's Wort (a herbal remedy used to treat depression); digoxin (a medication used to treat various heart conditions); clopidogrel (a medication used to prevent clotting events, such as heart attack or stroke); tacrolimus (a medication used to prevent organ rejection). If your doctor has prescribed two antibiotics (amoxicillin and clarithromycin) in addition to Stomezul to treat stomach ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor about any other medications you are taking.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.

Pregnancy

Your doctor will decide whether you should take Stomezul during pregnancy.

Breastfeeding

It is not known whether Stomezul passes into breast milk. Therefore, you should not take this medication during breastfeeding.

Driving and Operating Machines

It is unlikely that Stomezul will affect your ability to drive or operate machines. However, uncommon or rare side effects, such as dizziness and blurred vision (see section 4), may occur. In this case, do not drive or operate machines.

Stomezul Contains Glucose and Sucrose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medication.

3. How to Take Stomezul

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The medication is not recommended for children under 12 years of age. If you have been taking this medication for a long time (especially more than a year), your doctor will monitor your treatment. If your doctor has prescribed the medication to be taken on demand (when needed), you should inform your doctor about any changes in your symptoms.

How Much to Take

Your doctor will tell you how many tablets to take and for how long. This depends on your disease, age, and liver function. The usual doses are listed below. Adults

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease

If your doctor has found minor damage to the esophageal mucosa, the usual dose of Stomezul is 40 mg. The medication is taken once a day for 4 weeks. If the esophageal changes do not heal during this time, your doctor may prescribe the medication 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 controlling the symptoms, your doctor may prescribe the medication to be taken on demand (when needed), up to one 20 mg tablet per day. If you have severe liver problems, your doctor may prescribe a lower dose. Treatment of Duodenal Ulcer Caused by Helicobacter pylori Infection and Prevention of its Recurrence The usual dose is one 20 mg tablet twice a day for one week. Your doctor will also prescribe two antibiotics, such as amoxicillin and clarithromycin.

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

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

Prevention of Stomach Ulcer in Patients Taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The usual dose is one 20 mg tablet per day.

Treatment of Excessive Stomach Acid Production Caused by Changes in the Pancreas (Zollinger-Ellison Syndrome)

The usual dose is one 40 mg tablet twice a day. Your doctor will adjust the dose according to your needs and determine how long you should take the medication. The maximum dose is 80 mg twice a day. Long-Term Treatment After Prevention of Recurrent Bleeding from Gastrointestinal Ulcers with Esomeprazole in Injectable 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 your 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 esophageal changes do not heal during this time, your doctor may prescribe the medication 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 controlling the symptoms, your doctor may prescribe the medication to be taken on demand (when needed), up to one 20 mg tablet per day. If you have severe liver problems, your doctor may prescribe a lower dose. Treatment of Duodenal Ulcer Caused by Helicobacter pylori Infection and Prevention of its Recurrence The usual dose is one 20 mg tablet twice a day for one week. Your doctor will also prescribe two antibiotics, such as amoxicillin and clarithromycin.

How to Take the Medication

The medication can be taken at any time of the day. The medication 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 protect the medication from stomach acid. It is essential not to damage the pellets.

Instructions for Dividing the Tablet

The tablet should be divided as shown in the picture:

What to Do if You Have Difficulty Swallowing

If you have 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 all the medication is taken, fill the glass with water to half, stir, and drink the liquid. Undissolved particles contain the medication - do not chew or crush them. if you are unable to swallow, 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 if You Take More Stomezul Than You Should

If you take more Stomezul than you should, contact your doctor or pharmacist immediately.

What to Do if You Miss a Dose of Stomezul

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

What to Do if You Stop Taking Stomezul

Take the medication for as long as your doctor has prescribed it. Stopping treatment or taking the medication with interruptions without consulting your doctor may reduce the effectiveness of the treatment. If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

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

If You Experience Any of the Following Serious Side Effects, Stop Taking Stomezul and Contact Your Doctor Immediately:

Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction) (rare: may affect up to 1 in 1,000 people). Redness of the skin with blistering or peeling. It is also possible to have blisters, bleeding in the mouth, eyes, lips, genitals, or high fever and joint pain. This is known as erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis (very rare: may affect less than 1 in 10,000 people). 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 signs of liver problems (very rare: may affect less than 1 in 10,000 people). This medication may very rarely affect the number of white blood cells, leading to reduced immunity. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with local infection symptoms, such as sore throat, mouth, or urinary problems, you should contact your doctor immediately to have a blood test to rule out a lack of white blood cells (agranulocytosis). It is essential to inform your doctor about the medication you are taking (very rare: may affect less than 1 in 10,000 people). Other side effects: Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

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

• blood disorders, such as reduced white blood cell or platelet count (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 onset of wheezing or shortness of breath (bronchospasm)
• mouth inflammation
• fungal infections of the digestive tract (thrush)
• hair loss
• skin rash after sun exposure, increased sensitivity to sunlight
• joint pain or muscle pain
• general feeling of being unwell
• increased sweating

Very Rare (may affect less than 1 in 10,000 people):

• 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 you take this medication for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and rapid heartbeat. If you experience any of these symptoms, you should contact your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your 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 you experience any side effects, including any not listed in this package leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Stomezul

Keep the medication out of the sight and reach of children. Do not use this medication 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 stated. 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 of the bottle: 6 months. Keep the bottle tightly closed to protect from moisture. 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. Contents of the Package and Other Information

What Stomezul Contains

• The active substance is esomeprazole. Each gastro-resistant tablet contains 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• Other ingredients are: tablet core: sucrose, maize starch, glucose liquid, hydroxypropylcellulose, povidone, talc, titanium dioxide (E171), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, glycerol monostearate, propylene glycol, stearic acid, polysorbate 80, simethicone, microcrystalline cellulose, macrogol 6000, crospovidone, silicon dioxide, anhydrous, magnesium stearate. Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide red (E172).

What Stomezul Looks Like and Contents of the Package

Pink, oval, coated tablets with a dividing line on both sides. The tablet can be divided into equal doses. The medication 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 Medication and its Names in Other EU Countries

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 package leaflet: 06/2025 Information intended for healthcare professionals only: Administration of the Medication Through a Gastric Tube If the patient is unable to 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 of the Medication Through a Gastric Tube

• 1. Put the tablet in the appropriate syringe and fill the syringe with about 25 ml of water and about 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 with pellets.
• 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 as 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 the syringe and remove any remaining sediment. For some tubes, it may be necessary to add 50 ml of water.