Esomeprazole Sandoz 20 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Esomeprazol Sandoz 20 mg gastro-resistant tablets EFG

Esomeprazole

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Esomeprazol Sandoz is and what it is used for
2. What you need to know before taking Esomeprazol Sandoz
3. How to take Esomeprazol Sandoz
4. Possible adverse effects
5. How to store Esomeprazol Sandoz
6. Contents of the pack and other information

1. What Esomeprazol Sandoz is and what it is used for

Esomeprazol Sandoz contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid in your stomach.

Esomeprazol Sandoz is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer after initial control with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid moves up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazol Sandoz

Do not take Esomeprazol Sandoz

• if you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to medicines similar in structure, whose active ingredient names end in -prazole (such as pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if you are taking medicines containing the active substance nelfinavir, used to treat HIV infection,
• if you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking esomeprazole or other related medicines.

If any of these apply to you, do not take esomeprazole. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Sandoz.

Warnings and precautions

Talk to your doctor or pharmacist before starting Esomeprazol Sandoz:

• if you have severe liver problems,
• if you have severe kidney problems,
• if you are scheduled for a specific blood test (Chromogranin A),
• if you have ever had a skin reaction after treatment with a medicine similar to esomeprazole used to reduce stomach acid.

Skin rash and skin reactions

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with esomeprazole may need to be stopped. Remember to mention any other symptoms you may notice, such as joint pain.

Serious skin reactions have been reported with esomeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using esomeprazole and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Esomeprazole may mask symptoms of other diseases. Therefore, if you experience any of the following events before or while taking esomeprazole, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (indicating blood in the stool).

If you have been prescribed esomeprazole “on-demand,” you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as esomeprazole, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Children

The use of esomeprazole is not recommended in children under 12 years of age, as there is insufficient data.

Other medicines and Esomeprazol Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because esomeprazole can affect how some medicines work, and some medicines can influence the effect of esomeprazole.

Do not take esomeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).

The following medicines may alter the effects of esomeprazole and vice versa:

• atazanavir, a medicine used to treat HIV infection,
• ketoconazole, itraconazole, or voriconazole, medicines used to treat fungal infections.

If necessary, your doctor will adjust the dose of esomeprazole in patients on long-term treatment or with severely reduced liver function.

• erlotinib, used to treat cancer,

• medicines metabolized by a specific enzyme, such as:

• diazepam, a sedative used to calm and induce sleep,

• citalopram, imipramine, clomipramine, used to treat depression,

• phenytoin, used to treat epilepsy and certain pain conditions.

If necessary, your doctor will reduce the dose of these medicines, especially when used occasionally. If you are taking phenytoin, your doctor will monitor your blood levels, particularly when starting or stopping esomeprazole treatment.

• warfarin, phenprocoumon, acenocoumarol, medicines used to prevent blood clots,
• cilostazol, used to treat intermittent claudication (leg pain while walking caused by poor blood flow),
• cisapride, used to treat stomach and intestinal problems,
• methotrexate, a chemotherapy medicine used at high doses to treat cancer. If you are receiving high-dose methotrexate, your doctor may temporarily stop your esomeprazole treatment,
• rifampicin, an antibiotic used to treat tuberculosis,
• St. John’s wort, a herbal remedy for depression,
• digoxin, a medicine used to treat various heart conditions,
• clopidogrel, used to prevent atherothrombotic diseases (such as heart attack or stroke),
• tacrolimus, used to prevent organ transplant rejection.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin along with esomeprazole to treat Helicobacter pylori-related ulcers, it is very important that you inform your doctor if you are taking any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will decide whether you can take esomeprazole during this time.

Breastfeeding

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

Driving and using machines

Esomeprazole is unlikely to affect your ability to drive or operate tools or machinery. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). Do not drive or operate machinery if you experience any of these effects.

Esomeprazol Sandoz contains glucose and sucrose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Esomeprazol Sandoz

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Esomeprazol Sandoz is not recommended for children under 12 years of age.
• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told you how many tablets to take and for how long. This will depend on your condition, age, and liver function.
• The recommended doses are indicated below.

Adults

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is 40 mg of esomeprazole once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one tablet of esomeprazole 20 mg once daily.
• If your esophagus is not affected, the recommended dose is one tablet of esomeprazole 20 mg once daily. Once your condition is under control, your doctor may instruct you to take the medicine only when needed, up to a maximum of one 20 mg esomeprazole tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg esomeprazole tablet twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole tablet once daily for 4 to 8 weeks.

To prevent gastric ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole tablet once daily.

For the treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 40 mg of esomeprazole twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

For continued treatment to prevent rebleeding from peptic ulcer after intravenous esomeprazole:

• The usual dose is one 40 mg esomeprazole tablet once daily for 4 weeks.

Use in adolescents (from 12 years of age)

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is 40 mg of esomeprazole once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one 20 mg esomeprazole tablet once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg esomeprazole tablet once daily. Once your condition is under control, your doctor may instruct you to take the medicine only when needed, up to a maximum of one 20 mg esomeprazole tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg esomeprazole tablet twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

How to take this medicine

• You may take the tablets at any time of day.
• You may take the tablets with or without food.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules that prevent the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Place the tablets in a glass of water (non-carbonated). Do not use other liquids.

• Stir until the tablets disintegrate (the solution will not be clear). Drink the mixture immediately or within 15 minutes. Always stir just before drinking.

• To ensure you have taken the full dose, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medication; do not chew or crush the granules.

• If you cannot swallow at all, the tablets can be dispersed in water and administered via a syringe. They can then be delivered directly into the stomach through a tube (gastric tube).

If you take more Esomeprazol Sandoz than you should

If you take more Esomeprazol Sandoz than your doctor has prescribed, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Esomeprazol Sandoz

• If you forget to take a dose, take it 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 a forgotten dose.

If you stop taking Esomeprazol Sandoz

Always take the prescribed dose for the length of time indicated by your doctor. If you stop treatment without consulting your doctor, you may reduce the effectiveness of the treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following serious adverse effects, stop taking this medicine and contact a doctor immediately:

• Sudden difficulty breathing, swelling of the lips, tongue and throat or of the whole body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare: may affect up to 1 in 1,000 people).
• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to serious and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be a case of “erythema multiforme”, “Stevens-Johnson syndrome” or “toxic epidermal necrolysis” (very rare: may affect up to 1 in 10,000 people).
• Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), very rarely observed.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems (very rare: may affect up to 1 in 10,000 people).
• In very rare cases, this medicine may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of general condition, or fever with signs of a localized infection such as neck pain, sore throat, mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in white blood cells (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about your current medication (very rare: may affect up to 1 in 10,000 people).
• Severe liver problems that may lead to liver failure and brain disease, which may cause confusion, unusual behavior, or dizziness (encephalopathy) (very rare: may affect up to 1 in 10,000 people).

Other adverse effects:

Common (may affect up to 1 in 10 people)

• headache,
• effects on stomach or intestine: stomach pain, constipation, diarrhea, gas (flatulence),
• feeling sick (nausea) and/or being sick (vomiting),
• benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people)

• swelling of hands, feet and ankles,
• insomnia,
• dizziness,
• tingling and numbness sensations,
• drowsiness,
• dry mouth,
• changes in blood tests indicating liver function,
• itching,
• skin rash,
• urticaria (hives),
• hip, wrist or spine fracture (if this medicine is used at high doses and for a long period of time),
• sensation of spinning (vertigo).

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

• blood disorders such as decreased number of white blood cells or platelets (this may cause weakness, bruising, or increased risk of infections),
• low sodium levels in the blood. This may cause weakness, vomiting, and cramps,
• restlessness, confusion, and depression,
• altered taste,
• blurred vision,
• sudden sensation of breathlessness or difficulty breathing (constriction of the airways),
• inflammation of the oral mucosa,
• a fungal infection known as “candidiasis” which may affect the esophagus,
• hair loss,
• dermatitis due to exposure to sunlight,
• joint or muscle pain,
• general feeling of discomfort,
• increased sweating.

Very rare (may affect up to 1 in 10,000 people):

• similar decrease in the number of white and red blood cells and platelets,
• aggression,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• muscle weakness,
• severe kidney disorders,
• enlargement of the breasts in men.

Frequency not known (cannot be estimated from available data)

• If you are being treated with this medicine for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (microscopic colitis) which may cause diarrhea.
• Skin rash, possibly accompanied by joint pain.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister or bottle after EXP. The expiry date refers to the last day of the month indicated.

Aluminum/aluminum blisters and Aclar/aluminum blisters

Do not store above 25 °C.

High-density polyethylene (HDPE) container

Storage before opening the HDPE container: Do not store above 30 °C.

Storage after first opening of the HDPE container: Do not store above 30 °C.

Expiry after first opening of the container: 6 months.

Keep the container tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Sandoz

• The active substance is esomeprazol. Each gastro-resistant tablet contains 20 mg of esomeprazol (as magnesium dihydrate salt).

• The other components are:

Tablet core: sucrose, corn starch, liquid glucose, hydroxypropylcellulose, povidone, talc, titanium dioxide (E171), methacrylic acid and ethyl acrylate copolymer (1:1), glycerol monostearate, propylene glycol, stearic acid, polysorbate 80, simethicone, microcrystalline cellulose, macrogol 6000, crospovidone, colloidal anhydrous silica, magnesium stearate.

Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Esomeprazol Sandoz 20 mg are light pink, oval, gastro-resistant tablets.

Esomeprazol Sandoz 20 mg is available in blister packs containing 7, 14, 15, 28, 30, 56, 60, 90, 98, 100 and 100x1 gastro-resistant tablets, and in HDPE bottles containing 7, 14, 15, 28, 30, 56, 60, 90, 98, 100 and 250 gastro-resistant tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

S.C. Sandoz S.R.L

4 and 7A Livezeni Street,

540472, Targu Mures, Mures County

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

LEK S.A.

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

LEK Pharmaceuticals d.d.

Verovskova 57,

1526 Ljubljana

Slovenia

or

Novartis Pharmaceutical

Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana,

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Esomeprazol Sandoz 20 mg magensaftresistente Tabletten

Denmark: Esomeprazol Sandoz

Estonia: NEXMEZOL 20mg

Spain: Esomeprazol Sandoz 20 mg gastro-resistant tablets EFG

Slovenia: Nillar 20 mg gastrorezistente tablete

Finland: Esomeprazol Sandoz 20 mg enterotabletti

Hungary: Esomeprazol Sandoz 20 mg gyomornedv-ellenálló tabletta

Lithuania: Nexmezol 20 mg skrandyje neirios tabletes

Latvia: Nexmezol 20 mg zarnas škistošas tabletes

Poland: Stomezul, 20 mg, tabletki dojelitowe

Date of the most recent review of this summary: February 2026.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Administration via gastric tube by medical personnel:

If the patient is unable to swallow, the tablets may be dispersed in water and administered via a gastric tube. It is important to carefully verify the suitability of the syringe and tube selected.

Administration via gastric tube

1. Place the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air.

For some tubes, dispersion in 50 ml of water is required to prevent particles from blocking the tube.

2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it. The syringe must be kept with the tip pointing upwards to prevent blockage.
6. Reposition the syringe with the tip pointing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 6 if necessary to flush any remaining residue. For some tubes, 50 ml of water may be required.