Esomeprazole Sandoz 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Esomeprazol Sandoz 40 mg gastro-resistant tablets EFG

Esomeprazole

Read the entire leaflet carefully before you start taking this medicine because 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; do not give it to other people, even if they have the same symptoms as you, because it could 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 side 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

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach moves up into the oesophagus (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 medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazole may also be used to prevent the development of ulcers if you are taking NSAIDs.
• Excessive stomach acid production due to a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer after initial intravenous esomeprazole therapy.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach moves up into the oesophagus (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 to esomeprazole, whose active substances have names ending in -prazole (such as pantoprazole, lansoprazole, rabeprazole, omeprazole),
• if you are taking medicines containing the active substance nelfinavir, used for the treatment of 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 to take 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 it may be necessary to stop treatment with esomeprazole. Remember to mention any other symptoms you may experience, such as joint pain.

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

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

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 fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you 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 may affect how some medicines work, and some medicines may 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, particularly when used occasionally. If you are taking phenytoin, your doctor will monitor your blood levels, especially when starting or stopping treatment with esomeprazole.

• warfarin, phenprocoumon, acenocoumarol, medicines used to prevent blood clots.

Your doctor will monitor your blood clotting values, particularly when starting or stopping treatment with esomeprazole.

• cilostazol, used to treat intermittent claudication (leg pain occurring while walking due to 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 being treated with 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 used 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 in addition to esomeprazole to treat ulcers caused by Helicobacter pylori, 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 period.

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 use machines. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should 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 him before taking this medicine.

3. How to take Esomeprazol Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. 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 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 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 in patients 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 re-bleeding 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 gastro-resistant 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 amoxicillin and clarithromycin.

How to take this medicine

• You may take the tablets at any time of day.
• You may take the tablets with food or on an empty stomach.
• 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.

Tablet splitting

The tablet may be divided into equal doses. Split the tablets as illustrated in this image.

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 again just before drinking.

• To ensure you have taken the full dose, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine; 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 prescribed by your doctor, 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 number: 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, the effectiveness of the treatment may be reduced.

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 severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This could be "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 tiredness, 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 cell count (agranulocytosis) by means of a blood test. It is important that, in this case, you inform your doctor about your 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,
• stomach or intestinal effects: 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,
• hives (urticaria),
• 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 blood. This may cause weakness, vomiting and cramps,
• agitation, confusion and depression,
• altered taste,
• blurred vision,
• sudden sensation of breathlessness or difficulty breathing (constriction of 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,
• aggressiveness,
• 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, magnesium levels in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle twitching, disorientation, seizures, dizziness or increased heart rate. If you experience any of these symptoms, consult a doctor immediately. Low magnesium levels may also cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation of the intestine (microscopic colitis) which may lead to diarrhea.
• Skin rash, possibly with joint pain.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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

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

Shelf life after first opening 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. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If 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 Esomeprazole Sandoz

• The active substance is esomeprazole. Each gastro-resistant tablet contains 40 mg of esomeprazole (as magnesium dihydrate salt).
• The other components are:

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

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

Appearance of the product and pack contents

Esomeprazole Sandoz 40 mg are gastro-resistant, pink, oval tablets, with a linear notch on each side. The tablet may be divided into equal doses.

Esomeprazole Sandoz 40 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.

Centro Empresarial Parque Norte

Edificio Roble

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 European Economic Area member states under the following names:

Austria: Esomeprazol Sandoz 40 mg magensaftresistente Tabletten

Denmark: Esomeprazol Sandoz

Estonia: NEXMEZOL 40mg

Spain: Esomeprazol Sandoz 40 mg comprimidos gastrorresistentes EF

Slovenia: Nillar 40 mg gastrorezistente tablete

Finland: Esomeprazol Sandoz 40 mg enterotabletti

Hungary: Esomeprazol Sandoz 40 mg gyomornedv-ellenálló tabletta

Lithuania: Nexmezol 40 mg skrandyje neirios tabletes

Latvia: Nexmezol 40 mg zarnas škistošas tabletes

Poland: Stomezul, 40 mg, tabletki dojelitowe

Date of latest review of this leaflet: February 2026.

Detailed information on this medicine 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 physicians:

If the patient is unable to swallow, the tablets may be dissolved 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 an appropriate syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air.

For certain tubes, dispersion in 50 ml of water may be required to prevent particles from blocking the tube.

2. Shake the syringe immediately for about 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, shake it, and keep the syringe 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 5 if necessary to flush any remaining residue. For certain tubes, 50 ml of water may be required.