ESOMEPRAZOL SANDOZ 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Sandoz 40 mg Gastro-Resistant Tablets EFG

Esomeprazol

Read the package leaflet carefully before starting to take this medicine, because it contains important information for you.

Keep this package leaflet, you may need to read it again.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Esomeprazol Sandoz contains a medicine called esomeprazol, which belongs to a group of medicines called “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 is when acid from the stomach rises up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or the upper part of the intestine (duodenum) that are infected with a bacterium called Helicobacter Pylori.If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazol can also be used to prevent ulcers if you are taking NSAIDs.
• Excessive acidity in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation of prevention of bleeding from peptic ulcers induced with intravenous esomeprazol.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). This is when acid from the stomach rises up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or the upper part of the intestine (duodenum) that are infected with a bacterium called Helicobacter Pylori.If you have this condition, your doctor may 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 allergicto esomeprazol or any of the other ingredients of this medicine (listed in section 6),
• if you are allergicto medicines similar to esomeprazol (e.g. pantoprazol, lansoprazol, rabeprazol, omeprazol),
• if you are taking a medicine that contains the active substance nelfinavir (used to treat HIV infection),
• if you have ever developed a severe skin rash, blistering, or peeling after taking esomeprazol or other medicines similar to esomeprazol.
• .

If you are in any of these situations, do not take esomeprazol. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Sandoz.

Warnings and precautions

Consult 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 to have a specific blood test (Chromogranin A).
• if you have ever had a skin reaction after treatment with a medicine similar to esomeprazol to reduce stomach acid.

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

If you get a rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as you may need to stop treatment with esomeprazol. Remember to mention any other symptoms you may notice, such as joint pain.

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

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (stained with blood).

If you have been prescribed esomeprazol “on demand”, you should contact your doctor if the symptoms of your disease persist or change.

If you are taking proton pump inhibitors like esomeprazol, especially for a period of more than one year, you may have a slightly increased risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Children

Esomeprazol is not recommended for children under 12 years of age, as there is not enough data.

Other medicines and Esomeprazol Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because esomeprazol may affect the way some medicines work and some medicines may affect the effect of esomeprazol.

Do not take esomeprazol if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

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

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

If necessary, your doctor will adjust the dose of esomeprazol in patients with ongoing treatment or with severely reduced liver function,

• erlotinib, used to treat cancer,
• medicines metabolized by a specific enzyme, such as:

• diazepam, a sedative to calm and induce sleep,
• citalopram, imipramine, clomipramine, for the treatment of depression,
• phenytoin, for the treatment of epilepsy and certain pain conditions.

If necessary, your doctor will reduce the dose of these medicines, especially during occasional use. If you are taking phenytoin, your doctor will monitor your blood levels, especially when starting or stopping treatment with esomeprazol,

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

Your doctor will monitor your blood clotting values, especially when starting or stopping treatment with esomeprazol,

• cilostazol, (used to treat intermittent claudication, (pain in the legs that occurs when walking and is caused by a lack of blood flow),
• cisapride, used to treat stomach and intestine problems,
• methotrexate, (a chemotherapy medicine used at high doses to treat cancer), if you are being treated with methotrexate at high doses, your doctor may temporarily stop your treatment with esomeprazol,
• rifampicin, an antibiotic (used to treat tuberculosis),
• St. John's Wort, a herbal treatment for depression,
• digoxin, a medicine to treat different heart conditions,
• clopidogrel, used to prevent atherothrombotic diseases (such as a heart attack or stroke),
• tacrolimus, used to prevent rejection after an organ transplant.

If your doctor has prescribed you the antibiotics amoxicillinand clarithromycinin addition to esomeprazol to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicine.

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 medicine.

• Pregnancy

Your doctor will decide whether you can take esomeprazol during this period.

• Breastfeeding

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

Driving and using machines

Esomeprazol is unlikely to affect your ability to drive or use tools or machines. However, sometimes side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you experience any of these effects.

Esomeprazol Sandoz contains glucose and sucrose.

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Esomeprazol Sandoz

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are 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 time, your doctor will need to monitor you (especially if you take it for more than a year).
• If your doctor has told you to take this medicine only when you notice 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 to take them. This will depend on your situation, 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 slightly affected, the recommended dose is 40 mg of esomeprazol once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not healed yet.
• Once your esophagus has healed, the recommended dose is one 20 mg esomeprazol tablet once a day.
• If your esophagus is not affected, the recommended dose is one 20 mg esomeprazol tablet once a day. Once your condition has been controlled, your doctor may tell you to take your medicine only when needed, up to a maximum of one 20 mg esomeprazol 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 esomeprazol tablet twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg esomeprazol tablet once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg esomeprazol tablet once a day.

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

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

For the continuation of prevention of bleeding from peptic ulcers induced with intravenous esomeprazol:

• The usual dose is one 40 mg esomeprazol tablet once a day 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 slightly affected, the recommended dose is 40 mg of esomeprazol once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not healed yet.
• Once your esophagus has healed, the recommended dose is one 20 mg esomeprazol tablet once a day.
• If your esophagus is not affected, the recommended dose is one 20 mg esomeprazol tablet once a day. Once your condition has been controlled, your doctor may tell you to take your medicine only when needed, up to a maximum of one 20 mg esomeprazol 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 esomeprazol tablet twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

Taking this medicine

• You can take the tablets at any time of the day.
• You can 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.

Dividing tablets

The tablets can be divided into equal doses. Divide the tablets as shown in this image.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

Put the tablets in a glass of water (still water). Do not use other liquids.

Stir until the tablets disintegrate (the solution will not be transparent).

• Drink the mixture immediately or within 15 minutes. Stir just before drinking.

To ensure that you have taken all the medicine, rinse the glass well with half a glass of water and drink. 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 introduced into a syringe. They can then be administered 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 indicated, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, 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 the missed dose.

If you stop taking Esomeprazol Sandoz

Always take the prescribed dose for the duration 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 all people suffer from them.

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

• A sudden difficulty breathing, swelling of lips, tongue, and throat or body in general, skin rash, fainting or difficulty swallowing (severe allergic reaction) (Rare: may affect up to 1 in 1,000 people).
• Redness of the skin with blisters or peeling. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals or high fever and joint pain may also appear. This could be "erythema multiforme", "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (Very rare: may affect up to 1 in 10,000 people).
• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.
• Yellow skin, dark urine, and fatigue that can 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 an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of your general condition or fever with symptoms of a local infection such as neck, throat, mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) through a blood test. It is essential that, in this case, you inform about your medication (very rare: may affect up to 1 in 10,000 people).
• Severe liver problems that can lead to liver failure and brain disease, which can cause confusion or unusual behavior and dizziness (encephalopathy) (very rare: may affect up to 1 in 10,000 people).

Other adverse effects:

Frequent(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

• swelling of hands, feet, and ankles,
• insomnia,
• dizziness,
• tingling and numbness sensation,
• drowsiness,
• dry mouth,
• alteration of blood tests that determine 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),
• feeling that everything is spinning (vertigo).

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

• blood disorders such as a decrease in the number of white blood cells or platelets. (this can cause weakness, bruising, or increase the likelihood of infections),
• low sodium levels in the blood. This can cause weakness, vomiting, and cramps,
• agitation, confusion, and depression,
• taste alteration,
• blurred vision,
• sudden feeling of shortness of breath or difficulty breathing (constriction of the airways),
• inflammation of the oral mucosa,
• an infection known as "candidiasis" that can affect the esophagus and is caused by a fungus,
• hair loss,
• dermatitis due to sun exposure,
• joint or muscle pain,
• feeling of general malaise,
• 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,
• increase in breast size in men.

Frequency Not Known (cannot be estimated from available data)

If you are being treated with this medicine for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

• Inflammation in the intestine (microscopic colitis) (inflammation in the intestine) can lead to diarrhea.

• Skin rash, possibly with joint pain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Esomeprazol Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date indicated on the packaging and on the blister or container of tablets after CAD. The expiration date is the last day of the month indicated.

Aluminum/aluminum and aclar/aluminum blisters

Do not store at a temperature above 25 °C.

High-density polyethylene (HDPE) container

Storage before opening the HDPE container:

Do not store at a temperature above 30°C.

Storage after the first opening of the HDPE container:

Do not store at a temperature above 30 °C

Expiration after the first opening of the container: 6 months.

Keep the container perfectly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Esomeprazol Sandoz

• The active principleis esomeprazol. Each gastro-resistant tablet contains 40 mg of esomeprazol (as magnesium dihydrate salt).

• The other components are:

• Core of the tablet:sucrose, cornstarch, 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, anhydrous colloidal silica, magnesium stearate.

• Coating of the tablet:hypromellose, macrogol 6000, titanium dioxide (E171), talc, red iron oxide (E172).

Appearance of the Product and Container Content

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

Esomeprazol Sandoz 40 mg is presented in blister packs with 7, 14, 15, 28, 30, 56, 60, 90, 98, 100, and 100x1 gastro-resistant tablets, and in HDPE containers with 7, 14, 15, 28, 30, 56, 60, 90, 98, 100, and 250 gastro-resistant tablets.

Only some package 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 Medicine is Authorized in the Member States of the European Economic Area:

Austria: Esomeprazol Sandoz 40 mg magensaftresistente Tabletten

Bulgaria: ???????? 40 MG ????????-????????? ????????

Denmark: Esomeprazol Sandoz

Estonia: NEXMEZOL 40mg

Spain: Esomeprazol Sandoz 40 mg comprimidos gastrorresistentes EFGEslovenia: 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

Norway: Esomeprazol Sandoz 40 mg enterotabletter

Poland: Stomezul

Portugal: Esomeprazol Sandoz

Date of the Last Revision of this Prospectus: February 2025

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

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This information is intended only for healthcare professionals:

Administration through a gastric tube by doctors:

If the patient is unable to swallow, the tablets can be dissolved in water and administered through a gastric tube. It is essential to carefully verify the suitability of the selected syringe and tube.

Administration through a gastric tube

1. Insert 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 avoid clogging the tube.

1. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.
2. Hold the syringe with the tip upwards and check that the tip has not been obstructed.
3. Connect the syringe to the tube while maintaining the previous position.
4. Shake the syringe and place it with the tip downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake. The syringe must be kept with the tip upwards to avoid obstruction.
5. Put the syringe back with the tip downwards and inject immediately another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.
6. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to drag any remaining sediment. For some tubes, 50 ml of water are necessary.