Patient Information Leaflet

Esomeprazol Sandoz 40 mg gastro-resistant tablets EFG

Esomeprazol

Read this 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Esomeprazol Sandoz

3.How to take Esomeprazol Sandoz

4.Possible side effects

5.Storage of Esomeprazol Sandoz

6.Contents of the pack and additional information

Esomeprazol Sandoz contains a medication called esomeprazole, which belongs to a group of medications 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 rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Infected ulcers in the stomach or upper part of the small intestine (duodenum) caused by a bacteria called Helicobacter Pylori. If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Medication-induced gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazole can 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 bleeding from peptic ulcers induced with intravenous esomeprazole.

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Infected ulcers in the stomach or upper part of the small intestine (duodenum) caused by a bacteria called Helicobacter Pylori. If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not takeEsomeprazol Sandoz

• if you areallergicto esomeprazol or any of the other ingredients of this medication (listed in section 6),
• if you areallergicto similar medications, with an active ingredient that ends in -prazol (such as pantoprazol, lansoprazol, rabeprazol, or omeprazol),
• if you are taking medications that contain the active substance nelfinavir, used to treat HIV infection
• if you have ever developed a severe skin rash or peeling, blisters, and/or mouth sores after taking esomeprazol or other related medications.
• .

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

Warnings and precautions

Consult your doctor or pharmacist before starting to takeEsomeprazol Sandoz:

• if you have severe liver problems,
• if you have severe kidney problems,
• if you are scheduled to have a specific blood test (Cromogranina A).
• if you have ever had a skin reaction after treatment with a similar medication 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 medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you develop a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt esomeprazol treatment. Remember to mention any other symptoms you may notice, such as joint pain

Esomeprazol may mask 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 experience stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

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

If you are taking proton pump inhibitors such as esomeprazol, especially for a period of more than one year, it may slightly increase the risk of fractures 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

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

Other medications and Esomeprazol Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because esomeprazol may affect the way some medications work and some medications may influence the effect of esomeprazol.

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

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

• atazanavir,a medication for HIV treatment,
• ketoconazol,itraconazolor voriconazol, medications used to treat fungal infections.

In case necessary,your doctor will adjust the esomeprazol dose in patients with continuous treatment or severely reduced liver function,

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

• diazepam, a sedative to calm and induce sleep,
• citalopram,imipramina,clomipramina, for depression treatment,
• fenitoína,for epilepsy and certain pain states.

In case necessary, your doctor will reduce the dose of these medications, particularly during occasional use. If you take fenitoína, your doctor will monitor your blood levels, particularly when starting or stopping esomeprazol treatment,

• warfarina, fenprocumón, acenocumarol,medications used to prevent blood clot formation.

Your doctor will monitor blood coagulation values, particularly when starting or stopping esomeprazol treatment,

• cilostazol, (used to treat intermittent claudication, (pain in the legs that occurs when walking and is caused by poor blood circulation),
• cisaprida,used to treat stomach and intestinal problems,
• metotrexato, (a chemotherapy medication used at high doses to treat cancer), if you are being treated with high-dose metotrexato, your doctor may temporarily interrupt esomeprazol treatment,
• rifampicina,an antibiotic (used to treat tuberculosis),
• hierba de San Juan,a herbal treatment for depression,
• digoxina,a medication to treat various heart diseases,
• clopidogrel,used to prevent atherothrombotic diseases (such as a heart attack or stroke),
• tacrolimus,used to prevent rejection after organ transplantation

If your doctor has prescribed the antibioticsamoxicilinaandclaritromicinain addition to esomeprazol to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Pregnancy and breastfeeding

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

• Pregnancy

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

• Breastfeeding

The passage of esomeprazol into breast milk is unknown. Therefore, do not take esomeprazol during breastfeeding.

Driving and operating machinery

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

Esomeprazol Sandoz contains glucose and saccharose.

If your doctor has indicated that you have anintolerance to certainsugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

How much to take

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

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

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

For the prevention of gastric ulcers if you are taking NSAIDs:

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

For the treatment of excessive stomach acid 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 for how long you should take this medication. The maximum dose is 80 mg twice a day.

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

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

How to take this medication

• 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 medication from being destroyed by the stomach acid. It is essential not to damage the granules.

Division of tablets

The tablet can be divided into equal doses. Divide 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 (without gas). 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 always just before drinking.

-To ensure that you have taken all the medication, rinse the glass well with half a glass of water and drink. 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 introduced into a syringe. Subsequently, they can 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

What to do 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 compensate for the missed dose.

What to do if you interrupt the treatment with Esomeprazol Sandoz

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

• Sudden difficulty breathing, swelling of the 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. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals, or high fever and joint pain. It 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.
• Yellow skin, dark urine, and fatigue that may be symptoms of liver problems (Very rare: may affect up to 1 in 10,000 people).
• In rare cases, this medicine may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever and severe worsening of your general condition or high fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out a decrease in white blood cell count (agranulocytosis) through a blood test. It is essential to inform your doctor about your medication in this case (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 or unusual behavior and make you feel dizzy (encephalopathy) (Very rare: may affect up to 1 in 10,000 people).

Other side effects:

Common (may affect up to 1 in 10 people)

• Headache,
• Effects on the stomach or intestines: stomach pain, constipation, diarrhea, gas (flatulence),
• Feeling sick (nausea)/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,
• Sensation of tingling and numbness,
• Drowsiness,
• Dry mouth,
• Alteration of blood tests that determine liver function,
• Itching,
• Skin rash
• Hives,
• Fracture of the hip, wrist, or spine (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 a decrease in white blood cells or platelets. (This may cause weakness, bruises, or increase the risk of infections),
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps,
• Agitation, confusion, and depression,
• Alteration of taste,
• Blurred vision,
• Sudden sensation of lack of air or difficulty breathing (constriction of the airways),
• Inflammation of the mucous membrane of the mouth,
• A known infection called "candidiasis" that may affect the esophagus and is caused by a fungus,
• Hair loss,
• Dermatitis caused by exposure to sunlight,
• Pain in the joints or muscles,
• Sensation of general discomfort,
• Increased sweating.

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

• Similar decrease in white blood cells and red blood cells and platelets,
• Aggression,
• To see, feel, or hear things that do not exist (hallucinations),
• Weakness of the muscles,
• Severe kidney problems,
• 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, it is possible that the levels of magnesium in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, go to your doctor immediately. Low magnesium levels may 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) may lead to diarrhea.

• Skin rash, possibly with joint pain.

Reporting of side effects

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

Keepthis medicationout of the sight andreach of children.

Do notusethis medication after the expiration date indicated on the carton and on the blister or container of tablets after CAD. The expiration dateis the last day of the month indicated.

Aluminum/aluminum blisters and clear/aluminum

Do notstore at a temperature above25 °C.

High-density polyethylene (HDPE) container

Storage before opening the HDPE container:

Do not store at a temperature above 30ºC.

Storage after the first opening of the HDPE container:

Do notstore at a temperature above 30°C

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

Keepthe container perfectly closed to protect it from moisture.

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Esomeprazol Sandoz

• Theactive ingredientisesomeprazole. Each gastro-resistant tablet contains 40 mg of esomeprazole (as magnesium dihydrate salt).

• The other components are:

• Tablet core:sucrose, cornstarch, liquid glucose, hydroxypropylcellulose, povidone, talc, titanium dioxide (E171), copolymer of methacrylic acid and ethyl acrylate (1:1), glyceryl monostearate, propylene glycol, stearic acid, polysorbate80,simethicone, 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 contents of the package

Esomeprazol Sandoz 40 mg are gastro-resistant tablets, pink, oval, with a linear incision 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 commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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. Domaniewska50 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

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

Austria:Esomeprazol Sandoz40 mg gastro-resistant tablets

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

Denmark:Esomeprazol Sandoz

Estonia:NEXMEZOL 40mg

Spain:Esomeprazol Sandoz 40 mg gastro-resistant tablets EFG
Slovenia:Nillar 40 mg gastro-resistanttablets

Finland:Esomeprazol Sandoz 40 mg enteric-coated tablets

Hungary:Esomeprazol Sandoz 40 mg gastro-resistant tablet

Lithuania:Nexmezol 40 mg gastro-resistant tablets

Latvia:Nexmezol 40 mg gastro-resistant tablets

Norway:EsomeprazolSandoz 40 mg enteric-coated tablets

Poland:Stomezul

Portugal:Esomeprazol Sandoz

Date of the last review of this leaflet: February 2025

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely 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 check 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, a dispersion in 50 ml of water is required to prevent particles from blocking the tube.

2.Immediately agitate the syringe for approximately 2 minutes to disperse the tablet.

3.Hold the syringe with the tip upwards and check that the tip has not become blocked.

4.Connect the syringe to the tube while maintaining the previous position.

5.Agitate the syringe and place it with the tip downwards.Inject immediately 5-10 ml into the tube. Invert the syringe after injection and agitate. The syringe must be kept with the tip upwards to prevent blockage.

6.Place the syringe with the tip downwards and inject immediately 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 draw any remaining sediment. For some tubes, 50 ml of water is required.