Prospect: Information for the Patient

Esomeprazole Viatris 20 mg gastro-resistant tablets EFG

Esomeprazole

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Esomeprazole Viatris and what it is used for

2.What you need to know before taking Esomeprazole Viatris

3.How to take Esomeprazole Viatris

4.Possible adverse effects

5.Storage of Esomeprazole Viatris

6.Contents of the pack and additional information

Esomeprazol Viatris contains an active ingredient called esomeprazol.This belongs to a group of medicines known as proton pump inhibitors.These work by reducing the amount of acid produced by the stomach.

Esomeprazol Viatris 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 heartburn.

-Stomach ulcers or upper small intestine ulcers infected by a bacteria called “Helicobacter pylori”. If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

-Stomach ulcers caused by certain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Viatris can also be used to prevent stomach ulcers or ulcers in the upper small intestine if you are taking NSAIDs.

-Excessive stomach acid produced by a growth in the pancreas (Zollinger-Ellison syndrome).

-Continuation treatment to prevent bleeding from peptic ulcers induced with esomeprazol intravenous.

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 heartburn.

-Ulcers in the stomach or upper small intestine (duodenum) that are infected by a bacteria calledHelicobacter 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 take EsomeprazolViatris

-If you areallergic(hypersensitive) to esomeprazol, or any of the other components of this medication (listed in section 6).

-If you are allergic to any other proton pump inhibitor, medications that reduce stomach acid secretion (for example, pantoprazol, lansoprazol, rabeprazol, omeprazol).

-If you are taking a medication that contains nelfinavir (used in the treatment of HIV infections).

-If you have ever developed a severe skin rash or skin peeling, blistering, or ulcers in the mouth after taking esomeprazol or other related medications.

If you find yourself in any of these situations, do not take esomeprazol. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazol Viatris:

-If you have severe liver problems.

-If you have severe kidney problems.

-

-If you have ever had a skin reaction after treatment with a similar medication to EsomeprazolViatrisfor reducing stomach acid.

• If you are scheduled to have a specific blood test (Cromagranina A).

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

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

-You lose a lot of weight without reason and have trouble swallowing.

-You experience stomach pain or indigestion.

-You begin to vomit food or blood.

-Your stools appear black (blood-stained).

If you are taking esomeprazolon demandand your symptoms persist or change, consult your doctor.

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

Skin eruptions and symptoms

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

Severe skin eruptions have occurred in patients taking esomeprazol (see also section 4). The rash may include mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes). These severe skin eruptions usually appear after symptoms similar to the flu, such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

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

If, at any time during treatment (even after several weeks), you develop a rash or any of these skin symptoms, stop taking this medication and contact your doctor immediately.

Use of EsomeprazolViatriswith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is because Esomeprazol Viatris may affect how some medications work, and some medications may influence the effect of Esomeprazol Viatris.

Do not take Esomeprazol Viatris if you are taking a medication that containsnelfinavir(used for HIV treatment).

Inform your doctor or pharmacist if you are taking any of the following medications:

-Atazanavir (used for HIV treatment).

-Clopidogrel (used to prevent blood clots).

-Ketoconazole, itraconazole, or voriconazole (for fungal infections).

-Erlotinib (used for cancer treatment).

-Citalopram, imipramine, clomipramine (for depression treatment).

-Diazepam (used for anxiety, muscle relaxation, or epilepsy).

-Fenitoin (for epilepsy). If you are taking fenitoin, your doctor will need to monitor when you start or stop taking Esomeprazol Viatris.

-Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Viatris.

-Cilostazol (used for intermittent claudication – pain in the legs when walking due to insufficient blood supply).

-Cisaprida (used for indigestion and stomach burning).

-Digoxina (used to treat heart problems).

-Metotrexato (a chemotherapy medication used in high doses for cancer treatment) – if you are taking high doses of metotrexato, your doctor may temporarily interrupt your treatment with Esomeprazol Viatris.

-Tacrolimus (organ transplant).

-Rifampicina (used for tuberculosis treatment).

-St. John's Wort (Hypericum perforatum)(used to treat depression).

If your doctor has prescribed antibiotics amoxicilina and claritromicina, in addition to Esomeprazol Viatris, for treating ulcers caused byHelicobacter pylori, it is essential to inform your doctor if you are taking any other medication.

Taking EsomeprazolViatriswith food and drinks

You can take the tablets with or without food.

Pregnancy, lactation, and fertility

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

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

The passage of Esomeprazol Viatris into breast milk is unknown. Therefore, do not take Esomeprazol Viatris during lactation.

Driving and operating machines

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

EsomeprazolViatriscontains saccharose

This medication contains sugar spheres that contain saccharose, a type of sugar.

If your doctor has indicated that you have anintolerance to certain sugars, consult with them before taking this medication.

Esomeprazol Viatris contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

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

-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 told 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 tell you how many tablets to take and for how long. It will always depend on your disease, your age, and how your liver works.

-The usual dose is indicated below:

Adults 18 years of age and older

To treat heartburn caused by gastroesophageal reflux disease (GERD):

-If your doctor has determined that your esophagus (gullet) is slightly damaged, the recommended dose is one esomeprazole tablet 40 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your gullet has not healed.

-The recommended dose once your gullet has healed is one esomeprazole tablet 20 mg once a day.

-If your gullet has not been damaged, the recommended dose is one esomeprazole tablet 20 mg per day. Once the situation is under control, your doctor may tell you to take your medication as and when you need it, up to a maximum of one esomeprazole tablet 20 mg per day.

-If you have severe liver problems, your doctor will tell you a lower dose.

To treat ulcers caused byHelicobacter pyloriinfection and to prevent their recurrence:

-The recommended dose is one esomeprazole tablet 20 mg twice a day for one week.

-Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

To treat stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs):

-The recommended dose is one esomeprazole tablet 20 mg once a day for4 to8 weeks.

To prevent stomach ulcers or ulcers in the upper part of the small intestine if you are taking NSAIDs:

-The recommended dose is one esomeprazole tablet 20 mg once a day.

To treat excessive acid in the stomach caused by a tumor in the pancreas (Zollinger Ellison syndrome):

-The recommended dose is one esomeprazole gastro-resistant tablet 40 mg twice a day.

-Your doctor will adjust the dose according to your needs and will decide for how long you will have to take the medication. The maximum dose is 80 mg twice a day.

Continuation treatment for the prevention of bleeding from peptic ulcers induced by intravenous administration:

-The recommended dose is one esomeprazole gastro-resistant tablet 40 mg once a day for 4 weeks.

Use in adolescents 12 years of age and older

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one esomeprazole gastro-resistant tablet 40 mg per 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 esomeprazole gastro-resistant tablet 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one esomeprazole gastro-resistant tablet 20 mg once a day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

To treat ulcers caused byHelicobacter pyloriinfection and to prevent their recurrence:

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

Taking 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.

What to do if you have difficulty swallowing the tablets

??If you have difficulty swallowing the tablets:

-Insert the tablet into the middle of a glass of water without gas. Do not use other liquids.

-Stir until the tablet dissolves (the mixture will not be transparent). You can drink the mixture immediately or within 30 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 (gastrostomy tube).

Children under 12 years of age

Esomeprazole gastro-resistant tablets are not recommended for children under 12 years of age.

Older adults

No dose adjustment is necessary for older adults.

If you take more Esomeprazol Viatris than you should

If you take more Esomeprazol than you should, 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.

If you forget to take Esomeprazol Viatris

• If you forget to take a dose, take it as soon as you remember, unless it is almost time to take your next dose.
• Do not take a double dose to compensate for the missed doses.

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

Like all medications, Esomeprazol Viatris may cause side effects, although not everyone will experience them.

If you notice any of the following severe side effects, stop taking esomeprazol and seek medical attention immediately:-Yellowish skin, dark urine, and fatigue that may be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.

• ,A sudden difficulty breathing,inflammation of the lips, tongue, and throat or body, skin rash, dizziness, or swallowing difficulties (severe allergic reaction).

These side effects are rare and may affect up to 1 in 1,000 people.

• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These side effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

-Headache.

-Effects on your stomach or intestines: diarrhea, stomach pain, constipation, flatulence.

-Dizziness (nausea) or discomfort (vomiting).

• Benign polyps in the stomach.

Rare (may affect up to 1 in 100 people)

-Swelling of the feet and ankles.

-Sleep disturbances (insomnia).

-Dizziness, tingling, numbness.

-Dizziness.

-Dry mouth.

-Changes in blood tests that control how your liver functions.

-Skin rash, hives, and itching.

-Fracture of the hip, wrist, or spine (if Esomeprazol is taken at high doses or for long periods).

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

-Blood disorders such as a reduced number of white blood cells or platelets. This causes weakness, bruises, or more frequent infections.

-Low sodium levels in the blood. This can cause weakness, discomfort (vomiting), and cramps.

-Feeling agitated, confused, or depressed.

-Changes in taste.

-Eye problems such as blurred vision.

-Sudden feeling of difficulty breathing or shortness of breath (bronchospasm).

-Inflammation of the inside of the mouth.

-A fungal infection called “candidiasis” that can affect the intestines and is caused by a fungus.

-Liver problems, including jaundice that can cause yellowish skin, dark urine, and fatigue.

-Hair loss (alopecia).

-Sunburn rash.

-Joint pain (arthritis) or muscle pain (myalgia).

-General feeling of discomfort and lack of energy.

-Increased sweating.

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

-Changes in blood counts including agranulocytosis (lack of white blood cells).

-Aggression.

-Seeing, feeling, or hearing things that do not exist (hallucinations).

-Severe liver problems that lead to liver failure and brain inflammation.

-Sudden appearance of a severe skin rash or blisters or peeling of the skin. This may be associated with a high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,drug reaction with eosinophilia and systemic symptoms).

-Muscle weakness.

-Severe kidney problems.

-Enlargement of the breasts in men.

Unknown frequency (cannot be estimated from available data)

-If you are taking esomeprazol for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels in the blood can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, report them immediately to your doctor. Low magnesium levels in the blood can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

-Inflammation in the intestine (causing diarrhea).

-Skin rash, possibly with joint pain.

In rare cases, Esomeprazol may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as fever with aseveredecline in general condition or fever with symptoms of a local infection such as neck pain, throat pain, 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) through a blood test. It is essential that, in this case, you report your medication.

Reporting 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 Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date indicated on the carton and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above30°C.

Store in the original packaging (blister) to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Esomeprazol Viatris

- The active ingredient is Esomeprazol. Cada comprimido contains 20 mg of esomeprazol as the amorphous magnesium salt.

- The other components are:

Core of the tablet : Hidroxipropilcelulosa (E-463), Crospovidona (Type A), Coating: Povidona (K30), Macrogol 400, Macrogol 4000, Macrogol 6000, Hipromelosa ftalato (HP-55S), Hipromelosa ftalato (HP-50), Dietilftalato, Hidroxipropilcelulosa, Celulosa microcristalina (PH 101), Celulosa microcristalina (PH 112), Crospovidona (Type B), Estearil fumarato de sodio, Opadry 03B86651 Marrón ( HMPC 2910/Hipromelosa 6cP, dióxido de titanio (E171), Macrogol/PEG 400, óxido de hierro rojo (E172) , Sugar spheres (sacarosa and cornstarch), Talco (E553b) (see section 2 “Esomeprazol Viatris contains sacarosa”).

Appearance of Esomeprazol Viatris and packaging contents

Esomeprazol Viatris are film-coated, oval, biconvex, and brick-red to brown-colored tablets, with the inscription “E5” in relief on one face and smooth on the other face.

The medicinal product is presented in OPA-Al-PE-desiccant-HDPE/ Alu and Poliamida/Al/PVC/Al blister packs containing 14, 28, and 56 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLÍN

Ireland

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027- Madrid

Spain

This leaflet has been approved in the following EEA countries with the following names:

Spain: Esomeprazol Viatris 20 mg gastro-resistant tablets EFG

Italy: Ezoran 20 mg Compresse Gastro-resistenti

Portugal: Esomeprazol Pharmakern 20 mg gastro-resistant tablets

Last revision date of this leaflet: February 2025

For detailed and updated information on this medicinal product, please visit 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 via 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 the pellets from blocking the tube.

2. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.

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

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

5. Shake the syringe and place it with the tip pointing downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip pointing upwards to prevent the tip from becoming blocked).

6. Place the syringe with the tip pointing 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 in the syringe. For some tubes, 50 ml of water is required.