Package Leaflet: Information for the User

Esomeprazole 20 mg gastro-resistant tablets EFG

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, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Esomeprazol Pensa contains a medicine called esomeprazol that belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazol Pensa 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.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected 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.
• Ulcers caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Pensa can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).

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.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected 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 take Esomeprazol Pensa

• If you are allergic to esomeprazol or any of the other components of this medication (listed in section 6).
• If you are allergic to other medications in the group of proton pump inhibitors (for example pantoprazol, lansoprazol, rabeprazol, omeprazol).
• If you are taking a medication that contains nelfinavir (used in the treatment of HIV infection).
• 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 esomeprazol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take esomeprazol if:

• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a similar medication to Esomeprazol Pensa for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranina A).

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

Esomeprazol may mask symptoms of other diseases.Therefore, if you notice 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 begin to vomit food or blood.

• Your stools appear black (blood-stained).

If you have been prescribed esomeprazol only when you notice some symptoms, you should contact your doctor if the symptoms of your disease persist or change.

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

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 esomeprazol treatment. Remember to mention any other symptoms you may notice, such as joint pain.

Children under 12 years

Esomeprazol Pensa tablets are not recommended for children under 12 years old.

Use of Esomeprazol Pensa with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, even those purchased without a prescription. This is because esomeprazol may affect how some medications work and some medications may influence the effect of esomeprazol.

Do not take esomeprazol if you are taking:

• a medication that containsnelfinavir(used to treat HIV infection).

Inform your doctor if you are using any of the following medications:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, clomipramine (for depression treatment).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking esomeprazol.
• Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazol.
• Cilostazol (used to treat intermittent claudication (leg pain caused by poor blood circulation)).
• Cisapride (used to treat indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy medication used at high doses to treat cancer). If you are taking high doses of methotrexate, your doctor may temporarily interrupt your esomeprazol treatment.
• Tacrolimus (organ transplant).
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

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

Use of Esomeprazol Pensa with food and drinks

You can take the tablets with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. Your doctor will decide if you can take esomeprazol during this period.

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

Driving and operating machines

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

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.

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 stomach acid. It is essential not to damage the granules.

What to do if you have difficulty swallowing

If you have difficulty swallowing the tablets:

• Place the tablets in a glass of water without gas. Do not use other liquids.
• Stir until the tablets disintegrate (the solution 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. They can then be administered directly into the stomach through a tube (gastric tube).

How much to take

Your doctor will have told you how many tablets to take and when to take them. This will depend on your situation, age, and liver function. The recommended doses are indicated below.

Use in adults aged 18 years and older

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 one Esomeprazol Pensa 40 mg tablet per 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 Esomeprazol Pensa 20 mg tablet per day.
• If your esophagus is not affected, the recommended dose is one Esomeprazol Pensa 20 mg tablet per day. Once your condition has been controlled, your doctor may instruct you to take your medication as needed, up to a maximum of one Esomeprazol Pensa 20 mg 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 Esomeprazol Pensa 20 mg tablet 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 Esomeprazol Pensa 20 mg tablet per day for 4 to 8 weeks.

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

• The recommended dose is one Esomeprazol Pensa 20 mg tablet per day.

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

• The recommended dose is Esomeprazol Pensa 40 mg 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.

Use in adolescents aged 12 years and older

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 one Esomeprazol Pensa 40 mg tablet per 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 Esomeprazol Pensa 20 mg tablet per day.
• If your esophagus is not affected, the recommended dose is one Esomeprazol Pensa 20 mg 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 Esomeprazol Pensa 20 mg tablet twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

Use in children under 12 years of age

Esomeprazole is not recommended for children under 12 years of age.

Older adults

No dose adjustment is necessary for older adults.

If you take too much Esomeprazol Pensa

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Esomeprazol Pensa

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 (two doses at once) to make up for the missed dose.

Like all medicines, Esomeprazol Pensa can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking esomeprazol 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).
• Redness of the skin with blisters or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellow skin, dark urine, and fatigue, which may be symptoms of liver problems.
• Widespread rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

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

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign stomach polyps.

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep disturbance).
• Dizziness, tingling, numbness, somnolence.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if esomeprazol is used at high doses and for a long period).

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

• Blood disorders such as a decrease in white blood cells or platelets. This can cause weakness, bruises, or increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Altered taste.
• Eye disorders such as blurred vision.
• Sudden feeling of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• A fungal infection known as "candidiasis" that can affect the esophagus.
• Liver problems including jaundice that can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Joint pain (arthralgia) 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 the number of cells in the blood, including agranulocytosis (decrease in white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that can lead to liver failure or brain inflammation.
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. These symptoms may be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney problems.
• Increased breast size in men.

Frequency not known (the 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 can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, esomeprazol may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever and worsening of the 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 cells (agranulocytosis) through a blood test. It is essential to report your medication in this case.

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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label, the box, or blister pack after CAD. The expiration date is the last day of the month indicated.

Blister Packs:Do not store at a temperature above30°C. Store in the original packaging to protect it from moisture.

Bottles:Do not store at a temperature above30°C. Shelf life after the first opening of the bottle: 100 days. Keep the bottle perfectly closed to protect it from moisture.

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

Composition of Esomeprazol Pensa

The active ingredient is esomeprazole. There are two concentrations of Esomeprazol Pensa gastro-resistant tablets that contain 20 mg or 40 mg of esomeprazole (as sodium salt).

The other components are:

• Core:Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), monoestearate of glycerol, polysorbate 80, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and copolymer of methacrylic acid-ethyl acrylate), triethylcitrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearate fumarate.
• Coating:Opadry II Light Blue 85F30663 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine / indigo blue FD&C #2 (E132) and yellow iron oxide (E172)).

Appearance of the product and content of the container

Esomeprazol Pensa 20 mg gastro-resistant tablets are oval-shaped and blue in color. They are presented in containers of 14, 28, 56, or 100 (clinical container) tablets in blister packs and 14, 28, or 100 (clinical container) tablets in bottles.Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this prospectus:January 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/