Package Insert: Information for the Patient

Esomeprazole Pensa 20 mg Hard Gastroresistant Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isEsomeprazole Pensaand for what it is used

2. What you need to know before starting to takeEsomeprazole Pensa

3. How to takeEsomeprazole Pensa

4. Possible adverse effects

5. Storage ofEsomeprazole Pensa

6. Contents of the package and additional information

Esomeprazol Pensa contains a medicine called esomeprazole 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).
• Continuation treatment for the prevention of 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.
• 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 esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the group of proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine that contains nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash or peeling of the skin, blistering or ulcers in the mouth after taking esomeprazole or other related medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esomeprazol Pensa

• 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 medicine to Esomeprazol Pensa to reduce stomach acid.
• If you are due to have a specific blood test (Cromogranin A).

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

Esomeprazol Pensa may mask the symptoms of other diseases.Therefore, if you notice any of the following events before taking or while taking Esomeprazol Pensa, 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 (blood-stained).

If you have been prescribed Esomeprazol Pensa 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 Pensa, especially for a period of more than one year, may slightly increase the risk of breaking a hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

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

Use of Esomeprazol Pensa with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes medicines bought without a prescription. This is because Esomeprazol Pensa may affect the way some medicines work and some medicines may influence the effect of Esomeprazol Pensa.

Do not take Esomeprazol Pensa if you are taking a medicine that containsnelfinavir(used for the treatment of HIV infection).

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

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used for the prevention of blood clots).
• Ketoconazole, itraconazole or voriconazole (used for fungal infections).
• Erlotinib (used in the treatment of cancer).
• Citalopram, imipramine, clomipramine (used for the treatment of depression).
• Diazepam (used for the treatment of 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 Pensa.
• Medicines used to make the blood thinner such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Pensa.
• Cilostazol (used for the treatment of intermittent claudication – pain in the legs when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (chemotherapy medicine used at high doses in the treatment of cancer) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol Pensa.
• Tacrolimus (organ transplant).
• Rifampicin (used for the treatment of tuberculosis).
• St. John's Wort (Hypericum perforatum) (used for depression).

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

Taking Esomeprazol Pensa with food and drinks

You can take the capsules with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will decide if you can take Esomeprazol Pensa during this period.

The safety of Esomeprazol Pensa for use during pregnancy has not been established. Therefore, Esomeprazol Pensa should not be taken during pregnancy.

Driving and using machines

Esomeprazol Pensa 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.

Esomeprazol Pensa containssucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. 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 have told you how many capsules to take and when to take them. This will depend on your situation, age, and liver function.
• The recommended doses are indicated below.

Adults 18 years of age 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 capsule per day for 4 weeks. Your doctor may tell 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 capsule per day.
• If your esophagus is not affected, the recommended dose is one Esomeprazol Pensa 20 mg capsule per day. Once your condition has been controlled, your doctor may tell you to take your medicine only when you notice some symptoms, up to a maximum of one Esomeprazol Pensa 20 mg capsule 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 capsule 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 capsule 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 capsule per day.

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

• The recommended dose is one Esomeprazol Pensa 40 mg capsule twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take this medication. The maximum dose is 80 mg twice a day.

Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously:

• The recommended dose is one Esomeprazol Pensa 40 mg capsule per day for 4 weeks.

Use in adolescents 12 years of age 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 capsule per day for 4 weeks. Your doctor may tell 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 capsule per day.
• If your esophagus is not affected, the recommended dose is one Esomeprazol Pensa 20 mg capsule 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 capsule 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 capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain 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

• If you have difficulty swallowing the capsules:

- Open the capsule and pour the granules into a glass of water without gas. Do not use other liquids.

- Remove the mixture and drink it immediately or within 30 minutes. Always stir just before drinking.

- To ensure that you have taken all the medication, rinse the glass with 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 granules can be mixed with a little water and introduced into a syringe. They can then be administered directly into the stomach through a tube (gastrostomy tube).

Children under 12 years of age

Esomeprazol Pensa is not recommended for children under 12 years of age.

Older adults

No adjustment of the dose is necessary in older adults.

If you take more Esomeprazol Pensa than you should

If you take more Esomeprazol Pensa than your doctor has told you to, 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, 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 doses.

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

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

If you notice any of the following serious side effects, stop taking Esomeprazol Pensa 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.
• Sleep disturbance (insomnia).
• 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 Pensa 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 the number of white blood cells or platelets. This may cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• An infection known as "candidiasis" that may affect the esophagus and is caused by a fungus.
• Liver problems including jaundice that may cause yellow skin, dark urine, and fatigue.
• Loss of hair (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthritis) or muscles (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 blood cells, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Liver disorders that may 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 disorders.
• Increased breast size in men.

Frequency not known(the frequency cannot be estimated from the available data)

• If you are being treated with Esomeprazol Pensa for more than three months, it is possible that magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see a doctor immediately. Low magnesium levels may also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Pensa may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever with severe 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 the number of white blood cells (agranulocytosis) through a blood test. It is essential to inform your doctor about your medication in this case.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough theSpanish 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 medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Blister:

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Bottle:

Do not store at a temperature above 30°C. Keep the container perfectly closed to protect it from moisture.

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

Esomeprazol Pensa Composition

• The active ingredient is esomeprazole (as sodium salt). Each capsule contains 20 mg of esomeprazole (as sodium salt).
• The other components are:

Capsule Content: esferas of sugar (cornstarch and sucrose), methylcellulose, talc, titanium dioxide (E171), monoestearate of glycerol, polisorbate 80, copolymer of methacrylic acid – ethyl acrylate, sodium lauryl sulfate, and triethyl citrate.

Capsule Coating: carrageenan, potassium chloride, iron oxide red, titanium dioxide (E171), hypromellose, and black printing ink (containing shellac, anhydrous alcohol, isopropyl alcohol, propylene glycol, butyl alcohol, ammonium hydroxide, potassium hydroxide, purified water, and iron oxide black E-172).

Product Appearance and Packaging Content

Esomeprazol Pensa 20 mg are clear pale pink opaque hard capsules of size 4 (approximately 14 mm), printed (head ES/body 20) and containing spherical granules.

Esomeprazol Pensa 20 mg is available in:

-Aluminum/Aluminum blisters of 14, 28, and 56 capsules.

-White opaque polyethylene (PE) bottles, containing silica gel as a desiccant, with a polyethylene (PE) stopper of 14 and 28 capsules.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible Manufacturer:

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Last Review Date of this Leaflet:January 2025

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

This information is intended solely for healthcare professionals

Administration via Gastrostomy Tube

1. Open the capsule and empty the pellets into an appropriate 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. Agitate the syringe immediately to distribute the granules uniformly in the suspension.
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 the tip from becoming blocked).
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.

Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to draw any sediment remaining in the syringe. For some tubes, 50 ml of water is required.