Package Insert: Information for the Patient

Esomeprazole MABO 20 mg Hard Gastrorresistant Capsules EFG

Esomeprazole

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 who 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 is Esomeprazole MABO and how is it used

2. What you need to know before starting to take Esomeprazole MABO

3. How to take Esomeprazole MABO

4. Possible adverse effects

5. Storage of Esomeprazole MABO

6. Contents of the package and additional information

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

Esomeprazol MABO 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 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.

• Ulcers caused by medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol MABO 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 to prevent bleeding from peptic ulcers induced with esomeprazol intravenously.

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 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 Esomeprazol MABO:

• 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 proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, or 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 find yourself in any of these situations, do not take Esomeprazol MABO. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol MABO.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esomeprazol MABO

• 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 MABO to reduce stomach acid.
• if you are scheduled to have a specific blood test (Cromogranin A).

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

If your doctor has prescribed Esomeprazol MABO 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 MABO, 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 MABO. Remember to mention any other symptoms you may notice, such as joint pain.

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

Use of Esomeprazol MABO 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 purchased without a prescription. This is because Esomeprazol MABO may affect the way some medicines work and some medicines may influence the effect of Esomeprazol MABO.

Do not take Esomeprazol MABO 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 cancer treatment).
• Citalopram, imipramine, clomipramine (used for depression treatment).
• Diazepam (used for 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 MABO.
• Medicines used to make the blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol MABO.
• Cilostazol (used for 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 used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol MABO.
• Tacrolimus (organ transplant).
• Rifampicin (used for tuberculosis treatment).
• St. John's Wort (Hypericum perforatum) (used for depression).

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

Taking Esomeprazol MABO with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

Esomeprazol MABO 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 MABO containssucrose

Esomeprazol MABO containsespheres of sugar that contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication 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 indicated how many capsules you should 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 capsule of Esomeprazol MABO 40 mg per day for 4 weeks. Your doctor may indicate that you 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 capsule of Esomeprazol MABO 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of Esomeprazol MABO 20 mg once a day. Once your condition has been controlled, your doctor may indicate that you take your medication only when you notice some symptoms, up to a maximum of one capsule of Esomeprazol MABO 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:

• La dosis recomendada es una cápsula de Esomeprazol MABO 20 mg dos veces al día durante una semana.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

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

• La dosis recomendada es una cápsula de Esomeprazol MABO 20 mg once a day for 4 to 8 weeks.

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

• La dosis recomendada es una cápsula de Esomeprazol MABO 20 mg once a day.

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

• La dosis recomendada es una cápsula de Esomeprazol MABO 40 mg 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 capsule of Esomeprazol MABO 40 mg once a 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 enteric-coated capsule of Esomeprazol MABO 40 mg per day for 4 weeks. Your doctor may indicate that you 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 enteric-coated capsule of Esomeprazol MABO 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one enteric-coated capsule of Esomeprazol MABO 20 mg once a 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:

• La dosis recomendada es una cápsula gastrorresistente de Esomeprazol MABO 20 mg dos veces al día durante una semana. Your doctor will also prescribe antibiotics known as, for example, amoxicillin and clarithromycin.

How to take this medication

• Puede tomar las cápsulas a cualquier hora del día.
• Puede tomar las cápsulas con alimentos o con el estómago vacío.
• Trague las cápsulas enteras con un vaso de agua. No mastique ni triture las cápsulas. Esto es debido a que las cápsulas contienen gránulos que impiden que el medicamento sea destruido por el ácido del estómago. Es importante no dañar los gránulos.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the capsules:

- Abra la cápsula y vacíe los gránulos en medio vaso de agua sin gas. No se deben utilizar otros líquidos.

- Remueva la mezcla y bébala inmediatamente o en el plazo de 30 minutos. Remover siempre justo antes de beber.

- Para asegurar que ha tomado toda la medicación, enjuagar bien el vaso con medio vaso de agua y beber. Las partículas sólidas contienen la medicación – no mastique ni triture los gránulos.

• Si no puede tragar en absoluto, los gránulos se pueden mezclar con un poco de agua e introducirse en una jeringa. A continuación pueden administrarse directamente al estómago a través de una sonda (sonda gástrica).

Children under 12 years of age

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

Older adults

No es necesario ajustar la dosis en pacientes de edad avanzada.

If you take more Esomeprazol MABO than you should

If you take more Esomeprazol MABO 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.

If you forget to take Esomeprazol MABO

• Si usted olvida tomar una dosis, tómela tan pronto como lo recuerde. No obstante, si falta poco tiempo para su siguiente toma, no tome la dosis que olvidó.

• No tome una dosis doble (dos dosis a la vez) para compensar las dosis olvidadas.

Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

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 Esomeprazol MABO and contact a doctor immediately:

• A 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 enlarged lymph nodes (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.

Infrequent(may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if Esomeprazol MABO is used at high doses and for a long period).

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

• 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 sensation 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 may cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthralgia) or muscles (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing 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 problems
• Enlargement of the breasts in men.

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

• If you are being treated with Esomeprazol MABO 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 reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol MABO may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as 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 of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directlythrough theSpanish System for the 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 humidity.

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

Esomeprazol MABO Composition

-The active ingredient is esomeprazole.

Esomeprazol MABO capsules contain 20 mg of esomeprazole(as sodium salt).

The other components are:

Capsule Content:

Espheres of sugar (cornstarch and sucrose), methylcellulose, talc, titanium dioxide (E171), monoestearate of glycerol, polisorbate 80, sodium lauryl sulfate, copolymer of methacrylic acid and triethylcitrate.

Capsule Coating:

Carrageenan, potassium chloride, iron oxide red(E-172), titanium dioxide (E171), hypromellose, and printing ink (containing shellac, potassium hydroxide, and iron oxide black E-172).

Product Appearance and Packaging Content

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

Esomeprazol MABO 20 mg is available in:

Aluminum/Aluminum Blister Packs:

7, 14, 15, 28, 30, 56, 60, 90 (2x45), and 100 (2x50)capsules

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Rejas 2, planta 1

28821 Coslada, Madrid

Spain

Responsible Manufacturer:

TOWA PHARMACEUTICAL EUROPE S.L.

C/ San Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2025

Detailed and updated 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 nasogastric or gastric tube

1. Add the contents of one capsule to approximately 25 ml or 50 ml of water. (For some tubes, a dispersion in 50 ml of water is required to prevent the pellets from blocking the tube). Shake.

2.Empty the suspension into a syringe and add approximately 5 ml of air.

3. Immediately shake the syringe for approximately 2 minutes to disperse the pellets.

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

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

6. 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 prevent the tip from becoming blocked).

7. 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.

8. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 6 if necessary to remove any sediment remaining in the syringe. For some tubes, 50 ml of water is required.

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.