Package Insert: Information for the Patient

Esomeprazole Normon 20 mg Hard Gastrorresistant 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 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 Normon and how is it used

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

3. How to take Esomeprazole Normon

4. Possible adverse effects

5. Storage of Esomeprazole Normon

6. Contents of the package and additional information

Esomeprazol Normon 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 Normon 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.
• 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 medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Normon 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 esomeprazole intravenously.

Adolescents aged 12 years 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 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 Normon:

• If you are allergic to esomeprazole or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to other medications in the group of proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, or omeprazole).
• 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 peeling of the skin, formation of blisters or ulcers in the mouth after taking Esomeprazol Normon or other related medications.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esomeprazol Normon

• 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 Esomeprazol Normon for reducing stomach acid.
• if you are scheduled to have a specific blood test (Cromogranin A).

Esomeprazol Normon may mask the symptoms of other diseases.Therefore, if you notice any of the following events before taking or while taking Esomeprazol Normon, 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 your doctor has prescribed Esomeprazol Normon 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 Normon, 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 Normon. 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 treatment with Esomeprazol Normon. Stop taking Esomeprazol Normon 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 Normon with other medications

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

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

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

• 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 Normon.
• Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Normon.
• 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 medication used at high doses for cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol Normon.
• 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 Normon to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Taking Esomeprazol Normon 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 medication. Your doctor will decide if you can take Esomeprazol Normon during this period.

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

Driving and operating machinery

Esomeprazol Normon 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 Normon containssucrose

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

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 capsule of Esomeprazol Normon 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 yet healed.
• Once your esophagus has healed, the recommended dose is one capsule of Esomeprazol Normon 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of Esomeprazol Normon 20 mg once a 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 capsule of Esomeprazol Normon 20 mg per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused byHelicobacter pyloriinfection and to prevent their recurrence:

• La dosis recomendada es una cápsula de Esomeprazol Normon 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 Normon 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 Normon 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 Normon 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 Normon 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 capsule of Esomeprazol Normon 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 yet healed.
• Once your esophagus has healed, the recommended dose is one capsule of Esomeprazol Normon 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of Esomeprazol Normon 20 mg once a day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused byHelicobacter pyloriinfection and to prevent their recurrence:

• La dosis recomendada es una cápsula gastrorresistente de Esomeprazol Normon 20 mg dos veces al día durante una semana. Your doctor will also prescribe antibiotics such 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.

• If you cannot swallow at all, the granules can be mixed with a little water and introduced into a syringe. Then they can be administered directly into the stomach through a tube (gastric tube).

Children under 12 years of age

Esomeprazol Normon 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 Normon than you should

If you take more Esomeprazol Normon than your doctor has told you, 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 Normon

• 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 Normon 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 polyps in the stomach.

Less frequent(may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep disturbance).
• Dizziness, tingling, numbness, drowsiness.
• Dizziness.
• Dry mouth.
• Abnormal blood tests that determine liver function.
• Rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if Esomeprazol Normon 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 an increased risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, 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.
• 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 Normon 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, seizures, 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 periodic tests to monitor your magnesium levels.
• Inflammation in the intestine (may cause diarrhea).
• Rash, possibly with joint pain.

In very rare cases, Esomeprazol Normon 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 is apossibleside effect that does 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:No special temperature storage conditions are required. 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. The product must be used within 200 days after the first opening of the bottle.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Esomeprazol Normon

-The active ingredient is esomeprazol.

Esomeprazol Normon capsules contain 20 mg of esomeprazol(as sodium salt).

The other components are:

Content of the capsule:

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.

Covering of thecapsule:

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

Appearance of the product and content of the package

Esomeprazol Normon 20 mg are hard, pale pink opaque capsules in body and cap, size 4 (approximately 14 mm), printed (cap ES/body 20), and containing spherical granules.

Esomeprazol Normon 20 mg is available in:

Aluminum/Aluminum blister:

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

White opaque polyethylene (PE) bottles, containing silica gel as a desiccant, with a polyethylene (PE) screw cap:

7, 10, 14, 15, 20, 28, 30, 56, 60, 90, 98, 100, and 500capsules

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Responsible for manufacturing:

TOWA Pharmaceutical Europe S.L.

C/ de Sant Martí, 75-97

Martorelles, 08107 Barcelona

Spain

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/81797/P_81797.html

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This information is intended solely for healthcare professionals:

Administration through nasogastric or gastric tube

1. Add the contents of a 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 pointing 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 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).

7. 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.

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.

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