Package Insert: Information for the Patient

Esomeprazol Normon 40 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 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 is Esomeprazol Normon and how is it used

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

3. How to take Esomeprazol Normon

4. Possible adverse effects

5. Storage of Esomeprazol 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 burning.

• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment for the prevention of bleeding from a peptic ulcer 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.

Do not take Esomeprazol Normon:

• 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, formation of blisters or ulcers in the mouth after taking Esomeprazol Normon or other related medicines.

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 medicine to Esomeprazol Normon to reduce stomach acid.
• if you are due 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 begin to vomit food or blood.
• Your stools appear black (bloodstained).

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 spinal column. 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 sun-exposed areas, 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 medicines

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

Do not take Esomeprazol Normon 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 Normon.
• Medicines used to make the 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 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 medicine.

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

The safety of Esomeprazol Normon for use during pregnancy has not been established. Therefore, do not take Esomeprazol Normon during pregnancy.

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 contains sugar spheres containing 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 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 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 Esomeprazol Normon 40 mg capsule 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

• The recommended dose is one Esomeprazol Normon 40 mg capsule 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.

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

• The recommended dose is one Esomeprazol Normon 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 Normon 40 mg gastro-resistant capsule 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

How to take this medication

• Possible to take the capsules at any time of the day.
• Possible to 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 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 empty the granules into a half 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 well with a half 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. Subsequently, 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 adjustment of the dose is necessary in older adults.

If you take more Esomeprazol Normon than you should

If you take more Esomeprazol Normon 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 Normon

• 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 compensate for the missed doses.

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

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 enlargement of 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.
• 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 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 can cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This can 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 can 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 malaise 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 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
• 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 can 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 can 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.

Esomeprazol Normon Composition

-The active ingredient is esomeprazole.

Esomeprazol Normon capsules contain 40 mg of esomeprazole(as sodium salt).

The other components are:

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

Product Appearance and Packaging Content

Esomeprazol Normon 40 mg are hard, pink, opaque capsules in body and cap, size 2 (18 mm approximately) printed (cap ES/body 40) and containing spherical granules.

Esomeprazol Normon 40 mg is available in:

Aluminum/Aluminum Blister Packs:

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

Polyethylene (PE) White Opaque Bottles, containing silica gel as a desiccant, with a polyethylene (PE) tamper-evident cap:

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

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Responsible Manufacturer:

TOWA Pharmaceutical Europe S.L.

C/ de Sant 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/

You can access detailed and updated information on this medicinal product 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/81798/P_81798.html

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This information is intended solely for healthcare professionals:

Administration via 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 unused medicinal product and all materials that have come into contact with it will be disposed of in accordance with local regulations.