ESOMEPRAZOL NORMON 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Normon 40 mg Gastro-Resistant Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Esomeprazol Normon and what is it used for
2. What you need to know before you take Esomeprazol Normon
3. How to take Esomeprazol Normon
4. Possible side effects
5. Storage of Esomeprazol Normon
6. Contents of the pack and other information

1. What is Esomeprazol Normon and what is it used for

Esomeprazol Normon contains a medicine called esomeprazol, which 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 is where acid from the stomach escapes into the gullet (the tube that connects the mouth to the stomach), causing pain, inflammation, and heartburn.

• Excessive acid production in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation of prevention of bleeding from peptic ulcers induced with esomeprazol intravenous.

Adolescents from 12 years of age:

• Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube that connects the mouth to the stomach), causing pain, inflammation, and heartburn.

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

Do not take Esomeprazol Normon:

• If you are allergic to esomeprazol 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, omeprazole).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a severe skin rash or blistering of the skin, peeling of the skin, or mouth ulcers after taking Esomeprazol Normon or other medicines similar to Esomeprazol Normon.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazol Normon

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 difficulty 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 Normon only when you notice symptoms, you should contact your doctor if the symptoms of your disease persist or change.

Taking a proton pump inhibitor like Esomeprazol Normon, especially over a period of more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get 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 immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Esomeprazol Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is because Esomeprazol Normon may affect how some medicines work and some medicines may affect the effect of Esomeprazol Normon.

Do not take Esomeprazol Normon if you are taking a medicine that contains nelfinavir(used to treat HIV infection).

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

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (used for fungal infections).
• Erlotinib (used in the treatment of cancer).
• Citalopram, imipramine, clomipramine (used to treat depression).
• 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 you when you start or stop taking Esomeprazol Normon.
• Medicines used to make the blood more fluid, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Normon.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood pumping).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in the treatment of cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol Normon.
• 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 along with Esomeprazol Normon to treat ulcers caused by Helicobacter pylori, it is very important that you 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, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazol Normon during this time.

It is not known if Esomeprazol Normon passes into breast milk. Therefore, you should not take Esomeprazol Normon during breast-feeding.

Driving and using machines

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

Esomeprazol Normon containssucrose

Esomeprazol Normon contains sugar spheres that contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Esomeprazol Normon

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long 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 medicine only when you notice 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 from 18 years of age

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found 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 healed yet.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

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

Continuation of prevention of bleeding from peptic ulcers induced with esomeprazol intravenous:

• The recommended dose is one capsule of Esomeprazol Normon 40 mg once a day for 4 weeks.

Use in adolescents from 12 years of age

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found that your esophagus is slightly affected, the recommended dose is one gastro-resistant 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 healed yet.
• If you have severe liver problems, your doctor may prescribe a lower dose.

Taking this medicine

• 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 medicine from being destroyed by the acid in the stomach. It is important 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 half a glass of still water. Do not use other liquids.
• Stir the mixture and drink it immediately or within 30 minutes. Always stir just before drinking.
• To make sure you have taken all the medicine, rinse the glass with half a glass of water and drink. The solid particles contain the medicine – do not chew or crush the granules.
• If you cannot swallow at all, the granules can be mixed with a little water and inserted into a syringe. The granules can then 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.

Elderly patients

No dose adjustment is necessary in elderly patients.

If you take more Esomeprazol Normon than you should

If you take more Esomeprazol Normon than you should, 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, telephone: 91 562 04 20, indicating the medicine 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 the same time) to make up for missed doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you observe any of the following serious adverse effects, stop taking Esomeprazol Normon and contact a doctor immediately:

• A sudden difficulty breathing, swelling of 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 of the lips, eyes, mouth, nose, and genitals may also appear. This could be a "Stevens-Johnson Syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and fatigue that can 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 effects are rare and may affect up to 1 in 1,000 people.

Other adverse effects include:

Frequent(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Disruption of sleep (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the 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 likelihood of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alteration.
• Eye disorders such as blurred vision.
• Sudden sensation of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems including jaundice that can cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Pain in the joints (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 patients)

• Changes in the number of cells in the blood, 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 can be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.

Frequency Not Known(frequency cannot be estimated from available data)

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

In very rare cases, Esomeprazol Normon can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of your general condition or fever with symptoms of a local infection such as pain in the neck, throat, mouth, 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 important that, in this case, you inform about your medication.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Esomeprazol Normon

-Keep this medicine out of sight and reach of children.

-Do not use this medicine 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. Keep 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 thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Normon

-The active ingredient is esomeprazole.

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

The other components are:

Contents of the capsule:

Sugar spheres (sodium carboxymethylcellulose (from corn) and sucrose), methylcellulose, talc, titanium dioxide (E171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid copolymer, and triethyl citrate.

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).

Appearance of the Product and Package Contents

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

Esomeprazol Normon 40 mg is available in:

Aluminum/Aluminum blisters:

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) inviolable screw cap:

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Manufacturer:

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:

Date of the Last Revision of this Prospectus:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (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 only for healthcare professionals:

Administration through a nasogastric or gastric tube

1. Add the contents of a capsule to approximately 25 ml or 50 ml of water. (For some tubes, dispersion in 50 ml of water is required to avoid clogging the tube). Shake.
2. Empty the suspension into a syringe and add approximately 5 ml of air.
3. Shake the syringe immediately for approximately 2 minutes to disperse the pellets.
4. Hold the syringe with the tip up and check that the tip is not clogged.
5. Connect the syringe to the tube while maintaining the previous position.
6. Shake the syringe and place it with the tip down. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip up to avoid clogging the tip).
7. Put the syringe back with the tip down 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 flush any sediment remaining in the syringe. For some tubes, 50 ml of water are necessary.

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