ESOMEPRAZOL NORMOGEN 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Esomeprazol Normogen 20 mg Gastro-Resistant Tablets 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, even if you think they might be unrelated to the medicine. See section 4.

Contents of the Package Leaflet

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

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

Esomeprazol Normogen 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 is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This is when acid from the stomach escapes into the gullet (the tube that carries food from the mouth to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or the first part of the intestine (duodenum) that are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers in the stomach caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol can also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation of prevention of bleeding from a peptic ulcer with esomeprazol given by injection.

Adolescents from 12 years of age

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

Ulcers in the stomach or the first part of the intestine (duodenum) that are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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

Do not take Esomeprazol Normogen

• 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 (e.g. 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 reaction or blistering of the skin, mouth, eyes, or genitals after taking Esomeprazol Normogen or other medicines similar to Esomeprazol Normogen.

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

Warnings and precautions

Tell your doctor or pharmacist before taking esomeprazol:

• if you have severe liver problems.
• if you have severe kidney problems.
• if you have ever had a skin reaction after treatment with a medicine similar to esomeprazol to reduce stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

Esomeprazol may mask the symptoms of other diseases. Therefore, if you notice any of the following before or while taking esomeprazol, 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 only when you notice symptoms, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like esomeprazol, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures.

Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop taking esomeprazol. Remember to mention any other symptoms that 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 Esomeprazol Normogen treatment. Stop taking Esomeprazol Normogen and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children under 12 years of age

Information on dosing for children from 1 to 11 years is presented in the product information for esomeprazol sachets (consult your doctor or pharmacist if you need additional information).

Using Esomeprazol Normogen 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 may affect how some medicines work and some medicines may affect how esomeprazol works.

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

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

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, clomipramine (for 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 Normogen.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Normogen.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood circulation).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol Normogen.
• Tacrolimus (after organ transplantation).
• 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 as well as esomeprazol to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor if you are taking any other medicine.

Taking Esomeprazol Normogen with food and drink

You can take the tablets 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 or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take esomeprazol during this time.

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

Driving and using machines

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

Esomeprazol Normogen contains sucrose.

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

3. How to take Esomeprazol Normogen

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, 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 one year).
• If your doctor has told you to take this medicine only when you notice symptoms, tell your doctor if your symptoms change.

How much to take

• Your doctor will have told you how many tablets to take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are given below:

Use in adults aged 18 years and over

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

• If your doctor has found that your gullet (esophagus) is slightly damaged, the recommended dose is one 40 mg esomeprazol tablet once a 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 20 mg esomeprazol gastro-resistant tablet once a day.
• If your esophagus is not damaged, the recommended dose is one 20 mg esomeprazol gastro-resistant tablet once a day. Once your condition has been controlled, your doctor may tell you to take your medicine only when you notice symptoms, up to a maximum of one 20 mg esomeprazol gastro-resistant tablet 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 them from coming back:

• The recommended dose is one 20 mg esomeprazol gastro-resistant tablet twice a day for one week.
• Your doctor will also prescribe antibiotics called, for example, amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one 20 mg esomeprazol gastro-resistant tablet once a day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one 20 mg esomeprazol gastro-resistant tablet once a day.

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

• The recommended dose is one 40 mg esomeprazol tablet 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 a peptic ulcer with esomeprazol given by injection:

• The recommended dose is one 40 mg esomeprazol tablet once a day for 4 weeks.

Use in adolescents aged 12 years and over

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

• If your doctor has found that your gullet (esophagus) is slightly damaged, the recommended dose is one 40 mg esomeprazol gastro-resistant tablet once a 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 20 mg esomeprazol gastro-resistant tablet once a day.
• If your esophagus is not damaged, the recommended dose is one 20 mg esomeprazol gastro-resistant tablet 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 them from coming back:

• The recommended dose is one 20 mg esomeprazol gastro-resistant tablet twice a day for one week.
• Your doctor will also prescribe antibiotics called, for example, amoxicillin and clarithromycin.

Taking this medicine

• You can take the tablets at any time of the day.
• You can take the tablets with food or on an empty stomach.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated 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 tablets:

• Put the tablets in a glass of water without gas. Do not use other liquids.
• Stir until the tablets break up (the solution will not be clear). You can drink the mixture immediately or within 30 minutes. Always stir just before drinking.
• To make sure you take all the medicine, rinse the glass well 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 tablets can be dispersed in water and given through a syringe directly into the stomach (gastric tube).

Use in children under 12 years of age

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

Information on dosing for children from 1 to 11 years is presented in the product information for esomeprazol sachets (consult your doctor or pharmacist if you need additional information).

Elderly patients

No dose adjustment is necessary in elderly patients.

If you take more Esomeprazol Normogen than you should

If you take more esomeprazol than your doctor has prescribed, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, you can also call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Esomeprazol Normogen

• 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 the missed dose.

If you have any other questions about 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 takingEsomeprazol Normogenand 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. Important 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.
• Sleep disturbance (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.
• Hip, wrist, or spine fracture (if Esomeprazol Normogen 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 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.
• Joint pain (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 people)

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggressiveness.
• 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 Normogen for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can 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 of the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, esomeprazol can affect white blood cells, causing an immune deficiency.

If you have an infection with symptoms such as fever with a severeworsening 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 does not appear 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. Storage of Esomeprazol Normogen

• Keep this medicine out of the sight and reach of children.
• Do not store at a temperature above 25°C.
• 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.
• Keep this medicine in its original packaging to protect it from moisture.

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. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Normogen

• The active ingredient is esomeprazol. Each gastro-resistant tablet contains 20 mg of esomeprazol (as esomeprazol magnesium dihydrate).
• The other components are:

Core of the tablet: sugar spheres (sucrose and sodium carboxymethylcellulose (from corn)), hydroxypropylcellulose (E463), light magnesium oxide (E530).

Coating: povidone K-30, mannitol (E421), vegetable magnesium stearate (E470b), methacrylic acid copolymer, polysorbate 80 (E433), triethyl citrate (E1507), glycerol monostearate 40-55 (E472a), hypromellose, macrogol 8000, silicified microcrystalline cellulose (E460i), microcrystalline cellulose (E460i), crospovidone (type A), copovidone, talc, opadry pink 20A54019 (composed of hypromellose, hydroxypropylcellulose (E463), titanium dioxide (E171), talc, and red iron oxide (E172)).

Appearance of the Product and Package Contents

Pink, oval, biconvex tablets, with beveled edges, film-coated, and smooth on both sides.

Esomeprazol Normogen 20 mg is presented in OPA/Al/PE-Al/PE blister packs, available in packs of 14, 28, and 56 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6, 28760 Tres Cantos (Madrid), Spain.

Date of the Last Revision of this Prospectus: February 2025

Other Sources of Information

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/83401/P_83401.html

This information is intended for healthcare professionals:

Administration through a gastric tube

1. Insert the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, dispersion in 50 ml of water is required to avoid clogging the tube.
2. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip up and check that the tip is not clogged.
4. Connect the syringe to the tube while maintaining the previous position.

5. 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).

1. 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.
2. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any remaining sediment from the syringe. For some tubes, 50 ml of water are required.