ESOMEPRAZOL NORMOGEN 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet:information for the user

Esomeprazol Normogen 40 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, as 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 symptoms 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 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. Storing 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. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazol is used for the treatment of the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach) causing pain and inflammation.
• Stomach acid produced too much by a growth in the pancreas (Zollinger-Ellison syndrome).
• Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazol intravenous.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach) causing pain and inflammation.

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 inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazol).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to esomeprazol that reduces stomach acid.

If any of the above apply to you, do not take esomeprazol. If you are not sure, consult your doctor or pharmacist before taking esomeprazol.

Warnings and precautions

Consult 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 that reduces stomach acid.
• if you are due to have a specific blood test (Chromogranin A).

Esomeprazol may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are takingesomeprazol, contact your doctor immediately:

• You lose a lot of weight for no reason and have problems swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

If your doctor has prescribed esomeprazol only when you have 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 your treatment with esomeprazol. Also 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 rash with eosinophilia and systemic symptoms (DRESS), have been reported with Esomeprazol Normon treatment. 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.

Children under 12 years of age

Information on dosages for children from 1 to 11 years is presented in the esomeprazol sachet product information (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 that you can buy without a prescription. This is because esomeprazol can affect how some medicines work and some medicines can 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 – pain in the legs 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 (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 in addition to esomeprazol to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor about any other medicine you are taking.

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 any tools or machines. However, sometimes side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use any tools or machines if you are affected.

Esomeprazol Normogencontains sucrose.

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

3. How to take Esomeprazol Normogen

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor will want to regularly check how you are taking it (especially if you are taking it for more than one year).
• If your doctor has told you to take this medicine as and when you need it, you should contact your doctor if your symptoms change.

How much to take

• Your doctor will tell 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 above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• If you have severe liver problems, your doctor may give you a lower dose.

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

• The recommended dose is one 40 mg 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 for. The maximum dose is 80 mg twice a day.

Prevention of re-bleeding following treatment of bleeding ulcers with esomeprazol intravenous:

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

Use in adolescents aged 12 years and above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg 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 oesophagus has not yet healed.
• If you have severe liver problems, your doctor may give you a lower dose.

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 pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Put the tablet in a glass of water. Do not use other liquids.
• Stir until the tablet breaks up (the mixture will not be clear). You can drink this mixture immediately or within 30 minutes. Always stir well before drinking.
• To make sure that you have taken all of the medicine, rinse the glass with half a glass of water and drink. The solid pieces contain the medicine – do not chew or crush them.

• If you cannot swallow at all, the tablets can be dispersed in water and mixed with a syringe. This can then be given through a nasogastric tube.

Use in children under 12 years of age

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

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

Elderly patients

No dose adjustment is necessary for elderly patients.

If you take more Esomeprazol Normogen than you should

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

In case of overdose or accidental ingestion, you can also contact the National Poison Centre on Tel. 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the 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, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

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 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.
• Disruption of sleep (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Feeling of vertigo.
• 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 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.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling 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).
• 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 Normogen for more than three months, 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 may 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 report 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 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 you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines 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 40 mg of esomeprazol (as esomeprazol magnesium dihydrate).
• The other components are:

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

Coating: povidone K-30, mannitol (E421), vegetable magnesium stearate (E470b), methacrylic acid - ethyl acrylate 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, with the engraving "40" on one face and smooth on the other.

Esomeprazol Normogen 40 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/83402/P_83402.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).
6. 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.
7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any sediment remaining in the syringe. For some tubes, 50 ml of water are necessary.