ESOMEPRAZOL ALMUS 40 mg GASTRO-RESISTANT TABLETS

Introduction

Patient Information Leaflet

It

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Esomeprazol Almus is and what it is used for
2. What you need to know before taking Esomeprazol Almus
3. How to take Esomeprazol Almus
4. Possible side effects
5. Storage of Esomeprazol Almus
6. Package contents and additional information

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

Esomeprazol Almus contains a medicine called esomeprazole, which belongs to a group of medicines called "proton pump inhibitors". These reduce the amount of acid produced by the stomach.

Esomeprazole is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up the esophagus (the tube that goes from the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or upper intestine that are infected with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
• To prevent stomach ulcers if you are taking NSAIDs.
• Excessive acidity in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent bleeding from peptic ulcers induced with esomeprazole intravenously.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up the esophagus (the tube that goes from the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or upper intestine that are infected with a bacterium 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 taking Esomeprazol Almus

Do not take Esomeprazol Almus

• 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 medicines in the group of 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 developed a severe skin rash, blistering, or peeling after taking Esomeprazol Almus or other similar medicines.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esomeprazol Almus

• 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 esomeprazole to reduce stomach acid.
• If you are scheduled to have a specific blood test (Chromogranin A).

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 Almus. Stop taking Esomeprazol Almus and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Esomeprazol Almus may mask the symptoms of other diseases. Therefore, if you notice any of the following events before taking or while taking Esomeprazol Almus, 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 Almus 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 esomeprazole, especially for a period of more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash and skin symptoms

If you suffer 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 esomeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may involve ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after symptoms similar to those of the flu, such as fever, headache, and body pain. The rash may cover large areas of the body with blisters and peeling skin.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Taking Esomeprazol Almus with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

This includes medicines obtained without a prescription. This is because esomeprazole may affect how some medicines work, and some medicines may influence the effect of esomeprazole.

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

Inform 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 (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 esomeprazole.
• Medicines used to make blood more fluid, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazole.
• Cilostazol (used to treat intermittent claudication – leg pain when walking due to insufficient blood pumping).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (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 esomeprazole.
• 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 in addition to esomeprazole 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 Almus with food and drinks

You can take the tablets with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can take esomeprazole during this period.

It is not known if esomeprazole passes into breast milk. Therefore, you should not take esomeprazole during breastfeeding.

Driving and using machines

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

Esomeprazol Almus contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

Esomeprazol Almus contains sucrose and lactose

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

3. How to take Esomeprazol Almus

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If 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 one year).
• If your doctor has told you to take this medicine only when you notice symptoms, inform your doctor if the symptoms change.
• Your doctor will have told you how many tablets to take and when to take them. This will depend on your situation, age, and liver function.
• The recommended doses are indicated below.

Use in adults from 18 years of age

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 Almus 40 mg tablet per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not healed yet.
• The recommended dose once the esophagus has healed is one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If you have not suffered damage to the esophagus, the recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet per day. Once the condition is controlled, your doctor may indicate that you take your medicine when needed, up to a maximum of one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For treating ulcers caused by Helicobacter pylori infection and preventing them from coming back:

• The recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet twice a day for one week.
• Your doctor will also indicate that you take antibiotics, such as amoxicillin and clarithromycin.

For treating stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet per day for 4 to 8 weeks.

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

• The recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet per day.

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

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

Continuation treatment to prevent bleeding from peptic ulcers induced with esomeprazole intravenously:

• The recommended dose is one Esomeprazol Almus 40 mg tablet per 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 determined that your esophagus is slightly affected, the recommended dose is one Esomeprazol Almus 40 mg tablet per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not healed yet.
• The recommended dose once the esophagus has healed is one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If you have not suffered damage to the esophagus, the recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For treating ulcers caused by Helicobacter pylori infection and preventing them from coming back:

• The recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet twice a day for one week.

Your doctor will also indicate that you take antibiotics, such as 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 stomach acid. 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 non-carbonated water. Do not use other liquids.
  • Stir until the tablets disintegrate (the solution will not be transparent). You can drink the mixture immediately or within 30 minutes. Always stir just before drinking.
  • To ensure that you have taken 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 introduced into a syringe. Then, they can be administered directly into the stomach through a tube (gastric tube).

Use in children under 12 years of age

Esomeprazol Almus gastro-resistant tablets are not recommended for children under 12 years of age.

Elderly patients

No dose adjustment is necessary in elderly patients.

If you take more Esomeprazol Almus than you should

If you take more Esomeprazol Almus 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Esomeprazol Almus

• 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 to make up for missed doses.

If you have any other doubts 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 taking Esomeprazol Almus and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems. These effects are rare and can affect up to 1 in 1,000 people.
• A sudden difficulty breathing, swelling of lips, tongue, and throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and can affect up to 1 in 1,000 people.
• The sudden appearance of a severe skin rash or redness with blisters or peeling can occur even after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become severe and widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms". These effects are very rare and can affect up to 1 in 10,000 people.
• Widespread rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Other adverse effects include:

Frequent (can 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 (can 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 esomeprazole is used at high doses and for a long period)

Rare (can 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 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 yellow 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.
• Bronchospasm

Very rare (can 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, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disorders.
• Increased breast size in men.

Frequency not known (cannot be estimated from available data)

• If you are being treated with esomeprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, 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 in the intestine (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Almus can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening of the general condition or fever with symptoms of a local infection such as 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. Conservation of Esomeprazol Almus

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the label, box, or blister after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging (blister) or keep the bottle perfectly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Almus

• The active ingredient is esomeprazole. It contains 40 mg of esomeprazole (as esomeprazole magnesium trihydrate).
• The other components are: sugar spheres (sucrose and cornstarch), hypromellose, talc, polysorbate 80, magnesium stearate, copolymer of methacrylic acid and ethyl acrylate (1:1), Plasacryl HTP 20 (glycerol monostearate, triethyl citrate, and polysorbate 80), glycerol monostearate, triethyl citrate, macrogol, lactose monohydrate, cornstarch, silicified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica), crospovidone, povidone, and anhydrous colloidal silica, liquid paraffin (light), titanium dioxide (E171), red iron oxide (E172).

Appearance of the Product and Package Contents

Esomeprazol Almus 40 mg are gastro-resistant, oval, biconvex tablets, pink in color, and have "E4" engraved on one side.

Esomeprazol Almus 40 mg is available in Alu/alu blisters of 7, 14, 28, 30, 56, 60, 90, 98, and 105 tablets or in an HDPE bottle with a silica gel desiccant in the cap of 28, 56, 60, 75, 90, 98, 100, 105, 120, and 500 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Manufacturer

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, N°7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the Last Revision of this Prospectus:July 2025

This medicine is authorized in the Member States of the European Economic Area with the following names:

NL: Esomeprazol Liconsa 40 mg maagsapresistente tabletten

DE: Esomeaxiro 40 mg magensaftresistente Tablette

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

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This information is intended only 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 prevent the pellets from 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 drag any sediment that remains in the syringe. For some tubes, 50 ml of water are necessary.