ESOMEPRAZOL ALMUS 20 mg GASTRO-RESISTANT TABLETS

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

Esomeprazol Almus contains a medicine called esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that your stomach produces.

Esomeprazole 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 which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers or ulcers in the part of the gut that leads out of the stomach (duodenum) caused by a 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.
• Stomach ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• To prevent stomach ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Treatment of continuation of prevention of bleeding from peptic ulcer 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 which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers or ulcers in the part of the gut that leads out of the stomach (duodenum) caused by a 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 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 proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• 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 esomeprazole that reduces stomach acid.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 that reduces stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazole. If you get any of the symptoms of a severe skin reaction, stop taking Esomeprazol Almus and contact your doctor immediately.

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

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

Skin rash and skin symptoms

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 esomeprazole. Remember to also mention any other symptoms that you may have, such as arthralgia (joint pain).

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazole (see also section 4). The rash may cover a large area of the body and may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and itchy eyes). These severe skin reactions may start with a fever, headache, body aches and then a rash develops. The rash may cover a large area of the body and may include blisters and peeling skin.

If you get any of these symptoms, stop taking this medicine and contact your doctor immediately.

Taking Esomeprazol Almus 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 esomeprazole may affect how these medicines work or they may affect how esomeprazole works.

Do not take Esomeprazol Almus if you are taking a medicine containing 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 (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, relax muscles or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking esomeprazole.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazole.
• Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your esomeprazole treatment.
• Tacrolimus (used 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 with esomeprazole to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor about any other medicines you are taking.

Taking Esomeprazol Almus 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 esomeprazole during this time.

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

Driving and using machines

Esomeprazol Almus is unlikely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness or blurred vision (see section 4) may uncommonly or rarely occur. Do not drive or use any tools or machines if you are affected by these side 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 you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Esomeprazol Almus

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 your condition.
• 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.
• 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 described below.

Use in adults aged 18 years and above

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

• If your doctor has found that your esophagus is slightly damaged, the recommended dose is one Esomeprazol Almus 40 mg tablet per 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.
• The recommended dose once the esophagus has healed is one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If your esophagus has not been damaged, the recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet per day. Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of stomach ulcers caused by Helicobacter pylori infection and to prevent 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 prescribe antibiotics called amoxicillin and clarithromycin for you to take with esomeprazole.

For the treatment of 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 4-8 weeks.

For the prevention of 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 too much acid 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 will need to take this medicine for. The maximum dose is 80 mg twice a day.

Treatment of continuation of prevention of bleeding from peptic ulcer induced with esomeprazol intravenous:

• The recommended dose is one Esomeprazol Almus 40 mg tablet per day for 4 weeks.

Use in adolescents aged 12 years and above

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

• If your doctor has found that your esophagus is slightly damaged, the recommended dose is one Esomeprazol Almus 40 mg tablet per 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.
• The recommended dose once the esophagus has healed is one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If your esophagus has not been damaged, the recommended dose is one Esomeprazol Almus 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of stomach ulcers caused by Helicobacter pylori infection and to prevent 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 prescribe antibiotics called amoxicillin and clarithromycin for you to take with esomeprazole.

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 tablets in a glass of water. Do not use other liquids.
  • Stir until the tablets break 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 you get the full dose, rinse the glass with half a glass of water and drink it. 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 given through a syringe (e.g. a large syringe for people who cannot swallow).

Use in children under 12 years of age

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

Older people

No dose adjustment is necessary in older people.

If you take more Esomeprazol Almus than you should

If you take more Esomeprazol Almus than you should, talk to your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the National Poison Centre, telephone: 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, skip the missed dose.
• Do not take a double dose 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 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 may 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

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 esomeprazole 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 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.
• Bronchospasm

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, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of breasts 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, 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 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.

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

Appearance of the Product and Package Contents

Esomeprazol Almus 20 mg are gastro-resistant oval tablets, biconvex, light pink in color, and have "E2" engraved on one side.

Esomeprazol Almus 20 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 250 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 20 mg maagsapresistente tabletten

DE: Esomeaxiro 20 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 flush any sediment remaining in the syringe. For some tubes, 50 ml of water are necessary.