Esomeprazole Almus 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Almus 40 mg gastro-resistant tablets EFG

Read the entire package 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 questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the package 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. How to store Esomeprazol Almus
6. Contents of the pack and other 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 known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazole is used for the treatment of the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid moves up into the oesophagus (the tube from the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or upper part of the 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 known as NSAIDs (non-steroidal anti-inflammatory drugs).
• Prevention of stomach ulcers in patients taking NSAIDs.
• Excessive stomach acid production caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcers following intravenous esomeprazole therapy.

Adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). This occurs when stomach acid moves up into the oesophagus (the tube from the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or upper part of the 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 to 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 containing nelfinavir (used in the treatment of HIV infection).
• If you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking Esomeprazol Almus or other related medicines.

Do not take esomeprazole if any of these situations apply to you. If you are unsure, consult your doctor or pharmacist before taking esomeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 used 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 association with treatment with Esomeprazol Almus. Stop taking Esomeprazol Almus and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Esomeprazol Almus may mask symptoms of other diseases. Therefore, if you experience any of the following events before 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 have symptoms, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as esomeprazole, particularly for 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 may increase the risk of osteoporosis).

Skin rash and skin symptoms

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with esomeprazole may need to be stopped. 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 mouth, throat, nose, genital ulcers, and conjunctivitis (red, swollen eyes). These severe skin rashes usually appear after flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blistering and skin peeling.

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 containing 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, itraconazol or voriconazole (for fungal infections).
• Erlotinib (used in cancer treatment).
• Citalopram, imipramine, clomipramine (for treatment of 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 when you start or stop taking esomeprazole.
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazole.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood flow).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – 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 medicines.

Taking Esomeprazol Almus with food and drinks

You may 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 become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take esomeprazole during this time.

It is unknown whether esomeprazole passes into breast milk. Therefore, esomeprazole should not be taken during breast-feeding.

Driving and using machines

Esomeprazole is unlikely to affect your ability to drive or use tools or machines. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). You should not drive or use machines if you experience 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 diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Esomeprazol Almus

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has instructed you to take this medicine only when you experience 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 condition, age, and liver function.
• The recommended doses are indicated below.

Use in adults aged 18 years and older

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 daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once the esophagus has healed is one gastro-resistant Esomeprazol Almus 20 mg tablet once daily.
• If you have not experienced esophageal damage, the recommended dose is one gastro-resistant Esomeprazol Almus 20 mg tablet daily. Once the condition is under control, your doctor may instruct you to take the medicine as needed, up to a maximum of one gastro-resistant Esomeprazol Almus 20 mg tablet daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For treating ulcers caused by Helicobacter pylori infection and preventing their recurrence:

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

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

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

For preventing stomach ulcers in patients taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one gastro-resistant Esomeprazol Almus 20 mg tablet once daily.

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

• The recommended dose is one Esomeprazol Almus 40 mg tablet twice daily.
• 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 daily.

Continuation treatment to prevent rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one Esomeprazol Almus 40 mg tablet once daily for 4 weeks.

Use in adolescents aged 12 years and older

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 daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once the throat has healed is one gastro-resistant Esomeprazol Almus 20 mg tablet once daily.
• If you have not experienced damage to the throat, the recommended dose is one gastro-resistant Esomeprazol Almus 20 mg tablet daily.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For treating ulcers caused by Helicobacter pylori infection and preventing their recurrence:

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

Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

How to take this medicine

• You may take the tablets at any time of day.
• You may 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:
  • Place the tablets in a glass of still (non-carbonated) water. Do not use other liquids.
  • Stir until the tablets disintegrate (the solution will not be transparent). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.
  • To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.
• If you are completely unable to swallow, the tablets may be dispersed in water and administered via a syringe directly into the stomach through a gastric tube.

Use in children under 12 years of age

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

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Almus than you should

If you take more Esomeprazol Almus than prescribed by your doctor, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

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 further 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 everyone will experience them.

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

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
• Sudden difficulty breathing, swelling of the lips, tongue, and throat, or swelling of the whole body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• Sudden appearance of a severe rash or redness of the skin with blistering or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms (DRESS)". These effects are very rare and may 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 observed very rarely.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhoea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling and numbness sensations, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• Skin rash, hives, itching.
• Fracture of hip, wrist, or spine (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 decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as "candidiasis" that may affect the oesophagus.
• Liver problems including jaundice, which may cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.
• Bronchospasm.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood cell counts, including agranulocytosis (reduction in white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. These symptoms may 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 the breasts in men.

Frequency not known (cannot be estimated from available data)

• If you are being treated with esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (which may lead to diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Almus may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a serious deterioration in general condition, or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) through a blood test. It is important that, in such cases, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Almus

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

Do not use this medicine after the expiry date stated on the label, carton, or blister pack after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Store in the original packaging (blister) or keep the container tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Almus

• The active substance is esomeprazole. It contains 40 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 and ethyl acrylate copolymer (1:1), plasacryl HTP 20 (glycerol monostearate, triethyl citrate and polysorbate 80), glycerol monostearate, triethyl citrate, macrogol, monohydrate lactose, corn starch, silicified microcrystalline cellulose (microcrystalline cellulose and anhydrous colloidal silica), crospovidone, povidone and anhydrous colloidal silica, liquid paraffin (light), titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and contents of the pack

Esomeprazol Almus 40 mg are pink, oval-shaped, biconvex gastro-resistant tablets, marked with "E4" on one side.

Esomeprazol Almus 40 mg is available in Alu/Alu blisters containing 7, 14, 28, 30, 56, 60, 90, 98 and 105 tablets or in HDPE bottles with a silica gel desiccant in the cap containing 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 most recent review of this leaflet: July 2025

This medicinal product is authorized in the European Economic Area member states under the following names:

NL: Esomeprazol Liconsa 40 mg maagsapresistente tabletten

DE: Esomeaxiro 40 mg magensaftresistente Tablette

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

This information is intended for healthcare professionals only:

Administration via gastric tube

1. Place the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For certain tubes, dispersion in 50 ml of water may be required to prevent pellet blockage of the tube.
2. Immediately shake the syringe vigorously for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip downward. Immediately inject 5–10 ml into the tube.

After injection, invert the syringe and shake (the syringe must be kept with the tip upward to prevent blockage of the tip).

1. Reposition the syringe with the tip downward and immediately inject 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 certain tubes, 50 ml of water may be required.