Package Insert: Information for the Patient

Esomeprazole Aristo 20 mg Hard Gastroresistant Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

6. Contents of the pack and additional information

Esomeprazol Aristo contains a medication called esomeprazole that belongs to a group of medications called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazoleis used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria calledHelicobacter pylori. If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medications called NSAIDs (nonsteroidal anti-inflammatory drugs). Esomeprazole can also be used to prevent the formation of ulcers in the stomach if you are taking NSAIDs.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously.

Adolescents aged 12years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria calledHelicobacter pylori. If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Esomeprazol Aristo

• 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 for the treatment of HIV infection).
• if you have ever developed a severe skin rash or skin peeling, blistering, or ulcers in the mouth after taking esomeprazole or other related 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 taking esomeprazole

• if you have severe liver problems;
• if you have severe kidney problems;
• if you have ever had a skin reaction after treatment with a similar medicine to esomeprazole to reduce stomach acid. Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazole treatment. Stop taking esomeprazole and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4;
• if you are due to have a specific blood test (Cromogranin A).

Esomeprazole may mask the symptoms of other diseases.Therefore, if you notice any of the following events before taking or while taking esomeprazole, 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 esomeprazole "on demand" (only when you notice some symptoms), you should contact your doctor if your symptoms persist or change.

If you are taking esomeprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in blood potassium and calcium levels. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

Taking a proton pump inhibitor like esomeprazole, especially for a period of more than one year, may slightly increase the risk of breaking a hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

Skin eruptions and symptoms

If you experience a skin eruption, especially in sun-exposed areas, 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 eruptions have been reported in patients taking esomeprazole (see also section 4). The eruption may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin eruptions usually appear after symptoms similar to the flu, such as fever, headache, and body aches. The eruption may cover large areas of the body with blisters 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.

Children under 12 years

Esomeprazole is not recommended for children under 12 years.

Other medicines and Esomeprazol Aristo

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.This includes medicines obtained without a prescription. This is because esomeprazole may affect the way some medicines work and some medicines may influence the effect of esomeprazole.

Do not take esomeprazole capsules if you are taking a medicine that contains nelfinavir (used in the treatment of HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used in the treatment of cancer).
• Citalopram, imipramine, or clomipramine (for depression).
• Diazepam (used for 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 make the blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking esomeprazole.
• Cilostazol (used for 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 (chemotherapy medicine used at high doses for cancer treatment) If you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with esomeprazole.
• Tacrolimus (organ transplant).
• Rifampicin (used for tuberculosis treatment).
• 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 to inform your doctor if you are taking any other medicine.

Use of Esomeprazol Aristo with food and drinks

You can take the capsules with food or on an empty stomach

Pregnancy and breastfeeding

If you are pregnant or 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.

The safety of esomeprazole during pregnancy and breastfeeding has not been established. Therefore, do not take esomeprazole during breastfeeding.

Driving and operating machinery

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

Esomeprazol Aristo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

• If you take this medication for a long period of time, your doctor will need to monitor you (especially if you take it for more than a year).
• If your doctor has told you to take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take

Use in adults 18 years and olderand 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 capsule of esomeprazole 40 mg 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 capsule of esomeprazole 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of esomeprazole 20 mg per day. Once your condition has been controlled, your doctor may tell you to take the medication only when needed, up to a maximum of one capsule of esomeprazole 20 mg 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 their recurrence:

• The recommended dose is one capsule of esomeprazole 20 mg twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is one capsule of esomeprazole 20 mg once a day for 4 to 8 weeks.

For the prevention of gastric ulcers if you are taking NSAIDs:

• The recommended dose is one capsule of esomeprazole 20 mg once a day.

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

• The recommended dose is one capsule of esomeprazole 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide for how long you should take this medication. The maximum dose is 80 mg twice a day.

Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenous:

• The recommended dose is one capsule of esomeprazole 40 mg once a day for 4 weeks.

Use in adolescents 12 years and olderand 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 capsule of esomepazol 40 mg 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 capsule of esomepazol 20 mg once a day.
• If your esophagus is not affected, the recommended dose is one capsule of esomepazol 20 mg 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 their recurrence:

• The recommended dose is one capsule of esomepazol 20 mg twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

How to take this medication

• You can take the capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain coated granules that prevent the medication from being destroyed by stomach acid. It is essential not to damage the granules.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and disperse the contents in a half glass of water without gas. Do not use other liquids.
• Shake the mixture and drink it immediately or within the next 30 minutes. Always shake the mixture just before drinking it. The solution will not be transparent.
• To ensure that you have taken all the medication, rinse the glass by filling it with water up to the middle and drink it. The solid particles contain the medication, do not chew or crush the granules.

Use in children under 12 years

Esomeprazole is not recommended for children under 12 years.

Older adults

No adjustment of the dose is necessary in older adults.

If you take more Esomeprazole Aristo than you should

If you take more esomperazol than your doctor has told you, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Esomeprazole Aristo

• 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 once) to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking esomeprazole and contact a doctor immediately:

• Yellow skin, dark urine, and fatigue that 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 body in general, 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 skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals may occur. Skin rashes may become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It may be a "multiforme erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis" or "drug reaction with eosinophilia and systemic symptoms". These effects are very rare and may affect up to 1 in 10,000 people.
• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Other side effects include:

Frequent:may affect up to 1 in 10 people

• Headache.
• Effects on the stomach or intestine: diarrhea, stomach pain, constipation, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Occasional:may affect up to 1 in 100 people

• Swelling of the feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling, numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine(if esomeprazole is usedat 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 may cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• A known infection called "candidiasis" that may affect the esophagus and is caused by a fungus.
• Liver problems including jaundice that may cause yellow skin, dark urine, and fatigue.
• Loss of hair (alopecia).
• Sunlight dermatitis.
• Pain in the joints (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.
• To see, feel, or hear things that do not exist (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. 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.

Unknown frequency:the frequency cannot be estimated from the available data

• Inflammation of the intestine (may cause diarrhea).
• Skin rash, possibly with joint pain.
• Low magnesium levels in the blood (hypomagnesemia) (see section 2 "Warnings and precautions").

In very rare cases, esomeprazole may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever with a severe worsening of the general condition or high fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, 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 essential that, in this case, you inform your doctor about the medication you are currently taking.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system:Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not store at a temperature above 25°C.
• Store in the original packaging (blister) or keep the container (bottle) perfectly closed to protect it from moisture.
• Do not use this medication after the expiration date that appears on the container and on the blister or bottle after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Esomeprazole Aristo gastro-resistant capsules composition:

• The active ingredient is esomeprazole.

There are two different doses of Esomeprazole Aristo gastro-resistant capsules containing 20 mg or 40 mg of esomeprazole (as magnesium dihydrate salt).

• The other components are:

Capule content

Filling:carboxymethylcellulose, microcrystalline cellulose, mannitol, sodium hydroxide, sodium hydrogen carbonate

Coating:polyethylene glycol-polyvinyl alcohol copolymer, sodium hydroxide, talc, titanium dioxide (E171), hydrated colloidal silica.

Gastro-resistant coating:poly(methacrylic acid-co-ethyl acrylate) (1:1), triethyl citrate, talc, titanium dioxide (E171)

Capule:

Crown:gelatin, iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172)

Body:gelatin, titanium dioxide (E171)

Product appearance and packaging content

Esomeprazole Aristo 20 mg gastro-resistant hard capsules

Hard capsule with white opaque body and yellow opaque crown containing white or almost white gastro-resistant granules.

The capsules are presented in high-density polyethylene bottles with desiccant and a polypropylene stopper and aluminum/aluminum blisters. Do not ingest the desiccant that comes in the bottle.

Packaging sizes:

14, 28, and 56 capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid. Spain

Responsible manufacturer

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

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

Germany:Esogasec 20 mg magensaftresistente Hartkapseln

Spain:Esomeprazole Aristo 20 mg gastro-resistant hard capsules EFG

France:ESOMEPRAZOLE EVOLUGEN PHARMA 20 mg, gastro-resistant gelatin capsule

Poland:Esogasec

Portugal:Esomeprazole Aristo 20 mg gastro-resistant capsules

Sweden:Esomeprazole Net 20 mg enteric capsules hard

Last review date of this leaflet: April 2025

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.