Esomeprazole AuroVitas Spain 40 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Esomeprazole Aurovitas Spain 40 mg gastro-resistant tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as 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, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Esomeprazole Aurovitas Spain is and what it is used for
2. What you need to know before taking Esomeprazole Aurovitas Spain
3. How to take Esomeprazole Aurovitas Spain
4. Possible adverse effects
5. Storage of Esomeprazole Aurovitas Spain
6. Contents of the pack and other information

1. What Esomeprazol Aurovitas Spain is and what it is used for

Esomeprazol Aurovitas Spain 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.

Esomeprazol Aurovitas Spain is used for the treatment of the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent rebleeding from peptic ulcer after initial treatment with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before taking Esomeprazol Aurovitas Spain

Do not take Esomeprazol Aurovitas Spain

• If you are allergic (hypersensitive) to esomeprazole or to any of the other components 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 or peeling skin, blistering, or mouth ulcers after taking esomeprazole or other related medicines.

If any of these situations apply to you, do not take Esomeprazol Aurovitas Spain. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Aurovitas Spain.

Warnings and precautions

Before taking this medicine, consult your doctor or pharmacist:

• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Aurovitas Spain used to reduce stomach acidity.
• If you have severe liver problems.
• If you have severe kidney problems.
• If you are scheduled to have a specific blood test (Chromogranin A).

Esomeprazol Aurovitas Spain may mask symptoms of other conditions. Therefore, if you experience any of the following events before or while taking Esomeprazol Aurovitas Spain, 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 Esomeprazol Aurovitas Spain has been prescribed only for use when symptoms occur, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Esomeprazol Aurovitas Spain, especially for 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 rashes 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 it may be necessary to discontinue treatment with Esomeprazol Aurovitas Spain. Remember to mention any other symptoms you may notice, such as joint pain.

Serious 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 immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children under 12 years of age

Information on dosing for children aged 1 to 11 years is provided in the product information for esomeprazole in sachets (consult your doctor or pharmacist if you need additional information).

Other medicines and Esomeprazol Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because Esomeprazol Aurovitas Spain may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Aurovitas Spain.

Do not take Esomeprazol Aurovitas Spain if you are taking:

• A medicine containing nelfinavir (used to treat HIV infection).

Inform 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 the 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 Esomeprazol Aurovitas Spain.
• Medicines used to thin the blood, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Aurovitas Spain.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient 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 interrupt your treatment with Esomeprazol Aurovitas Spain.
• 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 Aurovitas Spain to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicine.

Esomeprazol Aurovitas Spain with food and drink

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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 Esomeprazol Aurovitas Spain during this time.

It is unknown whether Esomeprazol Aurovitas Spain passes into breast milk. Therefore, Esomeprazol Aurovitas Spain should not be taken during breastfeeding.

Driving and using machines

Esomeprazol Aurovitas Spain is unlikely to affect your ability to drive or operate tools or machinery. However, adverse effects such as dizziness or blurred vision may occur rarely or very rarely (see section 4). Do not drive or operate machinery if you experience any of these effects.

Esomeprazol Aurovitas Spain contains sunset yellow S (E110)

This medicine may cause allergic reactions because it contains sunset yellow S (E110). It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.

Esomeprazol Aurovitas Spain contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per gastro-resistant tablet; hence, it is essentially "sodium-free".

3. How to take Esomeprazol Aurovitas Spain

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, 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.

How much to take

• 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 mildly affected, the recommended dose is one tablet of Esomeprazol Aurovitas Spain 40 mg once 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

• The recommended dose is Esomeprazol Aurovitas Spain 40 mg 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 for prevention of rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one tablet of Esomeprazol Aurovitas Spain 40 mg 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 mildly affected, the recommended dose is one tablet of Esomeprazol Aurovitas Spain 40 mg gastro-resistant tablets 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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 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 cannot swallow at all, the tablets may be dispersed in water and administered via a syringe. They can then be delivered directly into the stomach through a tube (gastric tube).

• Use in children under 12 years of age

Esomeprazole gastro-resistant tablets are not recommended for children under 12 years of age. Information on dosing for children aged 1 to 11 years is provided in the product information for esomeprazole in sachets (consult your doctor or pharmacist if you need additional information).

• Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Aurovitas Spain than you should

If you take more esomeprazole than your doctor has prescribed, 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 telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Esomeprazol Aurovitas Spain

• 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 the same time) to make up for a forgotten dose.

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

4. Possible adverse effects

Like all medicines, Esomeprazol Aurovitas Spain may cause adverse effects, although not everyone experiences them.

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

• Sudden difficulty breathing, swelling of lips, tongue and throat, or swelling of the 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.
• 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 appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (epidermal peeling and superficial mucosal membrane damage), potentially leading to life-threatening consequences. This could be "erythema multiforme," "Stevens-Johnson syndrome," or "toxic epidermal necrolysis." 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 very rarely observed.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, 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 disturbances (insomnia).
• Dizziness, tingling sensation, numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormalities in blood tests assessing liver function.
• Skin rash, hives, skin itching.
• Fracture of the hip, wrist, or spine (if Esomeprazol Aurovitas Spain is used at high doses and for a prolonged 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 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 esophagus.
• Liver problems including jaundice, which may cause yellowish skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (reduction in white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden appearance 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 (DRESS).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

Frequency not known (frequency cannot be estimated from available data)

• If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and 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 diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Aurovitas Spain may affect white blood cells, causing immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a localized 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 white blood cell count (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, consult 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 Aurovitas Spain

• 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 after EXP. The expiry date refers to the last day of the month indicated.

Blister packs:

• Do not store above 30°C.
• Keep in the original packaging to protect from moisture.

Vials:

• Do not store above 30°C.

• Shelf life after first opening of the vial: 100 days.

• Keep the vial tightly closed to protect from moisture.

• Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Aurovitas Spain

• The active substance is esomeprazole. There are two strengths of Esomeprazol Aurovitas Spain gastro-resistant tablets containing 20 mg or 40 mg of esomeprazole (as sodium salt).

• The other components are:

• Core: Microcrystalline cellulose spheres (microcrystalline cellulose and water), hypromellose (E464), talc (E553b), titanium dioxide (E171), glycerol monostearate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (sodium lauryl sulfate, polysorbate 80 and methacrylic acid-ethyl acrylate copolymer), triethyl citrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A) and sodium stearyl fumarate.

• Coating: Opadry II Dark Blue 85F30662 (partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake / FD&C Blue #2 (E132), black iron oxide (E172) and FD&C Yellow #6 / Orange Yellow S aluminum lake (E110)).

Appearance of the product and contents of the pack

• Esomeprazol Aurovitas Spain 40 mg gastro-resistant tablets are blue, oval-shaped gastro-resistant tablets.
• Esomeprazol Aurovitas Spain 40 mg is available in packs of 14, 28 and 56 tablets in blister packs, and 28 tablets in a bottle.
• Hospital pack of 100 tablets in blister packs and bottles.
• Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Towa Pharmaceutical Europe S.L.

C/ San Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

Date of the most recent review of this leaflet: January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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, a dispersion in 50 mL of water may be required to prevent pellet blockage.
2. Shake the syringe immediately for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip facing 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 facing downwards. Immediately inject 5–10 mL into the tube. After injection, invert the syringe, shake it (the syringe must be kept with the tip facing upwards to prevent blockage of the tip).
6. Reposition the syringe with the tip facing downwards and immediately inject 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 remaining residue from the syringe. For certain tubes, 50 mL of water may be required.