Esomeprazole Aurovitas Spain 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Esomeprazol Aurovitas Spain is and what it is used for
2. What you need to know before taking Esomeprazol Aurovitas Spain
3. How to take Esomeprazol Aurovitas Spain
4. Possible side effects
5. How to store Esomeprazol 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 to treat the following conditions:

Adults

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

• Stomach or upper intestinal (duodenal) ulcers associated with infection by a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Gastric ulcers caused by medications known as NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol Aurovitas Spain may also be used to prevent the formation of ulcers if you are taking NSAIDs.

• Excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

• Continuation treatment to prevent rebleeding from peptic ulcer previously treated with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers associated with infection by a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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 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 or peeling of the skin, blistering or mouth ulcers after taking esomeprazole or related medicines.

If you are in any of these situations, 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 for reducing 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 weight significantly 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 symptom relief when needed, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Esomeprazol Aurovitas Spain, 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 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 treatment with Esomeprazol Aurovitas Spain may need to be stopped. 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

Dosage information for children aged 1 to 11 years may be found in the product information of other esomeprazole presentations in sachets (consult your doctor or pharmacist if you need further information).

Other medicines and Esomeprazol Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have recently taken, or might 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 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 make the blood less likely to clot, 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 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 Esomeprazol Aurovitas Spain.
• 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 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 medicines.

Esomeprazol Aurovitas Spain with food and drink

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 Esomeprazol Aurovitas Spain during this period.

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

Driving and using machines

Esomeprazol Aurovitas Spain 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). Do not drive or use machines if you experience any of these effects.

Esomeprazol Aurovitas Spain contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per gastro-resistant tablet; therefore, 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 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 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. Once the esophagus has healed, the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet once daily.
• If your esophagus is not affected, the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet once daily. Once your condition has been controlled, your doctor may instruct you to take the medicine only when you experience symptoms, up to a maximum of one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet 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 Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

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

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

To prevent gastric ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

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

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 to prevent rebleeding from peptic ulcer induced with intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole tablet once daily 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 40 mg gastro-resistant tablet of Esomeprazol Aurovitas Spain 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.
• Once the esophagus has healed, the recommended dose is one gastro-resistant tablet of Esomeprazol Aurovitas Spain once daily.
• If your esophagus is not affected, the recommended dose is one gastro-resistant tablet of Esomeprazol Aurovitas Spain once daily.
• 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 gastro-resistant tablet of Esomeprazol Aurovitas Spain twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, 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 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

Esomeprazol Aurovitas Spain is 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 further 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 Esomeprazol Aurovitas Spain 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 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 produce 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 (peeling of the epidermis and superficial mucous membranes) with potentially 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 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 disturbances (insomnia).
• Dizziness, tingling and numbness sensations, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, skin itching.
• Fracture of hip, wrist, or spine (if Esomeprazol Aurovitas Spain 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 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 yellowing of the 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).
• Aggression.
• 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 disorders.
• Breast enlargement in men.

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

• If you are taking esomeprazole for more than three months, magnesium levels in blood 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, consult your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation of the intestine (which may cause diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Aurovitas Spain may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of general condition, or fever with signs of a 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 white blood cell count (agranulocytosis) via 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 through the Spanish Pharmacovigilance System for Human Medicines: 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 sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton, or blister pack 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. Dispose of containers and unused medicines at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help 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 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 Light Blue 85F30663 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake / FD&C Blue #2 (E132) and yellow iron oxide (E172)).

Nature of the product and contents of the pack

• Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablets are blue, oval, gastro-resistant tablets.
• Esomeprazol Aurovitas Spain 20 mg is available in blister packs of 14, 28 and 56 tablets, and in bottles containing 28 tablets.
• Hospital pack: 100 tablets in blisters 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 latest revision 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 some tubes, a dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe 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 downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip pointing upwards to prevent blockage of the tip).
6. Reposition the syringe with the tip 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 some tubes, 50 ml of water may be required.