Package Leaflet: Information for the User

Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablets EFG

Read this 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

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

3. How to take Esomeprazol Aurovitas Spain

4. Possible side effects

5. Storage of Esomeprazol Aurovitas Spain

6. Contents of the pack and additional information

Esomeprazol Aurovitas Spain contains a medicine called esomeprazol that belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazol Aurovitas Spain is used to treat the following disorders:

Adults and adolescents aged 12 years or older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up 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 called Helicobacter pylori. If you have this disorder, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Stomach ulcers caused by medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Aurovitas Spain can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).

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.
• If you are taking a medicine that contains nelfinavir (used in 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 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 if:

• You have ever had a skin reaction after treatment with a similar medicine to Esomeprazol Aurovitas Spain to reduce stomach acid. If you have a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazol Aurovitas Spain. Remember to mention any other symptoms you may notice, such as joint pain.
• You have severe liver problems.
• You have severe kidney problems.
• You are due to have a specific blood test (Cromogranin A)

Esomeprazol Aurovitas Spain may mask the symptoms of other diseases.Therefore, if you observe any of the following events before taking or while taking Esomeprazol Aurovitas Spain, contact your doctor immediately:

• You lose a lot of weight without reason and have trouble swallowing.
• You experience stomach pain or indigestion.
• You begin to vomit food or blood.

• Your stools appear black (blood-stained).

If your doctor has prescribed Esomeprazol Aurovitas Spain only when you notice some symptoms, you should contact your doctor if the symptoms of your disease persist or change.

Taking a proton pump inhibitor like Esomeprazol Aurovitas Spain, 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 (which may increase the risk of osteoporosis).

Severe skin reactions that include Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to 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.

Children

Esomeprazol Aurovitas Spain tablets are not recommended for children under 12 years old.

Other medicines and Esomeprazol Aurovitas Spain

Inform your doctor or pharmacist if you are using or have recently used other medicines, even those purchased without a prescription. This is because Esomeprazol Aurovitas Spain may affect the way 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 that contains nelfinavir (used for the treatment of HIV infection).

Inform your doctor if you are using any of the following medicines:

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used for the prevention of blood clots)
• Ketoconazole, itraconazole or voriconazole (for fungal infections).
• Erlotinib (used for cancer treatment)
• Citalopram, imipramine, clomipramine (for depression treatment).
• 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 Esomeprazol Aurovitas Spain.
• Medicines used to make the blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Aurovitas Spain.
• 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 high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol Aurovitas Spain
• Tacrolimus (organ transplant)
• Rifampicin (used for tuberculosis treatment)
• St. John's Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed antibiotics amoxicillin and clarithromycin in addition to Esomeprazol Aurovitas Spain to treat ulcers caused by Helicobacter pylori, it is very important to inform your doctor if you are taking any other medicine.

Esomeprazol Aurovitas Spain with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will decide if you can take Esomeprazol Aurovitas Spain during this period.

The passage of Esomeprazol Aurovitas Spain into breast milk is unknown. Therefore, do not take Esomeprazol Aurovitas Spain during breastfeeding.

Driving and operating machines

Esomeprazol Aurovitas Spain 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 Aurovitas Spain contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. 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.

Taking this medication

• 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 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

• If you have difficulty swallowing the tablets:

• Put the tablets in a glass of water without gas. Do not use other liquids.
• Stir until the tablets disintegrate (the solution will not be transparent). You can drink the mixture immediately or within 30 minutes. Stir always just before drinking.
• To ensure that you have taken all the medication, rinse the glass well with half a glass of water and drink. The solid particles contain the medication – do not chew or crush the granules.

• If you cannot swallow at all, the tablets can be dispersed in water and introduced into a syringe. They can then be administered directly into the stomach through a tube (gastric tube).

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 situation, age, and liver function.
• The recommended doses are indicated below.

Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

Adults and children aged 12 years and over:

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is 40 mg 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.
• Once your esophagus has healed, the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet per day.
• If your esophagus is not affected, the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet per day. Once your condition has been controlled, your doctor may tell you to take your medication when needed, 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.

Treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• Adults and adolescents aged 12 years and over: the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet twice a day for one week.
• Your doctor will also prescribe antibiotics such as amoxicillin and clarithromycin.

Treatment of gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs):

• Adults aged 18 years and over: the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet per day for 4 to 8 weeks.

Prevention of gastric ulcers if taking NSAIDs:

• Adults aged 18 years and over: the recommended dose is one Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablet per day.

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

• Adults aged 18 years and over: the recommended dose is Esomeprazol Aurovitas Spain 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take this medication. The maximum dose is 80 mg twice a day.

If you take more Esomeprazol Aurovitas Spain than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication 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 once) to compensate for the missed dose.

Like all medications, Esomeprazol Aurovitas Spain may cause side effects, although not everyone will experience them.

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

• Sudden difficulty breathing, swelling of the lips, tongue, and throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellow skin, dark urine, and fatigue, which may be symptoms of liver problems.
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

These side effects are rare, occurring between 1 and 10 in every 10,000 people.

Other side effects include:

Frequent (Between 1 and 10 in every 100 people)

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

Occasional (Between 1 and 10 in every 1,000 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, numbness, somnolence.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, or spine (if Esomeprazol Aurovitas Spain is used at high doses for a long period)

Rare (Between 1 and 10 in every 10,000 people)

• Blood disorders such as a decrease in white blood cells or platelets. This can cause weakness, bruises, or increase the risk 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 lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of 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 yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthritis) or muscles (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare (In less than 1 in every 10,000 people)

• Changes in the number of cells in the blood, including agranulocytosis (decrease in white blood cells).
• Aggression.
• To see, feel, or hear 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 may be accompanied by high fever and joint pain. (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Severe kidney disorders.
• Enlargement of the breasts in men.
• Low levels of magnesium in the blood. This can cause weakness, nausea (vomiting), cramps, tremors, and arrhythmias (alterations in heart rhythm).

Unknown frequency

• If you are taking esomeprazol for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see a doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation in the intestine (may cause diarrhea)
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Aurovitas Spain may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever with severe worsening of the general condition or 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 white blood cells (agranulocytosis) through a blood test. It is essential to inform your doctor about your medication in this case.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label, the box, or blister pack after CAD. The expiration date is the last day of the month indicated.

Blister Packs:

Do not store above30°C.

Store in the original packaging to protect it from moisture.

Bottles:

Do not store above30°C.

Shelf life after the first opening of the bottle: 100 days

Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Esomeprazol Aurovitas Spain

• The active ingredient is esomeprazole. There are two concentrations of Esomeprazol Aurovitas Spain gastro-resistant tablets that contain 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), monoestearate of glycerol, polysorbate 80, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and copolymer of methacrylic acid-ethyl acrylate), triethylcitrate (E1505), macrogol, microcrystalline cellulose (E460i), crospovidone (type A), and sodium stearate fumarate.
• Coating:Opadry II Light Blue 85F30663 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine / indigo blue FD&C #2 (E132) and yellow iron oxide (E172)).

Appearance of the product and content of the container

• Esomeprazol Aurovitas Spain 20 mg gastro-resistant tablets are oval-shaped, blue-colored gastro-resistant tablets.
• Esomeprazol Aurovitas Spain 20 mg is presented in blister packs of 14, 28, and 56 tablets, and in a 28-tablet bottle.
• 100-tablet clinical pack in blister and bottle.
• Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

The holder is:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

The manufacturer is:

Towa Pharmaceutical Europe S.L.

C/ San Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/