Package Leaflet: Information for the User

Esomeprazol Alter 40 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

1.What is Esomeprazol Alter and what it is used for

2.What you need to know before you start taking Esomeprazol Alter

3.How to take Esomeprazol Alter

4.Possible side effects

5Storage of Esomeprazol Alter

6.Contents of the pack and additional information

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

Esomeprazol Alteris used for the treatment of the following disorders:

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• 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.

Do not take Esomeprazol Alter

• If you are allergic (hypersensitive) to esomeprazole or to any of the other components of this medication (including those listed in section 6).
• If you are allergic toother medications in the group of proton pump inhibitors.
• If you are taking a medication 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 medications.

If you find yourself in any of these situations, do not take Esomeprazol Alter. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Alter.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Esomeprazol Alter if:

• You have severe liver problems.
• You have severe kidney problems.
• You have ever had a skin reaction after treatment with a similar medication to Esomeprazol Alter to reduce stomach acid.

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Esomeprazol Alter. Remember to mention any other symptoms you may notice, such as joint pain.

• You are scheduled to have a specific blood test (Cromogranin A)

Severe skin reactions, including 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.

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

• You lose a lot of weight without reason and have trouble swallowing.
• You experience stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

If you have been prescribed Esomeprazol Alter only when you notice symptoms, you should contact your doctor if your disease symptoms persist or change.

Children

The use of Esomeprazol Alter tablets is not recommended in children under 12 years old.

Esomeprazol Alter interaction with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription. This is because Esomeprazol Alter may affect the way some medications work and some medications may influence the effect of Esomeprazol Alter.

Do not take Esomeprazol Alter if you are taking:

• A medication that containsnelfinavir(used for HIV treatment).

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

• Atazanavir (used for HIV treatment).
• Ketoconazole, itraconazole or voriconazole (for fungal infections).
• Citalopram, imipramine, clomipramine (for depression treatment).
• Diazepam (used for anxiety treatment, 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 Alter.
• Medications used to make blood thinner, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Alter.
• Cisapride (used for indigestion and stomach burning).

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin in addition to Esomeprazol Alter to treat ulcers caused byHelicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Esomeprazol Alter with food and drinks

You can take the tablets with or without food.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or plan to become pregnant, consult your doctor before using this medication. Your doctor will decide if you can take Esomeprazol Alter during this period.

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

Driving and using machines

Esomeprazol Alter is unlikely to affect your ability to drive or use tools or machines.

Esomeprazol Alter contains yellow orange S (E110)

This medication may cause allergic reactions because it contains yellow orange S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow the exact administration instructions for 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.

Administration of this medication

• You can take the tablets at any time of the day.
• You can take the tablets with foodor 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:

• Placethe 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.

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

Adults and children aged 12 years and older:

• If your doctor has determined that your esophagus is slightly affected, the recommended dose is one Esomeprazol Alter 40 mg gastro-resistant tablet per day for 4 weeks. Your doctor may instruct you to take 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 tumor in the pancreas (Zollinger-Ellison syndrome):

• Adults aged 18 years and older: the recommended dose is Esomeprazol Alter 40 mg twice a day.
• Your doctor will adjust the doseaccording to your needs and also decide 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 intravenously:

• The recommended dose is one Esomeprazol Alter 40 mg tablet per day for 4 weeks.

If you take more Esomeprazol Alterthan you should

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

If you forget to take Esomeprazol Alter

• 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 takea double dose (two doses at once) to compensate for the missed dose.

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

If you notice any of the following severe side effects, stop taking Esomeprazol Alter and contact your 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.

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

Other side effects include:

Frequent (Between 1 and 10 in every 100 patients)

• 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 patients)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood tests that determine liver function.
• Skin rash, urticaria, itching skin.

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

• Blood disorders such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or an increased risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle 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 fungal infection known as "candidiasis" that can affect the esophagus.
• 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 (arthralgia) or muscles (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare (In fewer than 1 in every 10,000 patients)

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing 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.
• Increased breast size in men.
• Widespread rash, high body temperature, and increased size of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

Unknown frequency

Skin rash, possibly with joint pain

If you are taking Esomeprazol Alter 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 your 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.

If you are taking proton pump inhibitors such as Esomeprazol Alter, especially for more than a year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

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

Do not be alarmed by this list of possible side effects. It is likely that you will not experience any of them.

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 theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about 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 after CAD. The expiration date is the last day of the month indicated.

Blister packs:

• Do not store at a temperature above 30°C .
• Store in the original packaging to protect it from moisture.

Bottles:

• Do not store at a temperature above 30°C
• Validity period 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your 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.

Esomeprazole Alter Composition

-The active ingredient is esomeprazole. There are two concentrations of Esomeprazole Alter 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 Dark Blue 85F30662 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum lake carmine blue FD&C #2 (E132), iron oxide black (E172), and aluminum lake yellow FD&C #6 / orange yellow S (E110).

Product appearance and container content

• Esomeprazole Alter 40 mg gastro-resistant tablets are oval-shaped, blue tablets.

• Esomeprazole Alter 40 mg is available in blister packs of 14, 28, and 56 tablets.
• 100 tablets in a clinical pack in a blister and a bottle.
• Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder is:

Alter, S.A. Laboratories

Mateo Inurria, 30

28036 Madrid

Spain

The responsible manufacturer is:

Towa Pharmaceutical Europe S.L.C/ Sant Martí, 75-97

08107 Martorelles, Barcelona

Spain

Last review date of this leaflet: February 2025

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