ESOMEPRAZOL ALTER 40 mg GASTRO-RESISTANT TABLETS

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

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

Esomeprazol Alter is used for the treatment of the following conditions:

• Gastroesophageal reflux disease (GERD). This is when acid from the stomach goes back up into the esophagus (the tube that takes food from the mouth to the stomach) causing pain, inflammation, and heartburn.
• Excessive acidity in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation of prevention of rebleeding from peptic ulcers induced with intravenous esomeprazole.

2. What you need to know before taking Esomeprazol Alter

Do not take Esomeprazol Alter

• If you are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines of the proton pump inhibitor group.
• If you are taking a medicine that contains nelfinavir (used for HIV infection treatment).
• If you have ever developed a severe skin rash, blistering, or peeling after taking esomeprazole or other related medicines.

If you are in any of these situations, do not take Esomeprazol Alter. If you are not sure, 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.
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Alter to reduce stomach acidity.

If you get a skin rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as you may need to stop treatment with Esomeprazol Alter. Remember to mention any other symptoms you may notice, such as joint pain.

• A specific blood test (Chromogranin A) is scheduled

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), in relation to treatment with esomeprazole. Stop taking esomeprazole and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Esomeprazol Alter may mask the 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 have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (stained with blood).

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

Children

The use of Esomeprazol Alter gastro-resistant tablets is not recommended for children under 12 years of age.

Interaction of Esomeprazol Alter with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. This is because Esomeprazol Alter may affect how some medicines work and some medicines may affect the effect of Esomeprazol Alter.

Do not take Esomeprazol Alter if you are taking:

• A medicine that contains nelfinavir(used for HIV infection treatment).

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

• Atazanavir (used for HIV infection 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.
• Medicines used to make blood more fluid, such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Alter.
• Cisapride (used for indigestion and heartburn).

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

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 medicine. Your doctor will decide if you can take Esomeprazol Alter during this period.

It is not known if Esomeprazol Alter passes into breast milk. Therefore, you should 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 orange yellow S (E110)

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

3. How to take Esomeprazol Alter

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Taking this medicine

• 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 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:

• Put the tablets in a glass of still water. 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. Always stir just before drinking.
• To ensure you take all the medicine, rinse the glass well with half a glass of water and drink. The solid particles contain the medicine – 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. Then they can 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 from 12 years of age:

• 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 indicate that you take the same dose for another 4 weeks if your esophagus has not healed yet.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

• Adults from 18 years of age: the recommended dose is Esomeprazol Alter 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take this medicine. The maximum dose is 80 mg twice a day.

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

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

If you take more Esomeprazol Alter than 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 medicine 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 take a double dose (two doses at the same time) to make up for the missed dose.

4. Possible side effects

Like all medicines, Esomeprazol Alter can cause side effects, although not everybody gets them.

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

• A sudden difficulty in breathing, swelling of the lips, tongue, and throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Also, blisters and bleeding of the lips, eyes, mouth, nose, and genitals may appear. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellow skin, dark urine, and tiredness, which can be symptoms of liver problems.

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

Other side effects include:

Frequent (Between 1 and 10 of every 100 patients)

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

Uncommon (Between 1 and 10 of every 1,000 patients)

• Swelling of the feet and ankles.
• Disorders of sleep (insomnia).
• Dizziness, tingling, and numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching of the skin.

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

• Blood disorders such as a decrease in the number of white cells or platelets. This can cause weakness, bruising, or increase the likelihood of infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside 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 tiredness.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very rare (In less than 1 of every 10,000 patients)

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white 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 can 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.
• Widespread rash, high body temperature, and enlargement of the lymph nodes (DRESS or drug hypersensitivity syndrome), which is very rare.

Frequency not known

Skin rash, possibly with joint pain

If you are taking Esomeprazol Alter for more than three months, it is possible that the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to your doctor immediately. Low levels of magnesium can also produce a decrease in the levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like Esomeprazol Alter, especially for more than a year, you may have a slightly increased risk of fracture of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

In very rare cases, Esomeprazol Alter can affect the white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of your general condition or fever with symptoms of a local infection such as pain in the neck, throat, mouth, 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 important that, in this case, you inform about your medication.

Do not be alarmed by this list of possible side effects. You will probably not experience any of them.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Esomeprazol Alter

• Keep this medicine out of the sight and reach of children.

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

Blisters:

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

Bottles:

• Do not store above 30°C.
• Shelf life after opening the bottle: 100 days.
• Keep the bottle tightly closed to protect from moisture.

• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Esomeprazol Alter Composition

• The active ingredient is esomeprazol. There are two concentrations of Esomeprazol Alter gastro-resistant tablets that contain 20 mg or 40 mg of esomeprazol (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 at 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 hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol, talc, aluminum carmine indigo/blue FD&C #2 (E132), black iron oxide (E172), and aluminum yellow FD&C #6/orange yellow S (E110).

Product Appearance and Container Content

• Esomeprazol Alter 40 mg gastro-resistant tablets are oval, blue-colored tablets.

• Esomeprazol Alter 40 mg is available in packs of 14, 28, and 56 tablets in blisters.
• Clinical packaging of 100 tablets in blisters and bottles.
• Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The holder is:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

The manufacturer is:

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

08107 Martorelles, Barcelona

Spain

Date of the Last Revision of this Prospectus: February 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/