Esomeprazole Alter 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esomeprazol Alter 40 mg gastro-resistant tablets EFG

Read the entire 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 other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet:

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

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

Esomeprazol Alter contains a medicine called esomeprazol, 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 Alter is used to treat the following conditions:

• 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 acidity caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation of treatment to prevent re-bleeding from peptic ulcer following 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 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 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 apply to you, do not take Esomeprazol Alter. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Alter.

Warnings and precautions

Talk to 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 medicine similar to Esomeprazol Alter used to reduce stomach acid.

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

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

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported 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.

Esomeprazol Alter may mask the symptoms of other conditions. Therefore, if any of the following events occur before or while taking Esomeprazol Alter, 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 you have been prescribed Esomeprazol Alter only to take when you experience symptoms, you should contact your doctor if your symptoms persist or change.

Children

The use of Esomeprazol Alter gastro-resistant tablets is not recommended in 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 any other medicines, including those obtained without a prescription. This is because Esomeprazol Alter may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Alter.

Do not take Esomeprazol Alter 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).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• 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 Alter.
• 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 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 medicines.

Esomeprazole Alter with food and drink

You may take the tablets with or without food.

Pregnancy and lactation

If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can take Esomeprazol Alter during this period.

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

Driving and use of machines

Esomeprazol Alter is unlikely to affect your ability to drive or operate tools or machinery.

Esomeprazol Alter contains sunset yellow FCF (E110)

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

3. How to take Esomeprazole Alter

Follow exactly the administration instructions for this medicine given by your doctor. 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 your symptoms change.

Taking this medicine

• You can take the tablets at any time of 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:

• Place the tablets in a glass of still (non-carbonated) water. Do not use any other liquids.

• Stir until the tablets disintegrate (the solution will not be clear). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.

• To ensure you have taken all of the medication, rinse the glass thoroughly with half a glass of water and drink it. Solid particles contain the medication – do not chew or crush the granules.

• If you are completely unable to swallow, the tablets may be dispersed in water and drawn 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 advised 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.

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

Adults and children 12 years of age and older:

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one Esomeprazol Alter 40 mg gastro-resistant tablet daily 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 you a lower dose.

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

• Adults from 18 years of age: the recommended dose is Esomeprazol Alter 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 initiated with intravenous esomeprazole:

• The recommended dose is one tablet of Esomeprazol Alter 40 mg once daily 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 Toxicology Information Service at telephone number: 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 take a double dose (two doses at the same time) to make up for a forgotten dose.

4. Possible adverse effects

Like all medicines, Esomeprazol Alter can cause adverse effects, although not everyone will experience them.

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

• Sudden difficulty breathing, swelling of lips, tongue and throat or the whole body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. These could be signs of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

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

Other adverse effects include:

Common (Between 1 and 10 out of every 100 patients)

• Headache.
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

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

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• Skin rash, hives, skin itching.

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

• 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 fatigue.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (decreased number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset 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).
• Muscle weakness.
• Severe kidney disorders.
• Breast enlargement in males.
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

Frequency not known

Skin rash, possibly with joint pain.

If you are taking Esomeprazol Alter for more than three months, your blood magnesium levels may decrease. Low magnesium levels can 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.

If you are taking proton pump inhibitors such as Esomeprazol Alter, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (as they may increase the risk of osteoporosis).

In very rare cases, Esomeprazol Alter 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 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 decreased white blood cell count (agranulocytosis) via a blood test. In such cases, it is important to inform your doctor about your medication.

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

Reporting of adverse effects

If you experience any type of 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 through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Alter

• 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 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Alter

• The active substance is esomeprazole. There are two strengths of Esomeprazol Alter 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 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 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 Alter 40 mg gastro-resistant tablets are blue, oval-shaped gastro-resistant tablets.

• Esomeprazol Alter 40 mg is available in blister packs of 14, 28 and 56 tablets.

• Hospital pack of 100 tablets in blisters and bottle.

• Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization 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 latest revision of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/