ESOMEPRAZOL ALTER 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Esomeprazol Alter 20 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information

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

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

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

Esomeprazol Alter is used to treat the following conditions:

Adults and adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). This is when stomach acid rises up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the stomach or the upper part of the intestine (duodenum) that are infected with a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazol Alter can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive acidity in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

2. What you need to know before you take Esomeprazol Alter

Do not take Esomeprazol Alter

• If you are allergic (hypersensitive) to esomeprazol or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the same group of medicines as esomeprazol (proton pump inhibitors).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a severe skin rash or blistering of the skin, mouth, or eyes after taking esomeprazol or other medicines that reduce stomach acid.

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.
• You have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Alter to reduce stomach acid.

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

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

Severe skin reactions have been reported with esomeprazol, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking esomeprazol 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 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 when you notice symptoms, you should contact your doctor if your symptoms persist or change.

Children

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

Interaction of Esomeprazol Alter with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any 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 to treat HIV infection).

Tell 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 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 you when you start or stop taking Esomeprazol Alter.
• Medicines that are used to thin the blood, such as warfarin. Your doctor may need to monitor you 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 drink

You can take the tablets with or without food.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Your doctor will decide whether 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.

3. How to take Esomeprazol Alter

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long 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 medicine only when you notice symptoms, inform your doctor if your 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 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. Always stir just before drinking.
• To ensure that you have taken 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. 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 from 12 years of age:

• 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 indicate that you take the same dose for another 4 weeks if your esophagus has not healed yet.
• Once the esophagus has healed, the recommended dose is one Esomeprazol Alter 20 mg gastro-resistant tablet per day.
• If your esophagus is not affected, the recommended dose is one Esomeprazol Alter 20 mg gastro-resistant tablet per day. Once your condition has been controlled, your doctor may indicate that you take your medicine when you need it, up to a maximum of one Esomeprazol Alter 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:

• Adults and adolescents from 12 years of age: the recommended dose is one Esomeprazol Alter 20 mg gastro-resistant tablet twice a day for one week.
• Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• Adults from 18 years of age: the recommended dose is one Esomeprazol Alter 20 mg gastro-resistant tablet per day for 4 to 8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• Adults from 18 years of age: the recommended dose is one Esomeprazol Alter 20 mg gastro-resistant tablet per day.

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.

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, telephone: 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. Blisters in the mouth and eyes may also appear. This could be a sign of a condition known as 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:

Common (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, hives, 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 blood cells or platelets. This can cause weakness, bruising, or increase the risk 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, which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Joint pain (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 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 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 your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your 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 fractures 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 severe worsening 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) with a blood test. It is important that you inform your doctor about your medication in this case.

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 possible that they are not listed in this leaflet. You can also report side effects 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. Storage of Esomeprazol Alter

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

Do not use this medicine after the expiry date which is stated on the label, carton or blister after CAD. The expiry date is the last day of the month indicated.

Blister packs

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Bottles:

Do not store above 30°C.

Shelf life after first opening of 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 any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Alter

• The active ingredient is esomeprazole. There are two concentrations of Esomeprazol Alter gastro-resistant tablets containing 20 mg or 40 mg of esomeprazole (as sodium salt).
• The other ingredients 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 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 Package Contents

• Esomeprazol Alter 20 mg gastro-resistant tablets are oval, blue tablets.
• Esomeprazol Alter 20 mg is available in packs of 14, 28, and 56 tablets in blister packs.
• Clinical pack of 100 tablets in blister pack and bottle.
• Only some pack 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 Leaflet: February 2025

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