ESOMEPRAZOL FARMALIDER 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Farmalider 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

1. What is Esomeprazol Farmalider 20 mg and what is it used for
2. What you need to know before you take Esomeprazol Farmalider 20 mg
3. How to take Esomeprazol Farmalider 20 mg
4. Possible side effects
5. Storage of Esomeprazol Farmalider 20 mg
6. Contents of the pack and other information

1. What is Esomeprazol Farmalider 20 mg and what is it used for

Esomeprazol Farmalider 20 mg 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 Farmalider 20 mg is used for the treatment of 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 Farmalider 20 mg 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 Farmalider 20 mg

Do not take Esomeprazol Farmalider 20 mg:

• If you are allergic to esomeprazol or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines of the same group (e.g. pantoprazol, lansoprazol, rabeprazol, omeprazol).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever developed a severe skin rash or blistering of the skin, mouth, or eyes after taking Esomeprazol or other medicines of the same group.

If you are in any of these situations, do not take Esomeprazol Farmalider 20 mg. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Farmalider 20 mg.

Warnings and precautions

Before taking this medicine, tell your doctor 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 Farmalider to reduce stomach acid.

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

• It is planned that you will have a specific blood test (Chromogranin A)

Esomeprazol Farmalider 20 mg may mask the symptoms of other diseases. Therefore, if you notice any of the following events before or while taking Esomeprazol Farmalider 20 mg, 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 your doctor has prescribed Esomeprazol Farmalider 20 mg only when you notice symptoms, you should contact your doctor if your symptoms persist or change.

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

Using Esomeprazol Farmalider with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Esomeprazol Farmalider 20 mg may affect the way some medicines work and some medicines may affect the effect of Esomeprazol Farmalider 20 mg.

Do not take Esomeprazol Farmalider 20 mg 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).
• Erlotinib (used to treat cancer).
• 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 Farmalider 20 mg.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin along with Esomeprazol Farmalider 20 mg to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor if you are taking any other medicine.

Taking Esomeprazol Farmalider 20 mg with food and drinks

You can take the tablets with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if Esomeprazol Farmalider 20 mg passes into breast milk. Therefore, you should not take Esomeprazol Farmalider 20 mg during breastfeeding.

Driving and using machines

Esomeprazol Farmalider 20 mg is unlikely to affect your ability to drive or use tools or machines.

Esomeprazol Farmalider 20 mg contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Esomeprazol Farmalider 20 mg

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Esomeprazol Farmalider 20 mg gastro-resistant tablets are not recommended for children under 12 years of age.
• 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, tell 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 the acid in the stomach. 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 clear). You can drink the mixture immediately or within 30 minutes. Always stir just before drinking.
• To make sure 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 condition, age, and liver function.
• The usual doses are given below.

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

Adults and children from 12 years of age:

• If your doctor has found that your esophagus is slightly affected, the usual dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not healed yet.
• Once your esophagus has healed, the usual dose is one Esomeprazol Farmalider 20 mg gastro-resistant tablet once a day.
• If your esophagus is not affected, the usual dose is one Esomeprazol Farmalider 20 mg gastro-resistant tablet once a day. Once your condition has been controlled, your doctor may tell you to take your medicine only when you notice symptoms, up to a maximum of one Esomeprazol Farmalider 20 mg gastro-resistant tablet once a day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and to prevent their recurrence:

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

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

• Adults from 18 years of age: the usual dose is one Esomeprazol Farmalider 20 mg gastro-resistant tablet once a 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 usual dose is one Esomeprazol Farmalider 20 mg gastro-resistant tablet once a 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 usual dose is one Esomeprazol Farmalider 20 mg gastro-resistant tablet twice a day.

If you take more Esomeprazol Farmalider 20 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Esomeprazol Farmalider 20 mg

• 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 Adverse Effects

Like all medicines, Esomeprazol Farmalider 20 mg can cause adverse effects, although not all people will suffer from them.

The frequency of possible adverse effects listed below is defined using the following convention:

• very frequent (may affect more than 1 in 10 people)
• frequent (may affect up to 1 in 10 people)
• infrequent (may affect up to 1 in 100 people)
• rare (may affect up to 1 in 1,000 people)
• very rare (may affect up to 1 in 10,000 people)

If you observe any of the following serious adverse effects, stop taking Esomeprazol Farmalider 20 mg and contact a doctor immediately:

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

These effects are rare.

Other adverse effects include:

Frequent

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

Infrequent

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Vertigo sensation.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching.

Rare

• Blood disorders such as a decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or increase the likelihood of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alteration.
• Eye disorders such as blurred vision.
• Sudden feeling of 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 fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

Very Rare

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggressiveness.
• 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. 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.
• Low magnesium levels in the blood. This can cause weakness, nausea (vomiting), cramps, tremors, and arrhythmias (heart rhythm disorders). If you have very low magnesium levels, you may also have low calcium levels in the blood.

Frequency Not Known

• Inflammation of the intestine (can lead to diarrhea).
• If you are taking Esomeprazol Farmalider for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• If you are taking proton pump inhibitors like Esomeprazol Farmalider, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Farmalider 20 mg can affect 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 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 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.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

5. Storage of Esomeprazol Farmalider 20 mg

• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.
• Store in the original packaging to protect it from light and moisture.
• Do not use this medicine if you notice any change in the appearance of the tablets.
• Do not use the tablets after the expiration date (CAD) that appears on the packaging, box, or blister. The expiration date is the last day of the month indicated.
• Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the Sigre Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Farmalider

• The active ingredient is esomeprazol. Each gastro-resistant tablet contains 20 mg of esomeprazol (as magnesium dihydrate salt).
• The other components are:
  • Tablet core: glycerol monostearate, mannitol, methacrylic acid copolymer (Eudragit), Avicel, paraffin, polysorbate 80, polyvinylpyrrolidone, sodium stearyl fumarate, sugar spheres, talc, and triethyl citrate.
  • Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E-171), talc, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Pink, biconvex, and oblong film-coated tablet.

Esomeprazol Farmalider tablets are presented in PA/Al/PV/Al blister packs of 14, 28, 56, and 100 gastro-resistant tablets.

Marketing Authorization Holder

FARMALIDER, S.A.

C/ Aragoneses, 15

28108 Alcobendas (Madrid)

Manufacturer

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid), Spain

Or

FARMEA

10, Rue Bouché-Thomas. ZAC Sud D’Orgemont

F-49007 Angers, France

Or

LAMP S. PROSPERO S.P.A.

Via Della Pace, 25/A

41030 San Prospero (MO), Italy

Date of Last Revision of this Prospectus: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/