ESOMEPRAZOL LIDERFARM 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Esomeprazol Liderfarm 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. See section 4.

Contents of the pack

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

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

Esomeprazol Liderfarm 20 mg contains a medicine called esomeprazol. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazol Liderfarm 20 mg is used for the treatment of the following conditions:

Adults and adolescents from 12 years of age:

• Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Ulcers in the stomach or duodenum (the tube leading out of the stomach) that are infected with bacteria 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 Liderfarm 20 mg can also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

2. What you need to know before you take Esomeprazol Liderfarm 20 mg

Do not take Esomeprazol Liderfarm 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 proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazol).
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Liderfarm 20 mg.

If any of the above apply to you, do not take Esomeprazol Liderfarm 20 mg. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Liderfarm 20 mg.

Warnings and precautions

Before taking this medicine, tell your doctor 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 Liderfarm 20 mg. If you get a skin rash or signs of an allergic reaction (such as itching, reddening of the skin or difficulty in breathing), stop taking Esomeprazol Liderfarm 20 mg and consult your doctor immediately.

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

Esomeprazol Liderfarm 20 mg may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while taking Esomeprazol Liderfarm 20 mg, contact your doctor immediately:

• You lose a lot of weight for no reason and have problems swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained).

If your doctor has prescribed Esomeprazol Liderfarm 20 mg only when you have symptoms, you should contact your doctor if your symptoms change.

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazol. Stop taking esomeprazol and seek immediate medical attention if you get any of the symptoms described in section 4.

Taking Esomeprazol Liderfarm 20 mg 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 Liderfarm 20 mg can affect the way some medicines work and some medicines may affect the way Esomeprazol Liderfarm 20 mg works.

Do not take Esomeprazol Liderfarm 20 mg if you are taking:

• A medicine that contains nelfinavir(used to treat HIV infection).

Tell your doctor if you are taking:

• 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 Liderfarm 20 mg.

• Medicines that thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Liderfarm 20 mg.
• Cilostazol (used to treat intermittent claudication - a pain in the legs when walking which is caused by an inadequate blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) - if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol Liderfarm 20 mg.
• Rifampicin (used to treat tuberculosis).
• St John’s Wort (Hypericum perforatum) (used to treat depression).

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

Taking Esomeprazol Liderfarm 20 mg with food and drink

You can take the tablets with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 Liderfarm 20 mg passes into breast milk. Therefore, you should not take Esomeprazol Liderfarm 20 mg if you are breast-feeding.

Driving and using machines

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

Esomeprazol Liderfarm 20 mg contains sucrose

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

3. How to take Esomeprazol Liderfarm 20 mg

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Esomeprazol Liderfarm 20 mg gastro-resistant tablets are not recommended for children under 12 years.
• If you take this medicine for a long time, your doctor will want 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 have 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 or without food.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain coated granules which stop the medicine being broken down 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. Do not use other liquids.
• Stir until the tablets break up (the mixture will not be clear). You can drink the mixture straight away or within 30 minutes. Always stir well before drinking.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.
• If you cannot swallow at all, the tablets can be dispersed in water and given through a syringe (a syringe without a needle) into the stomach through a tube.

How much to take

• Your doctor will tell you how many tablets to take and when to take them. This will depend on your condition, age and kidney function.
• The usual doses are given below.

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD):

Adults and adolescents from 12 years of age:

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the usual dose is 40 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not healed yet.
• Once your oesophagus has healed, the usual dose is one Esomeprazol Liderfarm 20 mg gastro-resistant tablet once a day.
• If your gullet is not damaged, the usual dose is one Esomeprazol Liderfarm 20 mg gastro-resistant tablet each day. Once your condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one Esomeprazol Liderfarm 20 mg gastro-resistant tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and to stop them coming back:

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

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 Liderfarm 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 Liderfarm 20 mg gastro-resistant tablet once a day.

For the treatment of too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• Adults from 18 years of age: the usual dose is one Esomeprazol Liderfarm 40 mg gastro-resistant tablet twice a day.
• Your doctor will adjust the dose depending on your needs and also decide how long you will need to take the medicine for. The maximum dose is 80 mg twice a day.

If you take more Esomeprazol Liderfarm 20 mg than you should

If you have taken more Esomeprazol Liderfarm 20 mg than you should, contact your doctor or pharmacist immediately or go to the nearest hospital casualty department. Take the medicine pack with you.

If you forget to take Esomeprazol Liderfarm 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, skip the missed dose and continue as usual. 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 Liderfarm 40 mg can cause adverse effects, although not all people 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 Liderfarm 40 mg and contact a doctor immediately:

• Sudden difficulty breathing, swelling of lips, tongue, and throat, 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 that may 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.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, skin 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 disturbance.
• 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).
• Sunlight-induced dermatitis.
• 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 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 breast tissue 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 Liderfarm for more than three months, it is possible that your blood magnesium levels 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, 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 your magnesium levels.

• If you are taking proton pump inhibitors like Esomeprazol Liderfarm, 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 Liderfarm 40 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 Liderfarm 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

Esomeprazol Liderfarm Composition

• The active ingredient is esomeprazole. Each gastro-resistant tablet contains 40 mg of esomeprazole (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).

Product Appearance and Package Contents

Pink, biconvex, and oblong film-coated tablet.

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

Only some pack sizes may be marketed.

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 the 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/