ESOMEPRAZOL 40 mg Gastro-Resistant Tablets

Contents of the leaflet

1. Introduction
2. What is Esomeprazole Liderfarm 40 mg and what is it used for
3. What you need to know before you take Esomeprazole Liderfarm 40 mg
4. How to take Esomeprazole Liderfarm 40 mg
5. Possible side effects
6. Storage of Esomeprazole Liderfarm 40 mg
7. Packaging Content and Additional Information

Introduction

Patient Information Leaflet

Esomeprazole Liderfarm 40 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 Esomeprazole Liderfarm 40 mg and what is it used for
2. What you need to know before you take Esomeprazole Liderfarm 40 mg
3. How to take Esomeprazole Liderfarm 40 mg
4. Possible side effects
5. Storage of Esomeprazole Liderfarm 40 mg
6. Contents of the pack and further information

1. What is Esomeprazole Liderfarm 40 mg and what is it used for

Esomeprazole Liderfarm 40 mg contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazole Liderfarm 40 mg is used for the treatment of the following conditions:

• 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 discomfort.
• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of relapse of peptic ulcer bleed in patients treated with esomeprazole intravenously.

2. What you need to know before you take Esomeprazole Liderfarm 40 mg

Do not take Esomeprazole Liderfarm 40 mg

• If you are allergic to esomeprazole 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, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to esomeprazole that reduces stomach acid.

If any of the above apply to you, do not take Esomeprazole Liderfarm 40 mg. If you are not sure, consult your doctor or pharmacist before taking Esomeprazole Liderfarm 40 mg.

Warnings and precautions

• 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 esomeprazole that reduces stomach acid. If you get a skin rash or swelling, stop taking Esomeprazole Liderfarm 40 mg and contact your doctor immediately. Also, tell your doctor if you notice any other symptoms, such as fever or joint pain.
• A specific blood test (Chromogranin A)is planned.

Esomeprazole Liderfarm 40 mg may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking Esomeprazole Liderfarm 40 mg, contact your doctor immediately:

• Losing a lot of weight for no reason and having difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (blood-stained).

If you have been prescribed Esomeprazole Liderfarm 40 mg only when you have symptoms, you should contact your doctor if your symptoms get worse or if you notice any new symptoms.

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 in association with esomeprazole treatment. Stop taking esomeprazole and seek medical attention immediately if you get any of the symptoms described in section 4.

Using Esomeprazole Liderfarm 40 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 Esomeprazole Liderfarm 40 mg may affect how these medicines work or these medicines may affect how Esomeprazole Liderfarm 40 mg works.

Do not take Esomeprazole Liderfarm 40 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 Esomeprazole Liderfarm 40 mg.

• Medicines that thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole Liderfarm 40 mg.
• Cilostazol (used to treat intermittent claudication – a condition where the legs do not get enough blood and you experience pain).
• 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 Esomeprazole Liderfarm 40 mg treatment.
• 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 Esomeprazole Liderfarm 40 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 Esomeprazole Liderfarm 40 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.

Esomeprazole Liderfarm 40 mg is not likely to affect your ability to drive or use any tools or machines.

Esomeprazole Liderfarm 40 mg contains sucrose

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

3. How to take Esomeprazole Liderfarm 40 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.

• Esomeprazole Liderfarm 40 mg gastro-resistant tablets are not recommended for children under 12 years.
• If you take this medicine for a long period of 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, you should contact your doctor if your symptoms get worse or if you notice any new symptoms.

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 pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

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 this mixture straight away or within 30 minutes. Always stir well before drinking.
• To make sure you get the full dose of the medicine, 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 gastric 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 described below.

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

Adults and children aged 12 years and over:

• 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 gullet has not healed yet.
• If you have severe liver problems, your doctor may give you a lower dose.

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

• Adults aged 18 years and over: the usual dose is one Esomeprazole Liderfarm 40 mg gastro-resistant tablet twice a day.

Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine for. The maximum dose is 80 mg twice a day.

Prevention of relapse of peptic ulcer bleed in patients treated with Esomeprazole Liderfarm 40 mg intravenously:

• The usual dose is one Esomeprazole Liderfarm 40 mg tablet once a day for 4 weeks.

If you take more Esomeprazole Liderfarm 40 mg than you should

If you have taken more Esomeprazole Liderfarm 40 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 Esomeprazole Liderfarm 40 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 side effects

Like all medicines, Esomeprazole Liderfarm 40 mg can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined as:

• very common (may affect more than 1 in 10 people)
• common (may affect up to 1 in 10 people)
• uncommon (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 notice any of the following serious side effects, stop taking Esomeprazole Liderfarm 40 mg and contact a doctor immediately:

• Sudden onset of severe rash, blistering or peeling skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Severe skin rash, including blistering of the skin in areas exposed to the sun.
• Jaundice (yellowing of the skin or eyes) - this may be a sign of liver problems.

These effects are rare.

Other side effects include:

Common

• Headache.
• Stomach problems such as stomach pain, constipation, diarrhoea and wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
• Benign polyps in the stomach.

Uncommon

• Swelling of feet and ankles.
• Disturbed sleep.
• Dizziness, tingling (pins and needles), feeling sleepy.
• Spinning sensation (vertigo).
• Dry mouth.
• Abnormal liver function tests (seen in blood tests).
• Rash, itchy skin.

Rare

• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Agitation, confusion, depression.
• Disturbances in taste.
• Eye problems such as blurred vision.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Severe skin rash, including blistering of the skin in areas exposed to the sun.
• Jaundice (yellowing of the skin or eyes) - this may be a sign of liver problems.
• Loss of hair (alopecia).
• Photosensitivity reaction (skin reaction after exposure to sunlight or UV radiation).
• Pain in the joints (arthralgia) or muscles (myalgia).
• General feeling of being unwell (malaise) and lack of energy.
• Increased sweating.

Very rare

• Changes in blood count, including agranulocytosis (severe reduction in white blood cells).
• Aggression.
• Seeing, hearing or feeling things that are not there (hallucinations).
• Severe liver problems leading to liver failure and encephalopathy in patients with pre-existing liver disease.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Muscle weakness.
• Severe kidney problems.
• Breast swelling in men.
• Low levels of magnesium in the blood. This can cause weakness, tiredness, muscle cramps, and irregular heartbeat. Low levels of magnesium can also increase the risk of low levels of calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Frequency not known

• Inflammation in the gut (leading to diarrhoea).
• If you are taking Esomeprazole Liderfarm for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can cause tiredness, muscle cramps, seizures and an irregular heartbeat. If you get any of these symptoms, do not take any more Esomeprazole Liderfarm and tell your doctor as soon as possible. Low levels of magnesium can also lead to a reduction in the levels of potassium and calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

• If you are taking a proton pump inhibitor like Esomeprazole Liderfarm, especially over a period of more than one year, you may be at increased risk of fracture of the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• Severe skin rash, including blistering of the skin in areas exposed to the sun.

In very rare cases, Esomeprazole Liderfarm 40 mg may affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulty in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you inform your doctor about your medicine.

Do not be alarmed by this list of possible side effects. You may not get any of them.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Esomeprazole Liderfarm 40 mg

• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C.
• Store in the original package to protect from moisture.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Packaging Content and Additional Information

Composition of Esomeprazol Liderfarm

• The active ingredient is esomeprazol. Each gastro-resistant tablet contains 40 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).

Product Appearance and Packaging Content

Rosa-colored, 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 Leaflet: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/