ESOMEPRAZOL FARMALIDER 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

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

Esomeprazole Farmalider 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, inflammation and heartburn.
• Excessive acid production in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation of prevention of rebleeding from peptic ulcers with Esomeprazole Farmalider 40 mg intravenous.

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

Do not take Esomeprazole Farmalider 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 inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• 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 Esomeprazole that reduces stomach acid.

If you are in any of these situations, do not take Esomeprazole Farmalider 40 mg. If you are not sure, consult your doctor or pharmacist before taking Esomeprazole Farmalider 40 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 Pantoprazol Farmalider to reduce stomach acid.

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with Pantoprazol Farmalider. Also remember to mention any other symptoms that you may notice, such as joint pain.

• It is planned that you will have a specific blood test (Chromogranin A)
• Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with Esomeprazole. Stop taking Esomeprazole and contact your doctor immediately if you experience any of the following symptoms: blistering of the skin, mouth, eyes and genitals, skin peeling, fever, difficulty swallowing, high temperature, rash, enlarged lymph nodes and low blood pressure.

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

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools appear black (blood-stained).

If your doctor has prescribed Esomeprazole Farmalider 40 mg only when you notice symptoms, you should contact your doctor if the symptoms of your disease persist or change.

Using Esomeprazole 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 Esomeprazole Farmalider 40 mg may affect how these medicines work and these medicines may also affect how Esomeprazole Farmalider 40 mg works.

Do not take Esomeprazole Farmalider 40 mg if you are taking:

• A medicine that contains nelfinavir(used for HIV infection treatment).

Tell your doctor if you are taking any of the following medicines:

• Atazanavir (used for HIV infection treatment).
• Ketoconazole, itraconazole or voriconazole (for fungal infections).
• Erlotinib (used for cancer treatment).
• Citalopram, imipramine, clomipramine (for depression treatment).
• Diazepam (used for anxiety treatment, 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 Farmalider 40 mg.

• Medicines that are used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole Farmalider 40 mg.
• Cilostazol (used for intermittent claudication treatment – leg pain when walking caused by intermittent blood pumping).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapy drug used at high doses in cancer treatment) - if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazole Farmalider.
• Rifampicin (used for tuberculosis treatment).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole Farmalider 40 mg to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicine.

Taking Esomeprazole Farmalider 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.

It is not known if Esomeprazole Farmalider 40 mg passes into breast milk. Therefore, you should not take Esomeprazole Farmalider 40 mg during breast-feeding.

Driving and using machines

Esomeprazole Farmalider 40 mg is unlikely to affect your ability to drive or use any tools or machines.

Esomeprazole Farmalider 40 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 Esomeprazole Farmalider 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.

• The use of esomeprazole Farmalider 40 mg gastro-resistant tablets is not recommended in children under 12 years.
• 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 a year).

• If your doctor has told you to take this medicine only when you notice symptoms, inform your doctor if the 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 stop the medicine from being broken down by the acid in the stomach. It is important not to damage these granules.

What to do if you have difficulty swallowing

• If you have difficulty swallowing the tablets:

• Put the tablet in a glass of water. Do not use other liquids.
• Stir until the tablet breaks 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 all 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 syringe into the stomach (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 liver function.
• The usual doses are given below.

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

Adults and children over 12 years:

• If your doctor has found that your 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 yet healed.
• If you have serious 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 over 18 years: the usual dose is one Esomeprazole Farmalider 40 mg gastro-resistant tablet twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you will need to take this medicine. The maximum dose is 80 mg twice a day.

Continuation of prevention of rebleeding from peptic ulcers with Esomeprazole Farmalider 40 mg intravenous:

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

If you take more Esomeprazole Farmalider 40 mg 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 Esomeprazole Farmalider 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, 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, Esomeprazole Farmalider 40 mg can cause side effects, although not everybody gets them.

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

• 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 Farmalider 40 mg and contact a doctor immediately:

• Sudden difficulty in breathing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty in swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
• Widespread rash, high temperature and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) which is a rare condition.

These effects are rare.

Other side effects include:

Common

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

Uncommon

• Swelling of feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, numbness, somnolence.
• Feeling of vertigo.
• Dry mouth.
• Changes in blood tests that show how the liver is working.
• Skin rash, itching, urticaria.

Rare

• Blood disorders such as a reduced number of white cells or platelets. This may cause weakness, bruising or make you more likely to get infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
• Agitation, confusion, depression.
• Changes in taste.
• Eye problems such as blurred vision.
• Sudden onset of a severe rash or blistering or peeling of the skin and/or mucous membranes, possibly with fever, flu-like symptoms and/or enlarged lymph nodes (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
• Sudden difficulty in breathing, especially when accompanied by skin rash (anaphylactic reactions).
• Inflammation of the mouth.
• Infection called “candidiasis” that can affect the throat, the gut or the vagina.
• Liver problems, including jaundice which can cause yellow skin, dark urine and tiredness.
• Hair loss (alopecia).
• Sensitivity to sunlight.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• General feeling of being unwell 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 of the skin and/or mucous membranes, possibly with fever, flu-like symptoms and/or enlarged lymph nodes (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.
• Low levels of magnesium in the blood. This may cause fatigue, nausea, vomiting, cramps, tingling and arrhythmias (changes in heart rhythm). If you have low magnesium levels, you may also have low calcium levels in the blood.

Frequency not known

• Inflammation in the intestine (which can lead to diarrhoea).
• If you are taking Esomeprazol Farmalider for more than three months it is possible that the levels of magnesium in your blood may fall. Low magnesium levels can cause fatigue, muscle spasms, seizures, dizziness and an irregular heartbeat. If you get any of these symptoms, please tell your doctor promptly. Low magnesium levels can also cause 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 proton pump inhibitors like Esomeprazole Farmalider, especially over a period of more than one year, you may have a slightly higher 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).
• Rash, possibly with joint pain.

In very rare cases, Esomeprazole Farmalider 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Esomeprazole Farmalider 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 light and moisture.
• Do not use this medicine if you notice any change in the appearance of the tablets.
• Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Esomeprazol Farmalider Composition

• 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).

Product Appearance and Package Contents

Rose-colored, 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 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/