ESOMEPRAZOL 40 mg Gastro-Resistant Tablets

Contents of the leaflet

1. Introduction
2. What is esomeprazol vir and what is it used for
3. What you need to know before you take esomeprazol vir
4. How to take esomeprazol vir
5. Possible side effects
6. Storage of Esomeprazol Vir
7. Package Contents and Additional Information

Introduction

Patient Information: Summary of Product Characteristics

Esomeprazol Vir 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. See section 4.

Contents of the pack

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

1. What is esomeprazol vir and what is it used for

Esomeprazol vir contains a medicine called esomeprazol. It belongs to a group of medicines called ‘proton pump inhibitors’. These work by reducing the amount of acid that your stomach produces.

Esomeprazol vir 40 mg is used for the treatment of the following conditions:

Adults

? 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 ulcer with esomeprazol intravenous.

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, inflammation and heartburn.

2. What you need to know before you take esomeprazol vir

Do not take esomeprazol vir

? 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 inhibitors (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 that reduces stomach acid.

If any of the above apply to you, do not take esomeprazol vir. If you are not sure, talk to your doctor or pharmacist before taking esomeprazol vir.

Warnings and precautions

Talk to your doctor or pharmacist before taking esomeprazol vir

? If you have severe liver problems.

? If you have severe kidney problems.

? If you have ever had a skin reaction after treatment with a medicine that reduces stomach acid.

? If you are due to have a specific blood test (Chromogranin A).

Esomeprazol vir may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while you are taking esomeprazol vir, 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 you have been prescribed esomeprazol vir only when you have symptoms, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like esomeprazol vir, especially over a period of more than one year, may slightly increase your 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).

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 esomeprazol vir. Also remember to mention any other symptoms that you may have, such as joint pain.

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 contact your doctor immediately if you get any of the symptoms described in section 4.

Children under 12 years

Esomeprazol vir is not recommended for children under 12 years of age.

Using esomeprazol vir with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you have bought without a prescription. This is because esomeprazol vir may affect how these medicines work or they may affect how esomeprazol vir works.

Do not take esomeprazol vir 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).

? Clopidogrel (used to prevent blood clots).

? Ketoconazole, itraconazole or voriconazole (for fungal infections).

? Erlotinib (used to treat cancer).

? Citalopram, imipramine, clomipramine (for depression).

? Diazepam (used to treat anxiety, relax muscles or in epilepsy).

? Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking esomeprazol vir.

? Medicines that thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking esomeprazol vir.

? Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient 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 vir.

? Tacrolimus (used after organ transplantation).

? 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 in combination with esomeprazol vir 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 vir with food and drink

You can take the tablets with food or on an empty stomach.

Pregnancy, breast-feeding and fertility

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. Your doctor will decide whether you can take esomeprazol vir during this time.

It is not known if esomeprazol vir passes into breast milk. Therefore, you should not take esomeprazol vir during breast-feeding.

Driving and using machines

Esomeprazol vir is unlikely to affect your ability to drive or use any tools or machines. However, sometimes side effects such as dizziness or blurred vision (see section 4) can occur. Do not drive or use any tools or machines if you are affected in this way.

Esomeprazol vir contains sucrose. Esomeprazol vir contains sugar spheres which contain sucrose, a type of sugar. 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 vir

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

? If you are taking this medicine for a long time, your doctor will want to monitor you (especially if you take it for more than one year).

? If your doctor has told you to take this medicine as and when you need it, tell your doctor if your symptoms change.

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 recommended doses are as follows:

Adults aged 18 years and over

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

? If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one 40 mg gastro-resistant tablet of esomeprazol vir 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):

? The recommended dose is 40 mg of esomeprazol vir twice a day.

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

Continuation of prevention of rebleeding from peptic ulcer with esomeprazol intravenous:

• The recommended dose is one 40 mg tablet of esomeprazol vir once a day for 4 weeks.

Use in adolescents aged 12 years and over

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

? If your doctor has found that your oesophagus is slightly damaged, the recommended dose is one 40 mg gastro-resistant tablet of esomeprazol vir 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.

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 which stop the medicine from being broken down by the acid in your 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 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, 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 (orally or through a nasogastric tube).

Use in children under 12 years of age

Esomeprazol vir is not recommended for children under 12 years of age.

Elderly

No dose adjustment is necessary in elderly patients.

If you take more esomeprazol vir than you should

If you take more esomeprazol vir than you should, talk to a doctor or pharmacist straight away.

In case of overdose or accidental ingestion, contact the National Poison Centre on 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take esomeprazol vir

? 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.

? Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking esomeprazol vir 20 mg and contact a doctor immediately:

? Sudden onset of severe rash, swelling of the face, lips, tongue or throat or body, difficulty swallowing or breathing, or a severe allergic reaction (anaphylactic shock) which may cause difficulty breathing, rapid heartbeat, and a fall in blood pressure.

? Reddening of the skin with blisters or peeling and/or mouth blisters. There may also be severe inflammation and blistering of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), which may be associated with high fever, headache, sore throat and/or diarrhea.

? Yellowing of the skin or whites of the eyes (jaundice), dark urine and tiredness which can be symptoms of liver problems.

• Severe skin rash that may include itchy, red, and scaly skin, blisters that may contain pus, and skin peeling with or without fever, in some cases leading to life-threatening complications (DRESS syndrome or drug rash with eosinophilia and systemic symptoms).

These effects are rare and may affect up to 1 in 1,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: stomach pain, constipation, diarrhea, wind (flatulence).

? Nausea or vomiting.

• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

? Swelling of feet and ankles.

? Disturbances in sleep (insomnia).

? Dizziness, tingling, numbness or sensation of pricking (paraesthesia), somnolence.

? Feeling of vertigo.

? Dry mouth.

? Changes in blood tests that show how the liver is working.

? Skin rash, itching, urticaria.

? Fracture of the hip, wrist or spine (if esomeprazol vir is used in high doses and over a long period).

Rare (may affect up to 1 in 1,000 people)

? 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.

? Taste disturbances.

? 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 high fever, headache, sore throat and/or diarrhea, which may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis.

? Inflammation of the gut (leading to diarrhea) which may be associated with abdominal pain and fever.

? Inflammation of the liver which may cause jaundice, nausea, vomiting, loss of appetite, tiredness, and generally feeling unwell.

? Hair loss (alopecia).

? Skin rash, possibly with itching, which may be associated with a hypersensitivity reaction to the medicine.

? Joint pain (arthralgia) or muscle pain (myalgia).

? General feeling of being unwell (malaise) and lack of energy.

? Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

? Changes in the levels of certain substances in the blood which may lead to problems such as a reduced number of blood cells (e.g. agranulocytosis), which may cause weakness, bruising, and make you more likely to get infections.

? Aggression.

? Seeing, hearing, or feeling things that are not there (hallucinations).

? Liver problems, which can lead to liver failure and encephalopathy in rare cases.

? Sudden onset of severe rash, blistering or peeling of the skin and/or mucous membranes, which may be associated with high fever, headache, sore throat and/or diarrhea, and which may be signs of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis.

? Muscle weakness.

? Kidney problems.

? Breast swelling in men.

Frequency not known (cannot be estimated from the available data)

? If you are taking esomeprazol vir for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can make you feel tired, confused, dizzy, and cause muscle cramps, weakness and an irregular heartbeat. If you get any of these symptoms, do not take any more esomeprazol vir and tell your doctor as soon as possible. Low levels of magnesium can also lead to a reduction in the levels of other nutrients, including potassium and calcium. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

? Inflammation in the gut (leading to diarrhea) which may be associated with abdominal pain and fever.

? Skin rash, possibly with itching, which may be associated with a hypersensitivity reaction to the medicine.

In very rare cases, esomeprazol vir may affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as sore throat, mouth or urinary problems, 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazol Vir

? Keep this medication out of sight and reach of children.

? Do not store at a temperature above 30°C.

? Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

? Keep this medication in its original packaging (blister pack) to protect it from moisture.

? Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Vir

? The active ingredient is esomeprazol. There are two concentrations of esomeprazol vir gastro-resistant tablets containing 20 mg or 40 mg of esomeprazol (as magnesium dihydrate salt).

? The other components are Polysorbate 80, Macrogol (PEG 4000), Sugar spheres (sucrose and corn starch), Polyvinylpyrrolidone (PVP), Mannitol, Methacrylic acid copolymer (Eudragit L100-55), Triethyl citrate, Talc, Glycerol monostearate, Paraffin, Sodium stearyl fumarate, Cellulose and mannitol mixture (Avicel®), Hypromellose, Titanium dioxide (E171), Red iron oxide (E172), Yellow iron oxide (E172)

Appearance of the Product and Package Contents

? Esomeprazol vir 40 mg gastro-resistant tablets are film-coated, oval-shaped tablets of pink color

? The tablets are presented in blister packs in cartons and/or boxes of 14, 28, 56, and 100 tablets.

? Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Prospectus: February 2025

Other Sources of Information

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/

This information is intended only for healthcare professionals:

Administration through a nasogastric or gastric tube

1. Insert the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, dispersion in 50 ml of water is required to prevent the pellets from clogging the tube.

1. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.

1. Hold the syringe with the tip up and check that the tip is not clogged.

1. Connect the syringe to the tube while maintaining the previous position.
2. Shake the syringe and place it with the tip down. Inject immediately 5-10 ml into the tube.

Invert the syringe after injection and shake (the syringe must be kept with the tip up to avoid clogging the tip).

1. Put the syringe back with the tip down and inject immediately another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.

1. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to flush any sediment remaining in the syringe. For some tubes, 50 ml of water are required.