Package Insert: Information for the Patient

Esomeprazole Vir 20 mg Gastrorresistant Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is esomeprazole vir and how it is used

2. What you need to know before starting to take esomeprazole vir

3. How to take esomeprazole vir

4. Possible adverse effects

5. Storage of esomeprazole vir

6. Contents of the package and additional information

Esomeprazol vir contains a medication called esomeprazole that belongs to a group of medications called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

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

Adults

?Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.

?Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria called Helicobacter pylori.If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

?Ulcers caused by medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol vir 20 mg can also be used to prevent the formation of ulcers if you are taking NSAIDs.

?Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).

• Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously.

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Ulcers in the stomach or upper part of the small intestine (duodenum) that are infected by a bacteria called Helicobacter pylori.If you have this condition, it is likely that your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take esomeprazol vir

?If you are allergic to esomeprazol or any of the other components of this medication (listed in section 6).

?If you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazol, lansoprazol, rabeprazol, omeprazol).

?If you are taking a medication that contains nelfinavir (used in the treatment of HIV infection).

• If you have ever developed a severe skin rash or skin peeling, blistering or ulcers in the mouth after taking esomeprazol or other related medications.

If you are in any of these situations, do not take esomeprazol vir. If you are unsure, consult your doctor or pharmacist before taking esomeprazol vir.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 similar medication to esomeprazol vir for reducing stomach acid.

?If you are scheduled to have a specific blood test (Cromogranina A).

Esomeprazol vir may mask the symptoms of other diseases.Therefore, if you notice any of the following events before taking or while taking esomeprazol vir, contact your doctor immediately:

?If you lose a lot of weight without reason and have trouble swallowing.

?If you have stomach pain or indigestion.

?If you start vomiting food or blood.

?If your stools appear black (blood-stained).

If you have been prescribed esomeprazol vir only when you do not have any symptoms, you should contact your doctor if your disease symptoms persist or change.

Taking a proton pump inhibitor like esomeprazol vir, especially for a period of more than one year, may slightly increase the risk of breaking a hip, wrist or spinal column. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you develop a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with esomeprazol vir. Remember to mention any other symptoms you may notice, such as joint pain.

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 medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children under 12 years

Esomeprazol vir is not recommended for children under 12 years.

Use of esomeprazol vir with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. This includes medications purchased without a prescription. This is because esomeprazol vir may affect how some medications work and some medications may influence the effect of esomeprazol vir.

Do not take esomeprazol vir if you are taking a medication that contains nelfinavir (used for HIV treatment).

Inform your doctor if you are using any of the following medications:

?Atazanavir (used for HIV treatment).

?Clopidogrel (used for preventing blood clots).

?Ketoconazol, itraconazol or voriconazol (for fungal infections).

?Erlotinib (used in cancer treatment).

?Citalopram, imipramina, clomipramina (for depression treatment).

?Diazepam (used for anxiety, muscle relaxation or epilepsy).

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

?Medications used to make blood thinner, such as warfarina. Your doctor may need to monitor when you start or stop taking esomeprazol vir.

?Cilostazol (used for intermittent claudication – pain in the legs when walking caused by poor blood circulation).

?Cisaprida (used for indigestion and stomach burning).

?Digoxina (used for heart problems).

?Metotrexato (chemotherapy medication used at high doses for cancer treatment) – if you are taking high doses of metotrexato, your doctor may temporarily interrupt your treatment with esomeprazol vir.

?Tacrolimus (organ transplant).

?Rifampicina (used for tuberculosis treatment).

?St. John's Wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicilina and claritromicina in addition to esomeprazol vir for treating ulcers caused by Helicobacter pylori, it is very important to inform your doctor if you are taking any other medication.

Taking esomeprazol vir with food and drinks

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take esomeprazol vir during this period.

It is unknown if esomeprazol vir passes into breast milk. Therefore, do not take esomeprazol vir during breastfeeding.

Driving and using machines

Esomeprazol vir is unlikely to affect your ability to drive or use tools or machines. However, rare or very rare side effects such as dizziness or blurred vision (see section 4) may occur. Do not drive or use machines if you notice any of these side effects.

Esomeprazol vir contains saccharose.Esomeprazol vir contains sugar spheres that contain saccharose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

?If you take this medication 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 indicated that you should take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take

?Your doctor will have indicated how many tablets you should take and when to take them. This will depend on your situation, age, and liver function.

?The recommended doses are indicated below:

Adults 18 years of age and older

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

?If your doctor has determined that your esophagus is slightly affected, the recommended dose is one tablet of esomeprazole vir 40 mg or two tablets of esomeprazole vir 20 mg once a day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed. Once your esophagus has healed, the recommended dose is one tablet of esomeprazole vir 20 mg once a day.

?If your esophagus is not affected, the recommended dose is one tablet of esomeprazole vir 20 mg once a day. Once your condition has been controlled, your doctor may indicate that you take your medicine only when you notice some symptoms, up to a maximum of one tablet of esomeprazole vir 20 mg per day.

?If you have severe liver problems, your doctor may prescribe a lower dose.

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

?The recommended dose is one tablet of esomeprazole vir 20 mg twice a day for one week.

?Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

For the treatment of gastric ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs):

?The recommended dose is one tablet of esomeprazole vir 20 mg once a day for 4 to 8 weeks.

For the prevention of gastric ulcers if you are taking NSAIDs:

?The recommended dose is one tablet of esomeprazole vir 20 mg once a day.

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

?The recommended dose is 40 mg (one tablet of 40 mg or two tablets of 20 mg) of esomeprazole vir twice a day.

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

Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenous:

• The recommended dose is two tablets of esomeprazole vir 20 mg or one tablet of esomeprazole vir 40 mg once a day for 4 weeks.

Use in adolescents 12 years of age and older

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

?If your doctor has determined that your esophagus is slightly affected, the recommended dose is two tablets of 20 mg or one tablet of 40 mg of esomeprazole vir per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.

?Once your esophagus has healed, the recommended dose is one tablet of esomeprazole vir 20 mg once a day.

?If your esophagus is not affected, the recommended dose is one tablet of esomeprazole vir 20 mg once a day.

?If you have severe liver problems, your doctor may prescribe a lower dose.

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

?The recommended dose is one tablet of esomeprazole vir 20 mg twice a day for one week.

?Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

Take this medication

?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 medication from being destroyed by the stomach acid. It is essential 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.

-Remove until the tablets disintegrate (the solution will not be transparent). You can drink the mixture immediately or within 30 minutes. Remove always just before drinking.

-To ensure that you have taken all the medication, rinse the glass well with half a glass of water and drink. The solid particles contain the medication – 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 nasogastric tube.

Use in children under 12 years of age

No esomeprazole vir is recommended for children under 12 years of age.

Older adults

No dose adjustment is necessary for older adults.

If you take more esomeprazole vir than you should

?If you take more esomeprazole vir than your doctor has indicated, consult your doctor or pharmacist immediately.

?In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 5620420, indicating the medication and the amount ingested.

If you forget to take esomeprazole vir

?If you forget to take a dose, take it as soon as you remember. However, if there is little time left for your next dose, do not take the missed dose.

?Do not take a double dose (two doses at once) to compensate for the missed dose.

?If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Sudden difficulty breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

• Redness of the skin with blisters or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur. This could be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."

• Yellow skin, dark urine, and fatigue, which 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 side effects are rare and may affect up to 1 in 1,000 people.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

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

• Nausea or vomiting.

• Benign polyps in the stomach.

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.

• Sleep disturbance (insomnia).

• Dizziness, tingling, numbness, drowsiness.

• Dizziness.

• Dry mouth.

• Alteration of blood tests that determine liver function.

• Skin rash, urticaria, itching skin.

• Fracture of the hip, wrist, or spine (if esomeprazol vir 20 mg is used at high doses and for a long period).

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

• Blood disorders such as a decrease in the number of white blood cells or platelets. This may cause weakness, bruising, or increase the risk of infections.

• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.

• Restlessness, confusion, or depression.

• Alteration of taste.

• Eye disorders such as blurred vision.

• Sudden feeling of shortness of breath or difficulty breathing (bronchospasm).

• Inflammation in the interior of the mouth.

• A known infection called "candidiasis" that can affect the esophagus and is caused by a fungus.

• Liver problems, including jaundice that may cause yellow skin, dark urine, and fatigue.

• Hair loss (alopecia).

• Dermatitis caused by exposure to sunlight.

• Joint pain (arthritis) or muscle pain (myalgia).

• General feeling of discomfort and lack of energy.

• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (decrease in the number of white blood cells).

• Aggression.

• Seeing, feeling, or hearing things that do not exist (hallucinations).

• Liver disorders that may lead to liver failure or brain inflammation.

• Sudden appearance of severe skin rash, blisters, or peeling of the skin. These symptoms may 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.

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

• If you are being treated with esomeprazol vir for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

• Inflammation in the intestine (may cause diarrhea).

• Skin rash, possibly with joint pain.

In rare cases, esomeprazol vir may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as severe worsening of your general condition or fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, 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 essential to inform your doctor about your medication in this case.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

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

?Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at thePunto SIGREof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Esomeprazole Vir 20 mg Composition

?The active ingredient is esomeprazole. There are two concentrations of esomeprazole Vir tablets that contain 20 mg or 40 mg of esomeprazole (as magnesium dihydrate salt).

?The other components are Polysorbate 80, Macrogol (PEG 4000), Sugar spheres (sucrose and cornstarch), Polyvinylpyrrolidone (PVP), Mannitol, Copolymer of methacrylic acid (Eudragit L100-55), Triethyl citrate, Talc, Glycerol monostearate, Paraffin, Sodium stearyl fumarate, Cellulose and mannitol mixture (Avicel®), Hypromellose, Titanium dioxide (E171), Iron oxide red (E172), Iron oxide yellow (E172)

Product Appearance and Packaging Content

?Esomeprazole Vir 20 mg gastro-resistant tablets are oval-shaped tablets with a pink film coating.

?The tablets are presented inpacks with blisters in boxes and/or cartons of 14, 28, 56, and 100 tablets.

?Only some pack sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Last Review Date of this Leaflet: February 2025

Other Information Sources

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Administration through 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, a dispersion in 50 ml of water is required to prevent the pellets from blocking the tube.

2.Immediately agitate the syringe for approximately 2 minutes to disperse the tablet.

3.Hold the syringe with the tip upwards and check that the tip has not become blocked.

4.Connect the syringe to the tube while maintaining the previous position.

5.Agitate the syringe and place it with the tip downwards. Immediately inject 5-10 ml into the tube.

Invert the syringe after injection and agitate (the syringe must be kept with the tip upwards to prevent the tip from becoming blocked).

6.Place the syringe with the tip downwards and immediately inject another 5-10 ml into the tube. Repeat this procedure until the syringe is empty.

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