ESOMEPRAZOL VIR 20 mg GASTRO-RESISTANT TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Esomeprazol Vir 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 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 the stomach produces.

Esomeprazol vir is used to treat 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 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.

? Ulcers in the stomach or duodenum caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol vir 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).

• Prevention of relapse of bleeding peptic ulcers in patients treated with esomeprazol intravenously.

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.

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

Tell 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 an examination of your stomach or duodenum (the tube leading out of the stomach) with an endoscope.

Esomeprazol vir may hide the symptoms of other diseases. Therefore, if you notice any of the following, 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 your symptoms appear, 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 in 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. Remember to also mention any other side-effects like pain in your joints.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with esomeprazol treatment. Stop taking esomeprazol and contact your doctor immediately if you experience 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 can buy without a prescription. This is because esomeprazol vir can affect the way some medicines work and some medicines may affect the way 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:

? Atazanavir (used to treat HIV infection).

? Clopidogrel (used to prevent blood clots).

? Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).

? Erlotinib (used to treat cancer).

? Citalopram, imipramine, clomipramine (used to treat depression).

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

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

? Medicines used to thin the 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 condition where the legs do not get enough blood).

? Cisapride (used for indigestion and heartburn).

? Digoxin (used for heart problems).

? Methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your esomeprazol vir treatment.

? 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 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 machines. However, side effects such as dizziness or blurred vision may occur (see section 4). Do not drive or use machines if you are affected.

Esomeprazol vir contains sucrose

Esomeprazol vir contains sugar spheres which contain sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 regularly check how it is working.

? If your doctor has told you to take this medicine as and when you need it, you should contact 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 kidney function.

? The recommended dose is given below:

Adults aged 18 years and over

For gastro-oesophageal reflux disease (GORD):

? If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg tablet or two 20 mg tablets once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your oesophagus has not yet healed. Once the oesophagus has healed, the recommended dose is one 20 mg tablet once a day.

? If your gullet (oesophagus) is not damaged, the recommended dose is one 20 mg tablet each day.

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

For ulcers caused by Helicobacter pylori infection and to stop them coming back:

? The recommended dose is one 20 mg tablet twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

For stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

? The recommended dose is one 20 mg tablet each day for 4-8 weeks.

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

? The recommended dose is one 20 mg tablet each day.

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

? The recommended dose is 40 mg (one 40 mg tablet or two 20 mg tablets) 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.

Prevention of relapse of bleeding peptic ulcers in patients treated with esomeprazol intravenously:

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

Use in adolescents aged 12 years and over

For gastro-oesophageal reflux disease (GORD):

? If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg tablet or two 20 mg tablets once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your oesophagus has not yet healed.

? Once the oesophagus has healed, the recommended dose is one 20 mg tablet once a day.

? If your gullet (oesophagus) is not damaged, the recommended dose is one 20 mg tablet each day.

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

For ulcers caused by Helicobacter pylori infection and to stop them coming back:

? The recommended dose is one 20 mg tablet twice a day for one week. Your doctor will also prescribe two antibiotics for you to take at the same time.

How to take the tablets

? 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 pellets which stop the medicine from being broken down by the acid in the 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 immediately or within 30 minutes. Always stir well before drinking.
• To make sure that you have drunk all 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 syringe (oral syringe) into the stomach through a 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 patients over 65 years.

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 Information Service on 020 7188 7895 or your local hospital accident and emergency department, quoting 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

? Sudden difficulty breathing, swelling of 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. 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 can 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 and may affect up to 1 in 1,000 people.

Other adverse effects include:

Frequent (may affect up to 1 in 10 people)

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

? Nausea or vomiting.

• Benign polyps in the stomach.

Infrequent (may affect up to 1 in 100 people)

? Swelling of feet and ankles.

? Sleep disturbance (insomnia).

? Dizziness, tingling sensation, and numbness, drowsiness.

? Sensation of vertigo.

? Dry mouth.

? Alteration of blood tests that determine liver function.

? Skin rash, hives, skin itching.

? 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 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.

? Alteration of taste.

? Eye disorders such as blurred vision.

? Sudden sensation 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 that can cause yellow skin, dark urine, and fatigue.

? Hair loss (alopecia).

? Dermatitis due to sun exposure.

? Joint pain (arthralgia) 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 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.

? Increase in breast size in men.

Frequency not known (frequency cannot be estimated from 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 may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.

? Inflammation in the intestine (can lead to diarrhea).

? Skin rash, possibly with joint pain.

In very rare cases, esomeprazol vir may affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severe worsening 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 report your medication.

Reporting of Adverse Effects

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

5. Conservation of Esomeprazol Vir 20 mg

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

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

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

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

? Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of 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

Composition of Esomeprazol Vir 20 mg

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

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

Appearance of the Product and Package Contents

? Esomeprazol vir 20 mg gastro-resistant tablets are film-coated tablets of pink color with an oval shape

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

? Some package sizes may only 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 medicine 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 avoid 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 remaining sediment from the syringe. For some tubes, 50 ml of water are required.