ESOMEPRAZOL VIATRIS 20 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Esomeprazol Viatris

Do not take Esomeprazol Viatris

• If you are allergic (hypersensitive) 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 these apply to you, do not take esomeprazol. If you are not sure, talk to your doctor or pharmacist before taking esomeprazol.

Warnings and precautions

Tell your doctor or pharmacist before taking Esomeprazol Viatris:

• If you have severe liver problems.
• If you have severe kidney problems.

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• 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).

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 Viatris. Also remember to mention any other symptoms you notice, such as joint pain.

Esomeprazol Viatris may hide the symptoms of other diseases. Therefore, if you notice any of the following before or while taking Esomeprazol Viatris, 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 are taking esomeprazol on demand and your symptoms persist or change, consult your doctor.

If you are taking a proton pump inhibitor like esomeprazol, especially over a period of more than one year, you may be at increased risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash and skin symptoms

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. Also remember to mention any other symptoms you notice, such as joint pain.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported with esomeprazol (see section 4). Stop taking esomeprazol and contact your doctor immediately if you notice any of the following symptoms: blistering of the skin and/or mucous membranes, severe skin rash, and/or signs of allergy such as high temperature (fever), rash and swollen lymph nodes.

If at any time during esomeprazol treatment (even after several weeks) you experience a rash (even without other symptoms such as high temperature or enlarged lymph nodes), or any other symptoms such as joint pain or general malaise, stop taking esomeprazol and contact your doctor immediately.

Using Esomeprazol Viatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is because Esomeprazol Viatris may affect how these medicines work or these medicines may affect how Esomeprazol Viatris works.

Do not take Esomeprazol Viatris if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist 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 (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or 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 may need to monitor you when you start or stop taking Esomeprazol Viatris.
• Medicines used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Viatris.
• 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 in high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your Esomeprazol Viatris treatment.
• Tacrolimus (used after organ transplants).
• 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 Viatris 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 Viatris with food and drink

You can take the tablets with or without food.

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 Viatris during this time.

It is not known if Esomeprazol Viatris passes into breast milk. Therefore, you should not take Esomeprazol Viatris if you are breast-feeding.

Driving and using machines

Esomeprazol Viatris is not likely to affect your ability to drive or use any tools or machines. However, side effects such as dizziness and blurred vision (see section 4) may uncommonly or rarely occur. Do not drive or use any tools or machines if you are affected by these side effects.

Esomeprazol Viatris contains sugar

This medicine 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 medicine.

Esomeprazol Viatris contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, i.e. essentially ‘sodium-free’.

3. How to take Esomeprazol Viatris

Always take this medicine exactly as your doctor 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 are taking it for more than a 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 for how long. This will depend on your condition, age and how well your liver works.
• The recommended dose is described below:

Adults aged 18 years and above

To treat 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 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.
• The recommended dose once the oesophagus has healed is one 20 mg tablet once a day.
• If your oesophagus has not been damaged, the recommended dose is one 20 mg tablet each day.
• Once the condition has been controlled, your doctor may tell you to take your medicine as and when you need it, up to a maximum of one 20 mg tablet per day.
• If you have severe liver problems, your doctor may give you a lower dose.

To treat 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 called amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs:

• The recommended dose is one 20 mg tablet once a day for 4-8 weeks.

To prevent stomach ulcers or duodenal ulcers if you are taking NSAIDs:

• The recommended dose is one 20 mg tablet once a day.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg gastro-resistant tablet twice a day.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is 80 mg twice a day.

Prevention of rebleeding of gastric or duodenal ulcers with esomeprazol intravenous:

• The recommended dose is one 40 mg gastro-resistant tablet once a day for 4 weeks.

Use in adolescents aged 12 years and above

To treat 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 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.
• Once the oesophagus has healed, the recommended dose is one 20 mg gastro-resistant tablet once a day.
• If your oesophagus has not been damaged, the recommended dose is one 20 mg gastro-resistant tablet once a day.
• If you have severe liver problems, you may given a lower dose.

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

• The recommended dose is one 20 mg gastro-resistant tablet twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin.

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 the tablets

If you have difficulty swallowing the tablets:

• Put the tablet in half a glass of non-fizzy water. Do not use other liquids.
• Stir until the tablet breaks up (the mixture will not be clear). You can take the mixture immediately or within 30 minutes. Always stir well before taking.
• To make sure you get the full dose, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush them.

If you cannot swallow at all, the tablets can be mixed with water and given through a syringe into the stomach (gastric tube).

Children under 12 years of age

Esomeprazol gastro-resistant tablets are not recommended for children under 12 years of age.

Elderly

No dose adjustment is necessary for the elderly.

If you take more Esomeprazol Viatris than you should

If you take more Esomeprazol than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or go to the emergency department of your nearest hospital. Take the medicine and this leaflet with you.

If you forget to take Esomeprazol Viatris

• If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the next dose.
• Do not take a double dose 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, Esomeprazol Viatris can cause adverse effects, although not all people suffer from them.

If you notice any of the following serious adverse effects, stop taking esomeprazol and consult your doctor immediately:- Yellowish skin, dark-colored urine, and fatigue that can be symptoms of liver problems. These adverse effects are rare and may affect up to 1 in 1,000 people.

• A sudden difficulty breathing, swelling of the lips, tongue, and throat or body, rash, feeling of dizziness or difficulty swallowing (severe allergic reaction).

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

• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.

• Sudden appearance of a severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. There may also be severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals. Skin rashes can become severe and widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be a "multiform erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Effects on your stomach or intestine: diarrhea, stomach pain, constipation, flatulence.
• Feeling of dizziness (nausea) or discomfort (vomiting).
  • Benign polyps in the stomach.

Infrequent (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, numbness.
• Feeling of vertigo.
• Dry mouth.
• Changes in blood tests that control how your liver works.
• Skin rash, bumpy rash (urticaria), and itching of the skin.
• Fracture of the hip, wrist, or spine (if Esomeprazol is taken at high doses or for long periods).

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

• Blood problems such as a reduced number of white blood cells or platelets. This causes weakness, bruising, or frequent infections.
• Low sodium levels in the blood. This can cause weakness, discomfort (vomiting), and cramps.
• Feeling of agitation, confusion, or depression.
• Changes in taste.
• Vision problems such as blurred vision.
• Sudden feeling of difficulty breathing or shortness of breath (bronchospasm).
• Inflammation of the inside of the mouth.
• An infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Liver problems, including jaundice that can cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash after sun exposure.
• Pain in the joints (arthralgia) or muscle pain (myalgia).
• Feeling of general discomfort and lack of energy.
• Increased sweating.

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

• Changes in blood count, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden appearance of a severe rash or blisters or peeling of the skin. This may be associated with a high fever and joint pain (multiform erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

Frequency unknown (cannot be estimated from available data)

• If you are treated with esomeprazol for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels in the blood can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels in the blood can also cause a reduction in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation in the intestine (causing diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of your general condition or fever with symptoms of a local infection such as pain in the 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 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: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Esomeprazol Viatris

Keep out of sight and reach of children.

Do not use this medicine after the expiration date indicated on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep in the original packaging (blister pack) to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Esomeprazol Viatris

• The active ingredient is Esomeprazol. Each tablet contains 20 mg of esomeprazol as amorphous magnesium salt.

• The other components are:

Core of the tablet: Hydroxypropylcellulose (E-463), Crospovidone (Type A), Coating:Povidone (K30), Macrogol 400, Macrogol 4000, Macrogol 6000, Hypromellose phthalate (HP-55S), Hypromellose phthalate (HP-50), Diethyl phthalate, Hydroxypropylcellulose, Microcrystalline cellulose (PH 101), Microcrystalline cellulose (PH 112), Crospovidone (Type B), Sodium stearyl fumarate, Opadry 03B86651 Brown (HMPC 2910/Hypromellose 6cP, titanium dioxide (E171), Macrogol/PEG 400, red iron oxide (E172), Sugar spheres (sucrose and corn starch), Talc (E553b) (see section 2 "Esomeprazol Viatris contains sucrose").

Appearance of Esomeprazol Viatris and package contents

Esomeprazol Viatris are film-coated tablets, oval, biconvex, and light brick-red to brown in color, with the inscription "E5" in low relief on one side and smooth on the other side.

The medicine is presented in OPA-Al-PE-desiccant-HDPE/Alu and Polyamide/Al/PVC/Al blister packs of 14, 28, and 56 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027- Madrid

Spain

This prospectus has been approved in the following EEA countries with the following names:

Spain:Esomeprazol Viatris 20 mg gastro-resistant tablets EFG

Italy:Ezoran 20 mg Gastro-resistant tablets

Portugal:Esomeprazol Pharmakern 20 mg gastro-resistant tablets

Date of the last revision of this prospectus:February 2025

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/

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This information is intended only for healthcare professionals:

Administration through a 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.
2. Shake the syringe immediately for approximately 2 minutes to disperse the tablet.
3. Hold the syringe with the tip upwards and check that the tip is not clogged.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and place it with the tip downwards. Inject immediately 5-10 ml into the tube. Invert the syringe after injection and shake (the syringe must be kept with the tip upwards to prevent clogging of the tip).
6. Put the syringe back with the tip downwards and inject immediately 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 flush any sediment remaining in the syringe. For some tubes, 50 ml of water are required.