Esomeprazole Viatris 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Esomeprazol Viatris 20 mg gastro-resistant tablets EFG

Esomeprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Esomeprazol Viatris is and what it is used for

Esomeprazol Viatris contains an active substance called esomeprazole. It belongs to a group of medicines known as proton pump inhibitors. These work by reducing the amount of acid produced by the stomach.

Esomeprazol Viatris is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach moves up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazol Viatris may also be used to prevent the development of stomach ulcers or ulcers in the upper part of the small intestine if you are taking NSAIDs.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcers previously treated with intravenous esomeprazole.

Adolescents over 12 years of age

• Gastro-oesophageal reflux disease (GORD). This occurs when acid from the stomach moves up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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

Do not take Esomeprazol Viatris

• If you are allergic (hypersensitive) to esomeprazol or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any other proton pump inhibitor, medicines that reduce stomach acid secretion (for example, pantoprazol, lansoprazol, rabeprazol, omeprazol).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infections).
• If you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking esomeprazol or other related medicines.

Do not take esomeprazol if any of these situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Esomeprazol Viatris:

• 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 similar to Esomeprazol Viatris used to reduce stomach acidity.
  • If you are scheduled to have a specific blood test (Chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazol Viatris. Remember to mention any other symptoms you may notice, such as joint pain.

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

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

If you are taking esomeprazol on an "as-needed" basis and your symptoms persist or change, consult your doctor.

If you are taking proton pump inhibitors such as esomeprazol, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes and skin symptoms

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

Severe skin rashes have occurred in patients taking esomeprazol (see also section 4). The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These severe skin rashes usually appear after flu-like symptoms such as fever, headache, and body aches. The rash may cover large areas of the body with blisters and skin peeling.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazol treatment. Stop taking esomeprazol and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Taking Esomeprazol Viatris with other medicines

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

This is because Esomeprazol Viatris may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Viatris.

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

Inform 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 (for fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, clomipramine (for treatment of depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazol Viatris.
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Viatris.
• Cilostazol (used to treat intermittent claudication – leg pain while walking caused by inadequate blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used to treat heart problems).
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol Viatris.
• Tacrolimus (organ transplant).
• 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 addition to Esomeprazol Viatris to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol Viatris with food and drinks

You may take the tablets with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will decide whether you can take Esomeprazol Viatris during this time.

It is unknown whether Esomeprazol Viatris passes into breast milk. Therefore, Esomeprazol Viatris should not be taken during breastfeeding.

Driving and using machines

Esomeprazol Viatris is unlikely to affect your ability to drive or operate machinery. However, adverse effects such as dizziness and blurred vision may occur rarely or very rarely (see section 4). You should not drive or operate machinery if you experience any of these effects.

Esomeprazol Viatris contains sucrose

This medicine contains sugar spheres containing sucrose, a type of sugar.

If your doctor has told you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

Esomeprazol Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet; this is essentially “sodium-free”.

3. How to take Esomeprazol Viatris

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• 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 one year).
• If your doctor has instructed you to take this medicine only when you experience symptoms, inform 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, your age, and how well your liver is functioning.
• The usual dose is indicated below:

Adults from 18 years of age

To treat heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has determined that your esophagus (throat) is slightly damaged, the recommended dose is one 40 mg esomeprazole tablet once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your throat has not healed.
• The recommended dose once the throat has healed is one 20 mg esomeprazole tablet once daily.
• If your throat is not damaged, the recommended dose is one 20 mg esomeprazole tablet daily. Once symptoms are under control, your doctor may tell you to take the medicine as needed, up to a maximum of one 20 mg esomeprazole tablet per day.
• If you have severe liver problems, your doctor will prescribe a lower dose.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

• The recommended dose is one 20 mg esomeprazole tablet twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

To treat stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole tablet once daily for 4 to 8 weeks.

To prevent stomach ulcers or ulcers in the upper part of the small intestine if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole tablet once daily.

To treat excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg gastro-resistant esomeprazole tablet twice daily.
• Your doctor will adjust the dose according to your needs and decide how long you should take the medicine. The maximum dose is 80 mg twice daily.

Continuation treatment to prevent rebleeding from peptic ulcer following intravenous therapy:

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

Use in adolescents from 12 years of age

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 40 mg gastro-resistant esomeprazole tablet daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one 20 mg gastro-resistant esomeprazole tablet once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg gastro-resistant esomeprazole tablet once daily.
• 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 20 mg gastro-resistant esomeprazole tablet twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

How to take this medicine

• You may take the tablets at any time of day.
• You may 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 granules that prevent the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

?? If you have difficulty swallowing the tablets:

• Place the tablet in half a glass of still (non-carbonated) water. Do not use any other liquids.
• Stir until the tablet dissolves (the mixture will not be transparent). You may drink the mixture immediately or within 30 minutes. Always stir again just before drinking.
• To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush the granules.

?? If you cannot swallow at all, the tablets may be dispersed in water and drawn into a syringe. They can then be administered directly into the stomach through a tube (gastric tube).

Children under 12 years of age

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

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Viatris than you should

If you take more esomeprazole than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

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 for your next dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about 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 everyone will experience them.

If you notice any of the following serious adverse effects, stop taking esomeprazole and contact your doctor immediately:

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems. These adverse effects are rare and may affect up to 1 in 1,000 people.
• Sudden difficulty breathing, swelling of the lips, tongue, throat or body, skin rash, 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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.

• Sudden onset of 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 may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms (DRESS)".

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

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence.
• Feeling sick (nausea) or unwell (vomiting).
  • Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, numbness.
• Feeling of dizziness (vertigo).
• Dry mouth.
• Changes in blood tests monitoring liver function.
• Skin rash, raised rash (urticaria), and itching of the skin.
• Fracture of hip, wrist, or spine (if Esomeprazole is taken at high doses or for long periods).

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

• Blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising, or increased frequency of infections.
• Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting), and cramps.
• Feeling restless, confused, or depressed.
• Changes in taste.
• Vision problems such as blurred vision.
• Sudden feeling of difficulty breathing or shortness of breath (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection called "candidiasis" that may affect the intestine.
• Liver problems, including jaundice, which may cause yellowing of the skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise 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).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash, blisters, or skin peeling. This may be accompanied by high fever and joint pain (erythema multiforme, 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 not known (cannot be estimated from available data)

• If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low blood magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (causing diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazole may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe worsening of general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of EsomeprazolViatris

• The active substance is esomeprazole. Each tablet contains 20 mg of esomeprazole as amorphous magnesium salt.

• The other components are:

Tablet core: 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, iron oxide red (E172), Sugar spheres (sucrose and corn starch), Talc (E553b) (see section 2 “Esomeprazol Viatris contains sucrose”).

Appearance of EsomeprazolViatris and contents of the pack

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

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

Only certain pack 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
The Netherlands

or

Terapia S.A.
124 Fabricii Street,
400 632 Cluj Napoca
Romania

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 Madrid
Spain

This summary of product characteristics has been approved in the following EEA countries under the following names:

Spain: Esomeprazol Viatris 20 mg gastro-resistant tablets EFG
Italy: Ezoran 20 mg Compresse Gastro-resistenti
Portugal: Esomeprazol Pharmakern 20 mg gastro-resistant tablets

Date of most recent review of this summary: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) at http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Administration via gastric tube:

1. Place 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 may be required to prevent the pellets from blocking the tube.
2. Immediately shake the syringe for about 2 minutes to disperse the tablet.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Connect the syringe to the tube while maintaining the previous position.
5. Shake the syringe and position it with the tip downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be kept with the tip upwards to prevent blockage of the tip).
6. Re-position 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 flush any remaining residue from the syringe. For some tubes, 50 ml of water may be required.