Esomeprazole Davur 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazol Davur 20 mg gastro-resistant hard capsules EFG

Esomeprazol Davur 40 mg gastro-resistant hard capsules EFG

Read 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 questions, ask 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 you, because 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.

Leaflet contents:

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

2. What you need to know before taking Esomeprazol Davur

3. How to take Esomeprazol Davur

4. Possible side effects

5. How to store Esomeprazol Davur

6. Contents of the pack and other information

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

Esomeprazol Davur contains a medicine called esomeprazol magnesic dihydrate. 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 Davur is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back 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 Davur may also be used to help prevent ulcers in patients taking NSAIDs.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcer after initial intravenous esomeprazole therapy.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back 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.

2. What you need to know before taking Esomeprazol Davur

Do not take Esomeprazol Davur

• If you are allergic (hypersensitive) to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the group of proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking esomeprazole or other related medicines.
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazol Davur:

• 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 Davur used to reduce stomach acidity.
• If you are scheduled to have a specific blood test (chromogranin A).

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

• You lose weight significantly without reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You begin vomiting food or blood.
• Your stools appear black (blood-stained).

If Esomeprazol Davur has been prescribed only for use when symptoms occur, you should contact your doctor if your symptoms persist or change.

Taking proton pump inhibitors such as Esomeprazol Davur, particularly for periods longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Consult your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazol Davur. 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 association with esomeprazole treatment. Stop taking esomeprazole and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Children under 12 years of age

Esomeprazol Davur must not be used in children under 12 years of age due to lack of available data.

Taking Esomeprazol Davur with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because Esomeprazol Davur may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Davur.

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

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Erlotinib (used to treat cancer).
• Digoxin (used to treat heart problems).
• 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 Davur.
• Medicines used to thin the blood such as warfarin or clopidogrel. Your doctor may need to monitor when you start or stop taking Esomeprazol Davur.
• Cilostazol (used to treat intermittent claudication—leg pain while walking caused by insufficient blood flow).
• 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 discontinue your Esomeprazol Davur treatment.
• Tacrolimus (used in organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazol Davur 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 Davur with food and drink

You may take the capsules with or without food.

Pregnancy, breastfeeding, and fertility

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

Your doctor will decide whether you may take Esomeprazol Davur during this period.

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

Driving and using machines

Esomeprazol Davur is unlikely to affect your ability to drive or use tools or machines. However, adverse reactions such as dizziness and blurred vision are uncommon or rare (see section 4). If you are affected, you should not drive or operate machinery.

Esomeprazol Davur contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; therefore, it is essentially "sodium-free".

Esomeprazol Davur contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Esomeprazole Davur

Follow exactly the administration instructions for this medicine as indicated by your doctor. 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 notice symptoms, inform your doctor if the symptoms change.

How much to take

• Your doctor will have told you how many capsules to take and when to take them. This will depend on your condition, age, and liver function.
• The recommended doses are indicated below.

Adults aged 18 years 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 40 mg esomeprazole gastro-resistant capsule 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.
• The recommended dose once the esophagus has healed is one 20 mg esomeprazole gastro-resistant capsule once daily.
• If your esophagus has not been affected, the recommended dose is one 20 mg esomeprazole gastro-resistant capsule daily. Once the condition is controlled, your doctor will instruct you to take the medicine as needed, up to a maximum of one 20 mg esomeprazole gastro-resistant capsule 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 recurrences:

• The recommended dose is one 20 mg esomeprazole gastro-resistant capsule twice daily for one week.
• Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

The recommended dose is one 20 mg esomeprazole gastro-resistant capsule once daily for 4 to 8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is one 20 mg esomeprazole gastro-resistant capsule once daily.

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

• The recommended dose is one 40 mg esomeprazole gastro-resistant capsule twice daily.
• 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 daily.

Continuation treatment to prevent re-bleeding from peptic ulcer induced with intravenous esomeprazole:

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

Adolescents aged 12 years 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 40 mg esomeprazole gastro-resistant capsule 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.
• The recommended dose once the esophagus has healed is one 20 mg esomeprazole gastro-resistant capsule once daily.
• If your esophagus has not been affected, the recommended dose is one 20 mg esomeprazole gastro-resistant capsule daily. Once the condition is controlled, your doctor will instruct you to take the medicine as needed, up to a maximum of one 20 mg esomeprazole gastro-resistant capsule 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 recurrences:

• The recommended dose is one 20 mg esomeprazole gastro-resistant capsule twice daily for one week.
• Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

How to take this medicine

• You may take the capsules at any time of day.
• You may take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules 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 capsules

• If you have difficulty swallowing the capsules:

• Open the capsule and pour the granules into half a glass of still water. Do not use other liquids.

• You may drink the mixture immediately or within 30 minutes. Always stir well 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 granules may be dispersed in water and drawn into a syringe. They can then be administered directly into the stomach via a tube (gastric tube).

Children and adolescents under 12 years of age

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

Elderly patients

No dose adjustment is required in elderly patients.

If you take more Esomeprazol Davur than you should

If you take more Esomeprazol Davur than prescribed by your doctor, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420, indicating the medicine and the amount ingested.

If you forget to take Esomeprazol Davur

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you notice any of the following serious adverse effects, stop taking Esomeprazol Davur and contact a doctor immediately:

• Yellowing of the skin, dark urine, and tiredness, which may be symptoms of liver problems. These effects are rare, occurring in fewer than 1 in 1,000 patients.
• Sudden difficulty breathing, swelling of the lips, tongue, or throat, or swelling of the whole body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare, occurring in fewer than 1 in 1,000 patients.
• Sudden onset of a severe skin rash or redness of the skin with blistering 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 serious and widespread skin damage (epidermal peeling and superficial mucosal membranes), with potentially life-threatening consequences. This could be a case of “erythema multiforme”, “Stevens-Johnson syndrome”, or “toxic epidermal necrolysis”. These effects are very rare and may affect up to 1 in 10,000 people.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is observed very rarely.

Other adverse effects include:

Common (affects up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestine: stomach pain, constipation, diarrhoea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (affects up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (insomnia).
• Dizziness, tingling and numbness sensation, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal liver function blood tests.
• Skin rash, hives, skin itching.
• Fractures of the hip, wrist, and spine (if Esomeprazol Davur is used at high doses or for prolonged periods).

Rare (affects up to 1 in 1,000 people)

• Blood disorders such as decreased number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Altered taste.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” that may affect the intestine.
• Liver problems including jaundice, which may cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Dermatitis due to exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (decreased number of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Liver disorders that may lead to liver failure or brain inflammation.
• Sudden onset of severe skin rash, blisters, or skin peeling. These symptoms 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 disorders.
• 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 magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor as soon as possible. Low magnesium levels may also trigger a reduction in blood potassium or calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Inflammation of the intestine (causing diarrhoea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Davur 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 immediately to rule out a reduced white blood cell count (agranulocytosis) via 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, consult 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 website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Davur

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

OPA/Al/PE blister pack + DES/Al foil

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

OPA/Al/PVC/Al foil blister pack

Do not store above 30°C.

Store in the original container to protect it from moisture.

HDPE bottle

This medicine does not require any special storage temperature.

Keep the container tightly closed to protect it from moisture.

After first opening the bottle, the product should be used within 6 months.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Esomeprazol Davur

The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).

The other components are sugar spheres (sucrose and corn starch), povidone K30, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, macrogol 6000, talc (E553b), macrogol 6000, heavy magnesium carbonate, polysorbate 80 (E433), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% in the capsule granules, and gelatin (E441), titanium dioxide (E171) and red iron oxide (E172) in the capsule. See section 2: Esomeprazol Davur contains sucrose.

Appearance of the product and contents of the container

The body and cap of the 20 mg gastro-resistant hard capsules are slightly pink. The capsules contain white to off-white granules. Capsule size No. 3.

The body and cap of the 40 mg gastro-resistant hard capsules are slightly pink. The capsules contain white to off-white granules. Capsule size No. 1.

The capsules are available in packs of 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, and 100 capsules in blister packs, and in packs of 98 capsules with one capsule containing desiccant in HDPE bottles. Do not ingest the capsule containing the desiccant included in the pack.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid, Spain

Manufacturer

KRKA,

tovarna zdravil, d. d., Novo mesto,

Šmarješka cesta 6, 8501 Novo mesto,

Slovenia

Or

Merckle GmbH,

Ludwig-Merckle-Str. 3, 89143 Blaubeuren,

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Esomeprazol-CT 20 / 40 mg magensaftresistente Hartkapseln

Slovenia: Eslaver 20 / 40 mg trdegastrorezistentne kapsule

Spain: Esomeprazol Davur 20 mg gastro-resistant hard capsules EFG

Esomeprazol Davur 40 mg gastro-resistant hard capsules EFG

This leaflet was approved in July 2025

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/"

The following information is intended for healthcare professionals only:

Administration via gastric tube

1. Open the capsule and empty the pellets into a suitable syringe, then add approximately 25 ml of water and 5 ml of air.

For some tubes, dispersion in 50 ml may be necessary to prevent tube blockage.

2. Immediately shake the syringe to evenly distribute the granules throughout the suspension.

3. Immediately shake the syringe with the tip pointing upwards and check that the tip is not blocked.

4. Attach the syringe to the tube while keeping it in the upright position.

5. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. Invert the syringe after injection. (The syringe must remain with the tip pointing upwards to prevent blockage of the tip.)

6. Turn the syringe with the tip pointing downwards and 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 rinse any residue remaining in the syringe. For some tubes, 50 ml of water may be required.