Esomeprazole Davur 40 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 adverse 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 magnesium dihydrate 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 Davur is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows up into the esophagus (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 prevent the development of ulcers if you are taking NSAIDs.

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

• Continued treatment to prevent rebleeding from peptic ulcer following initial treatment with intravenous esomeprazole.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows up into the esophagus (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 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 acid.
• If you are scheduled to have a specific blood test (chromogranin A).

Esomeprazol Davur may mask symptoms of other diseases. 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 start 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, and 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, see your doctor as soon as possible, as it may be necessary to discontinue 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

Esomeprazol Davur must not be used in children under 12 years of age because there is no available data.

Taking Esomeprazol Davur with other medicines

Tell 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 make the blood less likely to clot, 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 when walking caused by poor 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 treatment with Esomeprazol Davur.
• Tacrolimus (for organ transplant).
• 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 drinks

You may take the capsules with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 Davur during this period.

It is not known whether Esomeprazol Davur passes into breast milk. Therefore, Esomeprazol Davur should 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 under control, 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 tumor in the pancreas (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 rebleeding 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 under control, 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 (non-carbonated) 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 through 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

No dose adjustment is required for 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, stating 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 once) 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, this medicine can cause adverse effects, although not everyone will experience 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 fatigue, which may be symptoms of liver problems. These effects are rare, occurring in less than 1 in 1,000 patients.
• Sudden difficulty breathing, swelling of the lips, tongue, or throat, or generalized swelling of the body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare, occurring in less than 1 in 1,000 patients.
• Sudden appearance of a severe skin rash or redness of the skin with blistering or peeling, even after several weeks of treatment. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (epidermal shedding and superficial mucosal membranes), potentially leading to 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.
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (affects up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling or numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, skin itching.
• Fractures of the hip, wrist, or 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 reduced numbers of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• 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 yellowing of the skin, dark urine, and fatigue.
• 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 (reduced number of white blood cells).
• Aggression.
• 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 manifest 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 potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Inflammation of the intestine (causing diarrhea).
• 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 deterioration in general condition, or fever with signs of localized infection such as neck pain, sore throat, mouth pain, or difficulty urinating, you should consult your doctor immediately 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 type of 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 packaging 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. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack 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, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, macrogol 6000, talc (E553b), heavy magnesium carbonate, polysorbate 80 (E433), copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30% in the capsule granules, and gelatin (E441), titanium dioxide (E171) and red iron oxide (E172) in the capsule.

Nature 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 a desiccant in HDPE bottles. Do not ingest the capsule containing the desiccant included in the pack.

Only certain pack sizes may be commercially available.

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 summary of product characteristics was approved in July 2025

Detailed and up-to-date 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 clogging.

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 an 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. Rotate the syringe so the tip points downwards and inject another 5–10 mL into the tube. Repeat this procedure until the syringe is empty.

7. Refill the syringe with 25 mL of water and 5 mL of air and repeat step 5 if necessary to clear any residue remaining in the syringe. For some tubes, 50 mL of water may be required.