Package Insert: Information for the User

Esomeprazole Davur 20 mg Hard Gastroresistant Capsules EFG

Esomeprazole Davur 40 mg Hard Gastroresistant Capsules EFG

Read the package insert carefully before starting to take the medication, as it contains important information for you.

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

6Contents of the Package and Additional Information

Esomeprazol Davur contains a medication called esomeprazole magnesium dihydrate. This belongs to a group of medications called "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 rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Ulcers in the stomach or upper part of the small intestine infected by a bacteria 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 certain medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Davur can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).

- Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously.

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.

Ulcers in the stomach or upper part of the small intestine infected by a bacteria called "Helicobacter pylori". If you have this condition, your doctor will also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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 are taking a medicine that contains nelfinavir (used in the treatment of HIV infection).

If you find yourself in any of these situations do not take Esomeprazol Davur. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Davur.

Warnings and precautions

Consult 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 similar medicine to Esomeprazol Davur for reducing stomach acid.
• If you are due to have a specific blood test (Cromogranin A).

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

• You lose a lot of weight without reason and have trouble swallowing.
• You experience stomach pain or indigestion.
• You begin to vomit food or blood.
• Your stools appear black (bloodstained).

If you have been prescribed Esomeprazol Davur only when you notice some symptoms, you should contact your doctor if the symptoms of your disease persist or change.

The use of proton pump inhibitors such as Esomeprazol Davur, especially for periods of time exceeding one year, may slightly increase the risk of suffering a hip, wrist, or spinal fracture. Consult your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Rashes and skin symptoms

If you experience a rash, especially in sun-exposed areas, go to your doctor as soon as possible, as it may be necessary to interrupt treatment with Esomeprazol Davur. Remember to mention any other symptoms you may notice, such as joint pain.

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

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.

Children under 12 years

Esomeprazol Davur should not be used in children under 12 years because there are no available data.

Taking Esomeprazol Davur with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, even those purchased without a prescription. This is because Esomeprazol Davur may affect the way 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 that containsnelfinavir(used for the treatment of HIV infection).

• Atazanavir (used for the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole, or voriconazole (for fungal infections).
• Ertonilib (used to treat cancer)
• Digoxin (used to treat heart problems)
• Citalopram, imipramine, clomipramine (for depression treatment).
• Diazepam (used to treat anxiety, as a muscle relaxant or for epilepsy).
• Fenitoin (for epilepsy). If you are taking phenytoin, your doctor will need to control when you start or stop taking Esomeprazol Davur.
• Medicines used to make blood thinner such as warfarin or clopidogrel. Your doctor may need to control when you start or stop taking Esomeprazol Davur.
• Cilostazol (used to treat intermittent claudication – pain in the legs when walking caused by poor blood circulation)
• Cisaprida (used for indigestion and heartburn).
• Digoxin (used for heart problems)
• Metotrexato (chemotherapy used at high doses to treat cancer) if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol Davur.
• Tacrolimús (organ transplant)
• Rifampicina (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 byHelicobacter pylori, it is very important to communicate with your doctor if you are taking any other medicine.

Taking Esomeprazol Davur with food and drinks

You can take the capsules with food or with an empty stomach.

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 if you can take Esomeprazol Davur during this period.

The passage of Esomeprazol Davur into breast milk is unknown. Therefore, Esomeprazol Davur should not be taken during breastfeeding.

Driving and operating machinery

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

Esomeprazol Davur contains sodium

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

Esomeprazol Davur contains sucrose

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• If you take this medication for a long period of time, your doctor will need to monitor you (especially if you take it for more than a year).
• If your doctor has indicated that you take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take

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

Adults 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 gastro-resistant capsule of esomeprazole per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once your esophagus has healed is one 20 mg gastro-resistant capsule of esomeprazole per day.
• If your esophagus has not been affected, the recommended dose is one 20 mg gastro-resistant capsule of esomeprazole per day. Once the disorder has been controlled, your doctor will indicate that you take the medication as needed, up to a maximum of one 20 mg gastro-resistant capsule of esomeprazole per day.
• 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 gastro-resistant capsule of esomeprazole twice a day for one week.
• Your doctor will indicate that you take in addition the antibiotics, for example amoxicillin and clarithromycin.

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

• The recommended dose is one 20 mg gastro-resistant capsule of esomeprazole per day for 4 to 8 weeks.

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

• The recommended dose is one 20 mg gastro-resistant capsule of esomeprazole per day.

For the treatment of excessive acidity produced by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is two 40 mg gastro-resistant capsules of esomeprazole per day.
• Your doctor will adjust the dose according to your needs and also decide for how long you should take this medication. The maximum dose is two 80 mg gastro-resistant capsules of esomeprazole per day.

Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously:

• The recommended dose is one 40 mg gastro-resistant capsule of esomeprazole per day for 4 weeks.

Adolescents 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 gastro-resistant capsule of esomeprazole per day for 4 weeks. Your doctor may indicate that you take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose once your esophagus has healed is one 20 mg gastro-resistant capsule of esomeprazole per day.
• If your esophagus has not been affected, the recommended dose is one 20 mg gastro-resistant capsule of esomeprazole per day. Once the disorder has been controlled, your doctor will indicate that you take the medication as needed, up to a maximum of one 20 mg gastro-resistant capsule of esomeprazole per day.
• 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 gastro-resistant capsule of esomeprazole twice a day for one week.
• Your doctor will indicate that you take in addition the antibiotics, for example amoxicillin and clarithromycin.

How to take this medication

• You can take the capsules at any time of the day.
• You can take the capsules with food or with 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 medication from being destroyed by the stomach acid. It is essential not to damage the granules.

What to do if you have difficulty swallowing the capsules

-Open the capsule and introduce the granules into a glass of water without gas. Do not use other liquids.

-You can drink the mixture immediately or within 30 minutes. Always stir just before drinking.

-To ensure that you have taken all the medication, rinse the glass well with half a glass of water and drink. The solid particles contain the medication – do not chew or crush the granules.

• If you cannot swallow at all, the granules can be dispersed in water and introduced into a syringe. You can then administer them directly into the stomach through a tube (gastrostomy tube).

Children and adolescents under 12 years

Esomeprazole Davur is not recommended for children under 12 years.

Seniors

No dose adjustment is required in elderly patients.

If you take more Esomeprazol Davur than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91 5620420, indicating the medication 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 compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Yellow skin, dark urine, and fatigue that 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, and throat or body in general, 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 severe skin rash or redness of the skin with blisters or peeling, even after several weeks of treatment. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals may occur. Skin rashes may become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It may be a "multiforme erythema", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

Other side effects include:

Frequent (affecting up to 1 in 10 people)

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

Occasional (affecting up to 1 in 100 people)

• Swelling of the feet and ankles.
• Insomnia (sleep disturbance).
• Dizziness, tingling, and numbness, somnolence.
• Sensation of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, urticaria, itching skin.
• Fracture of the hip, wrist, and spine (if Esomeprazol Davur is used at high doses or for prolonged periods of time)

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

• Blood disorders such as a decrease in the number of white blood cells or platelets. This may cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden sensation of lack of air or difficulty breathing (bronchospasm).
• Inflammation in the interior of the mouth.
• A known infection called "candidiasis" that may affect the intestine and is caused by a fungus.
• Liver problems including jaundice that may cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis caused by exposure to sunlight.
• Pain in the joints (arthritis) or muscles (myalgia).
• General feeling of discomfort and lack of energy.
• Increased sweating.

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

• Changes in the number of cells in the blood, including agranulocytosis (decrease in the number of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that may lead to liver failure or inflammation of the brain.
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. 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.

Reporting of side effects

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

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

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

Blister packaging OPA/Al/PE + DES/laminate Al

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Blister packaging OPA/Al/PVC/laminate Al

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from moisture.

HDPE Bottle

This medication does not require any special storage temperature.

Keep the packaging perfectly closed to protect it from moisture.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Esomeprazol Davur Composition

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

Product Appearance and Packaging Contents

The body and cap of the 20 mg gastro-resistant hard capsules are light pink in color. 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 light pink in color. The capsules contain white to off-white granules. Capsule size No. 1.

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

Only some packaging 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

Responsible for Manufacturing

KRKA,

pharmaceutical factory, 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 member states of the European Economic Area under the following names:

GermanyEsomeprazol-CT 20 / 40 mg gastro-resistant hard capsules

SloveniaEslaver 20 / 40 mg gastro-resistant hard capsules

SpainEsomeprazol Davur 20 mg gastro-resistant hard capsules EFG

Esomeprazol Davur 40 mg gastro-resistant hard capsules EFG

This leaflet was approved in April 2023

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

The following information is only for healthcare professionals:

Administration through a gastric tube

1.- Open the capsule and empty the pellets into the appropriate syringe and fill with approximately 25 ml of water and 5 ml of air.

For some tubes, a 50 ml dispersion is necessary to prevent the tube from clogging.

2.- Immediately agitate the syringe to distribute the granules homogeneously throughout the suspension.

3.- Immediately agitate the syringe with the tip pointing upwards and check that the tip is not clogged

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

5.- Agitate the syringe and position with the tip pointing downwards. Inject immediately 5 – 10 ml into the tube. Invert the syringe after injection. (The syringe must remain with the tip pointing upwards to prevent clogging at the tip).

6.- Rotate 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 clear any sediment that may have remained in the syringe. For some tubes, 50 ml of water may be necessary.