ESOMEPRAZOL DAVUR 40 mg HARD GASTRO-RESISTANT CAPSULES

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 the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Esomeprazol Davur and what is it used for
2. What you need to know before taking Esomeprazol Davur
3. How to take Esomeprazol Davur
4. Possible side effects
5. Storage of Esomeprazol Davur

6 Contents of the pack and further information

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

Esomeprazol Davur contains a medicine called esomeprazole magnesium dihydrate. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that the stomach produces.

Esomeprazol Davur is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.
• Stomach ulcers or ulcers in the part of the gut called the duodenum, which are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Davur can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

• Treatment of continuation of prevention of rebleeding of peptic ulcer induced with

esomeprazole intravenous.

Adolescents from 12 years of age

• Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain and inflammation.

Stomach ulcers or ulcers in the part of the gut called the duodenum, which are infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may 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 any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines which reduce stomach acid.
• If you are taking a medicine that contains nelfinavir (used to treat HIV infection).

If any of these apply to you, do not take Esomeprazol Davur. If you are not sure, talk to 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 that reduces stomach acid.
• If you are due to have a specific blood test (Chromogranin A).

Esomeprazol Davur may hide the symptoms of other diseases. Therefore, if you notice any of the following, contact your doctor immediately:

• Losing a lot of weight for no reason and having problems swallowing.
• Having stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Black tarry stools.

If your doctor has prescribed Esomeprazol Davur only when you have symptoms, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor like Esomeprazol Davur, especially over a period of more than one year, may slightly increase your risk of fracture of the hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Skin rash and skin reactions

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop treatment with Esomeprazol Davur. Also remember to mention any other symptoms that you may have, such as arthralgia (joint pain).

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis have been reported (see section 4). The rash may be a sign of an allergic reaction and may include other symptoms such as high temperature, swollen glands, swelling of the face, lips, tongue or throat, and may lead to more severe complications such as anaphylaxis (a severe, life-threatening allergic reaction). If you experience any of these symptoms, stop taking Esomeprazol Davur and contact your doctor immediately.

Children under 12 years

Esomeprazol Davur should not be used in children under 12 years because there is no information on its use in this age group.

Taking Esomeprazol Davur with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because Esomeprazol Davur may affect how these medicines work, and these medicines may also affect how Esomeprazol Davur works.

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

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Ertonilib (used to treat cancer).
• Digoxin (used to treat heart problems).
• Citalopram, imipramine, clomipramine (used to treat depression).
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you 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 you when you start or stop taking Esomeprazol Davur.
• Cilostazol (used to treat intermittent claudication – a condition where the legs do not get enough blood, resulting in pain when walking).
• Cisapride (used to treat indigestion and heartburn).
• Digoxin (used to treat 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 stop your treatment with Esomeprazol Davur.
• Tacrolimus (used to prevent organ rejection after 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 with Esomeprazol Davur to treat ulcers caused by Helicobacter pylori, it is very important that you tell your doctor about any other medicines you are taking.

Taking Esomeprazol Davur with food and drink

You can take the capsules with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

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

Esomeprazol Davur contains sodium

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

Esomeprazol Davur contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Esomeprazol Davur

Follow the instructions given by your doctor and do not exceed the recommended dose. If you are unsure, ask your doctor or pharmacist.

• If you take this medicine for a long time, your doctor will want to regularly check how you are doing, especially if you are taking it for more than a year.
• If your doctor has told you to take this medicine as and when you need it, you should contact your doctor if your symptoms change.

How much to take

• Your doctor will tell 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 given below.

Adults aged 18 years and older

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found that your esophagus is slightly damaged, the recommended dose is one 40 mg gastro-resistant capsule of esomeprazole per day for 4 weeks. Your doctor may tell you to take 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 gastro-resistant capsule of esomeprazole per day.
• If your esophagus has not been damaged, the recommended dose is one 20 mg gastro-resistant capsule of esomeprazole per day. Once the condition has been controlled, your doctor will tell you how to take your medicine as and when you need it, up to a maximum of one 20 mg gastro-resistant capsule of esomeprazole per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of stomach ulcers caused by Helicobacter pyloriinfection and to prevent them from coming back:

• The recommended dose is one 20 mg gastro-resistant capsule of esomeprazole twice a day for one week.
• Your doctor will also tell you to take antibiotics.

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

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

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

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

For the treatment of too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

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

Treatment of continuation of prevention of rebleeding of peptic ulcer induced with esomeprazole intravenous:

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

Adolescents aged 12 years and older

For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has found that your esophagus is slightly damaged, the recommended dose is one 40 mg gastro-resistant capsule of esomeprazole per day for 4 weeks. Your doctor may tell you to take 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 gastro-resistant capsule of esomeprazole per day.
• If your esophagus has not been damaged, the recommended dose is one 20 mg gastro-resistant capsule of esomeprazole per day. Once the condition has been controlled, your doctor will tell you how to take your medicine as and when you need it, up to a maximum of one 20 mg gastro-resistant capsule of esomeprazole per day.
• If you have severe liver problems, your doctor may give you a lower dose.

For the treatment of stomach ulcers caused by Helicobacter pyloriinfection and to prevent them from coming back:

• The recommended dose is one 20 mg gastro-resistant capsule of esomeprazole twice a day for one week.
• Your doctor will also tell you to take antibiotics.

Taking this medicine

• You can take the capsules at any time of the day.
• You can take the capsules with or without food.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated granules which stop the medicine from being broken down by the acid in the stomach. 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 mix the granules with half a glass of non-fizzy water. Do not use other liquids.
• You can drink the mixture straight away or within 30 minutes. Stir well before drinking. To make sure you get all the medicine, rinse the glass with half a glass of water and drink it.
• The solid particles contain the medicine – do not chew or crush them.
• If you cannot swallow at all, the granules can be mixed with water and given through a syringe into the stomach (gastric tube).

Children and adolescents under 12 years

Esomeprazol Davur is not recommended for children under 12 years.

Elderly

No dose adjustment is necessary in patients over 65 years.

If you take more Esomeprazol Davur than you should

If you take more Esomeprazol Davur than you should, talk to your doctor or pharmacist straight away.

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

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, skip 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 on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems. These effects are rare, occurring in less than 1 in 1,000 patients.
• Sudden difficulty breathing, swelling of 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 a severe skin rash or skin redness with blisters or peeling, even after several weeks of treatment. Blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes can become severe and widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be a "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

Other adverse 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.

Infrequent (affecting up to 1 in 100 people)

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

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 can cause weakness, bruising, or increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alteration.
• Eye disorders such as blurred vision.
• Sudden sensation of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the intestine and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Pain in the joints (arthralgia) or muscle pain (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).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Liver disorders that can lead to liver failure or brain inflammation.
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. These symptoms can 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.
• Increased breast size in men.

Frequency Not Known (cannot be estimated from available data)

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

In very rare cases, Esomeprazol Davur can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of your general condition or fever with symptoms of a local infection such as pain in the neck, throat, mouth, or difficulty urinating, you should consult your doctor as soon as possible to rule out a decrease in the number of white blood cells (agranulocytosis) through a blood test. It is important that, in this case, you inform your doctor about your medication.

Reporting Adverse Effects

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

5. Storage of Esomeprazol Davur

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

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

Blister pack OPA/Al/PE + film DES/Al foil

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Blister pack OPA/Al/PVC/Al foil

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 perfectly closed to protect it from moisture.

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

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

6. Package Contents and Additional Information

Composition of Esomeprazol Davur

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

The other ingredients 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), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion at 30% in the capsule granules, and gelatin (E441), titanium dioxide (E171), and red iron oxide (E172) in the capsule.

Appearance of the Product and Package Contents

The body and cap of the 20 mg gastro-resistant hard capsules are slightly pink in color. The capsules contain white to off-white granules. Capsule size 3.

The body and cap of the 40 mg gastro-resistant hard capsules are slightly pink in color. The capsules contain white to off-white granules. Capsule size 1.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

Alcobendas, 28108 Madrid

Manufacturer

KRKA,

tovarna zdravil, d. d., Novo mesto,

Šmarješka cesta 6, 8501 Novo mesto,

Slovenia

O

Merckle GmbH,

Ludwig-Merckle-Str. 3, 89143 Blaubeuren,

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Esomeprazol-CT 20 / 40 mg magensaftresistente Hartkapseln

Slovenia Eslaver 20 / 40 mg trdegastrorezistentne kapsule

Spain Esomeprazol Davur 20 mg cápsulas duras gastrorresistentes EFG

Esomeprazol Davur 40 mg cápsulas duras gastrorresistentes EFG

This prospectus was approved in April 2023

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

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, dispersion in 50 ml is necessary to prevent the tube from clogging.

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

3.- Shake the syringe immediately with the tip upwards and check that the tip is not clogged.

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

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

6.- Turn the syringe with the tip 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 clarify any sediment that has remained in the syringe. For some tubes, 50 ml of water are needed.