ESOMEPRAZOL DAVUR 20 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, 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”. 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 is where acid from the stomach escapes into the gullet (the tube that carries food from the mouth to the stomach) causing pain, inflammation, and heartburn.
• Ulcers in the stomach or duodenum (the first part of the intestine) caused 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.
• Ulcers in the stomach caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazol Davur can also be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Treatment continuation for the prevention of bleeding from a peptic ulcer 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 that carries food from the mouth to the stomach) causing pain, inflammation, and heartburn.

• Ulcers in the stomach or duodenum (the first part of the intestine) caused 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.

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 proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• 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, consult your doctor or pharmacist before taking Esomeprazol Davur.

Warnings and precautions

Tell 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 to reduce 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 before or while taking Esomeprazol Davur, contact your doctor immediately:

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

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

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

Skin rash and skin reactions

If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking Esomeprazol Davur. Remember to mention any other symptoms you notice, such as joint pain.

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

If you develop a rash or any of these skin reactions at any time during treatment (even after several weeks), 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 is no data available.

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 some medicines may affect how Esomeprazol Davur works.

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

• Atazanavir (used for 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).
• Diazepam (used for anxiety, as a muscle relaxant, or for epilepsy).
• Phenytoin (for 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 – leg pain when walking caused by poor blood circulation).
• 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 stop your treatment with Esomeprazol Davur.
• Tacrolimus (organ transplant).
• Rifampicin (used for tuberculosis treatment).
• 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 inform your doctor if you are taking any other medicine.

Taking Esomeprazol Davur with food and drink

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

Pregnancy, breast-feeding, 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 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 tools or machines. However, side effects such as dizziness and blurred vision are uncommon or rare (see section 4). If 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, consult them before taking this medicine.

3. How to take Esomeprazol Davur

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist.

• If you take this medicine for a long time, your doctor will need to monitor you (especially if you take it for more than one year).
• If your doctor has told you to take this medicine only when you notice symptoms, tell your doctor if your 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 listed below.

Adults aged 18 years and over

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 once a 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 once a day.
• If your esophagus is not damaged, the recommended dose is one 20 mg gastro-resistant capsule of esomeprazole once a day. Once the condition has been controlled, your doctor will tell you to take the medicine as needed, up to a maximum of one 20 mg gastro-resistant capsule of esomeprazole once a 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 recurrence:

• The recommended dose is one 20 mg gastro-resistant capsule of esomeprazole twice a day for one week.
• Your doctor will also prescribe 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 gastro-resistant capsule of esomeprazole once a day 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 gastro-resistant capsule of esomeprazole once a day.

For the treatment of excessive 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 this medicine. The maximum dose is 80 mg twice a day.

Treatment continuation for the prevention of bleeding from a peptic ulcer with esomeprazole intravenous:

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

Adolescents aged 12 years and over

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 once a 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 once a day.
• If your esophagus is not damaged, the recommended dose is one 20 mg gastro-resistant capsule of esomeprazole once a day. Once the condition has been controlled, your doctor will tell you to take the medicine as needed, up to a maximum of one 20 mg gastro-resistant capsule of esomeprazole once a 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 recurrence:

• The recommended dose is one 20 mg gastro-resistant capsule of esomeprazole twice a day for one week.
• Your doctor will also prescribe antibiotics, for example, amoxicillin and clarithromycin.

Taking this medicine

• You can take the capsules at any time of the day.
• You can 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 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 pour the granules into half a glass of water (non-fizzy). Do not use other liquids.
• You can drink the mixture straight away or within 30 minutes. Stir well just before drinking.
• To make sure you take all the medicine, rinse the glass well with half a glass of water and drink. The solid particles contain the medicine – do not chew or crush the granules.
  • 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 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 your doctor has prescribed, contact 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 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, do not take the missed dose.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you have any other 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 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 redness of the skin with blisters or peeling, even after several weeks of treatment. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be a "multiform erythema", "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 sensation, 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 likelihood of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• 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).
• Aggression.
• 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. (Multiform erythema, 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 magnesium levels in the blood 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 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 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 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 at a temperature 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 down the drain 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 hard gastro-resistant capsule contains 20 mg or 40 mg of esomeprazol (as esomeprazol magnesium dihydrate).

The other ingredients are sugar spheres (sucrose and cornstarch), 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 at 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 Package Contents

The body and cap of the 20 mg hard gastro-resistant 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 hard gastro-resistant capsules are slightly pink in color. The capsules contain white to off-white granules. Capsule size 1.

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

Only some package 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 hard gastro-resistant capsules EFG

Esomeprazol Davur 40 mg hard gastro-resistant capsules 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 is needed.