ESOMEPRAZOL KRKA 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Esomeprazol Krka 20 mg Gastro-Resistant Hard Capsules EFG

Read all of 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Esomeprazol Krka and what is it used for
2. What you need to know before you take Esomeprazol Krka
3. How to take Esomeprazol Krka
4. Possible side effects

5 Storage of Esomeprazol Krka

1. Contents of the pack and other information

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

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

Esomeprazole is used to treat the following conditions:

Adults

• Gastro-oesophageal reflux disease (GORD). 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 that are caused by a 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 NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazol Krka can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Prevention of bleeding from stomach ulcers caused by Helicobacter pyloriin patients who have been treated with esomeprazole injection.

Adolescents from 12 years of age

• Gastro-oesophageal reflux disease (GORD). 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 that are caused by a 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 you take Esomeprazol Krka

Do not take Esomeprazol Krka

• if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).

• if you are taking a medicine that contains nelfinavir (used to treat HIV infection).
• If you have ever had a skin reaction after treatment with a medicine similar to Esomeprazol Krka that reduces stomach acid.

If any of the above apply to you, do not take Esomeprazol Krka. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazol Krka.

Warnings and precautions

Talk to your doctor or pharmacist before taking Esomeprazol Krka

• 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 Krka that reduces stomach acid. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and erythema multiforme have been reported with Esomeprazol Krka. If you get any of the following symptoms, stop taking Esomeprazol Krka and contact your doctor immediately: severe skin rash, blisters, sores or ulcers in the mouth, redness and swelling of the skin, fever, flu-like symptoms, enlarged lymph nodes, itching and swelling of the hands, feet, ankles, face, lips, eyes or mouth.
• if you have been told that you have a low level of magnesium in your blood.

Esomeprazol Krka may hide the symptoms of other diseases. Therefore, if you are taking Esomeprazol Krka on a long-term basis, your doctor may need to keep a regular check on you:

• if you have ever had a stomach ulcer or stomach cancer.
• if you are taking a medicine that prevents blood clots, such as warfarin.

Children and adolescents

This medicine should not be used in children under the age of 12 years.

Other medicines and Esomeprazol Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you can buy without a prescription. This is because Esomeprazol Krka can affect the way some medicines work and some medicines can increase the chance of you getting side effects.

Taking Esomeprazol Krka with food and drink

You can take the capsules with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 Krka during this time.

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

Driving and using machines

Esomeprazol Krka is not likely to affect your ability to drive or use any tools or machines. However, sometimes dizziness or blurred vision may occur. Do not drive or use any tools or machines if you are affected in this way.

Esomeprazol Krka contains sucrose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Esomeprazol Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you are taking this medicine for a long time, your doctor may need to keep a regular check on you.

• If your doctor has told you to take this medicine as and when you need it, tell 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, your age and your liver function.
• The recommended dose is given below:

Use in adults aged 18 years and above

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule (or two 20 mg capsules) per day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your oesophagus has not healed yet.

Once the oesophagus has healed, the recommended dose is one 20 mg capsule per day.

• If your oesophagus has not been damaged, the recommended dose is one 20 mg capsule per day.
• If you have serious liver problems, your doctor may give you a lower dose.

For stomach ulcers caused byHelicobacter pyloriand to stop them coming back:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to be taken in combination with Esomeprazol Krka.

For stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

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

To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg capsule per day.

Treatment of too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg capsule (or two 20 mg capsules) twice a day.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for. The maximum dose is one 80 mg capsule (or two 40 mg capsules) twice a day.

Prevention of bleeding from stomach ulcers caused by Helicobacter pyloriin patients who have been treated with esomeprazole injection:

• The recommended dose is one 40 mg capsule (or two 20 mg capsules) per day for 4 weeks.

Use in adolescents from 12 years of age

For gastro-oesophageal reflux disease (GORD):

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg capsule (or two 20 mg capsules) per day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your oesophagus has not healed yet.
• Once the oesophagus has healed, the recommended dose is one 20 mg capsule per day.
• If your oesophagus has not been damaged, the recommended dose is one 20 mg capsule per day.
• If you have serious liver problems, your doctor may give you a lower dose.

For stomach ulcers caused by Helicobacter pyloriand to stop them coming back:

• The recommended dose is one 20 mg capsule twice a day for one week. Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin to be taken in combination with Esomeprazol Krka.

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 pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you have trouble swallowing the capsules

• If you have trouble swallowing the capsules:

1. Open the capsule and swallow the contents (pellets) directly with half a glass of water. Do not use other liquids.
2. Always stir the pellet/liquid mixture well before drinking it. Drink the mixture within 30 minutes.
3. To make sure that you have taken all of the medicine, rinse the glass with half a glass of water and drink it.

• If you cannot swallow at all, the capsule can be opened and the contents (pellets) mixed with some water, and the mixture can be administered through a gastric tube.

Use in children under 12 years of age

Esomeprazol Krka is not recommended for use in children under the age of 1 year. For children aged 1-11 years, the capsules are not suitable and you should talk to your doctor.

Elderly

No dose adjustment is necessary in patients over 65 years of age.

If you take more Esomeprazol Krka than you should

If you have taken more Esomeprazol Krka than you should, talk to your doctor or pharmacist straight away.

If you forget to take Esomeprazol Krka

• 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 and continue as usual. 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Esomeprazol Krka can cause adverse effects, although not all people suffer from them.

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

• Yellow skin, dark urine, and fatigue that can be symptoms of liver problems.

These effects are rare and may affect up to 1 in 1,000 people.

• Widespread rash, high body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rare.
• Sudden difficulty breathing, swelling of lips, tongue, throat, or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction).

These effects are rare and may affect up to 1 in 1,000 people.

• Sudden appearance of a skin rash or redness of the skin with blisters or peeling. Important blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also appear. Skin rashes can become serious and widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) with potentially fatal consequences. It could be a case of "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms".

These effects are very rare and may affect up to 1 in 10,000 people.

Other adverse effects include:

Frequent (may affect 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 (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Disruption of sleep (insomnia).
• Dizziness, tingling sensation, and numbness, drowsiness.
• Feeling of vertigo.
• Dry mouth.
• Alteration of blood tests that determine liver function.
• Skin rash, hives, itching of the skin.
• Fracture of the hip, wrist, or spine.

Rare (may affect 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 vomiting and cramps.
• Agitation, confusion, or depression.
• Alteration of taste.
• Eye disorders such as blurred vision.
• Sudden feeling of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• An infection known as "candidiasis" that can affect the esophagus and is caused by a fungus.
• Liver problems including jaundice that 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 (may affect 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. (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 the available data)

• If you are taking esomeprazol for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to 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 (can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Krka can affect white blood cells, causing an immune deficiency. If you have an infection with symptoms such as fever with a severeworsening of the general condition or fever with symptoms of a local infection such as neck pain, 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 report 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Esomeprazol Krka

Keep this medicine out of sight and reach of children.

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

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from moisture.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE point of 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 Krka

• The active ingredient is esomeprazol. Each capsule contains 20 milligrams of esomeprazol (as esomeprazol magnesium dihydrate salt).
• The other components (excipients) are sugar spheres (sucrose and cornstarch), povidone, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), heavy magnesium carbonate, polysorbate 80, and methacrylic acid - ethyl acrylate copolymer (1:1) dispersion at 30 percent in the capsule content (granules), and gelatin (E441), titanium dioxide (E171), and red iron oxide (E172) in the capsule coating. See section 2 "Esomeprazol contains sodium and sucrose".

Appearance of the Product and Package Contents

The body and cap of the capsule are light pink in color. The capsule contains white or almost white granules.

The capsules are available in blisters of 14 and 28 in a box.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

Date of the Last Revision of this Prospectus:June 2025

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