ESOMEPRAZOL KRKA 40 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Esomeprazol Krka 40 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 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 leaflet. See section 4.

Contents of the Package Leaflet

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
6. Contents of the pack and further information

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

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

Esomeprazol 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 caused by a bacterium called Helicobacter pylori. Esomeprazol is usually given together with antibiotics to get rid of the bacterium and allow the ulcer to heal.
• 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 pylori or non-steroidal anti-inflammatory drugs (NSAIDs).

Adolescents aged 12 years and above

• 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.

2. What you need to know before you take Esomeprazol Krka

Do not take Esomeprazol Krka

• if you are allergic to esomeprazol 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, omeprazol).

• if you are taking a medicine containing nelfinavir (used to treat HIV).
• 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.
• if you are due to have a specific blood test (Chromogranin A).

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

• you lose a lot of weight for no reason and have problems swallowing.
• you get stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (blood-stained).

If you have been prescribed Esomeprazol Krka only when your symptoms appear, you should contact your doctor if your symptoms persist or come back.

Taking a proton pump inhibitor like Esomeprazol Krka, especially over a period of more than one year, may slightly increase your risk of fracture in 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 reactions

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with Esomeprazol Krka. Remember to also mention any other symptoms that you may have, such as joint pain or fever.

• Severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with Esomeprazol Krka (see section 4). If you get any of the symptoms of these severe skin reactions, stop taking Esomeprazol Krka and contact your doctor or go to the hospital immediately.

Children under 12 years

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

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 how some medicines work and some medicines can affect how Esomeprazol Krka works.

Do not take Esomeprazol Krka if you are taking a medicine containing nelfinavir (used to treat HIV).

Tell your doctor if you are taking any of the following medicines:

• atazanavir (used to treat HIV),
• clopidogrel (used to prevent blood clots),
• ketoconazole, itraconazole or voriconazole (used to treat fungal infections),
• erlotinib (used to treat cancer),
• citalopram, imipramine or clomipramine (used to treat depression),
• diazepam (used to treat anxiety, relax muscles or in 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 Krka.

• medicines that are used to thin the blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazol Krka.

• cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply),
• cisapride (used for indigestion and heartburn),
• digoxin (used for heart problems),
• methotrexate (a chemotherapy medicine used to treat cancer) – if you are taking high doses of methotrexate, your doctor may need to temporarily stop your Esomeprazol Krka treatment,
• tacrolimus (used to prevent organ rejection after a 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 Krka 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 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, side effects such as dizziness or blurred vision may uncommonly or rarely occur (see section 4). Do not drive or use any tools or machines if you are affected by these side effects.

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 will want to monitor you (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 how long to take them for. 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 the treatment of heartburn caused by 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 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.
• If you have severe liver problems, your doctor may give you a lower dose.

For the 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 twice a day.
• Your doctor will adjust the dose depending on your needs and also decide how long you will need to take the medicine for. The maximum dose is two 40 mg capsules twice a day.

Prevention of bleeding from stomach ulcers caused by Helicobacter pylori or non-steroidal anti-inflammatory drugs (NSAIDs)

• The recommended dose is one 40 mg capsule per day for 4 weeks.

Use in adolescents aged 12 years and above

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD)

• If your doctor has found that your gullet (oesophagus) is slightly damaged, the recommended dose is one 40 mg gastro-resistant capsule 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.
• If you have severe liver problems, your doctor may give you a lower dose.

Taking this medicine

• You can take the capsules at any time of the day.
• You can take them with or without food.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules (because the granules inside the capsules may be released and the medicine may not work properly). It is important not to damage the granules.

What to do if you have trouble swallowing

• If you have trouble swallowing the capsules:

1. Open the capsule carefully and empty the granules into a glass of still water. Do not use other liquids.
2. Stir the mixture well.
3. Drink the mixture straight away or within 30 minutes. Always stir the mixture well before drinking it.
4. To make sure that you have taken all of 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 the granules.

• If you cannot swallow at all, the granules can be mixed with a little water and put into a syringe. The mixture can then be given through a nasogastric tube.

Use in children under 12 years of age

Esomeprazol is not recommended for children under 1 year of age. For children between 1 and 11 years old, the capsules are not suitable. Talk to your doctor.

Elderly

No dose adjustment is necessary for patients over 65 years.

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 or go to the nearest hospital casualty department immediately. Take the medicine pack with you.

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

If you notice any of the following 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 can affect up to 1 in 1,000 people.

• 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 and can affect up to 1 in 1,000 people.

• 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 liver damage (exfoliative dermatitis and superficial mucosal erosion) with potentially fatal consequences. This could be a case of "erythema multiforme", "Stevens-Johnson syndrome", or "toxic epidermal necrolysis".

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

• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and can 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.
• Nausea or vomiting.
• Benign polyps in the stomach.

Infrequent (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbance (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 (if esomeprazole is used at high doses and for a long period).

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 in the blood. 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 feeling of shortness of breath or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as "candidiasis" that can affect the esophagus.
• Liver problems, including jaundice, which can cause yellow skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Dermatitis due to sun exposure.
• Joint pain (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).
• 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.

• Increase in breast size in men.

Frequency not known (cannot be estimated from available data)

• If you are treated with esomeprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also cause a decrease in potassium or calcium levels in the blood.

Your doctor may decide to perform periodic tests to monitor your magnesium levels.

• Inflammation of the intestine (which can lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Krka can affect white blood cells, causing immune deficiency. If you have an infection with symptoms such as fever with a severe worsening 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 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 that is not listed in this leaflet. 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. Storage of Esomeprazol Krka

Keep out of sight and reach of children.

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

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Esomeprazol Krka

• The active ingredient is esomeprazole. Each capsule contains 40 milligrams of esomeprazole (as esomeprazole 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, titanium dioxide (E171), and red iron oxide (E172) in the capsule coating. See section 2 "Esomeprazol Krka contains sucrose and sodium".

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 blister packs 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 Leaflet: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/).