Esomeprazole Krka 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esomeprazol Krka 20 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

  • If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Esomeprazol Krka

3. How to take Esomeprazol Krka

4. Possible side effects

5. Storage of Esomeprazol Krka

6. Contents of the pack and other information

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

Esomeprazol Krka contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced by the stomach.

Esomeprazole is used for the treatment of the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Gastric ulcers caused by medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). Esomeprazole may also be used to prevent the development of ulcers if you are taking NSAIDs.

• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

• Continuation treatment to prevent rebleeding from peptic ulcer following intravenous esomeprazole therapy.

Adolescents aged 12 years and older

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid flows back up into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or upper intestinal (duodenal) ulcers caused by infection with a bacterium called Helicobacter pylori. If you have this condition, your doctor will likely also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazol Krka

Do not take Esomeprazol Krka

• if you are allergic 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 (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).
• If you have ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking Esomeprazol Krka or other related medicines.

If any of these situations apply to you, do not take esomeprazole. If you are unsure, consult 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 used to reduce stomach acid. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Esomeprazol Krka treatment. Stop taking Esomeprazol Krka and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
• If you are scheduled for a specific blood test (chromogranin A).

Esomeprazol Krka may mask symptoms of other diseases. Therefore, if you experience any of the following events before starting or while taking this medicine, contact your doctor immediately:

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

If you have been prescribed esomeprazole only when symptoms occur, you should contact your doctor if your symptoms persist or change.

Taking a proton pump inhibitor such as Esomeprazol Krka, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Skin rashes and skin symptoms

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Esomeprazol Krka may need to be stopped. Remember to mention any other symptoms you may notice, such as joint pain.

Serious skin rashes have occurred in patients taking esomeprazole (see section 4). The rash may include mouth, throat, nose, genital ulcers, and conjunctivitis (red, swollen eyes). These serious skin rashes usually appear after flu-like symptoms 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 and adolescents

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

Other medicines and Esomeprazol Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because Esomeprazol Krka may affect how some medicines work, and some medicines may influence the effect of Esomeprazol Krka.

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

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection),
• Clopidogrel (used to prevent blood clots),
• Ketoconazole, itraconazole, or voriconazole (for fungal infections),
• Erlotinib (used in cancer treatment),
• Citalopram, imipramine, clomipramine (for treatment of depression),
• Diazepam (used to treat anxiety, as a muscle relaxant, or for epilepsy),
• Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazol Krka,
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Krka.
• Cilostazol (used to treat intermittent claudication – leg pain when walking caused by poor blood flow),
• Cisapride (used for indigestion and heartburn),
• Digoxin (used for heart problems),
• Methotrexate (a chemotherapy medicine used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Esomeprazol Krka,
• Tacrolimus (organ transplant),
• Rifampicin (used to treat tuberculosis),
• St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Esomeprazol Krka to treat ulcers caused by Helicobacter pylori, it is very important that you inform your doctor if you are taking any other medicines.

Taking Esomeprazol Krka with food and drink

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, 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 Krka during this time.

It is unknown whether Esomeprazol Krka passes into breast milk. Therefore, Esomeprazol Krka should not be taken during breastfeeding.

Driving and using machines

Esomeprazole is unlikely to affect your ability to drive or use tools or machines. However, adverse effects such as dizziness or blurred vision may occur infrequently or rarely (see section 4). You should not drive or use machines if you experience any of these effects.

Esomeprazol Krka contains sucrose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Esomeprazol Krka

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• If you take this medicine for a long period of time, your doctor will need to monitor you (especially if you take it for more than one year).

• If your doctor has instructed you to take this medicine only when you experience symptoms, inform your doctor if your symptoms change.

How much to take:

• Your doctor will have told you how many capsules you should take and when to take them. This will depend on your condition, your age, and how well your liver is working.
• The recommended doses are given below:

Use in adults aged 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 gastroresistant esomeprazole capsule (or two 20 mg capsules) once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.

Once the esophagus has healed, the recommended dose is one 20 mg gastroresistant esomeprazole capsule once daily.

• If your esophagus is not affected, the recommended dose is one 20 mg gastroresistant esomeprazole capsule once daily. Once your condition is under control, your doctor may instruct you to take the medicine only when you experience symptoms, up to a maximum of one 20 mg gastroresistant esomeprazole capsule per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori and to prevent their recurrence:

• The recommended dose is one 20 mg gastroresistant esomeprazole capsule twice daily for one week.

• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

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

• The recommended dose is one 20 mg gastroresistant esomeprazole capsule once daily for 4 to 8 weeks.

For the prevention of gastric ulcers in patients taking NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose of esomeprazole 20 mg is one capsule once daily.

Treatment of excessive stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

• The recommended dose is one 40 mg (or two 20 mg) esomeprazole capsule twice daily.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Continuation treatment for prevention of rebleeding from peptic ulcer after intravenous esomeprazole:

• The recommended dose is one 40 mg (or two 20 mg) gastroresistant esomeprazole capsule once daily for 4 weeks.

Use in adolescents aged 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 (or two 20 mg) gastroresistant esomeprazole capsule daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• Once the esophagus has healed, the recommended dose is one 20 mg gastroresistant esomeprazole capsule once daily.
• If your esophagus is not affected, the recommended dose is one 20 mg gastroresistant esomeprazole capsule once daily.
• 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 their recurrence:

• The recommended dose is one 20 mg gastroresistant esomeprazole capsule twice daily for one week.
• Your doctor will also prescribe antibiotics such as, for example, amoxicillin and clarithromycin.

How to take this medicine

• You may take the capsules at any time of day.
• You may 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 granules inside protect the medicine from being affected by stomach acid. 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:

1. Carefully open the capsule and empty the contents (granules) into a glass of still (non-carbonated) water. Do not use other liquids.
2. Stir. Drink the mixture immediately or within the next 30 minutes. Always stir the mixture before drinking it.
3. To ensure you have taken all the medicine, rinse the glass thoroughly by filling it halfway with water and drink it. The solid particles contain the medication. Do not chew or crush the granules.

• If you are unable to swallow in any way, the capsule contents may be mixed with a small amount of water and drawn into a syringe. The mixture can then be administered directly into the stomach via a tube ("gastric tube").

Use in children under 12 years of age

The use of esomeprazole is not recommended in children under 1 year of age. For children between 1 and 11 years of age, capsules are not suitable. Please consult your doctor.

Elderly patients

Dose adjustment is not necessary in elderly patients.

If you take more Esomeprazol Krka than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91-562 04 20, indicating the medicine and the amount ingested.

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, do not take the missed dose.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you have any further questions about 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 everyone experiences them.

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

• Yellowing of the skin, dark urine, and fatigue, which may 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which is very rarely observed.
• Sudden difficulty breathing, swelling of the lips, tongue, throat, or entire body, 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. Severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms (DRESS)”.

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.
• Stomach or intestinal effects: stomach pain, constipation, diarrhea, gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function changes.
• Skin rash, hives, skin itching.
• Fracture of hip, wrist, or spine.

Rare (may affect up to 1 in 1,000 people)

• Blood disorders such as reduced number of white blood cells or platelets. This may cause weakness, bruising, or increased risk of infections.
• Low sodium levels in blood. This may cause vomiting and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Eye disorders such as blurred vision.
• Sudden sensation of breathlessness or difficulty breathing (bronchospasm).
• Inflammation inside the mouth.
• A fungal infection known as “candidiasis” that may affect the esophagus.
• Liver problems including jaundice, which may cause yellowish skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Sunlight-induced dermatitis.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of malaise and lack of energy.
• Increased sweating.

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

• Changes in blood cell counts, including agranulocytosis (reduced number of white blood cells).

• Aggressiveness.

• Seeing, feeling, or hearing things that are not real (hallucinations).

• Liver disorders that may lead to liver failure or brain inflammation.

• Sudden onset of severe skin rash, blisters, or skin peeling. 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.

• Breast enlargement in men.

Frequency not known (cannot be estimated from available data)

• If you are taking esomeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced 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 (which may cause diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Krka may affect white blood cells, causing immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a reduced number of white blood cells (agranulocytosis) via a blood test. It is important that, in such cases, you inform your doctor about the medication you are taking.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Esomeprazole Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazole Krka

• The active substance is esomeprazole. Each capsule contains 20 milligrams of esomeprazole (as esomeprazole magnesium dihydrate).
• The other components (excipients) are sugar spheres (sucrose and maize starch), 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 30 percent in the capsule content (granules); and gelatin (E441), titanium dioxide (E171), and iron oxide red (E172) in the capsule coating. See section 2 “Esomeprazole contains sodium and sucrose”.

Appearance of the product and contents of the pack

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

Capsules are available in blister packs of 14 and 28 in a carton.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

Date of the most recent review of this leaflet: June 2025

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