Esomeprazole Krka 40 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Esomeprazole 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, as you may need to read it again.

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

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Contents of this leaflet

1. What Esomeprazole Krka is and what it is used for
2. What you need to know before taking Esomeprazole Krka
3. How to take Esomeprazole Krka
4. Possible side effects
5. How to store Esomeprazole 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 from the throat to the stomach), causing pain, inflammation, and heartburn.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment to prevent re-bleeding from peptic ulcer after initial treatment with intravenous esomeprazole.

Adolescents aged 12 years and older

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

2. What you need to know before taking 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 medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used in the treatment of 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 Esomeprazol Krka. 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.
• if you are scheduled to have a specific blood test (chromogranin A).

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

• You lose weight significantly 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 Esomeprazol Krka has been prescribed only to be taken when symptoms occur, you should contact your doctor if 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 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 reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported 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.

Children under 12 years

This medicine must 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, including those 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 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 you when starting or stopping Esomeprazol Krka,
• Medicines used to thin the blood such as warfarin. Your doctor may need to monitor you when starting or stopping Esomeprazol Krka.
• Cilostazol (used to treat intermittent claudication – leg pain while 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 (used in organ transplantation),
• 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 or breastfeeding, think you may be pregnant, or are planning 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 rarely or very rarely (see section 4). Do 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; this is essentially “sodium-free”.

3. How to take Esomeprazol Krka

Follow exactly the administration instructions for esomeprazole as given by your doctor or pharmacist. 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 the 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 liver function.
• The recommended doses are indicated below:

Use in adults from 18 years of age

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

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one 40 mg esomeprazole capsule 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.
• If you have severe liver problems, your doctor may prescribe a lower dose.

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

• The recommended dose is one 40 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 to prevent re-bleeding from peptic ulcer induced by intravenous esomeprazole:

• The recommended dose is one 40 mg esomeprazole capsule once daily for 4 weeks.

Use in adolescents from 12 years of age

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

• If your doctor has determined that your esophagus is mildly affected, the recommended dose is one gastro-resistant esomeprazole 40 mg capsule per day for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
• If you have severe liver problems, your doctor may prescribe a lower dose.

How to take this medicine:

• You may take the capsules at any time of day.
• You may take it with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules (because the granules inside protect the medicine from being affected by stomach acids). It is important not to damage the granules.

What to do if you have trouble swallowing:

• 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 any 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 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 at all, the capsule contents may be mixed with a small amount of water and drawn into a syringe. The mixture will 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. The capsule formulation is not suitable for children between 1 and 11 years of age; 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 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, skip 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 produce adverse effects, although not everyone experiences them.

If you notice any of the following 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.

• 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 onset of a severe skin rash or redness of the skin with blistering or peeling, even after several weeks of treatment. Large blisters and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to severe and widespread liver damage (epidermal and superficial mucosal shedding) with potentially life-threatening consequences. This could be "erythema multiforme," "Stevens-Johnson syndrome," or "toxic epidermal necrolysis."

These effects are very rare and may 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 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.
• 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 or numbness, drowsiness.
• Sensation of vertigo.
• Dry mouth.
• Abnormal blood test results indicating liver function.
• Skin rash, hives, itching.
• Fracture of 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. This may cause weakness, bruising, or increase the likelihood of infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Altered taste.
• Eye disorders such as blurred vision.
• Sudden shortness of breath 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 yellowing of the 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 (reduction in 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 being treated with 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, consult your doctor immediately. Low magnesium levels may also lead to decreased 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 (may lead to diarrhea).
• Skin rash, possibly with joint pain.

In very rare cases, Esomeprazol Krka may affect white blood cells, causing immune deficiency. If you develop an infection with symptoms such as fever accompanied by a severe deterioration in general condition, or fever with signs of a local 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 this case, you inform your doctor about your medication.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the packaging. 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 or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Esomeprazol Krka

• The active substance is esomeprazole. Each capsule contains 40 milligrams of esomeprazole (as esomeprazole magnesium dihydrate).
• The other components (excipients) are sugar spheres (sucrose and corn 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 at 30 percent in the capsule contents (granules), and gelatin, titanium dioxide (E171), and iron oxide red (E172) in the capsule coating. See section 2 “Esomeprazol Krka contains sucrose and sodium”.

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization 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 Authorization 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/).