Package Leaflet: Information for the User

Esomeprazole Krka 40 mg Hard Capsules (Gastro-Resistant, Enteric Coated)

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as 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 even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Esomeprazol Krkacontains a medicine called esomeprazole that belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced by the stomach.

Esomeprazoleis used for the treatment of the following disorders:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.
• Excessive stomach acid produced by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Continuation treatment for the prevention of bleeding from peptic ulcers induced with esomeprazole intravenously

Adolescents 12 years of age and older

• Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach rises up into the esophagus (the tube that goes from the throat to the stomach) causing pain, inflammation, and burning.

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 that contains nelfinavir (used in the treatment of HIV infection).

If you find yourself in any of these situations, do not take Esomeprazol Krka. If you are unsure, consult your doctor or pharmacist before taking Esomeprazol Krka.

Warnings and precautions

Consult 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 similar medicine to Esomeprazol Krka to reduce stomach acid.
• if you are due to have a specific blood test (Cromogranin A).

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

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

If you have been prescribed Esomeprazol Krka only when you notice some symptoms, you should contact your doctor if the symptoms of the disease persist or change.

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

Rashes and skin symptoms

If you suffer a rash, especially on areas of skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Esomeprazol Krka. Remember to mention any other symptoms you may notice, such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may include mouth ulcers, throat, nose, genital, and conjunctivitis (red and swollen eyes). These severe skin rashes usually appear after similar symptoms to flu, 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 under 12 years

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

Other medicines and Esomeprazol Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription. This is because Esomeprazol Krka may affect the way some medicines work and some medicines may influence the effect of Esomeprazol Krka.

Do not take Esomeprazol Krka if you are taking a medicine that contains nelfinavir (used for the treatment of HIV infection).

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

• Atazanavir (used for the treatment of HIV infection),
• Clopidogrel (used for the prevention of blood clots),
• Ketoconazole, itraconazole, or voriconazole (for fungal infections),
• Erlotinib (used in cancer treatment),
• Citalopram, imipramine, clomipramine (for depression treatment),
• Diazepam (used for anxiety treatment, as a muscle relaxant or for epilepsy),

• Fenitoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor when you start or stop taking Esomeprazol Krka.

• Medicines used to make blood thinner such as warfarin. Your doctor may need to monitor when you start or stop taking Esomeprazol Krka.

• Cilostazol (used for intermittent claudication – leg pain when walking caused by poor blood circulation),
• Cisapride (used for indigestion and heartburn),
• Digoxin (used for heart problems),
• Metotrexate (chemotherapy used at high doses in cancer treatment) – if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Esomeprazol Krka,
• Tacrolimus (organ transplant),
• Rifampicin (used for tuberculosis treatment),
• 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 to inform your doctor if you are taking any other medicine.

Taking Esomeprazol Krka with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, if you think you may be pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide if you can take Esomeprazol Krka during this period.

The safety of Esomeprazol Krka for use during pregnancy has not been established. Therefore, Esomeprazol Krka should not be taken during pregnancy.

Driving and operating machinery

Esomeprazole is unlikely to affect your ability to drive or use tools or machines. However, rare side effects such as dizziness or blurred vision may occur (see section 4). Do not drive or use machines if you notice any of these side effects.

Esomeprazol Krka contains saccharose and sodium

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

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

Follow exactly the administration instructions for esomeprazol indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

• If your doctor has indicated that you take this medication only when you notice some symptoms, inform your doctor if the symptoms change.

How much to take:

• Your doctor will indicate how many capsules you should take and when to take them. This will depend on the pathology, your age, and the functioning of your liver.
• The recommended doses are indicated 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 capsule of esomeprazol 40 mg once a day for 4 weeks. Your doctor may indicate that you take 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 tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is one capsule of esomeprazol 40 mg twice a day.
• Your doctor will adjust the dose according to your needs and also decide for how long you should take this medication. The maximum dose is 80 mg twice a day.

Continuation treatment for the prevention of bleeding from peptic ulcers induced by esomeprazol intravenous:

• The recommended dose is one capsule of esomeprazol 40 mg once a day 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 gastric-resistant capsule of esomeprazol 40 mg per day for 4 weeks. Your doctor may indicate that you take 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 medication

• You can take the capsules at any time of the day.
• You can 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 they contain protect the medication from being affected by the stomach acid). It is essential not to damage the granules.

What to do if you have trouble swallowing:

• If you have difficulty swallowing the capsules:

1. Open the capsule carefully and empty the contents of the capsule (granules) into a glass of water without gas. Do not use other liquids.
2. Stir. Drink the mixture immediately or within the next 30 minutes. Always rinse the mixture before drinking it.
3. To ensure that you have taken all the medication, fill the glass with water up to the middle and drink it. The solid particles contain the medication. Do not chew or crush the granules.

• If you cannot swallow in any way, the contents of the capsule can be mixed with a little water and introduced into a syringe. Then it will be administered directly into the stomach with a tube ("gastric 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, capsules are not suitable. Consult your doctor.

Older adults

No dose adjustment is necessary for older adults.

If you take more Esomeprazol Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91-562 04 20, indicating the medication 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 once) to compensate for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Esomeprazol Krka can cause side effects, although not everyone will experience them.

If you notice any of the following side effects, stop taking Esomeprazol Krka and contact your doctor immediately:

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

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

• Sudden difficulty breathing, swelling of the lips, tongue, and throat or body in general, skin rash, fainting, or difficulty swallowing (severe allergic reaction)

These side effects are rare and may 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. Blisters may also appear and bleeding from the lips, eyes, mouth, nose, and genitals may occur. Skin rashes may turn into severe and widespread liver damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. It could be a “multiform erythema”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”, or “drug reaction with eosinophilia and systemic symptoms”.

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

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• Headache
• Effects on the stomach or intestines: stomach pain, constipation, diarrhea, gas
• Nausea or vomiting
• Benign stomach polyps

Occasional (may affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Sleep disturbance (insomnia)
• Dizziness, tingling, numbness, somnolence
• Sensation of vertigo
• Dry mouth
• Abnormal blood tests that determine liver function
• Skin rash, urticaria, itching
• Fracture of the hip, wrist, or spine (if esomeprazol 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 may cause weakness, bruising, or an increased risk of infections
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps
• Restlessness, confusion, or depression
• Alteration of taste
• Eye disorders such as blurred vision
• Sudden sensation of lack of air or difficulty breathing (bronchospasm)
• Inflammation in the interior of the mouth
• An infection known as “candidiasis” that may affect the esophagus and is caused by a fungus
• Liver problems including jaundice that may cause yellow skin, dark urine, and fatigue
• Hair loss (alopecia)
• Sunlight-induced dermatitis
• Joint pain (arthritis) 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
• To see, feel, or hear things that do not exist (hallucinations)
• Liver disorders that may lead to liver failure or brain inflammation
• Sudden appearance of severe skin rash, blisters, or peeling of the skin. 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

• Increased breast size in men

Frequency unknown (cannot be estimated from available data)

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

In rare cases, Esomeprazol Krka may affect white blood cells, causing immunodeficiency. If you have an infection with symptoms such as high fever and severe worsening of your general condition or fever with symptoms of a local infection such as neck pain, throat pain, mouth pain, 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 essential to inform your doctor about your medication in this case.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not usethis medicationafter the expiration date (EXP) shown on the packaging. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash.Deposit empty containers and unused medicines at the SIGRE point of your pharmacy.In case of doubtask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

Composition of Esomeprazol Krka

• The active ingredient is esomeprazole. Each capsule contains 40 milligrams of esomeprazole (as 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 copolymer of methacrylic acid - ethyl acrylate (1:1) dispersion at 30 percent in the capsule content (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 packaging

The body and the coating 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 sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

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

You can request more information about this medication 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 review of this leaflet: November 2023

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