Package Leaflet: Information for the Patient

Omeprazole Krka 40mg Hard Capsules

Read 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. 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Omeprazol Krka contains the active ingredient omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These medicines act by reducing the amount of acid produced by the stomach.

Omeprazole is used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected by a bacteria called “Helicobacter pylori”. If you have this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). Omeprazole can also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and≥10 kg

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
  In children, the symptoms of the disease may include the return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacteria called “Helicobacter pylori”. If your child has this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Omeprazol Krka

• If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine that contains nelfinavir (used for HIV infection).

If you are unsure, talk to your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazole.

Severe skin reactions have been reported in relation to omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustular psoriasis (AGPP). Stop taking omeprazole and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

Omeprazole may mask the symptoms of other diseases.Therefore, if you experience any of the following symptoms before starting to take omeprazole or during treatment, consult your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Abdominal pain or indigestion.
• Starting to vomit food or blood.
• Black stools (blood-stained stools).
• Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.
• Planned blood test (Cromogranin A).
• If you have ever had a skin reaction after treatment with a similar medicine to omeprazole for reducing stomach acid.

If you take omeprazole for a long period (more than 1 year), your doctor will probably perform regular check-ups. Inform your doctor of any new or unusual symptoms and circumstances whenever you visit your doctor.

If you are taking proton pump inhibitors like omeprazole, especially for more than a year, you may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt omeprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

Omeprazole may cause kidney inflammation. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your doctor of these signs.

This medicine may affect the way your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

• Extreme fatigue or lack of energy.
• Tingling.
• Pain or redness in the tongue or mouth ulcers.
• Muscle weakness.
• Visual disturbances.
• Memory problems, confusion, or depression.

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not administer this medicine to children under 1 year of age or <10

Other medicines and Omeprazol Krka

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medicines.

Omeprazole may affect the mechanism of action of some medicines and some medicines may affect omeprazole.

Do not take omeprazole if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

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

• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart problems).
• Diazepam (used to treat anxiety, relax muscles, or epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping omeprazole treatment.
• Medicines used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazole treatment.

• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in cases of organ transplantation).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).
• Cilostazol (used to treat intermittent claudication).
• Saquinavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Methotrexate (a chemotherapy drug used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily interrupt omeprazole treatment.

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor of any other medicines you are taking.

Taking Omeprazol Krka with food and drinks

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

Pregnancy and breastfeeding

Before taking omeprazole, inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will decide if you can take omeprazole during this time.

Your doctor will decide if you can take omeprazole if you are breastfeeding.

Driving and operating machines

Omeprazole is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Omeprazol Krka contains saccharose

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

The recommended dose is described below.

Use in adults:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, the recommended dose is 20 mg once a day for 4‑8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The recommended dose once the esophagus has healed is 10 mg once a day.
• If you do not have damage to the esophagus, the normal dose is 10 mg once a day.

Treatment ofulcers of the upper part of the intestine(duodenal ulcer):

• The recommended dose is 20 mg once a day for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment ofstomach ulcers(gastric ulcer):

• The recommended dose is 20 mg once a day for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 8 weeks.

• Preventionof the reappearanceof stomach and duodenalulcers:
• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment ofulcers of the stomach and duodenum caused by NSAIDs(nonsteroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once a day for 4‑8 weeks.

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The recommended dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their reappearance:

• The recommended dose is 20 mg of omeprazole twice a day for a week.
• Your doctor will also tell you to take two antibiotics, amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by atumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medication.

Use in children and adolescents:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

• Children over one year of age who weigh more than10 kgcan take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcerscausedby the infectionbyHelicobacter pyloriand prevention of their reappearance:

• Children over 4 years old can take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin, and clarithromycin, for your child.

How to take this medication

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they containcoated granulesthat prevent the medication from breaking down in the stomach acid. It is essential not to damage thegranules.

What to do if you or your child have trouble swallowing the capsules

• If you or your child have trouble swallowing the capsules:

• Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of water without gas, a sour fruit juice (e.g., apple, orange, or pineapple) or apple sauce.
• Always shake the mixture just before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.
• To ensure that all the medication has been taken, fill the glass of water to half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Omeprazol Krka than you should

If you have taken more omeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately.You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Omeprazol Krka

If you forget to take a dose, take it as soon as you remember. However, if there is little time left for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of thismedication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Omeprazol Krka and consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden sibilance), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding in the lips, eyes, mouth, nose, and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• Generalized rash, elevated body temperature, and inflammation of lymph nodes (pharmacological hypersensitivity syndrome) (rare).
• A red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems (rare).

Other side effects are:

Frequent side effects(may affect up to 1 in 10 people):

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon side effects(may affect up to 1 in 100 people):

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results that check liver function.
• Rash on the skin, hives, and itching.
• Fracture of the hip, wrist, and spine.
• General feeling of discomfort and lack of energy.

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

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Low sodium concentration in the blood. This can cause weakness, vomiting, and muscle cramps.
• Restlessness, confusion, or depression.
• Changes in taste.

• Visual problems, such as blurred vision.
• Sudden sensation of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis" that can affect the intestines and is caused by a fungus.

• Hair loss (alopecia).
• Rash on the skin with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects(affect less than 1 in 10,000 patients):

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.

• Muscle weakness.
• Enlargement of the breasts in men.
• Low magnesium concentration in the blood.

Side effects of unknown frequency (Cannot be determined from available data):

• Inflammation of the intestines (causing diarrhea).
• If you are taking omeprazole for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Rash on the skin, possibly with joint pain.

In very rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a general state of deterioration or fever with symptoms of local infection, such as neck pain, throat pain, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential to provide information about the medication you are taking at that time.

Do not worry about this list of possible side effects. You may not experience any of them. If you consider that any of the side effects you experience are severe or if you experience any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication 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 above30°C.

Store the blister pack in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at theSIGREcollection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Omeprazol Krka

• The active ingredient is omeprazole.Omeprazol Krka capsules contain 40mg of omeprazole.

-The other components are: cornstarch and sucrose; sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, poloxamer 80, titanium dioxide, methacrylic acid copolymer and ethyl acrylate copolymer.Components of the capsule: water, gelatin, titanium dioxide (E-171) andindigo carmine (E 132).

Appearance of the product and content of the packaging

The capsules are formed by an opaque white body and an opaque blue cap, containing spherical pellets with enteric coating, white to cream-colored.

Packaging sizes:

Blister packs of 14 and 28 capsules.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

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

Responsible for Manufacturing

Laboratorios Liconsa, S.A.,Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo,19200

Azuqueca de Henares (Guadalajara),

Spain

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

Last review date of this leaflet:May 2025

The 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/