PATIENT INFORMATION LEAFLET

Omeprazol KORHISPANA 40mg hard gastro-resistant capsules

Read this leaflet carefully before you start taking the medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1.What Omeprazol Korhispana is and what it is used for

2.Before taking Omeprazol Korhispana

3.How to take Omeprazol Korhispana

4.Possible side effects

1. Storage of Omeprazol Korhispana

6.Further information

Omeprazol Korhispana 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.

Omeprazol Korhispana 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 with 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). Omeprazol Korhispana 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 with 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 OmeprazolKorhispana

• if you are allergic (hypersensitive) to omeprazole or to any of the other components of Omeprazol Korhispana.
• if you are allergic to medications that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medication that contains nelfinavir (used for HIV infection).

If you are unsure, speak with your doctor or pharmacist before taking Omeprazol Korhispana.

Be especially careful with Omeprazol Korhispana

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

• You lose weight significantly without apparent reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (blood-stained stools).
• You have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• You have had a skin reaction after treatment with a similar medication to Omeprazol Korhispana for reducing stomach acid.

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

• Taking 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.
• If you are scheduled to have a specific blood test (Cromogranin A).

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Omeprazol Korhispana may affect the mechanism of action of some medications, and some medications may affect Omeprazol Korhispana.

Do not take Omeprazol Korhispana if you are taking a medication that contains nelfinavir (used to treat HIV infection).

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

• 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.
• Medications 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)

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

Taking Omeprazol Korhispana with food and drinks

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

Pregnancy and breastfeeding

Before taking Omeprazol Korhispana, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Omeprazol Korhispana during this time.

Your doctor will decide if you can take Omeprazol Korhispana while breastfeeding.

Driving and operating machines

Omeprazol Korhispana 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 operate machines.

Important information about some components of Omeprazol Korhispana

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

Follow exactly the administration instructions for Omeprazol Korhispana indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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

The usual doses are indicated below.

Adults:

Treatment of the symptoms ofGERD, such asheartburn and acid regurgitation:

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

• The usual dose once the esophagus has healed is 10mg once a day.
• If you do not have damage to the esophagus, the usual dose is 10mg once a day.

Treatment of theulcers of the upper part of the small intestine(duodenal ulcer):

• The usual dose is 20mg 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 40mg once a day for 4 weeks.

Treatment of thestomach ulcers(gastric ulcer):

• The usual dose is 20mg 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 40mg once a day for 8 weeks.

Preventionof the recurrenceof thestomach and duodenal ulcers:

• The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40mg once a day.

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

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

Prevention of the ulcers of the stomach and duodenumduring the administration ofNSAIDs:

• The usual dose is 20 mg once a day.

Treatment of theulcers causedby the infectionbyHelicobacter pyloriandprevention of their recurrence:

• The usual 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 the excess acid in the stomach caused by atumor in the pancreas (Zollinger-Ellison syndrome):

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

Children:

Treatment of the symptoms ofGERD, 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 of theulcerscausedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• 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 a cooked apple puree.
  • 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 Korhispana than you should

If you have taken more Omeprazol Korhispana than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Omeprazol Korhispana

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 compensate for the missed doses.

Like all medications, Omeprazol Korhispana may cause side effects, although not everyone will experience them.

If you experience any of the following rare but serious side effects, stop taking Omeprazol Korhispana and consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden onset of bronchospasm), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This may be a case of "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

• 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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results that check liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare side effects

• Blood disorders, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and bronchospasm.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty 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.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Abnormal blood counts, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and inflammation of the brain.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

In very rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a very poor general condition or fever with local infection symptoms, 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.

Unknown frequency:

If you are taking Omeprazol Korhispana 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, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, go to your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as Omeprazol Korhispana, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

Do not worry about this list of possible side effects. You may not experience any of them. If you consider any of the side effects you are experiencing to be 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, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

• Do not use Omeprazol Korhispana after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

• No special storage conditions are required.

• Keep the bottle perfectly closed to protect it from moisture.

• Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Omeprazol Korhispana

• The active ingredient is omeprazole. Omeprazol Korhispana capsules contain, 40mg ofomeprazole.

• The other components (excipients) are sugar spheres (sucrose and cornstarch), sodium carboxymethylstarch, sodium lauryl sulfate, povidone, potassium oleate, hydroxypropylmethylcellulose (hypromellose), copolymer of methacrylic acid and ethyl acrylate (1:1), triethyl citrate, titanium dioxide (E-171), talc, gelatin, quinoline yellow (E-104), erythrosine (E-127), indigotin (E-132), and water.

Appearance of the product and contents of the package

Omeprazol Korhispana 40mg capsules are formed by a orange-colored body and a blue-colored cap.

Package sizes:

HDPE bottles with 14 or 28 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for manufacturing

TEVA PHARMA S.L.U

Polígono Malpica c/ C, nº 4

50016 (Zaragoza)

This prospectus was approved in April 2024

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