Omeprazole Korhispana 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole KORHISPANA 20 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Omeprazole Korhispana is and what it is used for
2. Before you take Omeprazole Korhispana
3. How to take Omeprazole Korhispana
4. Possible side effects
5. How to store Omeprazole Korhispana
6. Further information

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

Omeprazol Korhispana contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Omeprazol Korhispana is used to treat the following conditions:

In adults:

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazol Korhispana may also be used to prevent the formation of ulcers if you are taking NSAIDs.
• Excess stomach acid 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 flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called "Helicobacter pylori". If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. Before taking Omeprazol Korhispana

Do not take Omeprazol Korhispana

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

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

Take special care with Omeprazol Korhispana

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

• You lose weight significantly without apparent reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your bowel movements are black (blood-stained stools).
• You have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• You have severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol Korhispana used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazol Korhispana. Remember to mention any other symptoms you may notice, such as joint pain.
• When taking omeprazole, inflammation of the kidney may occur. 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. You must report these signs to your treating doctor.
• If you are scheduled to have a specific blood test (chromogranin A).

If you take omeprazole for a long period (more than 1 year), your doctor will likely perform periodic check-ups. You should report any new or unusual symptoms or circumstances during every visit to your doctor.

Use of other medicines

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

Do not take Omeprazol Korhispana 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:

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

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

Taking Omeprazol Korhispana with food and drink

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

Pregnancy and breast-feeding

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

Your doctor will decide whether you can take Omeprazol Korhispana if you are breast-feeding.

Driving and using machines

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

Important information about some of the components of Omeprazol Korhispana

This medicine contains sucrose and lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Omeprazol Korhispana

Follow exactly the instructions for administering Omeprazol Korhispana as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The usual doses are indicated below.

Adults:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If your doctor confirms you have mild damage to the esophagus, the usual dose is 20 mg once daily 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 usual dose once the esophagus has healed is 10 mg once daily.

• If you do not have esophageal damage, the usual dose is 10 mg once daily.

Treatment of upper intestinal ulcers (duodenal ulcer):

• The usual dose is 20 mg once daily 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 daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The usual dose is 20 mg once daily 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 daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

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

Treatment of stomach and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once daily for 4–8 weeks.

Prevention of stomach and duodenal ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The usual dose is 20 mg of Omeprazol Korhispana twice daily for one week.

• Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

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

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

Children:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• Children over one year of age weighing more than 10 kg may take omeprazole. The dose for children is based on body weight, and the doctor will determine the correct dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may take the 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 contain enteric-coated granules that prevent the medicine from breaking down due to stomach acid. It is important not to damage the granules.

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

• If you or your child have difficulty swallowing the capsules:
  • Open the capsule and swallow the contents directly with half a glass of water, or pour the contents into a glass of still water, acidic fruit juice (e.g., apple, orange, or pineapple), or apple puree.
  • Always shake the mixture well just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
  • To ensure you have taken all the medicine, fill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine 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 it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, Omeprazol Korhispana may cause adverse effects, although not everyone experiences them.

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

• Sudden wheezing, swelling of the lips, tongue, throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. These could be signs of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Adverse effects may occur with certain frequencies, defined as follows:

Other adverse effects are:

Common adverse effects

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

Uncommon adverse effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormalities in blood tests used to monitor liver function.
• Skin rash, hives, and itching.
• General feeling of malaise and lack of energy.

Rare adverse effects

• Blood disorders, such as decreased white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection known as “candidiasis” that may affect the intestine.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash, blistering, or skin peeling. 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 males.

In very rare cases, omeprazole may affect the white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever associated with a severely deteriorated general condition, or fever with signs of localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about the medication you are taking at that time.

Frequency unknown:

If you are taking Omeprazol Korhispana for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

If you are taking proton pump inhibitors such as Omeprazol Korhispana, especially for a period longer than one year, there may be a slight increase in 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 rash, possibly with joint pain.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazol Korhispana

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

• Do not use Omeprazol Korhispana after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

• No special storage conditions are required.

• Keep the blister pack in the original outer packaging to protect it from moisture.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Additional Information

Composition of Omeprazol Korhispana

• The active substance is omeprazole. Omeprazol Korhispana capsules contain 20 mg of omeprazole.

• The other components (excipients) are sugar spheres (sucrose and corn starch), anhydrous lactose, hypromellose (hydroxypropylmethylcellulose), sodium lauryl sulfate, hydroxypropylcellulose (hypromellose), disodium hydrogen phosphate dodecahydrate, hypromellose phthalate, diethyl phthalate, gelatin, indigotine (E-132), quinoline yellow (E-104).

Appearance of the product and contents of the container

Omeprazol Korhispana 20 mg capsules consist of a body and a cap, both green in color.

Pack sizes:

Blister packs containing 14, 28 or 56 capsules.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

Laguna, 66-68-70. Polígono Industrial Urtinsa II

28923 Alcorcón

This summary of product characteristics was approved in April 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/