OMEPRAZOL KRKA 40 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Patient Information Leaflet

Omeprazole Krka 40 mg gastro-resistant hard capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Omeprazole Krka and what is it used for
2. What you need to know before you take Omeprazole Krka
3. How to take Omeprazole Krka
4. Possible side effects
5. Storage of Omeprazole Krka
6. Contents of the pack and further information

1. What is Omeprazole Krka and what is it used for

Omeprazole Krka 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.

Omeprazole is used to treat the following conditions:

In adults:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects 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 caused by a bacteria 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 medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole may be used to prevent ulcers if you are taking NSAIDs.
• Too much acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach), causing pain, inflammation and heartburn. In children, the symptoms of the disease can include return of stomach contents into the mouth (regurgitation), vomiting and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by a bacteria 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. What you need to know before you take Omeprazole Krka

Do not take Omeprazole 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 containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking omeprazole.

Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment. Stop taking omeprazole and contact your doctor immediately if you experience any of these symptoms.

Omeprazole may hide the symptoms of other diseases. Therefore, if you experience any of the following before or while taking omeprazole, contact your doctor immediately:

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (faeces stained with blood).
• If you have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• A specific blood test (Chromogranin A) is planned.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acid.

If you take omeprazole for a long period of time (more than 1 year), your doctor will probably keep you under regular surveillance. You should report any new or unusual symptoms to your doctor whenever you visit them.

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

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as you may need to stop your treatment with omeprazole. Also, mention any other symptoms that you may notice, such as joint pain.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of these signs.

This medicine may affect the way your body absorbs vitamin B12. If you have to take omeprazole for a long time, contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Numbness or tingling
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

Children

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

Other medicines and Omeprazole Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Omeprazole may affect the way some medicines work and some medicines may affect the way omeprazole works.

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

Tell 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 in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking omeprazole
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop taking omeprazole

• 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 (thrombi))
• Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with omeprazole.

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

Taking Omeprazole Krka with food and drinks

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

Pregnancy and breast-feeding

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

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

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur (see section 4). If affected, you should not drive or operate machinery.

Omeprazole Krka contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Omeprazole Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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 GORD, such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild oesophageal damage, 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 oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once a day.
• If you do not have oesophageal damage, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• 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 of gastric ulcers:

• 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 duodenal and gastric ulcers:
• 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 of duodenal and gastric ulcers caused by NSAIDs:

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

Prevention of duodenal and gastric ulcersduring NSAID therapy:

• The recommended dose is 20 mg once a day

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

• The recommended dose is 20 mg of omeprazole twice a day for one week.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

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

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

Use in children and adolescents:

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

• Children over 1 year of age who weigh more than 10 kg can take omeprazole. The dose for children is based on body weight and your doctor will decide the correct dose.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

• Children over 4 years of age 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 medicine

• 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 contain coated granules that prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

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

• If you or your child have problems 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 still water, acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
• Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To make sure you have taken all the medicine, fill the glass with water, rinse it well and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Krka than you should

If you have taken more omeprazole than your doctor prescribed, contact your doctor or pharmacist immediately. You can also contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Omeprazole 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 to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you notice 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 adverse effects, stop taking Omeprazol Krka and consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), 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. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).
• Widespread rash, high body temperature, and inflammation of the lymph nodes (Pharmacological hypersensitivity syndrome) (rare).
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems (rare).

Other adverse effects are:

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

Infrequent Adverse Effects(may affect up to 1 in 100 people):

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Fracture of the hip, wrist, and spine.
• Feeling of general discomfort and lack of energy.

Rare Adverse 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 likelihood of infections.
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste alterations.

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

• 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 Adverse Effects(affect less than 1 patient in 10,000):

• Blood count alterations, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.

• Muscle weakness.
• Increased breast size in males.
• Low magnesium levels in the blood.

Adverse Effects with Unknown Frequency (Cannot be determined from available data):

• Inflammation of the intestine (causing diarrhea).
• If you are taking omeprazole for more than three months, it is possible that magnesium levels in your blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole can affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as neck, throat, 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 that you provide information about the medication you are taking at that time.

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

Reporting Adverse Effects

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

5. Storage of Omeprazol Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 above 30°C.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Omeprazol Krka Composition

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

• The other ingredients are: cornstarch and sucrose; sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, methacrylic acid copolymer, and ethyl acrylate. Capsule components: water, gelatin, titanium dioxide (E-171), and indigo carmine (E 132).

Product Appearance and Package Contents

The capsules are formed by a white opaque body and a blue opaque cap, which contains spherical pellets with enteric coating, white to cream in color.

Package sizes:

Blisters of 14 and 28 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

Azuqueca de Henares (Guadalajara),

Spain

You can request more information about this medicine 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 revision of this prospectus:May 2025

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