Package Insert: Information for the User

Omekaste 20 mg Hard Gastric-Resistant Capsules

Omeprazole

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Omekastecontains omeprazole as its active ingredient. It belongs to a group of medications known as “proton pump inhibitors”. These medications work by reducing the amount of acid produced by the stomach.

Omekasteis indicated for adultsfor the short-term treatment of symptoms of acid reflux (e.g., heartburn, acid regurgitation).

Acid reflux is the backflow of acid from the stomach into the esophagus, which can become inflamed and painful. This can cause symptoms such as a burning sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may need to take the capsules for 2-3 consecutive days to achieve improvement in symptoms.

You should consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take Omekaste

• if you are allergic to omeprazole or any of the other ingredients of this medication (listed in section 6)
• 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 to treat HIV infection)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omekaste.

Do not take Omekaste for more than 14 days without consulting your doctor. If you do not experience relief, or if you feel that your symptoms worsen, consult your doctor.

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

• 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 (hematochezia).
• if you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have a history of gastric ulcers or gastrointestinal surgery.
• you are receiving ongoing treatment for indigestion or stomach acid reflux for 4 weeks or more.
• you continuously experience indigestion or stomach acid reflux for 4 weeks or more.
• you have jaundice or severe liver disease.
• you are over 55 years old and your symptoms have recently changed or are new.
• if you have ever had a skin reaction after treatment with a similar medication to Omekaste for reducing stomach acid.
• you are scheduled to have a specific blood test (Cromogranin A).

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 treatment with Omekaste. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as a preventive medication.

Taking omeprazole may cause inflammation in the kidneys. 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 should inform your doctor of these signs.

Children and adolescents

Children and adolescents under 18 years old should not take this medication.

Other medications and Omekaste

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications purchased without a prescription. This is because Omekaste may affect the mechanism of action of some medications and some medications may affect Omekaste.

Do not take Omekaste 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, posaconazole, 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 treatment with Omekaste.
• medications used to prevent blood clot formation, 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 transplants)
• 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)
• erlotinib (used to treat cancer)
• methotrexate (chemotherapy medication used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with Omekaste.

Taking Omekaste with food and drinks

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Omeprazole passes into breast milk but is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide if you can take Omekaste while breastfeeding.

Driving and operating machinery

Omekaste 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.

Omekaste contains saccharose

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.

Omekaste contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

The recommended dose is one 20 mg capsule once a day for 14 days. Contact your doctor if symptoms do not disappear after this time.

You may need to take the capsules for 2-3 consecutive days to achieve symptom improvement.

How to take this medication

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or with an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain granules coated with a substance that prevents the medication from breaking down in the stomach acid. It is essential not to spit out the granules. These granules contain omeprazole as the active ingredient and have a rich coating that protects them and prevents them from breaking down when they pass through the stomach. The granules release the active ingredient in the intestine, where it is absorbed by the body to produce an effect.

What to do if you have trouble swallowing the capsules

• If you 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 citrus 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 the halfway point, rinse it well, and drink the water.Do not use milk or carbonated water. The undissolved parts contain the medication; do not chew or crush them.

Use in children and adolescents

Children and adolescents under 18 years old should not take this medication.

If you take moreOmekastethan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeOmekaste

If you forgot 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 medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following rare but serious side effects, stop taking Omekaste 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).
• Redness of the skin with blistering or peeling. Intense blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This may be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

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.

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, 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 (may affect up to 1 in 1,000 people)

• Blood disorders, such as a decrease in white blood cells or platelets. This may 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 sibilance.
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps.
• Agitation, 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 may affect the intestines and is caused by a fungus.
• Liver problems, such as jaundice, which may 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 (may affect up to 1 in 10,000 people)

• Abnormal blood counts, 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.
• 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.

Unknown frequency (cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• Hypomagnesemia.
• Skin rash, possibly with joint pain.

In rare cases, Omekaste may affect white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a very deteriorated general state 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 not listed in this prospectus. You can alsoreport them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

Aluminum/Aluminum Blister:Store below 30°C.Store in the original packaging to protect it from moisture.

PVC-PVDC/Al Blister:Store below 25°C. Store in the original packaging to protect it from moisture.

Bottle:This medication does notrequire special storage conditions.Keep the bottle perfectly closed to protect it from moisture.

Validity period after the first opening of the bottle: 100 days.

Medicines should not be thrown away through the drains or in the trash.Deposit the packaging and medicines that you do not need at the SIGRE pointof the pharmacy. In case of doubt, please ask your pharmacisthow to dispose ofthepackaging and themedicines that you do notneed.By doing so, you will help protect the environment.

Composition of Omekaste

• The active ingredient is omeprazole. Each hard capsule contains 20 mg of omeprazole.
• The other components are: sugar spheres (sucrose and cornstarch), hypromellose , talc, titanium dioxide (E-171), sodium dihydrogen phosphate dihydrate, copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion, 30% (sodium lauryl sulfate, polysorbate 80, and copolymer of methacrylic acid and ethyl acrylate), triethyl citrate. Hard gelatin capsule : Body and cap: gelatin and titanium dioxide (E-171). Ink for printing : black ink (shellac, propylene glycol, potassium hydroxide, and iron oxide black (E-172)).

Appearance of the product and contents of the packaging

Hard gelatin capsules, white, opaque, (number #3) marked with “OM” on the cap and with the number “20” on the body, contain spherical pellets.

It is presented in HDPE white bottles with a cap and safety ring equipped with a desiccant. Each package contains 7 or 14 capsules.

It is presented in Alu/Alu blisters. Each package contains 7 or 14 capsules.

It is presented in PVC-PVDC/Alu blisters. Each package contains 7 or 14 capsules.

Some packaging sizes may only be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

TOWA PHARMACEUTICAL EUROPE S.L.

C/ de Sant Martí, 75-97 , Martorelles, 08107 Barcelona, Spain

Last review date of this leaflet: March 2023

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