Prospect: Information for the User

Omereflux 20 mg Hard Gastric-Resistant Capsules

Omeprazole

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

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read 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 prospect. See section 4.
• You should consult a doctor if you worsen or do not improve after 14 days.

Contents of the prospect

1. What Omereflux is and for what it is used
2. What you need to know before starting to take Omereflux
3. How to take Omereflux
4. Possible adverse effects
5. Storage of Omereflux
6. Contents of the package and additional information

Omereflux contains 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.

Omereflux is indicated for adults for 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 an improvement in symptoms.

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

Do not takeOmereflux

?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. Pantoprazol, lansoprazol, rabeprazol, esomeprazol).

?If you are taking a medicine that contains nelfinavir (used for HIV infection).

Warningsandprecautions

Consult your doctor or pharmacist before starting to take Omereflux.

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

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

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Starting to vomit food or blood.
• Black stools (hematochezia).
• Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• History of gastric ulcer or gastrointestinal surgery.
• Receiving continuous treatment for heartburn or stomach acid for 4 weeks or more.
• Continuously experiencing heartburn or stomach acid for 4 weeks or more.
• Jaundice or severe liver disease.
• Over 55 years old and your symptoms have recently changed or are new.
• Ever had a skin reaction after treatment with a similar medicine to Omereflux for reducing stomach acid.
• Planned blood test (Chromogranin 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 Omereflux. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as preventive medication.

When taking omeprazole, inflammation of the kidneys 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. Inform your doctor of these signs.

Children and adolescents

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

Other medicines andOmereflux

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

Do not take Omereflux if you are taking a medicine that containsnelfinavir(used to treat HIV infection).

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

• 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 Omereflux.
• 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 treatment with omeprazole.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (in cases of organ transplant).
• 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 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 Omereflux.

Taking Omereflux with food and drinks

See section 3.

Pregnancy,breastfeedingandfertility

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

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 Omereflux if you are breastfeeding.

Drivingandoperatingmachines

Omereflux 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.

Omereflux contains saccharose, ponceau 4R (E124) and sodium

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

This medicine may cause allergic reactions due to the presence of Ponceau 4R (E124).

This medicine 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 an improvement in symptoms.

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 contain coated granules that prevent the medication from breaking down due to stomach acid. It is essential not to damage the granules. These granules contain omeprazole as the active ingredient and have an enteric coating that protects 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 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 the halfway point, rinse it well, and drink the water.Do not usemilk or carbonated water. The solid 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.

What to do if you take more Omereflux than you should

If you have taken more Omereflux 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 taken.

What to do if you forget to take Omereflux

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.

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

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 Omereflux 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. Intense blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This could be "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.

Less frequent 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 help 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 problems, 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 bronchospasm.

?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, Omereflux may affect white blood cells in the blood and cause immunodeficiency. If you experience 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.

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 or pharmacist, 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 Pharmacovigilance 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 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 box and on the blister after CAD. The expiration date is the last day of the month indicated.

PVC-PVDC/Al blister: Store below 30°C. Store in the original packaging to protect it from moisture.

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

Composition ofOmereflux

The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.

The other components are:

Sugar spheres (sucrose and cornstarch), hypromellose, talc, titanium dioxide (E-171), dihydrogen phosphate disodium dihydrate, copolymer of methacrylic acid and ethyl acrylate (sodium lauryl sulfate, polysorbate 80) and triethyl citrate.

The gelatin capsule is composed of: titanium dioxide (E-171), Ponceau 4R (E-124) and gelatin.

Appearance of the product and content of the packaging

Omereflux 20 mg are hard gelatin capsules of white opaque/red opaque color, with dimensions of 15.8 mm ± 0.3 mm.

They are presented in PVC-PVDC/Al blister: 7 and 14 capsules.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (Spain)

Revision date of this leaflet:February 2024

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