OMEREFLUX 20 mg GASTRO-RESISTANT HARD CAPSULES

Read the entire leaflet carefully before starting to take this medicine, as it contains

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

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

Contents of the leaflet

1. What is Omereflux and what is it used for
2. What you need to know before taking Omereflux
3. How to take Omereflux
4. Possible side effects
5. Storage of Omereflux
6. Package contents and additional information

1. What is Omereflux and what is it used for

Omereflux contains the active ingredient 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.

Omereflux is indicated in adults for the short-term treatment of reflux symptoms (e.g., heartburn, acid regurgitation).

Reflux is the rise of acid from the stomach to the esophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest that rises 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 your doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omereflux

DonottakeO

?

?

?

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 your symptoms worsen, consult your doctor.

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

• Losing a lot of weight without apparent reason and having trouble swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomiting blood.
• Having black-colored stools (bloody stools).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Having a history of stomach ulcers or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Having persistent indigestion or heartburn for 4 weeks or more.
• Having jaundice or severe liver disease.
• Being over 55 years old and having recently changed or new symptoms.
• If you have ever had a skin reaction after treatment with a medicine similar to Omereflux to reduce stomach acidity.
• It is planned to perform a specific blood test (Chromogranin A) on you.

If you experience a skin rash, especially in areas of the skin exposed to the sun, 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 a preventive medication.

When taking omeprazole, kidney inflammation may occur. The 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 report these signs to your treating doctor.

Childrenandadolescents

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

OthermedicinesandOmereflux

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. This includes medicines obtained 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 contains nelfinavir(used to treat HIV infection).

Tell 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 in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Omereflux.
• 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 treatment with 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)).
• Erlotinib (used to treat cancer).
• Methotrexate (chemotherapy medicine 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,breast-feedingandfertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide if you can take Omereflux if you are breast-feeding.

Drivingandusingmachines

Omereflux is unlikely to affect your ability to drive or use tools or machines. 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), andsodium

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".

3. How to take Omereflux

Follow the administration instructions of the medicine contained in this leaflet or as 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 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 breaking down due to the action of stomach acid. It is important not to damage the granules. These granules contain omeprazole as the active ingredient and have an enteric coating that protects them and prevents them from breaking when passing 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 still water, acidic 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 you take all the medicine, fill the glass with water to the half, rinse it well, and drink the water. Do not usemilk or carbonated water. The solid parts contain the medicine; do not chew or crush them.

Use in children and adolescents

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

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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omereflux

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• Sudden wheezing, 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. There may also be blisters and bleeding in the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and tiredness, which can be symptoms of liver problems.

Other side effects are:

Common side 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.

Uncommon side 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).

? Changes in blood tests that check liver function.

? Skin rash, hives, and itching.

? Feeling of general discomfort and lack of energy.

Rare side effects (may affect up to 1 in 1,000 people)

? Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.

? Allergic reactions, sometimes very severe, which include swelling of the lips, tongue, and throat, fever, and wheezing.

? 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 difficulty breathing (bronchospasm).

? Dry mouth.

? Inflammation of the mouth.

? Infection called "candidiasis" that can affect the intestine and is caused by a fungus.

? Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and tiredness.

? Hair loss (alopecia).

? Skin rash with sun exposure.

? Joint pain (arthralgia) or muscle pain (myalgia).

? Serious kidney problems (interstitial nephritis).

? Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

? Changes in blood count, such as agranulocytosis (lack of white blood cells).

? Aggression.

? Seeing, feeling, or hearing things that do not exist (hallucinations).

? Serious liver problems that cause liver failure and brain inflammation.

? Sudden appearance of a severe rash, blistering, or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

? Muscle weakness.

? Enlargement of the breasts in men.

Frequency not known (cannot be estimated from available data)

? Inflammation of the intestine (which causes diarrhea).

? Hypomagnesemia.

? Skin rash, possibly with joint pain.

In very rare cases, Omereflux may affect the white blood cells in the blood 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 sore throat, mouth, 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 medicine you are taking at that time.

Do not worry about this list of possible side effects. You may not get any of them. If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omereflux

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

Do not use this medicine after the expiration date stated on the carton and blister after EXP. 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 via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

CompositionofOmereflux

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

The other ingredients are:

Sugar spheres (sucrose and cornstarch), hypromellose, talc, titanium dioxide (E-171), disodium hydrogen phosphate dihydrate, methacrylic acid copolymer, 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.

Appearanceoftheproductandpackagecontents

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

They come in PVC-PVDC/Al blisters: 7 and 14 capsules.

Marketingauthorizationholderandmanufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (Spain)

Dateoflastrevisionofthisleaflet:February 2024

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/