Package Insert: Information for the Patient

OmeprazoleAurovitas Pharma20 mg Hard Gastroresistant Capsules EFG

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated 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.

1.What is Omeprazole Aurovitas Pharma and what it is used for

2.What you need to know before starting to take Omeprazole Aurovitas Pharma

3.How to take Omeprazole Aurovitas Pharma

4.Possible adverse effects

5.Storage of Omeprazole Aurovitas Pharma

6.Contents of the package and additional information

This medicationcontains 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.

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

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 take Omeprazol Aurovitas Pharma:

• 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 other proton pump inhibitors (such as pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medication that contains nelfinavir (used for HIV infection).

Do not take omeprazole if you fall into any of the above cases. If you are unsure, speak with your doctor or pharmacist before taking omeprazole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take omeprazole.

Do not take omeprazole 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.

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

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Starting to vomit food or blood.
• Black stools (blood-stained feces).
• 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.
• Age 55 or older and recent or new symptoms.
• Having had a skin reaction after treatment with a similar medication to omeprazole for reducing stomach acid.
• Planned blood test (Cromogranina 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 omeprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, inflammation in 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.

Patients should not take omeprazole as preventive medication.

Taking Omeprazol Aurovitas Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. Omeprazole may affect the mechanism of action of some medications, and some medications may affect omeprazole.

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

You must inform your doctor specifically if you are takingclopidogrel(used to prevent blood clots).

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 omeprazole treatment.
• Medications used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping omeprazole treatment.
• 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).
• 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 omeprazole treatment.

Taking Omeprazol Aurovitas Pharmawith food and drinks

You can take your capsules with food or on an empty stomach. Do not chew or crush the capsules. Swallow the capsules whole with a glass of water.

Pregnancy and breastfeeding

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

Your doctor will decide if you can take omeprazole if you are breastfeeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use tools or machines.

Adverse effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Omeprazol Aurovitas Pharma 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.

Omeprazol Aurovitas Pharma contains Sodium

This medication contains less than 1 mmol 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 in the stomach's 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 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 solid parts contain the medication; do not chew or crush them.

If you take moreOmeprazole Aurovitas Pharmathan you should

If you have taken more omeprazole than recommended, consult your doctor or pharmacist immediately.

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 takeOmeprazole Aurovitas Pharma

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 medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following rare but serious side effects, stop takingomeprazoleand consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden onset of stridor), 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 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 can 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 stridor.
• Low sodium levels in the blood. This can 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 can affect the intestines and is caused by a fungus.
• Liver problems, such as jaundice, which can 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 onset of intense 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.
• Increased breast size in men.

Side effects of unknown frequency(cannot be estimated from available data)

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

In very rare cases, omeprazole 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 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 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 ofside 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 Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the outer and inner packaging after CAD.: The expiration date is the last day of the month indicated.
• Do not store at a temperature above25 °C.
• Store this medication in the original packaging to protect it from moisture.

Medications 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. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofOmeprazol Aurovitas Pharma

Content of the capsule: sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, and a 30% dispersion of a copolymer of methacrylic acid-ethyl acrylate (1:1).

Capsule coating: gelatin, quinoline yellow, and titanium dioxide.

Appearance of the product and content of the packaging

The gastro-resistant capsules of Omeprazol Aurovitas Pharma 20 mg are yellow opaque, containing white to cream-colored microspheres.

Aluminum blister: 14 capsules.

HDPE bottles with silica gel desiccant in the polypropylene cap: 14 capsules.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

Laboratorios Liconsa, S.A

Av. Miralcampo nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Last review date of this leaflet:November 2023

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