OMEPRAZOL AUROVITAS PHARMA 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

OmeprazoleAurovitas Pharma20 mg Hard Gastro-Resistant Capsules EFG

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

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

• Keep this leaflet, 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 mentioned in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 14 days.

Contents of the Package Leaflet

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

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

This medicine 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 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 a doctor if it worsens or does not improve after 14 days.

2. What you need to know before taking Omeprazole Aurovitas Pharma

Do not take Omeprazole Aurovitas Pharma:

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

Do not take omeprazole if you are in any of the above cases. If you are not sure, talk to 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 your symptoms worsen, consult your doctor.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black-colored stools (blood-stained feces).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have a history of stomach ulcers or gastrointestinal surgery.
• You are receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• You have persistent indigestion or heartburn for 4 weeks or more.
• You have jaundice or severe liver disease.
• You are over 55 years old and your symptoms have changed recently or are new.
• If you have ever had a skin reaction after treatment with a medicine similar to omeprazole to reduce stomach acidity.
• A specific blood test (Chromogranin A) is scheduled for you.

If you suffer from 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 omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation may occur. The signs and symptoms can 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 doctor.

Patients should not take omeprazole as a preventive medication.

Taking Omeprazole Aurovitas Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine, including those obtained without a prescription. Omeprazole may affect the mechanism of action of some medicines, and some medicines may affect omeprazole.

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

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

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 omeprazole.
• Medicines used to prevent blood clot formation, 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).
• 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 omeprazole.

Taking Omeprazole Aurovitas Pharma with 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 that 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.

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

Omeprazole Aurovitas Pharma contains Saccharose

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

Omeprazole Aurovitas Pharma contains Sodium

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

3. How to take Omeprazole Aurovitas Pharma

Follow the instructions for administration 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 substance and have an enteric coating that protects them and prevents them from breaking when passing through the stomach. The granules release the active substance in the intestine, where it is absorbed by the body to obtain an effect.

What to do if you have problems swallowing the capsules

• If you 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 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 have taken all the medicine, fill the glass with water to the halfway point, rinse it well, and drink the water. Do not use milk or carbonated water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Aurovitas Pharma than 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Omeprazole Aurovitas Pharma

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.

4. Possible side effects

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

If you notice any of the following serious but rare side effects, stop taking omeprazole 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. Intense blisters and bleeding on the lips, eyes, mouth, nose, and genitals may also appear. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and fatigue, 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 stomach polyps.

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 likelihood 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.
• Taste disturbances.
• 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 fatigue.
• Hair loss (alopecia).
• Skin rash with sun exposure.
• 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)

• Blood count changes, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Sudden appearance of an intense rash, blistering, or peeling of the skin. It 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.

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

• Inflammation of the intestine (which causes diarrhea).
• Hypomagnesemia.
• If you are taking omeprazole for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you have 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 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 important that you provide information about the medicine 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 think any of the side effects you are experiencing 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 mentioned in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Aurovitas Pharma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the outer and inner packaging after EXP.: The expiration date is the last day of the month indicated.
• Do not store above 25 °C.
• Keep this medicine in its original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Omeprazole Aurovitas Pharma

• The active substance is omeprazole. The hard gastro-resistant capsules contain 20 mg of omeprazole.
• The other ingredients are:

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

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

Appearance of the product and contents of the pack

Omeprazole Aurovitas Pharma 20 mg hard gastro-resistant capsules are yellow opaque capsules containing white to off-white spherical microgranules.

Aluminum blister pack: 14 capsules.

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avenida Miralcampo, 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Date of the last revision of this leaflet:November 2023

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/