Package Insert: Information for the Patient

Omeprazol Aurovitas Spain 20mg Hard Gastroresistant Capsules EFG

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

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1.What is Omeprazol Aurovitas Spain and what is it used for

2.What you need to know before starting to take Omeprazol Aurovitas Spain

3.How to take Omeprazol Aurovitas Spain

4.Possible adverse effects

5.Storage of Omeprazol Aurovitas Spain

6.Contents of the package and additional information

Omeprazol Aurovitas Spain contains the active ingredient omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These medicines act by reducing the amount of acid produced by the stomach.

Omeprazole is used to treat the following diseases:

Adults:

•Gastroesophageal reflux disease (GERD). In this condition, stomach acid flows up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.

•Ulcers in the upper part of the small intestine (duodenal ulcer) or in the stomach (gastric ulcer).

•Ulcers infected by a bacteria called “Helicobacter pylori”. If you have this disease, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.

•Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). Omeprazole can also be used to prevent the formation of ulcers if you are taking NSAIDs.

•Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

Children:

Children over 1 year of age and weighing = 10 kg

•Gastroesophageal reflux disease (GERD). In this condition, stomach acid flows up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

•Ulcers infected by a bacteria called “Helicobacter pylori”. If your child has this disease, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take Omeprazol Aurovitas Spain

•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. pantoprazole, lansoprazole, rabeprazole, esomeprazole).

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazol Aurovitas Spain.

Severe skin reactions have been reported in relation to omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized pustular psoriasis (AGPP). Stop taking omeprazole and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

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

•Unexplained weight loss and difficulty swallowing.

•Stomach pain or indigestion.

•Vomiting food or blood.

•Black stools (blood-stained stools).

•Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.

•Severe liver problems.

•If you have ever had a skin reaction after treatment with a similar medicine to omeprazole for reducing stomach acid.

•If you are due to have a specific blood test (Cromogranin A).

If you take omeprazole for a long period (more than 1 year), your doctor will probably perform regular check-ups. You should inform your doctor of any new or unusual symptoms and circumstances whenever you visit your doctor.

Taking a proton pump inhibitor like omeprazole, especially for more than a year, may slightly increase the risk of hip, wrist or spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to stop treatment with omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Omeprazole may cause kidney inflammation. 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.

This medicine may affect the way your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

• Extreme fatigue or lack of energy
• Numbness
• Pain or redness in the tongue or mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not administer this medicine to children under 1 year of age or <10>

Other medicines and Omeprazol Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes medicines that can be purchased without a prescription.

This is because 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 containsnelfinavir(used to treat HIV infection).

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

•Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections).

•Digoxin (used to treat heart problems).

•Diazepam (used to treat anxiety, relax muscles or in epilepsy).

•Fenitoin (used in epilepsy). If you are taking fenitoin, your doctor will need to monitor you when you start or stop treatment with omeprazole.

•Medicines used to prevent blood clotting, 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).

•Erlotinib (used to treat cancer).

•Metotrexate (chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of metotrexate, your doctor will need to temporarily stop treatment with omeprazole.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused byHelicobacter pyloriinfection, it is very important to inform your doctor of any other medicines you are taking.

Taking Omeprazol Aurovitas Spain with food and drinks

See section 3 “How to take Omeprazol Aurovitas Spain”.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become 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 omeprazole while breastfeeding.

Driving and using machines

Omeprazole 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.

Omeprazol Aurovitas Spain 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.

Omeprazol Aurovitas Spain contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

The recommended doses are indicated below.

Adults:

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

•If your doctor checks that you have mild damage to the esophagus, the recommended dose is 20mg once a day for 4-8 weeks. Your doctor may prescribe a dose of 40mg for another 8 weeks if the esophagus has not yet healed.

•The recommended dose once the esophagus has healed is 10mg once a day.

•If you do not have damage to the esophagus, the normal dose is 10mg once a day.

Treatment ofulcers in the upper part of the intestine (duodenal ulcer):

•The recommended dose is 20mg once a day for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.

•If the ulcer does not heal completely, the dose may be increased to 40mg once a day for 4 weeks.

Treatment ofstomach ulcers (gastric ulcer):

•The recommended dose is 20mg once a day for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.

•If the ulcer does not heal completely, the dose may be increased to 40mg once a day for 8 weeks.

Preventionof the reappearance ofstomach and duodenal ulcers:

•The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40mg once a day.

Treatment of stomach and duodenal ulcers caused byNSAIDs (nonsteroidal anti-inflammatory drugs):

•The recommended dose is 20 mg once a day for 4-8 weeks.

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

•The recommended dose is 20 mg once a day.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their reappearance:

•The recommended dose is 20 mg of omeprazole twice a day for a week.

•Your doctor will also prescribe two antibiotics, amoxicillin, clarithromycin, and metronidazole.

Treatment ofexcess acid in the stomach caused by atumor in the pancreas (Zollinger-Ellison syndrome):

•The recommended dose is 60 mg per day.

•Your doctor will adjust the dose according to your needs and will also decide for how long you should take the medication.

Use in children and adolescents:

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

•Children over 1 year of age who weigh more than 10 kg may take omeprazole. The dose of children is based on body weight and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their reappearance:

•Children over 4 years may take omeprazole. The dose of children is based on body weight and your doctor will decide the correct dose.

•Your doctor will also prescribe two antibiotics, amoxicillin, and clarithromycin.

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 acid. It is essential not to damage the granules.

What to do if you or your child have trouble swallowing the capsules

•If you or your child 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 a cooked 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 half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Omeprazol Aurovitas Spain than you should

If you have taken more omeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Omeprazol Aurovitas Spain

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 interrupt the treatment withOmeprazol Aurovitas Spain

Do not interrupt the treatment with omeprazole without first talking to your doctor or pharmacist.

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

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

If you experience any of the following rare side effects (may affect up to 1 in 1,000 people) or very rare side effects (may affect up to 1 in 10,000 people) but are severe, stop taking omeprazole 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). (rare)

•Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding in the lips, eyes, mouth, nose, and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)

• Generalized rash, elevated body temperature, and inflammation of lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome). (rare)
• A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis). (rare)

•Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. (rare)

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 disturbances (insomnia).

•Dizziness, tingling sensation, drowsiness.

•Sensation of spinning (vertigo).

•Abnormal blood test results that check liver function.

•Rash on the skin, 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.

•Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.

•Restlessness, confusion, or depression.

•Changes in taste.

•Visual problems, such as blurred vision.

•Sudden sensation of difficulty 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.

•Hair loss (alopecia).

•Rash on the skin 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 test results, 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.

•Erythema multiforme.

•Muscle weakness.

•Enlargement of the breasts in men.

Unknown frequency (frequency cannot be estimated from available data)

•Inflammation in the intestines (causing diarrhea).

•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 lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

•Rash on the skin, 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 deteriorated 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.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 label, carton, and blister after CAD. The expiration date is the last day of the month indicated.

Blister:Do not store at a temperature above 25°C.

Bottle:Do not store at a temperature above 30°C.

Store this blister in the original packaging or keep the bottle perfectly closed to protect it from moisture.

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

Composition ofOmeprazolAurovitas Spain

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

-The other components are sugar spheres (consisting of sucrose, cornstarch, water), dispersion of methacrylic acid-acrylic acid ethyl ester copolymer (1:1), hypromellose, talc, mannitol, macrogol 6000, titanium dioxide (E171), polysorbate 80, disodium phosphate, sodium lauryl sulfate.

Composition of the capsule:gelatin, water, titanium dioxide (E171), yellow quinoline (E104).

Appearance of the product and content of the container

Omeprazol Aurovitas Spain 20 mg capsules are formed by a yellow body and a yellow cap. The capsules contain white to light cream-colored spherical microgranules.

Container sizes:

Blister: 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280, and 500 capsules.

Bottle: 7, 14, 28, 30, 56, 60, 90, 100, and 500 capsules.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7. Industrial Park Miralcampo,

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this leaflet: January 2024

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/).