Prospect: information for the

Omeprazole VIR 20 mg Hard Gastroresistant Capsules EFG

Read the entire prospect carefully before starting to take the medication.

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

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

- This medication has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.

- If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

1. What isOmeprazole VIRand for what it is used

2. Before takingOmeprazole VIR

3. How to takeOmeprazole VIR

4. Possible adverse effects

5. Storage ofOmeprazole VIR

6. Additional informationl

Omeprazol Vircontains 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.

Omeprazol Viris used to treat the following diseases:

Adults:

• Gastroesophageal reflux disease (GERD). In this condition, stomach acid passes 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).Omeprazol VIRmay 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 =10 kg

• “Gastroesophageal reflux disease” (GERD). In this condition, stomach acid passes 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 the return of stomach contents to the mouth (regurgitation), 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 takeOmeprazol Vir

• if you are allergic (hypersensitive) to omeprazole or to any of the other ingredients ofOmeprazol Vir.

• if you are allergic to medications that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).

• if you are taking a medication that contains nelfinavir (used for HIV infection).

If you are unsure, speak with your doctor or pharmacist before takingOmeprazol Vir.

Be especially careful withOmeprazol Vir

Omeprazol Virmay mask the symptoms of other diseases. Therefore, if you experience any of the following symptoms before starting to takeOmeprazol Viror during treatment, consult your doctor immediately:

• You lose weight significantly without apparent reason and have trouble swallowing.

• You have stomach pain or indigestion.

• You start vomiting food or blood.

• Your stools are black (stained with blood).

• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.

• You have severe liver problems.

• If you have ever had a skin reaction after treatment with a similar medication to Omeprazol VIR for reducing stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Omeprazol VIR. Remember to mention any other symptoms you may notice, such as joint pain.

Before taking this medication, inform your doctor if:

• You are scheduled to have a specific blood test (Cromogranina A)

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

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. Inform your doctor of these signs.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Omeprazol Vir may affect the mechanism of action of some medications, and some medications may affect Omeprazol Vir.

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

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

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

• Digoxin (used to treat heart problems)

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

• Fenitoin (used in epilepsy). If you are taking fenitoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol VIR

• Medications used to prevent blood clot formation, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping treatment with Omeprazol VIR

• 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)

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

Taking Omeprazol Vir with food and drinks

You can take your capsules with food or on an empty stomach.

Pregnancy and breastfeeding

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

Your doctor will decide if you can take Omeprazol Vir if you are breastfeeding.

Driving and operating machinery

Omeprazol Vir 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.

Important information about some of the components of Omeprazol Vir

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

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

Follow exactly the administration instructions for Omeprazol Vir indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The usual doses are indicated below.

Adults:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

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

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

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

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

• The usual dose is 20 mg 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 40 mg once a day for 4 weeks.

Treatment ofstomach ulcers(gastric ulcer):

• The usual dose is 20 mg 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 40 mg once a day for 8 weeks.

Preventionof the reappearance ofstomach and duodenal ulcers:

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

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

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

Prevention of stomach and duodenal ulcersduring the administration ofAINEs:

• The usual dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of its reappearance:

• The usual dose is 20 mg of Omeprazol Vir twice a day for a week.

• Your doctor will also tell you to take two antibiotics from the following: amoxicillin,

clarithromycin and metronidazole.

Treatment ofexcess acid in the stomach caused bya tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg a day.

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

Children:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

• Children over one year of age who weigh more than10 kgcan take Omeprazol Vir. The dose for children is based on body weight and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionby Helicobacter pyloriand prevention of its reappearance:

• Children over 4 years can take Omeprazol Vir. The dose for children is based on body weight and your doctor will decide the correct dose.

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

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 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 Vir than you should

If you have taken more Omeprazol Vir 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.

If you forget to take Omeprazol Vir

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.

Like all medications, Omeprazol Vir may cause side effects, although not everyone will experience them.

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

• Sudden hissing sounds while breathing (sibilant breathing), swelling of the lips, tongue, and throat or body, skin rash, dizziness, or difficulty swallowing (severe allergic reaction).

• Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals.

It may be a case of "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".

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

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Frequent side effects

• Headache.

• Gastrointestinal effects: diarrhea, stomach pain, constipation, and gas (flatulence).

• Nausea or vomiting.

• Benign stomach polyps.

Infrequent side effects

• Swelling of the feet and ankles.

• Sleep disturbances (insomnia).

• Dizziness, tingling, drowsiness.

• Feeling 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

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.

• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and sibilant breathing.

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

• Restlessness, confusion, or depression.

• Taste disturbances.

• Visual disturbances, such as blurred vision.

• Sudden feeling 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.

• 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 (arthritis) or muscle pain (myalgia).

• Severe kidney problems (interstitial nephritis).

• Increased sweating.

Very rare side effects

• Abnormal blood counts, 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 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.

• Low magnesium levels in the blood.

In rare cases, Omeprazol Vir may affect white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as high fever and a severely deteriorated 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 that you provide information about the medication you are taking at that time.

Side effects of unknown frequency

If you are taking Omeprazol Vir 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, convulsions, dizziness, and 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.

If you are taking proton pump inhibitors such as Omeprazol Vir, especially for a period of more than a year, you may slightly increase the risk of hip, wrist, or spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they can increase the risk of osteoporosis).

Skin rash, possibly with joint pain.

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 Vigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep out of reach and sight of children.

• Do not use Omeprazol Vir after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

• Store below 30°C

• Store this blister in the original packaging to protect it from moisture.

• Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Omeprazol Vir

- The active ingredient is omeprazole. Omeprazol Vir contains 20 mg of omeprazole.

- The other components are: sugar spheres (sucrose and cornstarch), anhydrous lactose, hypromellose, sodium lauryl sulfate, hydroxypropyl cellulose, disodium dihydrogen phosphate, phthalate of hypromellose, and diethyl phthalate.

The gelatin capsule is composed of: gelatin, indigotin (E-132), and quinoline yellow (E-104).

Appearance of the product and contents of the package

Omeprazol Vir 20 mg capsules are formed by a green body and green cap.

Package sizes:

Packages containing 14, 28, or 56 capsules and a clinical package with 500 capsules.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70, 28923 ALCORCÓN (Madrid)

Spain

Last review date of this leaflet:March 2023

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