Package Insert: Information for the User

Omeprazol Viatris Pharmaceuticals20 mg Hard Gastrorresistant Capsules

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

Follow exactly the medication administration instructions 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 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 condition worsens or does not improve after 14 days.

1. What isOmeprazol Viatris Pharmaceuticalsand for what it is used

2. What you need to know before starting to takeOmeprazol Viatris Pharmaceuticals

3. How to takeOmeprazol Viatris Pharmaceuticals

4. Possible adverse effects

5. Storage ofOmeprazol Viatris Pharmaceuticals

6. Contents of the package and additional information

Omeprazol Viatris Pharmaceuticalscontains 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.

This medicineis indicated for adultsfor the short-term treatment of symptoms of acid reflux (for example, heartburn, acid regurgitation).

Acid 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 your doctor if symptoms worsen or do not improve after 14 days.

Do not takeOmeprazol Viatris Pharmaceuticals:

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

Do not takeOmeprazol Viatris Pharmaceuticalsif you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before takingOmeprazol Viatris Pharmaceuticals.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazol Viatris Pharmaceuticals.

Do not take this medication for more than 14 days without consulting your doctor. If you do not experience relief, or if your symptoms worsen, consult your doctor.

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

When taking omeprazole, kidney inflammation 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. You should inform your doctor of these signs.

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

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (hematochezia).
• 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 experiencing recent or new symptoms.
• Having had a skin reaction after treatment with a similar medication to Omeprazol Viatris Pharmaceuticals for reducing stomach acid.
• Planned blood test (chromogranin 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 discontinue treatment with Omeprazol Viatris Pharmaceuticals. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as a preventive medication.

Children and adolescents

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

Other medications and Omeprazol Viatris Pharmaceuticals

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription. This is because Omeprazol Viatris Pharmaceuticals may affect the mechanism of action of some medications and some medications may affect Omeprazol Viatris Pharmaceuticals.

Do not take Omeprazol Viatris Pharmaceuticals if you are taking a medication that contains nelfinavir (used for HIV infection).

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

• Ketoconazole, itraconazole, posaconazole, 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 treatment with Omeprazol Viatris Pharmaceuticals.
• 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 Viatris Pharmaceuticals.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used to treat HIV infection).
• Tacrolimus (used in organ transplants).
• 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).
• 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 treatment with Omeprazol Viatris Pharmaceuticals.

Taking Omeprazol Viatris Pharmaceuticals with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 Omeprazol Viatris Pharmaceuticals while breastfeeding.

Driving and operating machinery

Omeprazol Viatris Pharmaceuticals 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 Viatris Pharmaceuticals contains saccharose and sodium

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.

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

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

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 have 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 with 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 by the action of stomach acid. It is essential not to break the granules.

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 a cooked apple puree.
• 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. The remaining parts contain the medication; do not chew or crush them.

Use in children and adolescents

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

If you take moreOmeprazol Viatris Pharmaceuticalsthan 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 91 562 04 20, indicating the medication and the amount taken.

If you forgot to takeOmeprazol Viatris Pharmaceuticals

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.

If you interrupt treatment with Omeprazol Viatris Pharmaceuticals

Do not interrupt treatment with this medication without first speaking with your doctor or pharmacist.

If you have any other doubts 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 but serious side effects (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people), stop taking Omeprazol Viatris Pharmaceuticals and consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden onset of bronchospasm), 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 on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".(very rare)
• Generalized rash, high body temperature, and inflammation of lymph nodes (DRESS syndrome or drug-induced hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute 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.

Uncommon 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.
• 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 disorders, 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 muscle cramps.
• Agitation, 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).
• 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)

• Blood count abnormalities, 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.
• Polymorphic eruption.

• Muscle weakness.
• Increased breast size in men.

Unknown frequency (cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• If you are taking Omeprazol Viatris Pharmaceuticals for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform 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 regular tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol Viatris Pharmaceuticals may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a severely 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.

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 experience to be severe or if you experience any side effects 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 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 box after CAD or EXP. The expiration date is the last day of the month indicated.

• Blister: Do not store at a temperature above 25°C. Store in the original packaging to protect it from moisture.

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

Composition of Omeprazol Viatris Pharmaceuticals

The active ingredient is omeprazole. This medication contains 20 mg of omeprazole.

The other components are sugar spheres (sucrose and cornstarch), hypromellose, talc, titanium dioxide (E-171), disodium dihydrogen phosphate, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion at 30% (sodium lauryl sulfate, polysorbate 80, and copolymer of methacrylic acid-ethyl acrylate), triethyl citrate

Capsule: gelatin, titanium dioxide (E-171).

Printing ink: iron oxide black (E-172), potassium hydroxide, and shellac.

See section 2, Omeprazol Viatris Pharmaceuticals contains sucrose.

Appearance of the product and content of the container

Omeprazol Viatris Pharmaceuticals capsules are hard gelatin capsules of white opaque color marked with “OM 20” containing spherical granules.

PVC-PVDC/Al blister: 7 and 14 capsules.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing

Towa Pharmaceutical Europe S.L.

C/Sant Marti, 75-97

08107, Martorelles (Barcelona)

Spain

Last review date of this leaflet: March 2023

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