OMEPRAZOL VIATRIS PHARMACEUTICALS 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Viatris Pharmaceuticals20 mg hard gastro-resistant capsules

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 listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet

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

1. What is Omeprazole Viatris Pharmaceuticals and what is it used for

Omeprazole Viatris Pharmaceuticals 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.

This medicine is indicated in adults for the short-term treatment of symptoms of reflux (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 your doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omeprazole Viatris Pharmaceuticals

Do not takeOmeprazole Viatris Pharmaceuticals:

• If you are allergic to omeprazole or any of the other components 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 takeOmeprazole Viatris Pharmaceuticalsif you are in any of the above cases. If you are not sure, talk to your doctor or pharmacist before takingOmeprazole Viatris Pharmaceuticals.

Warnings and precautions

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

Do not take this medicine 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 Omeprazole Viatris Pharmaceuticals, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking Omeprazole Viatris Pharmaceuticals and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

Kidney inflammation may occur when taking omeprazole. 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 report these signs to your doctor.

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

• 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.
• A history of stomach ulcers or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Continuously suffering from indigestion or heartburn for 4 weeks or more.
• Suffering from jaundice or severe liver disease.
• Being over 55 years old and having recently changed or new symptoms.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Viatris Pharmaceuticals to reduce stomach acidity.
• Being scheduled for a specific blood test (Chromogranin A).

If you experience 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 Viatris Pharmaceuticals. Remember to mention any other symptoms you may notice, such as joint pain.

Patient should not take omeprazole as a preventive medication.

Children and adolescents

Children and adolescents under 18 years should not take this medicine.

Other medicines and Omeprazole Viatris Pharmaceuticals

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Omeprazole Viatris Pharmaceuticals may affect the way some medicines work and some medicines may affect Omeprazole Viatris Pharmaceuticals.

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

Tell 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)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Omeprazole Viatris Pharmaceuticals.
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop treatment with Omeprazole Viatris Pharmaceuticals
• 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 (thrombi))
• 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 Viatris Pharmaceuticals.

Taking Omeprazole Viatris Pharmaceuticals with food and drinks

See section 3.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole passes into breast milk but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide whether you can take Omeprazole Viatris Pharmaceuticals if you are breastfeeding.

Driving and using machines

Omeprazole 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 this happens, do not drive or use machines.

Omeprazole Viatris Pharmaceuticals contains sucrose and sodium

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

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

3. How to take Omeprazole Viatris Pharmaceuticals

Follow the instructions for administration of the medicine contained in this leaflet or as 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 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 being broken down by the acid in the stomach. It is important not to damage the granules.

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 non-carbonated 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 make sure you have taken all the medicine, fill the glass with water to about half, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

Use in children and adolescents

Children and adolescents under 18 years should not take this medicine.

If you take more Omeprazole Viatris Pharmaceuticals 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Omeprazole Viatris Pharmaceuticals

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.

If you stop taking Omeprazole Viatris Pharmaceuticals

Do not stop taking this medicine without talking to your doctor or pharmacist first.

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

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 Viatris Pharmaceuticals 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). (rare)
• Redness of the skin with blistering or peeling. Blisters or bleeding in the lips, eyes, mouth, nose, and genitals may also appear. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (rare)

Other side effects are:

Common 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 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 risk of infection.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• An infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash with sun exposure.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious 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).
• Serious liver problems that cause liver failure and brain inflammation.
• Erythema multiforme.

• Muscle weakness.
• Enlargement of the breasts in men.

Frequency not known(cannot be estimated from the available data)

• Inflammation of the intestine (which causes diarrhea).
• If you are treated with Omeprazole Viatris Pharmaceuticals for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazole Viatris Pharmaceuticals 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 sore throat, 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 are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Viatris Pharmaceuticals

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after CAD or EXP. The expiry date is the last day of the month shown.

• Do not store above 25°C. Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofOmeprazol Viatris Pharmaceuticals

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

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

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

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

See section 2, Omeprazol Viatris Pharmaceuticals contains sucrose.

Product Appearance and Packaging Contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Towa Pharmaceutical Europe S.L.

C/Sant Marti, 75-97

08107, Martorelles (Barcelona)

Spain

Date of the Last Revision of this Leaflet:June 2025

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.