Omeprazole Viatris Pharmaceuticals 20 mg gastro-resistant hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omeprazol Viatris Pharmaceuticals 20 mg gastro-resistant hard capsules

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 14 days.

Contents of the leaflet

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

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

Omeprazol 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 reflux symptoms (for example, heartburn, acid regurgitation).

Reflux is the backflow of acid from the stomach into the esophagus, which may become inflamed and cause pain. This can lead to symptoms such as a painful burning sensation in the chest rising 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 before experiencing symptom improvement.

You should consult your doctor if your symptoms worsen or do not improve after 14 days.

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

Do not take Omeprazol Viatris Pharmaceuticals:

• If you are allergic to omeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infection).

Do not take Omeprazol Viatris Pharmaceuticals if any of the above apply to you. If you are unsure, talk to your doctor or pharmacist before taking Omeprazol Viatris Pharmaceuticals.

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazol Viatris Pharmaceuticals.

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

Serious skin reactions have been reported with Omeprazol Viatris Pharmaceuticals treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking Omeprazol Viatris Pharmaceuticals and contact your doctor immediately if you experience any of these symptoms related to serious skin reactions described in section 4.

Kidney inflammation may occur during treatment with omeprazole. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. Inform your treating doctor if you notice any of these signs.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Begin vomiting food or vomiting blood.
• Black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• History of gastric ulcer or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or longer.
• Continuously experiencing indigestion or heartburn for 4 weeks or longer.
• Jaundice or severe liver disease.
• Are over 55 years of age and your symptoms have recently changed or are new.
• Have previously had a skin reaction after treatment with a medicine similar to Omeprazol Viatris Pharmaceuticals used to reduce stomach acid.
• Are scheduled to have a specific blood test (Chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, 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 preventive medication.

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

Other medicines and Omeprazol Viatris Pharmaceuticals

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you can buy without a prescription. This is because Omeprazol Viatris Pharmaceuticals may affect how some medicines work, and some medicines may affect Omeprazol Viatris Pharmaceuticals.

Do not take Omeprazol Viatris Pharmaceuticals if you are taking a medicine containing nelfinavir (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)
• 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.
• Medicines used to prevent blood clots, 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 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 Omeprazol Viatris Pharmaceuticals.

Taking Omeprazol Viatris Pharmaceuticals with food and drink

See section 3.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 infant when therapeutic doses are used. Your doctor will decide whether you can take Omeprazol Viatris Pharmaceuticals while breast-feeding.

Driving and using machines

Omeprazol Viatris Pharmaceuticals is unlikely to affect your ability to drive or use tools or machines. Adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

Omeprazol Viatris Pharmaceuticals contains sucrose and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult him 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 Omeprazol Viatris Pharmaceuticals

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 20 mg capsule once daily for 14 days. Contact your doctor if symptoms do not resolve after this time.

You may need to take the capsules for 2-3 consecutive days before experiencing symptom improvement.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may 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 enteric-coated granules designed to prevent the medicine from breaking down due to stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules:

• Open the capsule 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 juice), or apple puree.

• Always shake the mixture well just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.

• To ensure you have taken all the medicine, refill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

Use in children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

If you take more Omeprazol Viatris Pharmaceuticals than you should

If you have taken more omeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Omeprazol Viatris Pharmaceuticals

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Omeprazol Viatris Pharmaceuticals

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

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

4. Possible adverse effects

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

If you notice any of the following rare but serious adverse effects, stop taking Omeprazol Viatris Pharmaceuticals and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. 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 widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and fatigue, which may be signs of liver problems. (rare)

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormalities in blood tests used to monitor liver function.
• Skin rash, hives and itching.
• General feeling of discomfort and lack of energy.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Blood disorders, such as reduced white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing infections.
• Low sodium levels in the blood. This may cause weakness, vomiting and cramps.
• Restlessness, confusion or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection known as “candidiasis” which may affect the intestine.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Serious liver problems leading to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Breast enlargement in males.

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhoea).
• If you are taking Omeprazol Viatris Pharmaceuticals for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present 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 may also lead to reduced levels of potassium or calcium 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, Omeprazol Viatris Pharmaceuticals may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very 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 for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you provide information about the medicines you are taking at that time.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the carton after CAD or EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Viatris Pharmaceuticals

The active substance is omeprazole. This medicine 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 30% (sodium lauryl sulfate, polysorbate 80 and methacrylic acid-ethyl acrylate copolymer), triethyl citrate.

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

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

See section 2. Omeprazol Viatris Pharmaceuticals contains sucrose.

Appearance of the product and contents of the container

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

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 most recent review of this leaflet: June 2025

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