Package Leaflet: Information for the User

Omeprazol farmaMabo 20 mg Hard Capsules

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained 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 not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 14 days.

1. What isOmeprazol farmaMaboand what it is used for

2. What you need to know before starting to takeOmeprazol farmaMabo

3. How to takeOmeprazol farmaMabo

4. Possible side effects

5. Storage ofOmeprazol farmaMabo

6. Contents of the pack and additional information

This medicationcontains omeprazole as its active ingredient. It belongs to a group of medications known as “proton pump inhibitors”. These medications work by reducing the amount of acid produced by the stomach.

This medicationis indicated for adults for the short-term treatment of symptoms of acid reflux (e.g., 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 a doctor if symptoms worsen or do not improve after 14 days.

Do not takeOmeprazol farmaMabo:

• 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 to treat HIV infection).

Do not takethis medicationif you fall into any of the above categories. If you are unsure, consult your doctor or pharmacist before takingomeprazole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Do not takethis medicationfor more than 14 days without consulting your doctor. If you do not experience relief, or if your symptoms worsen, consult your doctor.

This medicationmay mask the symptoms of other diseases. Therefore, consult your doctor immediately if you experience any of the following symptoms before starting to takethis medicationor during treatment:

• 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 (hematochezia).
• you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have a history of gastric ulcers or gastrointestinal surgery.
• you are receiving ongoing treatment for heartburn or stomach acid reflux for 4 weeks or more.
• you continuously experience heartburn or stomach acid reflux for 4 weeks or more.
• you have jaundice or severe liver disease.
• you are over 55 years old and your symptoms have changed recently or are new.
• you have ever had a skin reaction after treatment with a similar medication to omeprazole for reducing stomach acid.
• you are scheduled to have a specific blood test (Cromogranina 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 interrupt treatment with this medication. Remember to mention any other symptoms you may notice, such as joint pain.

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.

Patients should not take omeprazole as preventive medication.

Children and adolescents

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

Taking Omeprazol farmaMabo with other medications

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

Do not take omeprazole 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, 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 to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping omeprazole treatment.
• 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 omeprazole treatment.
• 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)
• 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 omeprazole treatment.

Taking Omeprazol farmaMabo with food and drinks

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become 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 this medication while breastfeeding.

Driving and operating machinery

This medicationis 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 operate machinery.

Omeprazol farmaMabo 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 medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

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 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's acid. It is essential not to damage the granules. These granules contain omeprazole as the active ingredient and have an enteric coating that protects and prevents them from breaking down when they pass through the stomach. The granules release the active ingredient in the intestine, where it is absorbed by the body to produce an effect.

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 sour fruit juice (e.g., apple, orange, or pineapple) or apple compote.
• 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 you have taken all the medication, fill the glass of water to the halfway point, rinse it well, and drink the water. The solid 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 farmaMabothan 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 forget to takeOmeprazol farmaMabo

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.

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, stop taking this medicine 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).
• Redness of the skin with blistering or peeling. Intense blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. This may be a "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

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 disorders (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 problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and sibilance.
• 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 difficult 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 (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 count, 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.
• Sudden appearance of intense 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.
• Increased breast size in men.

Unknown frequency(cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• If you are taking this medicine 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 periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, this medicine can affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very poor 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 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 consider that any of the side effects you are experiencing are 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 Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keepthis medicationout of the sight and reach of children.
• Do not usethis medicationafter the expiration date that appears onthe boxafter CAD. 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 humidity.

• 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.Ask your pharmacist if you are unsure how to dispose ofthe containers and medicines you no longer need.This will help protect the environment.

Composition ofOmeprazol farmaMabo

• The active ingredient is omeprazole.This medicationcontains 20 mg of omeprazole.
• The other components are sugar spheres (contains saccharose and cornstarch), hypromellose,talc, titanium dioxide (E-171), dihydrogen phosphate dihydrate, sodium lauryl sulfate, polisorbate 80,copolymer of methacrylic acid and ethyl acrylate, copolymer of methacrylic acid and methyl methacrylate,triacetyl citrate.

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

Printing ink: iron oxide black (E-172), potassium hydroxideandshellac.See section 2Omeprazol farmaMabo contains Saccharose.

Appearance of the product and contents of the packaging

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

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

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

MABO-FARMA S.A..

C/Rejas, plant 1

28821, Coslada (Madrid)

Spain

Responsible manufacturer

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 theSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.