Package Leaflet: Information for the User

Omeprazol ABDrug 20 mg Hard Capsules EFG

Omeprazol

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

• Keep this leaflet, as you may need to read it again.
• 1. If you have any questions, ask your doctor or pharmacist.
  2. This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Omeprazol ABDrug and what it is used for

2.What you need to know before you start taking Omeprazol ABDrug

3.How to take Omeprazol ABDrug

4.Possible side effects

1. Storage of Omeprazol ABDrug

6.Contents of the pack and additional information

Omeprazol ABDrug contains 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 ABDrug is used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat with 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, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs).

Omeprazol ABDrugmay 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).

Omeprazol ABDrug may also be used to treat this condition.

Children over 1 year of age and weighing ≥ 10 kg

• “Gastroesophageal reflux disease” (GERD). In this disorder, stomach acid passes into the esophagus (the tube that connects the throat with 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 insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacteria called “Helicobacter pylori”. If your child has this disease, it is possible that your doctor will prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not takeOmeprazol ABDrug:

• if you are allergic to omeprazole or any of the other ingredients 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 take Omeprazol ABDrug if you fall into any of the above categories. If you are unsure, speak to your doctor or pharmacist before taking Omeprazol ABDrug.

Warnings and precautions

Consult your doctor or pharmacist before taking Omeprazol ABDrug.

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

Omeprazol ABDrug may mask the symptoms of other diseases. Therefore, if you experience any of the following symptoms before starting to take Omeprazol ABDrug or 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 (blood-stained stools).
• 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 medicine to Omeprazol ABDrug for reducing stomach acid.
• you are scheduled to have a specific blood test (chromogranin A).

If you have 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 ABDrug. 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.

You may need to have regular check-ups if you take Omeprazol ABDrug for a long time (more than 1 year). Inform your doctor of any new or unusual symptoms and circumstances whenever you visit your doctor.

Taking a proton pump inhibitor like Omeprazol ABDrug, especially for more than a year, may slightly increase the risk of breaking a hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

This medicine may affect the way your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

- extreme fatigue or lack of energy

- tingling sensation

- painful or inflamed tongue, mouth ulcers

- muscle weakness

- altered vision

- memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not administer this medicine to children under 1 year of age or <10

Taking Omeprazol ABDrug with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription.Omeprazol ABDrugmay affect the mechanism of action of some medicines and some medicines may affectOmeprazol ABDrug.

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

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

• Ketoconazole, posaconazole, 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 you start or stop treatment withOmeprazol ABDrug
• Medicines used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop treatment withOmeprazol ABDrug
• 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).
• Metotrexate (chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of metotrexate, your doctor will need to temporarily stop treatment withOmeprazol ABDrug.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused by the Helicobacter pylori infection, it is very important to inform your doctor of any other medicines you are taking.

Taking Omeprazol ABDrug 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 become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole is excreted in breast milk, but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide if you can take Omeprazol ABDrug if you are breastfeeding.

Driving and operating machinery

Omeprazol ABDrug 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 operate machinery.

Omeprazol ABDrug contains Saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Omeprazol ABDrug contains sodium

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

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

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

The recommended dose is described below:

Use in adults

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, the recommended 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 recommended dose once the esophagus has healed is 10 mg once a day.
• If you do not have damage to the esophagus, the recommended dose is 10 mg once a day.

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

• The recommended 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 recommended 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 recurrence ofstomach and duodenal ulcers:

• The recommended 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 bynonsteroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The recommended dose is 20 mg once a day.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their recurrence:

• The recommended dose is 20 mg ofOmeprazol ABDrugtwice a day for a week.
• Your doctor will also tell you to take two antibiotics, amoxicillin,
• clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by atumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medication.

Use in children

Treatment of symptoms of gastroesophageal reflux disease (GERD), such asheartburn and acid regurgitation:

• Children over one year of age who weigh more than 10 kg may takeOmeprazol ABDrug. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

• Children over 4 years old may takeOmeprazol ABDrug. 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 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 half, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take moreOmeprazol ABDrugthan you should

If you have taken moreOmeprazol ABDrugthan 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 ABDrug

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 or very rare but serious side effects, stop taking Omeprazol ABDrug and consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden onset of bronchospasm), 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 could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Generalized rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome). (rare) A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized 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.

Infrequent 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.
• Restlessness, 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)

• 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.

• Erythema multiforme

• Weakness of the muscles.
• Enlargement of the breasts in men.

Unknown frequency (cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• If you are taking Omeprazol ABDrug 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 reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular tests to monitor your magnesium levels.

In very rare cases, Omeprazol ABDrug may 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 medication you are taking at that time.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear 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 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 packaging after CAD. The expiration date is the last day of the month indicated.

• Aluminum/Aluminum Blister:

Store below 86°F (30°C).

Store in the original packaging to protect it from moisture.

• PVC-PVDC/Aluminum Blister:

Store below 77°F (25°C).

Store in the original packaging to protect it from moisture.

• Bottle:

No special storage conditions are required.

Validity period after the first opening of the bottle: 100 days.

Keep the bottle perfectly closed to protect it from moisture.

• Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofOmeprazol ABDrug

• The active ingredient is omeprazole. Omeprazol ABDrug hard gastro-resistant capsules contain 20 mg of omeprazole.

The other components are sugar spheres (saccharose and cornstarch), hypromellose (E-464),talco (E-553b), titanium dioxide (E-171), anhydrous sodium hydrogen phosphate(E-339 i), sodium lauryl sulfate, polisorbate 80,copolymer of methacrylic acid and ethyl acrylate, triethyl citrate (E-1505).Capsule:gelatin, titanium dioxide (E-171),printing ink (iron oxide black (E-172),

• potassium hydroxide and shellac).. See section 2Omeprazol ABDrugcontains Saccharose.

Appearance of the product and contents of the pack

Omeprazol ABDrugcapsules are hard gelatin capsules of white opaque colormarked with

OM20containing spherical granules.

HDPE bottle with cap and safety ring equipped with a desiccant: 14 and 28 capsules.

Alu/Alu blister: 14 and 28 capsules.

PVC-PVDC/Al blister: 14 and 28 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA, S.A

Calle Rejas 2, 1st floor

28821 Coslada (Madrid) Spain

Responsible for manufacturing

TOWA PHARMACEUTICAL EUROPE S.L.C/San Marti, 75-97

Martorelles, 08107, Barcelona

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Belgium:Prenome 10, 20, 40 mg gastro-resistant gel capsule

Spain:Omeprazol ABDrug20, 40 mg hard gastro-resistant capsule

Netherlands:Prenome 10, 20, 40 mg gastro-resistant capsule, hard

Poland: Prenome 10, 20, 40 mg hard gastro-resistant capsule

United Kingdom: Prenome 10, 20, 40 mg gastro-resistant capsule, hard

Romania: Prenome 10, 20, 40 mg gastro-resistant capsule

Revision date of this leaflet: March 2023

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