Package Insert: Information for the User

Omeprazole STADA 20 mg Hard Gastroresistant Capsules EFG

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

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as 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 package insert. See section 4.

Omeprazol STADA contains the active ingredient 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.

Omeprazol STADA 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 STADA can 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).

In children:

Children over 1 year of age and ≥ 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 inadequate 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 take Omeprazol STADA

• 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).

If you are unsure, talk to your doctor or pharmacist before taking Omeprazol STADA.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazol STADA.

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

• 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).
• You have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• You have had a skin reaction after treatment with a similar medicine to Omeprazol STADA for reducing stomach acid.
• You are scheduled to have a specific blood test (Cromogranina 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 STADA. Remember to mention any other symptoms you may notice, such as joint pain.

If you take Omeprazol STADA for a long period (more than 1 year), your doctor will likely perform regular check-ups. You should inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

If you are taking proton pump inhibitors such as Omeprazol STADA, especially for more than a year, you may have a slightly increased risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Omeprazole may interfere with some tests (Cromogranina A). To avoid this interference, treatment with omeprazole should be temporarily suspended at least 5 days before the test.

When taking omeprazole, inflammation of the kidneys may occur. Symptoms and signs 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.

Use of Omeprazol STADA with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription. Omeprazol STADA may affect the mechanism of action of some medicines, and some medicines may affect Omeprazol STADA.

Do not take Omeprazol STADA 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, 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 you start or stop treatment with Omeprazol STADA
• 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 with Omeprazol STADA
• Rifampicin (used to treat tuberculosis) Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ transplantation)
• 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 STADA
• 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)

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

Taking Omeprazol STADA with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 STADA if you are breastfeeding.

Driving and operating machinery

Omeprazol STADA 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 STADA contains saccharose

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

Omeprazol STADA contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. 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 usual doses are indicated below.

Adults:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation:

• If your doctor checks that you have mild damage to the esophagus, the usual 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 usual dose is 10 mg once a day.

Treatment ofulcers in the upper part of the 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 by(nonsteroidal anti-inflammatory drugs):

• 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 of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The usual dose is 20 mg of Omeprazol STADA twice a day for a week.
• Your doctor will also tell you to take two antibiotics from the following: 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 for how long you should take the medication.

Use in children and adolescents

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

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

Treatment ofulcers causedby the infectionby Helicobacter pyloriand prevention of their recurrence:

• Children over 4 years old may take Omeprazol STADA. The dose for children is based on body weight, and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics for your child, amoxicillin, and clarithromycin.

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 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 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.

What to do if you take more Omeprazol STADA than you should

If you have taken more Omeprazol STADA 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.

What to do if you forget to take Omeprazol STADA

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

What to do if you interrupt the treatment with Omeprazol STADA

Do not interrupt the treatment with Omeprazol STADA without first talking to your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following rare but serious side effects, stop taking Omeprazol STADA and consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden sibilance), swelling of the lips, tongue, and throat or body, skin rash, dizziness, 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."
• 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 stomach polyps

Infrequent 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 disorders, such as a decrease in white blood cells or platelets. This may cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, and sibilance.
• Low sodium levels in the blood. This may cause weakness, vomiting, and muscle cramps.
• Restlessness, 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 may 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 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.
• 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.
• Enlargement of the breasts in men.

Unknown frequency(cannot be estimated from available data)

• Inflammation in the intestines (causing diarrhea).
• If you are taking omeprazole for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels may 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 may also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

• Skin rash, possibly with joint pain.

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

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.

Blister:

Store below 30°C.

Keep the blister in the original packaging to protect it from moisture.

Bottles of HDPE:

Store below 30°C.

Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the 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. By doing so, you will help protect the environment.

Composition of Omeprazol STADA

-The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole

-The other components are: cornstarch and sucrose; sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, poloxamer 80, titanium dioxide, methacrylic acid copolymer and ethyl acrylate copolymer. Capsule components: water, gelatin, quinoline yellow (E-104), titanium dioxide (E-171).

Appearance of the product and content of the packaging

Omeprazol STADA is presented in the form of hard gelatin capsules of yellow opaque color, containing white to cream-colored spherical microgranules.

The capsules are supplied in Al/Al blisters or HDPE bottles containing 14, 28 or 56 capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Barcelona - SPAIN

Responsible manufacturer

Liconsa, S.A.

Avda. Miralcampo, 7.

P.I. Miralcampo

19200 Azuqueca de Henares

Guadalajara - Spain

Last review date of this leaflet:February 2023

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