Package Insert: Information for the User

Omeprazole Gobens 20mg Hard Gastroresistant Capsules EFG

Read this package insert carefully before starting to take the medication, as it contains important information for you:

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Omeprazol Gobens 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.

Omeprazole 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). Omeprazole 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 thestomach), causing pain, inflammation, and heartburn.
  In children, the 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 Gobens

• 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 omeprazole if you are in any of the above situations.

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

Warnings and precautions

Omeprazole may mask the symptoms of other diseases.Therefore, if you experience any of the following symptoms before starting to take omeprazole 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).
• 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 omeprazole for reducing stomach acid.

Before taking this medicine, inform your doctor if:

• you are due to have a specific blood test (Cromogranina A).

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

If you are taking proton pump inhibitors like omeprazole, especially for more than a year, you may slightly increase your risk of hip, wrist or spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you have a skin rash, especially on sun-exposed skin areas, consult your doctor as soon as possible, as it may be necessary to interrupt omeprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.

Omeprazole may cause kidney inflammation. The 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. Inform your doctor of these signs.

Omeprazol Gobens with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use other medicines. Omeprazole may affect the mechanism of action of some medicines and some medicines may affect omeprazole.

Do not take omeprazole 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 in epilepsy)
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop omeprazole treatment
• 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 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 medicine 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.

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

Omeprazol Gobens with food and drinks

You can take your capsules with food or on an empty stomach.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend 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 omeprazole if you are breastfeeding.

Driving and operating machinery

Omeprazole 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 Gobens contains sacarose and Ponceau 4R (E124, red cochineal A)

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

This medicine may cause allergic reactions because it contains Ponceau 4R (E124, red cochineal A)

This medicine contains less than 23 mg of sodium (1 mmol) 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 usual doses are indicated below.

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 20mg once a day for 4‑8 weeks. Your doctor may prescribe a dose of 40mg for another 8 weeks if the esophagus has not yet healed.

• The recommended dose once the esophagus has healed is 10mg once a day.
• If you do not have damage to the esophagus, the recommended dose is 10mg once a day.

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

• The recommended dose is 20mg 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 40mg once a day for 4 weeks.

Treatment ofstomach ulcers (gastric ulcer):

• The recommended dose is 20mg 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 40mg once a day for 8 weeks.

Preventionof the recurrenceof stomach and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40mg once a day.

Treatment of stomach and duodenal ulcers caused by nonsteroidal 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 pyloriand prevention of its recurrence:

• The recommended dose is 20 mg of omeprazole twice a day for a week.

• Your doctor will also indicate that you 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 for how long you should take the medication.

Children:

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

• Children over one year of age who weigh more than10 kgcan take omeprazole. The dose for children is based on body weight, and your doctor will decide the correct dose.

Treatment ofulcerscausedby the infectionbyHelicobacter pyloriand prevention of its recurrence:

• Children over 4 years old can take omeprazole. 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 containcoated granulesthat prevent the medication from breaking down in the stomach acid. It is essential not to damage thegranules.

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 citrus fruit juice (e.g., apple, orange, or pineapple), or a cooked 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 with water up to the middle, rinse it well, and drink the water. The solid parts contain the medication; do not chew or crush them.

If you take more Omeprazol Gobensthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Omeprazol Gobens

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 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 Gobens 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 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 counts, 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 a severe 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 Omeprazol 20 mg hard-gastrorresistent capsules for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Rash possibly with joint pain.

In very rare cases, omeprazol may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a very deteriorated general state 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, pharmacist, or nurse, 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 the Pharmacovigilance of Medicinal Products 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.

• HDPE Bottle: Keep the bottle perfectly closed to protect it from moisture.

• Alu/Alu Blister: Store below 30°C. Store in the original packaging to protect it from moisture.

• PVC-PVDC/Alu Blister: Store below 30°C. Store in the original packaging to protect it from moisture.

• Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Omeprazol Gobens

• The active ingredient is omeprazole. Omeprazol Gobens capsules contain 20 mg of omeprazole.

• The other components (excipients) aresugar spheres (sucrose and cornstarch), hypromellose, talc, titanium dioxide (E-171), dihydrogen phosphate dihydrate, copolymer of methacrylic acid and ethyl acrylate (sodium lauryl sulfate, polysorbate 80) and triethyl citrate. The gelatin capsule is composed of titanium dioxide (E-171), Ponceau 4R (E‑124, cochineal red A) and gelatin.

Appearance of the product and contents of the packaging

Omeprazol Gobens 20mg capsules are white opaque/red opaque.

HDPE bottle: 14, 28 and 56 capsules.

Alu/Alu blister: 14, 28 and 56 capsules. Clinical pack of 512 capsules.

PVC-PVDC/Alu blister: 14, 28 and 56 capsules. Clinical pack of 512 capsules.

Omeprazol Gobens is presented in the form of hard gelatin capsules, containing gastro-resistant microgranules of omeprazole, in packaging containing 14, 28, 56 or 512 capsules.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo 6, 28760 Tres Cantos, Madrid (Spain)

Date of the last review of this leaflet:June 2023

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/

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81392/P_81392.html