Package Leaflet: Information for the User

Omeprazole Pensa 20mg Hard Gastroresistant Capsules EFG

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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Omeprazole Pensa is and what it is used for

2.What you need to know before you start taking Omeprazole Pensa

3.How to take Omeprazole Pensa

4.Possible side effects

1. Storage of Omeprazole Pensa

6.Contents of the pack and other information

Omeprazol Pensa 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 Pensa 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 Pensa may 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, the 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 take Omeprazol Pensa

• if you are allergic (hypersensitive) to omeprazole or to any of the other components of Omeprazol Pensa.
• 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 for HIV infection).

If you are unsure, speak with your doctor or pharmacist before taking Omeprazol Pensa.

Warnings and precautions

Omeprazol Pensa may mask the symptoms of other diseases.Therefore, if you experience any of the following symptoms before starting to take Omeprazol Pensa 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.
• You have had a skin reaction after treatment with a similar medication to Omeprazol Pensa for reducing stomach acid. If you suffer 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 Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
• You are scheduled to have a specific blood test (Cromogranina A).
• Omeprazole may cause inflammation in the kidneys. 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.

If you take Omeprazol Pensa 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.

Other medications and Omeprazol Pensa

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Omeprazol Pensa may affect the mechanism of action of some medications, and some medications may affect Omeprazol Pensa.

Do not take Omeprazol Pensa 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 in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol Pensa
• Medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping treatment with Omeprazol Pensa
• 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 interrupt treatment with Omeprazol Pensa.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused byHelicobacter pyloriinfection, it is very important to inform your doctor of any other medications you are taking.

Taking Omeprazol Pensa with food and drinks

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

Pregnancy and breastfeeding

Before taking Omeprazol Pensa, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take Omeprazol Pensa during this time.

Your doctor will decide if you can take Omeprazol Pensa if you are breastfeeding.

Driving and operating machinery

Omeprazol Pensa 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 Pensa contains saccharose

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

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

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:

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

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

• The usual 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 usual 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 reappearanceofstomach and duodenal ulcers:

• The usual 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 NSAIDs(nonsteroidal anti-inflammatory drugs):

• The usual dose is 20 mg once a day for 4‑8 weeks.

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The usual dose is 20 mg once a day.

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their reappearance:

• The usual dose is 20 mg of Omeprazole Pensa 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 usual dose is 60 mg a day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medication.

Children:

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

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

Treatment ofulcerscausedby the infectionbyHelicobacter pyloriand prevention of their reappearance:

• Children over 4 years old can take Omeprazole Pensa. 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 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 sour fruit juice (e.g., apple, orange, or pineapple) or a compote of apple.
  • 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 more Omeprazole Pensa than you should

If you have taken more Omeprazole Pensa 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 take Omeprazole Pensa

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 Omeprazol Pensa and consult your doctor immediately:

• Sudden wheezing while breathing (sudden onset of wheezing), 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.

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, benign stomach polyps, constipation, and gas (flatulence).
• Nausea or vomiting.

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, or 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

• Blood disorders, 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 severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, 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.
• 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

• 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 inflammation of the brain.
• 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.
• Low magnesium levels in the blood.

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

Side effects of unknown frequency

• Inflammation in the intestine (which causes diarrhea).
• If you are taking Omeprazol Pensa 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, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.

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

Do not worry about this list of possible side effects. You may not experience any of them. If you consider any of the side effects you are experiencing to be severe or if you experience any side effects 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 not mentioned in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep out of the sight and reach of children.

• Do not use Omeprazol Pensa after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

• ?Blister: Do not store at a temperature above 25°C. Store this blister in the original packaging.

• Bottle: No special storage conditions are required. Keep the container perfectly closed to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at theSIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Omeprazol Pensa

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

• The other components are hydroxypropylmethylcellulose, dihydroxydipotassium phosphate, talc, titanium dioxide (E 171), acrylic acid copolymer, triethyl citrate, and sugar spheres (contains cornstarch and saccharose). Capsule: titanium dioxide (E 171), water, gelatin,printing ink (containingShellac, Ethyl alcohol, Isopropyl alcohol, Propylene glycol, N-butyl alcohol, Ammonium hydroxide, Potassium hydroxide, Purified water, Iron oxide black E-172).

Appearance of the product and contents of the packaging

Omeprazol Pensa capsules are formed by a white body marked with “20”and a white cap marked with “OM”

Package sizes:

HDPE bottles with14, 28, and 56capsules.

Blister pack with 14, 28, and 56 capsules, clinical packaging of 504 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet:February 2023

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