OMEPRAZOL PENSA 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Pensa 20mg Hard Gastro-Resistant Capsules EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Omeprazole Pensa and what is it used for
2. What you need to know before you take Omeprazole Pensa
3. How to take Omeprazole Pensa
4. Possible side effects
   1. Storing Omeprazole Pensa

1. Contents of the pack and further information

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

Omeprazole Pensa contains the active substance 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.

Omeprazole Pensa is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Ulcers caused by a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazole Pensa may also be used to prevent ulcers if you are taking NSAIDs.
• Too much 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” (GORD). In this condition, acid from the stomach escapes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, the symptoms of the disease can include the return of stomach contents into the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

Ulcers caused by a bacterium called Helicobacter pylori. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Omeprazole Pensa

Do not take Omeprazole Pensa

• if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Omeprazole Pensa.
• 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 to treat HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Pensa.

Warnings and precautions

Omeprazole Pensa may hide the symptoms of other diseases. Therefore, if you experience any of the following conditions before starting to take Omeprazole Pensa or during treatment, consult your doctor immediately:

• You lose a lot of weight without reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained feces).
• If 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 ever had a skin reaction after treatment with a medicine similar to Omeprazole Pensa to reduce stomach acid. If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Omeprazole Pensa. Remember to mention any other symptoms you may notice, such as joint pain.
• A specific blood test (Chromogranin A) is scheduled for you.
• When taking omeprazole, kidney inflammation can occur. The signs and symptoms can include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your doctor.

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

Other medicines and Omeprazole Pensa

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Omeprazole Pensa may affect the action of some medicines, and some medicines may affect Omeprazole Pensa.

Do not take Omeprazole Pensa if you are taking a medicine that contains nelfinavir(used to treat HIV infection).

Tell 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 treatment with Omeprazole Pensa
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop treatment with Omeprazole 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 (thrombi))
• 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 Omeprazole Pensa.

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

Taking Omeprazole Pensa with food and drinks

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

Pregnancy and breastfeeding

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

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

Driving and using machines

Omeprazole Pensa is unlikely to affect your ability to drive or use tools or machines. Side effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Omeprazole Pensa contains sucrose

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

3. How to take Omeprazole Pensa

Always take this medicine exactly as your doctor has told you. If you are not sure, check with 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 GORD, such as heartburn and acid regurgitation:

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

Treatment of duodenal ulcers:

• The normal 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 of gastric ulcers:

• The normal 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 of gastric and duodenal ulcers:

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

Treatment of gastric and duodenal ulcers caused by NSAIDs:

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

Prevention of gastric and duodenal ulcersduring NSAID therapy:

• The normal dose is 20 mg once a day.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

• The normal dose is 20 mg of Omeprazole Pensa twice a day for one week.

• Your doctor will also tell you to take two antibiotics: amoxicillin, clarithromycin, and metronidazole.

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

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Children:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

• Children over 1 year of age who weigh more than 10 kg can take Omeprazole Pensa. The dose for children is based on body weight, and the doctor will decide the correct dose.

Treatment of ulcers caused byHelicobacter pyloriinfectionand prevention of recurrence:

• Children over 4 years of age can take Omeprazole Pensa. The dose for children is based on body weight, and the doctor will decide the correct dose.
• The doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

How to take this medicine

• 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 medicine from being broken down by the acid in the stomach. It is important 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 non-carbonated water, acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce.
  • Always shake the mixture well before drinking it (the mixture will not be transparent). Then, drink the mixture immediately or within 30 minutes.
  • To make sure you have taken all the medicine, fill the glass with water, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Pensa than you should

If you have taken more Omeprazole Pensa than your doctor prescribed, talk to your doctor or pharmacist immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you notice any of the following rare but serious adverse effects, stop taking Omeprazol Pensa and consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), 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 may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Adverse effects can occur with certain frequencies, which are defined as follows:

Other adverse effects are:

Frequent Adverse Effects

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

Uncommon Adverse Effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

Rare Adverse Effects

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Allergic reactions, sometimes very intense, 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.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine 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 Adverse Effects

• Blood count alterations, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Sudden appearance of an intense rash, blistering, or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Increased breast size in males.
• Low magnesium levels in the blood.

In very rare cases, Omeprazol Pensa can affect the white blood cells in the blood and cause immunodeficiency. If you have an infection with symptoms such as fever with a very deteriorated general condition or fever with symptoms of local infection, such as neck, throat, 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 that you provide information about the medication you are taking at that time.

Adverse Effects of Unknown Frequency

• Inflammation of 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, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, consult your 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 one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Do not worry about this list of possible adverse effects. You may not experience any of them. If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Omeprazol Pensa

• Keep out of 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. Keep 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 thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Pensa

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

• The other components are hydroxypropyl methylcellulose, disodium phosphate dihydrate, talc, titanium dioxide (E 171), methacrylic acid copolymer, triethyl citrate, and sugar spheres (containing cornstarch and sucrose). Capsule: titanium dioxide (E 171), water, gelatin, printing ink (containing Shellac, Ethyl alcohol, Isopropyl alcohol, Propylene glycol, N-butyl alcohol, Ammonium hydroxide, Potassium hydroxide, Purified water, Black iron oxide E-172).

Appearance of the Product and Package Contents

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

Package sizes:

HDPE bottles with 14, 28, and 56 capsules.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Towa Pharmaceutical Europe, S.L.

C/ de Sant Martí 75-97

08107 Martorelles (Barcelona)

Spain

Date of the Last Revision of this Prospectus:February 2023

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