Package Leaflet: Information for the User

Omeprazole pensavital 20mg hard gastro-resistant capsules EFG

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• Si experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• Consult a doctor if your symptoms worsen or do not improve after 14 days.

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

2.What you need to know before taking Omeprazole pensavital

3.How to take Omeprazole pensavital

4.Possible side effects

1. Storage of Omeprazole pensavital

6.Contents of the pack and additional information

Omeprazol pensavital 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 pensavitalis indicated in adults for the short-term treatment of symptoms of acid reflux (for example, heartburn, acid regurgitation).

Acid reflux is the backflow of acid from the stomach into the esophagus, which can become inflamed and painful. This can cause symptoms such as a burning sensation in the chest that rises up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may need to take the capsules for 2-3 consecutive days to achieve an improvement in symptoms.

You should consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take Omeprazol pensavital

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

Warnings and precautions

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

Do not take Omeprazol pensavital for more than 14 days without consulting your doctor. If you do not experience relief, or if you feel that your symptoms are worsening, consult your doctor.

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

• 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 (hematochezia).
• if you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have a history of gastric ulcer or gastrointestinal surgery.
• you are receiving ongoing treatment for heartburn or stomach acid reflux for 4 weeks or more.
• you have persistent heartburn or stomach acid reflux for 4 weeks or more.
• you have jaundice or severe liver disease.
• you are over 55 years old and your symptoms have changed recently or are new.
• if you have ever had a skin reaction after treatment with a similar medicine to Omeprazol pensavital for reducing stomach acid.
• you are scheduled to have a specific blood test (Cromogranina A).
• when taking omeprazole, inflammation in the kidneys 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 must inform your doctor of these signs.

If you experience 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 pensavital. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as preventive medication.

Children and adolescents

Children and adolescents under 18 years old should not take this medicine.

Taking Omeprazol pensavital with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes medicines purchased without a prescription. This is because Omeprazol pensavital may affect the mechanism of action of some medicines and some medicines may affect Omeprazol pensavital.

Do not take Omeprazol pensavital if you are taking a medicine that contains nelfinavir (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 to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol pensavital
• medicines 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 pensavital
• 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 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 pensavital

Taking Omeprazol pensavital with food and drinks

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be 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 pensavital while breastfeeding.

Driving and using machines

Omeprazol pensavital 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 pensavital contains Saccharose

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

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

Follow exactly the administration instructions for Omeprazol pensavital indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one 20 mg capsule once a day for 14 days. Contact your doctor if symptoms do not disappear after this time.

You may need to take the capsules for 2-3 consecutive days to achieve improvement of symptoms.

How to take this medication

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or with 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. These granules contain omeprazole as the active ingredient and have an enteric coating that protects and prevents them from breaking down when passing through the stomach. The granules release the active ingredient in the intestine, where it is absorbed by the body to produce an effect.

What to do if you have trouble swallowing the capsules

• If you 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 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.Do not usemilk or carbonated water. The solid parts contain the medication; do not chew or crush them.

Use in children and adolescents

Children and adolescents under 18 years old should not take this medication.

If you take more Omeprazol pensavital than you should

If you have taken more Omeprazol pensavital 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 forgot to take Omeprazol pensavital

If you forgot 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 pensavital 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. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This may be a case of "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, benign stomach polyps, 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 intense, 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.
• 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 may 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.
• To see, feel, or hear 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 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.

Unknown frequency (cannot be estimated from available data)

• Inflammation in the intestines (which causes diarrhea).
• Hypomagnesemia
• Skin rash, possibly with joint pain.

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

Do not worry about this list of possible side effects. You may not experience any of them. If you consider that any of the side effects you experience are severe or if you experience any side effect 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 a side effect not mentioned in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medications 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 sight and reach of children.

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

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

• Aluminum/Aluminum Blister: Do not store above 25°C. Store in the original packaging to protect it from moisture.

• Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at theSIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Omeprazol pensavital

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

• The other components are hydroxypropylmethylcellulose, dihydrogen phosphate dihydrate, talc, titanium dioxide (E 171), acrylic acid copolymer, triethyl citrate, and sugar spheres (contains cornstarch and sucrose). 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). See section 2. Omeprazol pensavital contains Sucrose.

Appearance of the product and contents of the packaging

Omeprazol pensavital 20mg capsules are formed by a white body marked with “20”and a white cap marked with “OM”containing spherical granules.

Packaging sizes:

HDPE bottles with14capsules.

Blister pack with 14 capsules.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer

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