OMEPRAZOL PENSAVITAL 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprazole Pensavital 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.

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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.
• If you experience side effects, consult your doctor or pharmacist, even if they are not mentioned in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 14 days.

Contents of the Package Leaflet:

1. What is Omeprazole Pensavital and what is it 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

1. Package Contents and Additional Information

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

Omeprazole 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.

Omeprazole Pensavital is indicated in adults for the short-term treatment of reflux symptoms (e.g., heartburn, acid regurgitation).

Reflux is the rise of acid from the stomach to the esophagus, which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest that rises 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 your doctor if it worsens or does not improve after 14 days.

2. What you need to know before taking Omeprazole Pensavital

Do not take Omeprazole Pensavital

• if you are allergic to omeprazole or any of the other components 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazole Pensavital.

Do not take Omeprazole Pensavital for more than 14 days without consulting your doctor. If you do not experience relief, or if your symptoms worsen, consult your doctor.

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black-colored stools (bloody stools).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• History of stomach ulcers or gastrointestinal surgery
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Continuously suffering from indigestion or heartburn for 4 weeks or more
• Suffering from severe jaundice or liver disease.
• 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 medicine similar to Omeprazole Pensavital to reduce stomach acidity.
• A specific blood test (Chromogranin A) is scheduled.
• When taking omeprazol, kidney inflammation may occur. 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. You should report such signs to your treating physician.

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

Patient should not take omeprazole as a preventive medication.

Children and Adolescents

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

Taking Omeprazole Pensavital withother medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. This is because Omeprazole Pensavital may affect the mechanism of action of some medicines and some medicines may affect Omeprazole Pensavital.

Do not take Omeprazole Pensavital 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 Pensavital
• 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 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 (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 interrupt treatment with Omeprazole Pensavital

Taking Omeprazole Pensavital with food and drinks

See section 3.

Pregnancy and Breastfeeding

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 at therapeutic doses. Your doctor will decide if you can take Omeprazole Pensavital if you are breastfeeding.

Driving and Using Machines

Omeprazole Pensavital 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 Pensavital contains Saccharose

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

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is, essentially “sodium-free”.

3. How to take Omeprazole Pensavital

Follow exactly the administration instructions of Omeprazole 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 an improvement in symptoms.

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 breaking down due to the action of 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 them and prevents them from breaking 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 problems swallowing the capsules

• If you have problems 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 still water, acidic 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 you have taken all the medicine, fill the glass with water to the half, rinse it well, and drink the water. Do not usemilk or carbonated water. The solid parts contain the medicine; do not chew or crush them.

Use in Children and Adolescents

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

If you take more Omeprazole Pensavital than you should

If you have taken more Omeprazole Pensavital than prescribed by your doctor, consult 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 Pensavital

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed doses.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious but rare side effects, stop taking Omeprazole Pensavital and consult your doctor immediately:

• 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. Blisters in the mouth and eyes may also occur. This could be a sign of “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and tiredness, which can be symptoms of liver problems.

Other side effects are:

Common Side Effects(may affect up to 1 in 10 people)

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

Uncommon Side Effects(may affect up to 1 in 100 people)

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

Rare Side Effects(may affect up to 1 in 1,000 people)

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes very severe, which include 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 difficulty 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 tiredness.
• Hair loss (alopecia).
• Skin rash with sun exposure.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Side Effects(may affect up to 1 in 10,000 people)

• Blood count changes, 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 a severe skin rash, blistering, or peeling. This can 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.

Frequency Not Known(cannot be estimated from the available data)

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

In very rare cases, Omeprazole Pensavital may affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as sore throat, neck, or mouth, 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 medicine you are taking at that time.

Do not worry about this list of possible side effects. You may not experience any of them. If you think any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Pensavital

• Keep out of the sight and reach of children.

• Do not use Omeprazole Pensavital after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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

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

• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazole Pensavital

• The active ingredient is omeprazole. Omeprazole Pensavital capsules contain 20 mg of omeprazole.

• The other ingredients are hydroxypropyl methylcellulose, disodium phosphate dihydrate, talc, titanium dioxide (E 171), methacrylic acid copolymer, triethyl citrate, and sugar spheres (containing cornstarch and saccharose). 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). See section 2. Omeprazole Pensavital contains Saccharose.

Appearance of the Product and Package Contents

The Omeprazole Pensavital 20 mg capsules are formed by a white body marked with “20” and a white cap marked with “OM” that contain spherical granules.

Package sizes:

HDPE bottles with 14 capsules.

Al/Al Blister with 14 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 Leaflet:February 2023

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