IMPROZOL 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Prospect: Information for the User

Improzol 20 mg Hard Gastro-Resistant Capsules EFG

Omeprazole

Read the entire prospectus carefully before starting to take the medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly.

• Keep this prospectus, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. See section 4.
• You should consult your doctor if it worsens or does not improve after 14 days.

Contents of the Prospectus:

1. What is Improzol and what is it used for
2. What you need to know before taking Improzol
3. How to take Improzol
4. Possible adverse effects
5. Storage of Improzol
6. Package contents and additional information

1. What is Improzol and what is it used for

This medication contains the active ingredient omeprazole. It belongs to a group of medications called "proton pump inhibitors". These medications work by reducing the amount of acid produced by the stomach.

This medication 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 Improzol

Do not take Improzol:

• if you are allergic to omeprazole or any of the other components of this medication (included in section 6).
• 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).

Do not takethis medication if you are in any of the above cases. If you are not sure, talk to your doctor or pharmacist before takingomeprazole.

Warnings and precautions

Consult your doctor or pharmacist before taking this medication.

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

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

• Losing a lot of weight without apparent reason and having trouble swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomiting blood.
• Having black-colored stools (bloody stools).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Having a history of stomach ulcers or gastrointestinal surgery.
• Being treated continuously for indigestion or heartburn for 4 weeks or more.
• Having persistent indigestion or heartburn for 4 weeks or more.
• Having jaundice or severe liver disease.
• Being over 55 years old and having recently changed or new symptoms.
• If you have ever had a skin reaction after treatment with a medication similar to omeprazole to reduce stomach acidity.
• Being scheduled for a specific blood test (Chromogranin A).

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 this medication. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, 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 these signs to your doctor.

Patients should not take omeprazole as a preventive medication.

Children and adolescents

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

Taking Improzol with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or are about to take any other medication. This includes medications purchased without a prescription. This is because omeprazole may affect the mechanism of action of some medications and some medications may affect this medication.

Do not take omeprazole if you are taking a medication that contains nelfinavir(used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole, itraconazole, 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
• Medications 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
• 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 medication 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 this medication.

Taking Improzol with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if you can take omeprazole during that time.

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 if you are breastfeeding.

Driving and using machines

It is unlikely that this medication will affect your ability to drive or use tools or machines.

Adverse effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Improzol contains lactose, sucrose, and sodium

This medication contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Improzol

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

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 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 contain coated granules that prevent the medication from breaking down due to the action of stomach acid. It is important 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 obtain 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 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 medication, fill the glass with water to the halfway point, rinse it well, and drink the water. Do not use milk 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 of age should not take this medication.

If you take more Improzol than you should

If you have taken more omeprazole than recommended, 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 taken.

If you forget to take Improzol

If you forgot 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 adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

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

• Sudden whistling when breathing (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 on the lips, eyes, mouth, nose, and genitals may also appear.

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.

Other adverse effects are:

Common adverse effects(may affect up to 1 in 10 people)

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

Uncommon adverse 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 adverse 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 likelihood of contracting infections.
• Allergic reactions, sometimes very intense, 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 changes.
• 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 fatigue.
• Hair loss (alopecia).
• Skin rash with sun exposure.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse 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 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.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (which causes diarrhea).
• If you are being treated with this medication for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole may affect the 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 symptoms of local infection, such as sore throat, 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 medication you are taking at that time.

Do not worry about this list of possible adverse effects. You may not experience any of them. If you think 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 a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Omeprazol Vir-Pharma

Keep this medication out of 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.

Store below 30°C.

Keep this blister pack in the original packaging to protect it from moisture.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Improzol

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.

• The other components are: sugar spheres (sucrose and cornstarch), anhydrous lactose, hypromellose, sodium lauryl sulfate, hydroxypropyl cellulose, disodium phosphate dihydrate, hypromellose phthalate, and diethyl phthalate.

The gelatin capsule is composed of: gelatin, indigo carmine (E-132), and quinoline yellow (E-104).

Appearance of the product and package contents

Improzol 20 mg capsules are green with a green cap.

Package sizes:

Packages containing 7 or 14 capsules.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this prospectus:March 2023

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