Patient Information

Improzol 20 mg Hard Gastroresistant Capsules EFG

Omeprazole

Read this entire leaflet carefully before you start taking the 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.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

1. What is Improzol and what it is used for

2. What you need to know before taking Improzol

3. How to take Improzol

4. Possible side effects

5. Storage of Improzol

6. Contents of the pack and additional information

This medicationcontains the active ingredient omeprazole. It belongs to a group of medications called “proton pump inhibitors”. These medications act by reducing the amount of acid produced by the stomach.

This medication is 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 Improzol:

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

Do not takethis medicationif you fall into any of the above cases. If you are unsure, speak with 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 medicationmay mask the symptoms of other diseases. Therefore, consult your doctor immediately if you experience any of the following symptoms before starting to take this medication 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 experience severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have a history of gastric ulcers or gastrointestinal surgery.
• you are receiving ongoing treatment for heartburn or stomach acid reflux for 4 weeks or more.
• you continuously experience heartburn or stomach acid reflux for 4 weeks or more.
• you have jaundice or a 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 medication similar to omeprazole for reducing stomach acid.
• you are scheduled to have a specific blood test (Cromogranina A).

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

When taking omeprazole, inflammation of the kidneys may occur. Symptoms and signs 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.

Patients should not take omeprazole as preventive medication.

Children and adolescents

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

Taking Improzol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or would have 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 containsnelfinavir(used to treat HIV infection).

Inform 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 epilepsy)

• Phenobarbital (used in epilepsy). If you are taking phenobarbital, your doctor will have to monitor you when starting or stopping omeprazole treatment

• Medications used to prevent blood clot formation, such as warfarin or other vitamin K antagonists. Your doctor will have to monitor you when starting or stopping omeprazole treatment

• 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 have to temporarily stop omeprazole treatment.

Taking Improzol with food and drinks

See section 3.

Pregnancy, breastfeeding, and fertility

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

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 omeprazole if you are breastfeeding.

Driving and operating machinery

This medication is unlikely to affect your ability to drive or use tools or machines.

You may experience side effects such as dizziness and visual disturbances (see section 4). If they occur, you should not drive or operate machinery.

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; it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.oryour 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 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's 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 down when they pass 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 sour 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 of 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 old 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Improzol

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 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 Improzol and consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden onset of bronchospasm), 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 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.

Other side effects are:

Frequent side effects(may affect up to 1 in 10 people)

• Headache.

• Gastrointestinal effects: diarrhea, stomach pain, constipation, and gas (flatulence).

• Nausea or vomiting.

• Benign polyps in the stomach.

Less frequent side effects(may affect up to 1 in 100 people)

• Swelling of the feet and ankles.

• Sleep disturbances (insomnia).

• Dizziness, tingling sensation, drowsiness.

• Feeling 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 problems, 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 intense, including swelling of the lips, tongue, and throat, fever, and bronchospasm.

• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.

• Restlessness, confusion, or depression.

• Taste disturbances.

• Visual problems, such as blurred vision.

• Sudden feeling of difficult 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 (arthritis) 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 abnormalities, 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.

A sudden onset of intense rash, blistering, or peeling of the skin may occur.

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.

Unknown frequency (cannot be estimated from available data)

• Intestinal inflammation (causing diarrhea).
• If you are taking this medicine for more than three months, it is possible that your magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience 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 regular blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

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

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 experience 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 a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the 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.

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

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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, hydroxypropylcellulose, disodium dihydrogen phosphate, phthalate of hypromellose and diethyl phthalate.

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

Appearance of the product and contents of the packaging

Improzol 20 mg capsules are formed by a green body and green cap.

Packaging sizes:

Packages containing 7 or 14 capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet:March 2023

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