Package Insert: Information for the User

Omeprotect 20mg Hard Gastric-Resistant Capsules

omeprazole

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Follow exactly the medication administration instructions contained in this package insert or those provided by your doctor or pharmacist.
• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve after 14 days.

1.What is Omeprotect and what it is used for

2.What you need to know before starting to take Omeprotect

3.How to take Omeprotect

4.Possible adverse effects

1. Storage of Omeprotect

6.Contents of the package and additional information

Omeprotect 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.

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

Reflux is the backflow of acid from the stomach, 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 your doctor if symptoms worsen or do not improve after 14 days.

Do not take Omeprotect

• 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 containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medication that contains nelfinavir (used for HIV infection).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprotect.

Do not take Omeprotect for more than 14 days without consulting your doctor.

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

• 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 (blood-stained).
• 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 constantly 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.
• You are scheduled to have a specific blood test (Cromogranina A)
• You have ever had a skin reaction after treatment with a similar medication to Omeprotect for reducing stomach acid.

When taking omeprazole, inflammation in 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. 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 Omeprotect. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as preventive medication.

Other medications and Omeprotect

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication. Omeprazole may affect the mechanism of action of some medications and some medications may affect omeprazole.

Do not take omeprazole if you are taking a medication that contains nelfinavir (used for 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)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping omeprazole treatment
• Medications used to prevent blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need 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)

Taking Omeprotect with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

Your doctor will decide if you can take omeprazole if you are breastfeeding.

Driving and operating machinery

Omeprazole 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.

Omeprotect contains saccharose and sodium

This medication contains saccharose. 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. If in 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 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 on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they containcoated granulesthat prevent the medication from breaking down by the action of stomach acid. It is essential not to damage thegranules.

What to Do If You Have Trouble Swallowing the Capsules

If You Take More Omeprotect 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 ingested.

If You Forget to Take Omeprotect

If you forget 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.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Sudden hissing sounds while breathing (sudden sibilance), 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 may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

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

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, 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

• 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

• Changes in blood counts, 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 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.

Unknown frequency

• Inflammation of the intestines (which causes diarrhea).
• 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 fever with a general stateverydeteriorated 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 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 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 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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of the medication.

Keep this medication out of the sight and reach of children.

Do not use Omeprotect 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 the bottle perfectly closed or maintain the blister in the original packaging to protect it from moisture.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREcollection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Omeprotect

• The active ingredient is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components (excipients) are: sugar spheres (sucrose and cornstarch), carboxymethylcellulose sodium type A (from potato), sodium lauryl sulfate, povidone, trihydrate sodium phosphate, sodium hydroxide, hydroxypropylmethylcellulose, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate, titanium dioxide (E171), talc.
• The gelatin capsule is composed of: gelatin, titanium dioxide (E171), quinoline yellow (E104), indigo carmine (E132), erythrosine (E127).

Appearance of the product and content of the packaging

Omeprotect 20 mg capsules are formed by an orange-colored body and a dark blue-colored cap with microspherical gastric-resistant granules inside.

Packaging sizes:

HDPE bottles with 14 capsules or Al/Al blisters with 14 capsules.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma S.L.U.

c/Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas. Madrid (Spain)

Responsible for manufacturing:

Teva Pharma S.L.U.

Malpica Industrial Estate c/C 4

50016 Zaragoza

Spain

Last review date of this leaflet: August 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/