OMEPROTECT 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Omeprotect 20mg gastro-resistant hard capsules

omeprazole

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 it is a side effect not listed in this leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve after 14 days.

Contents of the package leaflet:

1. What is Omeprotect and what is it used for
2. What you need to know before you start taking Omeprotect
3. How to take Omeprotect
4. Possible side effects
   1. Storage of Omeprotect

1. Contents of the pack and further information

1. What is Omeprotect and what is it used for

Omeprotect contains the active substance 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 (e.g., heartburn, acid regurgitation) in adults.

Reflux is the rise of acid from the stomach, which can swell and hurt. It 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 your symptoms worsen or do not improve after 14 days.

2. What you need to know before you start taking Omeprotect

Do not take Omeprotect

• 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 Omeprotect.

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

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

• Unintentional weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or vomiting blood.
• Black-colored stools (blood-stained feces).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have a history of stomach ulcers or gastrointestinal surgery.
• You are receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• You have persistent indigestion or heartburn 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 are scheduled to have a specific blood test (Chromogranin A)
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprotect to reduce stomach acidity.

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.

If you suffer from 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 Omeprotect. Remember to mention any other symptoms you may notice, such as joint pain.

Patient should not take omeprazol as a preventive medication.

Other medicines and Omeprotect

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine. Omeprazole may affect the mechanism of action of some medicines, and some medicines may affect omeprazole.

Do not take omeprazole 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, 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
• 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
• 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))

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, tell your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can take omeprazole during that time.

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

Driving and using machines

Omeprazole 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.

Omeprotect contains sucrose and sodium

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

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

3. How to take Omeprotect

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. 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 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 being broken down by the acid in the stomach. It is important not to damage the granules.

What to do 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 about half, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Omeprotect

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.

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

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 Omeprotect and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. It could also be accompanied by blistering and bleeding in the lips, eyes, mouth, nose, and genitals. It could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Yellowing of the skin, dark urine, and tiredness, which can 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 intestine: 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 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

• 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. It 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

• 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 rash, blistering, or peeling of the skin. It can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Increased breast size in men.

Frequency not known

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

In very rare cases, omeprazole 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, or difficulty urinating, you should consult your doctor as soon as possible to have 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 suffering from is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprotect

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

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

Store below 30°C.

Keep the bottle tightly closed or keep the blister in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Omeprotect

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other components (excipients) are: sugar spheres (sucrose and cornstarch), sodium carboxymethyl starch type A (derived from potato), sodium lauryl sulfate, povidone, sodium phosphate hydrate, sodium hydroxide, hydroxypropyl methylcellulose, methacrylic acid and ethyl acrylate copolymer, 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 packaging contents

Omeprotect 20 mg capsules are formed by an orange body and a dark blue cap with gastric-resistant spherical microgranules inside

Packaging sizes:

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

Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Teva Pharma S.L.U.

Malpica Industrial Estate, c/C 4

50016 Zaragoza

Spain

Date of the last revision of this leaflet:August 2023

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