OMEPRAZOL TECNIMEDE 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

OmeprazoleTecnimede20mg 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 the instructions for administration 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 listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the package leaflet:

1. What is Omeprazole Tecnimede and what is it used for
2. What you need to know before taking Omeprazole Tecnimede
3. How to take Omeprazole Tecnimede
4. Possible side effects
5. Storage of Omeprazole Tecnimede
6. Contents of the pack and further information

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

Omeprazole Tecnimede 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.

Omeprazole is indicated in adults for the short-term treatment of symptoms of reflux (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 a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Omeprazole Tecnimede

Do not take Omeprazole Tecnimede

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

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

This medicine 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 or during treatment:

• Losing a lot of weight without apparent reason and having difficulty swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomiting blood.
• Having 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.
• Having a history of stomach ulcers or gastrointestinal surgery.
• Receiving ongoing treatment 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 medicine 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 omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as a preventive medication.

When taking omeprazole, kidney inflammation may occur. The signs and symptoms can 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.

Children and adolescents

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

Other medicines and Omeprazole Tecnimede

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. 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).
• Erlotinib (used to treat cancer).
• Methotrexate (used to treat rheumatoid arthritis and some cancers). If you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with omeprazole.
• 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 Omeprazole Tecnimede with food and drinks

See section 3. You can take your capsules with food or on an empty stomach.

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 it is unlikely to affect the baby when used at therapeutic doses. Your doctor will decide if you can take omeprazole while 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.

Omeprazole Tecnimede contains sucrose

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 Omeprazole Tecnimede

Follow the instructions for administration 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 breaking down due to the action of stomach acid. It is important not to damage the granules. These granules contain omeprazole as the active substance and have an enteric coating that protects them and prevents them from breaking when passing through the stomach. The granules release the active substance 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, rinse it well, and drink the water. Do notuse milk 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 Tecnimede than you should

If you have taken more omeprazole 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 ingested.

If you forget to take Omeprazole Tecnimede

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.

If you have any other questions 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 Omeprazole Tecnimede 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. This could also be associated with blistering and bleeding of the lips, eyes, mouth, nose, and genitals. 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, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

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).
• Alterations 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 infection.
• 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 when exposed to sunlight.
• 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 alterations, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can cause liver failure and brain inflammation.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. 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.

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 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 perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is important 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 of side effects

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

5. Storage of Omeprazole Tecnimede

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Blister: Do not store above 30°C. Store in the original packaging to protect from moisture.

Bottle: Do not store above 30°C. Keep the bottle tightly closed to protect 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 your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging and further information

Composition of Omeprazole Tecnimede

• The active substance is omeprazole. Omeprazole Tecnimede capsules contain 20 mg of omeprazole.
• The other ingredients are: granules: sodium lauryl sulfate, disodium phosphate, mannitol (E-421), hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E-171), copolymer of methacrylic acid and ethyl acrylate. Sugar sphere: sucrose and cornstarch. Gelatin capsule: gelatin, water, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the product and packaging contents

Omeprazole Tecnimede capsules are formed by a yellow body and cap that contain gastro-resistant omeprazole microgranules.

Packaging sizes:

Blister pack containing 14 capsules.

Bottle containing 14 capsules.

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13

28108 Alcobendas (Madrid) Spain.

Manufacturer

LICONSA, S.A.

Avda. Miralcampo, Nº 7, Pol. Ind.

Miralcampo (Azuqueca de Henares)

19200 - Spain

Date of last revision of this leaflet: May 2025

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/