Omeprazole Tecnimede 20 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OmeprazolTecnimede 20 mg gastro-resistant hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 14 days.

Contents of the leaflet:

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

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

Omeprazol 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 reflux symptoms (for example, heartburn, acid regurgitation):

Reflux is the backflow of acid from the stomach into the esophagus, which may become inflamed and cause pain. This can cause symptoms such as a painful 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 symptom improvement.

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

2. What you need to know before taking Omeprazol Tecnimede

Do not take Omeprazol 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 containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used for HIV infection).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take omeprazole.

Do not take omeprazole for longer 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 symptoms of other conditions. Therefore, consult your doctor immediately if you experience any of the following conditions before starting omeprazole or during treatment:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Begin vomiting food or vomiting blood.
• Black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• A history of gastric ulcer or gastrointestinal surgery.
• Receiving ongoing treatment for indigestion or heartburn for 4 weeks or more.
• Experiencing persistent indigestion or heartburn for 4 weeks or more.
• Jaundice or severe liver disease.
• Are over 55 years old and your symptoms have recently changed or are new.
• Have ever had a skin reaction after treatment with a medicine similar to omeprazole used to reduce stomach acid.
• Are scheduled to have a specific blood test (chromogranin A).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with omeprazole. Remember to mention any other symptoms you may notice, such as joint pain.

Patients should not take omeprazole as preventive medication.

When taking omeprazole, kidney inflammation may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report such signs to your treating doctor.

Children and adolescents

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

Other medicines and Omeprazol Tecnimede

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Omeprazole may affect how some medicines work, and some medicines may affect omeprazole.

Do not take omeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform 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 starting or stopping omeprazole treatment.
• Medicines used to prevent blood clots, 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 (used in 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 may 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 (thrombi)).

Taking Omeprazol Tecnimede with food and drink

See section 3. You may 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 is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take omeprazole while breastfeeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use tools or machines. Adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machines.

Omeprazol Tecnimede contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Omeprazol Tecnimede

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 20 mg capsule once daily for 14 days. Contact your doctor if symptoms do not resolve after this period.

You may need to take the capsules for 2–3 consecutive days before experiencing improvement in symptoms.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may take the 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 designed to prevent the medicine from breaking down under the action of stomach acid. It is important not to damage the granules. These granules contain omeprazole as the active substance and are enteric-coated to protect them and prevent breakdown as they pass through the stomach. The granules release the active substance in the intestine, where it is absorbed by the body to produce its effect.

What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules:

• Open the capsule and take 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 juice), or apple sauce.

• Always shake the mixture well just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.

• To ensure you have taken the full dose, add half a glass of water to the container, swirl well, and drink it. Do not use milk or carbonated water. The solid particles contain the medicine; do not chew or crush them.

Use in children and adolescents

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

If you take more Omeprazol Tecnimede than you should

If you have taken more omeprazole than prescribed by your doctor, consult your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Omeprazol Tecnimede

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Sudden wheezing, swelling of the lips, tongue and throat, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding may also occur in the lips, eyes, mouth, nose, and genitals. 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 adverse effects include:

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

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results indicating possible liver problems.
• Skin rash, hives, and itching.
• General malaise and lack of energy.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Blood problems, such as reduced white blood cells or platelets. This may cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue and throat, fever, and wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” that may affect the intestine.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash, blistering, or skin peeling. 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 males.

Frequency not known (cannot be estimated from available data):

• Inflammation of the intestine (causing diarrhoea).
• Hypomagnesaemia.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole may affect the white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a very poor general condition, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you inform your doctor about any medicines you are taking at that time.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of Omeprazol 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 refers to the last day of the month indicated.

Blister pack: Do not store above 30 °C. Keep 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Storage of the container and additional information

Composition of OmeprazolTecnimede

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

Appearance of the product and contents of the container

Omeprazol Tecnimede capsules consist of yellow body and cap containing gastro-resistant omeprazole microgranules.

Container 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 the most recent review of this leaflet: May 2025

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