OMEPRAZOL TECNIGEN 20 mg HARD GASTRORESISTENT CAPSULES

Introduction

Package Leaflet: Information for the User

OmeprazoleTecniGen20 mg hard gastro-resistant capsules EFG

Omeprazole

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

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Omeprazole TecniGen and what is it used for
2. What you need to know before you take Omeprazole TecniGen
3. How to take Omeprazole TecniGen
4. Possible side effects

5 Storage of Omeprazole TecniGen

1. Contents of the pack and further information.

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

Omeprazole TecniGen 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 TecniGen is used to treat the following conditions:

In adults:

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.

• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).

• Ulcers caused by a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Omeprazole TecniGen may be used to prevent ulcers if you are taking NSAIDs.

• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• “Gastroesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, the symptoms of the disease can include return of stomach contents to the mouth (regurgitation), vomiting, and insufficient weight gain.

Children over 4 years of age and adolescents

• Ulcers caused by a bacterium called Helicobacter pylori. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Omeprazole TecniGen

Do not take OmeprazoleTecniGen

• 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 to treat HIV infection).

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole TecniGen.

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazole TecniGen.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with omeprazole. Stop taking omeprazole and consult your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

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

• Loses a lot of weight without apparent reason and has difficulty swallowing.
• Has stomach pain or indigestion.
• Starts vomiting food or vomiting blood.
• Has black stools (stools stained with blood).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Has severe liver problems.

• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol TecniGen to reduce stomach acidity.
• If you are scheduled to have a specific blood test (Chromogranin A)

Kidney inflammation can occur when taking omeprazole. 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 take Omeprazol TecniGen for a long time (more than 1 year), your doctor will probably perform regular check-ups. You should report any new or unusual symptoms and circumstances whenever you visit your doctor.

Taking a proton pump inhibitor like Omeprazol TecniGen, especially for a period of more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get 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 Omeprazol TecniGen. Remember to mention any other symptoms you may notice, such as joint pain.

Children

Some children with chronic diseases may require long-term treatment despite it not being recommended. Do not give this medicine to children under 1 year of age or < 10 kg.

Use of OmeprazolTecniGenwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. Omeprazol TecniGen may affect the action of some medicines and some medicines may affect Omeprazol TecniGen.

Do not take Omeprazol TecniGen 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, posaconazole, 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 Omeprazol TecniGen
• 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 Omeprazol TecniGen
• 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))
• Erlotinib (used to treat cancer)
• Methotrexate (chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop your treatment with Omeprazol TecniGen.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform them of any other medicines you are taking.

OmeprazolTecniGenwith food and drinks

See section 3

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Omeprazole passes into breast milk but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide whether you can take Omeprazol TecniGen if you are breastfeeding.

Driving and using machines

Omeprazol TecniGen 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 this happens, do not drive or use machines.

OmeprazolTecniGencontains sucrose

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

Omeprazol TecniGen contains sodium

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

3. How to take Omeprazol TecniGen

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.

The recommended dose is:

Adults:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild damage to the esophagus, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The usual dose once the esophagus has healed is 10 mg once a day.
• If you do not have damage to the esophagus, the usual dose is 10 mg once a day.

Treatment of ulcers in the upper part of the intestine(duodenal ulcer):

• The usual dose is 20 mg once a day for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of stomach ulcers(gastric ulcer):

• The usual dose is 20 mg once a day for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 8 weeks.

Preventionof the recurrence of stomach and duodenal ulcers:

• The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment of stomach and duodenal ulcers caused by NSAIDs(non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once a day for 4-8 weeks.

Prevention of stomach and duodenal ulcersduring NSAID therapy:

• The usual dose is 20 mg once a day

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of recurrence:

• The usual dose is 20 mg of Omeprazol TecniGen twice a day for one week.
• Your doctor will also tell you to take two antibiotics: amoxicillin and clarithromycin.

Treatment of excess acid in the stomachcaused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Use in children and adolescents:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation

• Children over 1 year of age who weigh more than 10 kg can take Omeprazol TecniGen. The dose for children is based on body weight and the doctor will decide the correct dose.

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of recurrence:

• Children over 4 years of age can take Omeprazol TecniGen. The dose for children is based on body weight and the doctor will decide the correct dose.
• The doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

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 or your child have problems swallowing the capsules

• If you or your child 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 well before drinking it (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To make sure you have taken all the medicine, fill the glass with water, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more OmeprazolTecniGenthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take OmeprazolTecniGen

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 forgotten doses.

If you stop taking OmeprazolTecniGen

Do not stop taking Omeprazol TecniGen without first talking to your doctor or pharmacist.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you notice any of the following rare adverse effects(may affect up to 1 in 1,000 people)or very rare (may affect up to 1 in 10,000 people) but serious, stop taking Omeprazol TecniGenand consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". (very rare)
• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems. (rare)

Other adverse effects are:

Frequent adverse effects (may affect up to 1 in 10 patients)

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

Infrequent adverse effects (may affect up to 1 in 100 patients)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormal liver function tests.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

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

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infection.
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disorders.
• Visual problems, such as blurred vision.
• Sudden feeling of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• Infection called "candidiasis" that can affect the intestine and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Abnormal blood counts, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Steven-Johnson syndrome.
• Muscle weakness.
• Increased breast size in men.

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (can cause diarrhea)
• If you take Omeprazol TecniGen for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also cause a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, Omeprazol TecniGen can 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 neck, throat, 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 that you provide information about the medication you are taking at that time.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Omeprazol TecniGen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, bottle, label, or blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 30 ºC.

Aluminum/aluminum blister: Store in the original packaging to protect it from moisture. HDPE bottle: Keep the bottle tightly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Omeprazol TecniGen Composition

• The active ingredient is omeprazol. Each capsule contains 20 mg of omeprazol.

• Capsule content:sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, sodium hydrogen phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, methacrylic acid-ethyl acrylate copolymer (1:1).
• Capsule shell:gelatin. The 20 mg capsules also contain the colorants quinoline yellow (E 104) and titanium dioxide (E 171).

Product Appearance and Package Contents

Hard gastro-resistant capsule.

Omeprazol TecniGen 20 mg: opaque yellow capsule containing white or almost white spherical microgranules.

Package sizes:

Blister packs with 7, 14, 15, 28, 30, 50, 56, and 60 capsules; and clinical packaging of 100, 140, 280, and 500 capsules.

HDPE plastic containers with 5, 7, 14, 28, 56, 60 capsules; and clinical packaging with 500 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13-3º D. Edificio América. Polígono Arroyo de la Vega.

28108 Alcobendas

Madrid. Spain

Manufacturer

LABORATORIOS LICONSA, S.A.

Av. Miralcampo, nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

Date of the Last Revision of this Leaflet:May 2023

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