Package Insert: Information for the User

OmeprazoleTecniGen20 mg Hard Gastroresistant Capsules EFG

Omeprazole

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

• Keep this package insert, as you may need to read it again.

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

• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Omeprazole TecniGen

4. Possible adverse effects

5. Storage of Omeprazole TecniGen

6. Contents of the package and additional information

Omeprazol TecniGencontains 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.

Omeprazol TecniGenis used to treat the following diseases:

In adults:

• “Gastroesophageal reflux disease” (GERD). In this condition, stomach acid flows up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn.

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

• Ulcers infected by a bacteria called “Helicobacter pylori”. If you have this disease, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.

• Ulcers caused by certain medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). Omeprazol TecniGenmay also 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” (GERD). In this condition, stomach acid flows up into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected by a bacteria called“Helicobacter pylori”. If your child has this disease, your doctor may prescribe antibiotics to treat the infection and allow the ulcer to heal.

Do not take OmeprazolTecniGen

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

Do not take this medication if any of the above situations affect you. If you are unsure, speak with your doctor or pharmacist before taking Omeprazol TecniGen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazol TecniGen.

Severe skin reactions have been reported in relation to omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute pustular psoriasis (PEGA). 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 mask the symptoms of other diseases. Therefore, if you experience any of the following symptoms before starting to take Omeprazol TecniGen or during treatment, consult your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Starting to vomit food or blood.
• Black stools (blood-stained feces).
• Severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Severe liver problems.

• If you have ever had a skin reaction after treatment with a similar medication to Omeprazol TecniGen for reducing stomach acid.
• If you are scheduled to have a specific blood test (Cromogranina A).

Taking omeprazole may cause kidney inflammation. 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 inform your doctor of these signs.

If you take Omeprazol TecniGen for a long period (more than 1 year), your doctor will likely perform regular check-ups. You should inform your doctor of any new or unusual symptoms and circumstances whenever you visit.

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

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue 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 administer this medication to children under 1 year of age or <10>

Use of Omeprazol TecniGen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.This includes medications that can be purchased without a prescription.Omeprazol TecniGen may affect the mechanism of action of some medications, and some medications may affect Omeprazol TecniGen.

Do not take Omeprazol TecniGen if you are taking a medication that contains nelfinavir (used to treat HIV infection)

Inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole, itraconazole, posaconazole, 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 treatment with Omeprazol TecniGen.
• 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 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).
• Erlotinib (used to treat cancer).
• Methotrexate (chemotherapy medication used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily discontinue your treatment with Omeprazol TecniGen.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin to treat ulcers caused by Helicobacter pylori infection, it is essential to inform your doctor of any other medications you are taking.

Omeprazol TecniGen with food and drinks

See section 3

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.Omeprazol passes into breast milk but is unlikely to affect the baby when used in therapeutic doses.Your doctor will decide if you can take Omeprazol TecniGen while breastfeeding.

Driving and operating machinery

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 they do, you should not drive or operate machinery.

Omeprazol TecniGen contains saccharose

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.

Omeprazol TecniGen contains sodium

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

Follow exactly the administration instructions for OmeprazolTecniGenas indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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 GERD, such asheartburn and acid regurgitation:

• If your doctor checks 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 ofulcers in the upper part of the small 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 ofstomach 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 ofstomach 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 byNSAIDs(nonsteroidal anti-inflammatory drugs):

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

Prevention of stomach and duodenal ulcersduring the administration ofNSAIDs:

• The usual dose is 20 mg once a day

Treatment ofulcers causedby the infectionbyHelicobacter pyloriandprevention of their recurrence:

• The usual dose is 20 mg of Omeprazol TecniGentwice a day for a week.
• Your doctor will also prescribe two antibiotics, amoxicillin, clarithromycin, and metronidazole.

Treatment of excess acid in the stomach caused by atumor 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 will also decide how long you should take the medication.

Use in children and adolescents:

Treatment of symptoms of GERD, such asheartburn and acid regurgitation

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

Treatment ofulcers causedby the infectionbyHelicobacter pyloriand prevention of their recurrence:

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

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 contain coated granules that prevent the medication from breaking down in the stomach acid. It is essential not to damage the granules.

What to do if you or your child have trouble swallowing the capsules

• If you or your child have trouble 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 water without gas, a sour fruit juice (e.g., apple, orange, or pineapple), or a compote of apple.
• 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 all the medication has been taken, fill the glass of water to half, rinse it well, and drink the water. The solid parts contain the medication; 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take OmeprazolTecniGen

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 interrupt the treatment with OmeprazolTecniGen

Do not stop taking OmeprazolTecniGenwithout first consulting your doctor or pharmacist.

If you have any doubts about the use of this medication, consult 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 side effects (may affect up to 1 in 1,000 people)or very rare but serious side effects (may affect up to 1 in 10,000 people), stop taking Omeprazol TecniGenand consult your doctor immediately:

• Sudden hissing sounds when breathing (sudden sibilance), 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. Blisters may also appear intensely and bleeding in the lips, eyes, mouth, nose, and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."(very rare)
• Generalized rash, elevated body temperature, and inflammation of lymph nodes (DRESS syndrome or pharmacological hypersensitivity syndrome). (rare)
• A red, scaly, and generalized rash with protuberances under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).(rare)
• Yellow discoloration of the skin, dark urine, and fatigue, which may be symptoms of liver problems.(rare)

Other side effects are:

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

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

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, 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 (may affect up to 1 in 1,000 patients)

• Blood disorders, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Low sodium levels in the blood. This can 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 can affect the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Muscle or joint pain (arthralgias or myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggression.
• To see, feel, or hear things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestines (may cause diarrhea).
• If you take Omeprazol TecniGenfor more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, 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 TecniGenmay affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a verybadgeneral condition or fever with local infection symptoms, 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.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, website: www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of that medicine.

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

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

Do not store at a temperature above 30 °C.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. By doing so, you will help protect the environment.

Composition of OmeprazoleTecniGen

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

• Content of the capsule:sugar spheres (sucrose and cornstarch), laurilsulfate of sodium, hydrogen phosphate of sodium, manitol, hypromelose, macrogol 6000, talc, polisorbate 80, titanium dioxide, copolymer of methacrylic acid-ethylacrylate (1:1).
• Capsule coating:gelatin. The 20 mg capsules also contain the colorants yellow of quinoleine (E 104) and titanium dioxide (E 171).

Appearance of the product and content of the container

Hard-gastrorresistente capsule.

OmeprazoleTecniGen20 mg: opaque yellow capsule containing white cream or almost white spherical microgranules.

Container sizes:

Blister-type containers with 7, 14, 15, 28, 30, 50, 56, and 60 capsules; and clinical container with 100, 140, 280, and 500 capsules.

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

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

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, Industrial Park Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

Last review date of this leaflet:May 2023

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