OMEPRAZOL ARISTOGEN 20 mg HARD GASTRO-RESISTANT CAPSULES

2. What you need to know before taking Omeprazole Aristogen

Do not take Omeprazole Aristogen

• 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 to treat HIV infection).

Do not take Omeprazole Aristogen if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Omeprazole Aristogen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omeprazole Aristogen.

When taking omeprazole, kidney inflammation may occur. The signs and symptoms may include decreased urine output 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.

Omeprazole Aristogen may mask the symptoms of other diseases. Therefore, if you experience any of the following conditions before starting to take Omeprazole Aristogen or during treatment, consult your doctor immediately:

• You lose a lot of weight without apparent reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained feces).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.
• If you are taking proton pump inhibitors like Omeprazole Aristogen, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazole to reduce stomach acidity.
• You are scheduled to have a specific blood test (Chromogranin A).

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

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 Aristogen. Remember to mention any other symptoms you may notice, such as joint pain.

Children

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

Using Omeprazole Aristogen with other medicines

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

Do not take Omeprazole Aristogen 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 Omeprazole Aristogen
• 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 Aristogen
• 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 may temporarily stop your treatment with Omeprazol)

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

Omeprazole Aristogen 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 medicine. Your doctor will decide if you can take Omeprazole Aristogen during this time.

Omeprazole is excreted in breast milk, but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide if you can take Omeprazole Aristogen if you are breastfeeding.

Driving and using machines

Omeprazole Aristogen 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 use machines.

Omeprazole Aristogen contains sucrose

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

3. How to take Omeprazole Aristogen

Follow the instructions for administration of Omeprazole Aristogen indicated by your doctor or pharmacist. You should 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 as heartburn and acid regurgitation:

• If your doctor confirms that you have mild esophageal damage, the normal 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 recommended dose once the esophagus has healed is 10 mg once a day.
• If you do not have esophageal damage, the normal dose is 10 mg once a day.

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

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

Prevention of stomach and duodenal ulcersduring the administration of NSAIDs:

• The normal dose is 20 mg once a day

Treatment of ulcers causedby Helicobacter pyloriinfectionand prevention of their recurrence:

• The normal dose is 20 mg of Omeprazole Aristogen twice a day for one week.
• Your doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

Treatment of excess acid in the stomach caused 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 GERD, such as heartburn and acid regurgitation

• Children over 1 year of age who weigh more than 10 kg can take Omeprazole Aristogen. 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 their recurrence:

• Children over 4 years of age can take Omeprazole Aristogen. 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 breaking down due to the action of stomach acid. It is important not to damage the granules.

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

• If you or your child have difficulty 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 non-carbonated 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 the halfway point, rinse it well, and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Omeprazole Aristogen than you should

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

If you forget to take Omeprazole Aristogen

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 stop taking Omeprazole Aristogen

Do not stop taking Omeprazole Aristogen without first consulting your doctor or pharmacist.

If you have any other 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 all people suffer from them.

If you notice any of the following rare but serious adverse effects, stop taking Omeprazol Aristogen and 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).
• 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".
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

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).
• Alterations in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general 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 likelihood of infections.
• Allergic reactions, sometimes very intense, including 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 alterations.
• Visual problems, such as blurred vision.
• Sudden feeling of difficult 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 fatigue.
• Hair loss (alopecia).
• Skin rash with exposure 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)

• Blood count alterations, 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.
• Sudden appearance of an intense 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.
• Increased breast size in males.

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (can produce diarrhea)
• If you are taking Omeprazol Aristogen for more than three months, it is possible that magnesium levels in your 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 produce 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 Aristogen can affect the white blood cells in the blood 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 important that you provide information about

Do not worry about this list of possible adverse effects. You may not experience any of them.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. 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 about the safety of this medicine.

5. Conservation of Omeprazol Aristogen

Keep this medicine out of sight and reach of children.

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

Do not store at a temperature above 30 °C.

PVC-PVDC/aluminum blister: Store in the original packaging to protect it from moisture. HDPE bottle: Keep the bottle perfectly 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. In case of doubt, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omeprazol Aristogen

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

Capsule content:sugar spheres (sucrose and cornstarch), sodium lauryl sulfate, anhydrous disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide, and 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1). See section 2. "Omeprazol Aristogen contains sucrose".

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

Enteric-coated hard capsule.

Omeprazol Aristogen 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:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid.

Manufacturer

LABORATORIOS LICONSA, S.A.

Av. Miralcampo, nº7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

Date of the last revision of this prospectus: January 2023.

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