Product Information for the Patient

Omeprazol Normon 40 mg Powder for Solution for Infusion EFG

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse, or pharmacist.
• If you experience any adverse effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this product information. See section 4.
• .

1.What is Omeprazol Normon and how is it used

2.What you need to know before using Omeprazol Normon

3.How to use Omeprazol Normon

4.Possible adverse effects

5.Storage of Omeprazol Normon

6.Contents of the package and additional information

Omeprazol Normon contains the active ingredient omeprazole. It belongs to a group of medicines called “proton pump inhibitors” that act by reducing the amount of acid produced by the stomach.

Omeprazole powder for solution for infusion may be used as an alternative to oral treatment.

Do not use Omeprazol Normon

• if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine that contains nelfinavir (used for HIV infection).

Do not administer Omeprazol Normon if you are affected by any of the above situations. In case of doubt, speak with your doctor, nurse or pharmacist before administering this medicine.

Warnings and Precautions

Consult your doctor, nurse or pharmacist before receiving Omeprazol Normon.

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced eosinophilia and systemic symptoms (DRESS), and generalized acute pustular psoriasis (PEGA), have been reported in relation to Omeprazol Normon treatment. You should stop taking Omeprazol Normon and seek medical attention immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.

Omeprazol Normon may mask the symptoms of other diseases.Therefore, if you experience any of the following symptoms before starting to use Omeprazol NORMON or after it has been administered, speak immediately with your doctor:

• you lose weight significantly without apparent reason and have trouble swallowing.
• you have stomach pain or indigestion.
• you start vomiting food or blood.
• your stools are black (blood-stained).
• you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• you have severe liver problems.
• you have ever had a skin reaction after treatment with a similar medicine to Omeprazol Normon for reducing stomach acid.
• you are scheduled to have a specific blood test (Cromogranin A).

If you are taking proton pump inhibitors such as Omeprazol Normon, especially for a period of more than one year, you may slightly increase the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may 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 interrupt treatment with Omeprazol NORMON. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, inflammation of the kidneys may occur. 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 inform your doctor of these signs.

Children and Adolescents

Do not administer this medicine to children under 18 years of age. The experience with the use of intravenous formulations of Omeprazol Normon in pediatric patients is limited.

Other Medicines and Omeprazol Normon

Inform your doctor, nurse or pharmacist if you are taking or have recently taken or may need to take any other medicine, including those purchased without a prescription. This is because Omeprazol Normon may affect the mechanism of action of some medicines and some medicines may affect the mechanism of action of Omeprazol NORMON.

Do not take Omeprazol NORMON if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Inform your doctor, nurse 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 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 clotting, 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 (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 medicine used in high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor will need to temporarily interrupt omeprazole treatment.

If your doctor has prescribed antibiotics amoxicillin and clarithromycin in addition to Omeprazol Normon to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor of any other medicines you are taking.

Pregnancy, Breastfeeding and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor, nurse or pharmacist before administering this medicine.

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 Omeprazol Normon while breastfeeding.

Driving and Operating Machines

It is unlikely that Omeprazol Normon will 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.

Important Information about Some Components of Omeprazol Normon

This medicine contains less than 23mg (1mmol) of sodium per 40mg omeprazole vial, making it essentially "sodium-free".

• This medication is administered to adults, including elderly individuals, in whom oral administration is not possible

.

• Experience with the use of intravenous formulations of omeprazol in children is very limited.
• This medication will be administered by a doctor, who will decide the amount needed.
• They will administer the medication as an infusion into a vein.

If they have administered more Omeprazol Normon than prescribed

If you believe you have been administered more omeprazol than prescribed, inform your doctor immediately.

If you have any other questions about the use of this medication, consult your doctor, nurse, or pharmacist.

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

If you notice any of the following rare or very rare but serious side effects, stop taking omeprazole and consult your doctor immediately:

• Sudden hissing sounds while breathing (sudden onset of bronchospasm), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction). The frequency of this side effect is rare.
• Redness of the skin with the formation of blisters or peeling. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis". The frequency of this side effect is very rare.
• Generalized rash, elevated body temperature, and enlargement of lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The frequency of this side effect is rare.
• Red, scaly, and generalized rash with skin protuberances and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis). The frequency of this side effect is rare.

• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. The frequency of this side effect is rare.

Other side effects are:

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

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

Less frequent side 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 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 people)

• 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.
• Sensation of agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of hissing or 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.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Abnormal blood count, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing 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.

Unknown frequency(cannot be estimated from available data)

• Inflammation of the intestines (causing diarrhea).
• If you are taking Omeprazol Normon for more than three months, it is possible that magnesium levels in the blood will decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of localized infection, 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, nurse, 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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this 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 vial and packaging after CAD. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

• Validity period after reconstitution:

The reconstituted infusion solution with 9 mg/ml of sodium chloride (0.9%) should be used within the course of 12 hours following preparation.

The reconstituted infusion solution with 50 mg/ml of glucose (5%) should be used within the course of 6 hours following preparation.

From a microbiological standpoint, this medication should be used immediately, unless reconstituted in controlled and validated aseptic conditions.

• Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

• The active ingredient is omeprazole. Each vial of powder for solution for infusion contains an amount of omeprazole sodium equivalent to 40mg of omeprazole.

• The other components (excipients) are disodium edetate dihydrate and sodium hydroxide.

Appearance of the product and contents of the package

It is presented in 1 vial.

The white powder contained in the vial must be incorporated into a solution before administration.

Package sizes: 1 and 50 vials.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid

SPAIN

This leaflet has been reviewed in:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/67270/P_67270.html

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This information is intended solely for doctors or healthcare professionals:

The entire content of each vial must be dissolved in approximately 5ml and immediately diluted to 100ml. A solution for infusion of 9mg/ml of sodium chloride (0.9%) or a solution for infusion of 50mg/ml of glucose (5%) must be used. The pH of the infusion solution affects the stability of omeprazole, which is why it should not be diluted in other solvents or in other quantities.

Preparation

1. Draw out 5ml of infusion solution from the 100ml bottle or bag.
2. Add this volume to the vial containing the lyophilized omeprazole and mix well until you are sure that all the omeprazole has dissolved.
3. Draw out the omeprazole solution again with the syringe.
4. Transfer the solution to the infusion bag or bottle.
5. Repeat steps 1‑4 until you are sure that all the omeprazole has been transferred from the vial to the infusion bag or bottle.

Alternative method for preparing infusions in flexible containers

1. Use a double transfer needle and connect it to the injection membrane of the infusion bag. Connect the other end of the needle to the vial containing the lyophilized omeprazole.
2. Dissolve the omeprazole by pumping infusion solution between the infusion bag and the vial and vice versa.
3. Check that all the omeprazole has dissolved.

The solution for infusion should not be used if particles are observed in the reconstituted solution.

The infusion solution will be administered intravenously as a perfusion over 20‑30 minutes.