OMEPRAZOL NORMON 40 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Omeprazole Normon 40 mg Powder for Solution for Infusion EFG

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• .

Contents of the Package Leaflet:

1. What is Omeprazole Normon and what is it used for
2. What you need to know before using Omeprazole Normon
3. How to use Omeprazole Normon
4. Possible side effects
5. Storage of Omeprazole Normon
6. Contents of the pack and other information

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

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

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

2. What you need to know before using Omeprazole Normon

Do not use Omeprazole 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 of the proton pump inhibitor group (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine that contains nelfinavir (used for HIV infection).

Omeprazole Normon should not be administered to you if you are affected by any of the above conditions. If in doubt, talk to your doctor, pharmacist, or nurse before being given this medicine.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before receiving Omeprazole Normon.

Severe skin reactions, such as 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 Normon. You should stop taking Omeprazole Normon and seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.

Omeprazole Normon may mask the symptoms of other diseases. Therefore, if you experience any of the following conditions before starting to use Omeprazole Normon or after being administered, talk to your doctor immediately:

• Losing a lot of weight without reason and having trouble swallowing.
• Having stomach pain or indigestion.
• Starting to vomit food or vomiting blood.
• Having 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.
• Having severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Normon to reduce stomach acidity.
• If you are scheduled to have a specific blood test (Chromogranin A).

If you are taking proton pump inhibitors like Omeprazole Normon, especially for 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 can increase the risk of osteoporosis).

If you experience a skin rash, especially in areas of the skin exposed to the sun, talk to your doctor as soon as possible, as it may be necessary to interrupt treatment with Omeprazole Normon. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms can 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. Experience with the use of intravenous formulations of Omeprazole Normon in pediatric patients is limited.

Other Medicines and Omeprazole Normon

Tell your doctor, pharmacist, or nurse if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription. This is because Omeprazole Normon may affect the action of some medicines and some medicines may affect the action of Omeprazole Normon.

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

Tell your doctor, pharmacist, or nurse if you are taking any of these 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
• 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
• 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 high doses of methotrexate, your doctor will need to temporarily stop treatment with Omeprazole Normon.

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

Pregnancy, Breastfeeding, and Fertility

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

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

Driving and Using Machines

Omeprazole Normon is unlikely to affect your ability to drive or use tools or machines. 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 of the Ingredients of Omeprazole Normon

This medicine contains less than 23 mg (1 mmol) of sodium per 40 mg vial of omeprazole, so it is essentially “sodium-free”.

3. How to Use Omeprazole Normon

• This medicine is administered to adults, including the elderly, in whom oral administration is not possible

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• Experience with the use of intravenous formulations of omeprazole in children is very limited.
• This medicine will be administered by a doctor, who will decide the amount you need.
• The medicine will be administered to you as an infusion into a vein.

If You Have Been Given More Omeprazole Normon Than You Should

If you think you have been given more omeprazole than you should, tell your doctor immediately.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If You Notice Any of the Following Serious Side Effects, Stop Using Omeprazole and Consult Your Doctor Immediately(May Affect Up to 1 in 1000 People) or Very Rare (May Affect Up to 1 in 10,000 People) but Serious:

• Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction). The frequency of this side effect is rare.
• Redness of the skin with blistering or peeling. It can also appear as intense blisters and bleeding in the lips, eyes, mouth, nose, and genitals. It could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. The frequency of this side effect is very rare.
• Widespread rash, high body temperature, and increase in the size of lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency of this side effect is rare.
• 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). The frequency of this side effect is rare.

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

Other side effects are:

Common Side Effects(May Affect Up to 1 in 10 People)

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

Uncommon Side Effects(May Affect Up to 1 in 100 People)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Changes in blood tests that check liver function.
• Rash, hives, and itching.
• Feeling of general discomfort and lack of energy.

Rare Side Effects(May Affect Up to 1 in 1000 People)

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the likelihood of infections.
• .
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Feeling of agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden wheezing or difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called “candidiasis” that can affect the intestine and is caused by a fungus.
• .
• Hair loss (alopecia).
• Rash on the skin with exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Side Effects(May Affect Up to 1 in 10,000 People)

• Blood count changes, 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.
• Increased size of the breasts in men.

Frequency Not Known(Cannot Be Estimated from Available Data)

• Inflammation of the intestine (causing diarrhea).
• If you are treated with Omeprazole Normon for more than three months, it is possible that the magnesium levels in your blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, 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 periodic blood tests to monitor your magnesium levels.
• Skin rash, possibly with joint pain.

In very rare cases, omeprazole 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 sore throat, 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 the medicine you are taking at that time.

Reporting Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Normon

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date is the last day of the month stated.

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

• Validity period after reconstitution:

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

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

From a microbiological point of view, this medicine should be used immediately, unless it has been reconstituted in controlled and validated aseptic conditions.

• Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the Pack and Other Information

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

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

Appearance and Packaging

It is presented in 1 vial.

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

Package sizes: 1 and 50 vials.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid

SPAIN

This leaflet was last revised in:February 2025

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

You can access detailed and updated information on 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 only for healthcare professionals:

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

Preparation

1. Withdraw 5 ml of infusion solution from the 100 ml bottle or infusion bag using a syringe.
2. Add this volume to the vial containing the omeprazole lyophilizate and mix well until you are sure that all the omeprazole has dissolved.
3. Withdraw the omeprazole solution again using 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 of preparation of 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 omeprazole lyophilizate.
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.

Do not use if particles are observed in the reconstituted solution.

The infusion solution will be administered as an intravenous infusion over 20-30 minutes.