Omeprazole Normon 40 mg powder for solution for infusion EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Omeprazol Normon 40 mg powder for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, nurse, or pharmacist.
• If you experience any side effects, talk to your doctor, nurse, or pharmacist, even if they are possible side effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Omeprazol 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 Omeprazol Normon

Do not use Omeprazol Normon

• if you are allergic (hypersensitive) to omeprazole or to 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 containing nelfinavir (used for HIV infection).

Omeprazol Normon must not be given to you if any of the above situations apply to you. If in doubt, speak with your doctor, nurse, or pharmacist before being given this medicine.

Warnings and precautions

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

Serious skin adverse reactions have been reported in association with treatment with Omeprazol Normon, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). You must stop taking Omeprazol Normon and seek immediate medical attention if you experience any symptoms related to these serious skin adverse reactions described in section 4.

Omeprazol Normon may mask symptoms of other diseases. Therefore, if you experience any of the following conditions either before starting treatment with Omeprazol Normon or after beginning treatment, speak to your doctor immediately:

• You lose weight significantly without apparent reason and have difficulty swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your bowel movements are black (blood-stained stools).
• 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 have ever had a skin reaction after treatment with a medicine similar to Omeprazol Normon used to reduce stomach acid.
• If you are scheduled to undergo a specific blood test (Chromogranin A).

If you are taking proton pump inhibitors such as Omeprazol Normon, especially for more than one year, you may have a slightly increased risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you develop a skin rash, particularly in areas of skin exposed to sunlight, consult your doctor as soon as possible, since it may be necessary to discontinue treatment with Omeprazol Normon. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, inflammation of the kidney may occur. 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 treating physician.

Children and adolescents

Do not administer this medicine to patients under 18 years of age. Experience with 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 might need to take any other medicines, including those obtained without a prescription. This is because Omeprazol Normon may affect the way some medicines work, and some medicines may affect the action of Omeprazol Normon.

Do not take Omeprazol Normon if you are taking a medicine containing 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, to relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping 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 starting or stopping treatment with omeprazole
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in 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 (a chemotherapy medicine used in high doses to treat cancer). If you are taking a high dose of methotrexate, your doctor will need to temporarily discontinue treatment with Omeprazol Normon.

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

Pregnancy, breastfeeding and fertility

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

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

Driving and using machines

It is unlikely that Omeprazol Normon will affect your ability to drive or operate tools or machinery. Adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, you should not drive or use machinery.

Important information about some of the components of Omeprazol Normon

This medicine contains less than 23 mg (1 mmol) of sodium per 40 mg omeprazole vial and is therefore considered essentially "sodium-free".

3. How to use Omeprazol Normon

• This medicine is administered to adults, including elderly people, when oral administration is not possible.

• Experience with intravenous omeprazole formulations in children is very limited.

• This medicine will be administered by a doctor, who will determine the dose required.

• The medicine will be given as an intravenous infusion.

If you have been given more Omeprazol Normon than you should have

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

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

4. Possible adverse effects

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

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop using omeprazole and consult your doctor immediately:

• Sudden wheezing (sudden wheezing), swelling of the lips, tongue and throat or of the body, skin rash, fainting or difficulty swallowing (severe allergic reaction). The frequency of this adverse effect is rare.

• Reddening of the skin with blistering or peeling. Severe blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. The frequency of this adverse effect is very rare.

• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The frequency of this adverse effect is rare.

• Widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). The frequency of this adverse effect is rare.

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

Other adverse effects are:

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

• Headache.
• Stomach or intestinal effects: diarrhoea, stomach pain, constipation, and gas (flatulence).
• Malaise (nausea or vomiting).
• Benign polyps in the stomach.

Uncommon adverse 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).
• Abnormalities in blood tests used to monitor liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

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

• Blood-related problems, such as reduced white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing infections.
• .
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Feeling of restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden sensation of wheezing or difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” that may affect the intestine.
• .
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from the available data)

• Inflammation in the intestine (causing diarrhoea).
• If you are being treated with Omeprazol Normon for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present 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 may also lead to reduced levels of potassium or calcium 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 may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severely deteriorated general condition, or fever with signs of localized infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you provide information about the medicines you are taking at that time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the vial and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

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

• Validity period after reconstitution:

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

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

From a microbiological standpoint, this medicine should be used immediately, unless reconstitution has been carried out under controlled and validated aseptic conditions.

• Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 sodium omeprazole equivalent to 40 mg of omeprazole.

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

Appearance of the product and contents of the pack

It is presented in 1 vial.

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

Pack 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 reviewed in: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

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

This information is intended for healthcare professionals only:

The entire contents of each vial must be dissolved in approximately 5 ml and immediately diluted to 100 ml. A solution for infusion containing 9 mg/ml sodium chloride (0.9%) or a solution for infusion containing 50 mg/ml glucose (5%) must be used. The pH of the infusion solution affects the stability of omeprazole; therefore, it must not be diluted in other solvents or in different volumes.

Preparation

1. Withdraw 5 ml of infusion solution from the 100 ml infusion bag or bottle using a syringe.
2. Add this volume to the vial containing the lyophilized omeprazole and mix thoroughly until complete dissolution of omeprazole is ensured.
3. Withdraw the omeprazole solution again using the syringe.
4. Transfer the solution to the infusion bag or bottle.
5. Repeat steps 1–4 to ensure that all 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-ended transfer needle and connect it to the injection port 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 back and forth between the infusion bag and the vial.
3. Check that all omeprazole has dissolved.

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

The solution for infusion must be administered as an intravenous infusion over 20–30 minutes.