PANTOPRAZOL NORMOGEN 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Pantoprazol Normogen 40 mg powder for solution for injection EFG

Read all of this leaflet carefully before you start takingthis 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Pantoprazol Normogen and what is it used for
   1. What you need to know before you use Pantoprazol Normogen
   2. How to use Pantoprazol Normogen

1. Possible side effects

5 Storage of Pantoprazol Normogen

1. Contents of the pack and further information

1. What is Pantoprazol Normogen and what is it used for

Pantoprazol Normogen contains the active substance pantoprazol.

Pantoprazol Normogen is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used to treat diseases related to stomach and intestinal acid. This medicine is injected into a vein and will only be given to you if your doctor considers that injection of pantoprazol is more convenient for you than pantoprazol tablets at this time. The tablets will replace the injections as soon as your doctor considers it appropriate.

Pantoprazol Normogen is used for the treatmentin adults of:

• Reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid reflux from the stomach.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you use Pantoprazol Normogen

Do not use Pantoprazol Normogen

• If you are allergic to pantoprazol or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to medicines that contain other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Pantoprazol Normogen:

• If you have severeliver problems. Tell your doctor if you have ever had liver problems in the past. He will monitor your liver enzymes more frequently. If there is an increase in liver enzymes, treatment should be discontinued.
• Talk to your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazol.
• Taking a proton pump inhibitor like pantoprazol, especially for more than a year, may increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told that you are at risk of osteoporosis (e.g. if you are taking corticosteroids
• If you are taking Pantoprazol Normogen for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to your doctor immediately. Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Normogen to reduce stomach acid.
• If you get 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 discontinue treatment with Pantoprazol Normogen. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• Unintentional weight loss.
• Vomiting, especially if it is repeated.
• Blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit.
• If you notice blood in your stools, which may appear black or tarry.
• Difficulty swallowing, or pain when swallowing.
• Pale appearance and feeling of weakness (anemia).
• Chest pain.
• Stomach pain.

• Severe or persistent diarrhea, as Pantoprazol Normogen has been associated with a small increase in infectious diarrhea.
• There have been reports of serious skin reactions in relation to treatment with Pantoprazol Normogen, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazol Normogen and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.

Your doctor will decide if you need any additional tests to rule out a malignant disease, as pantoprazol may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, further investigations will be carried out.

Children and adolescents

The use of pantoprazol is not recommended in children, as it has not been tested in children under 18 years of age.

Use ofand Pantoprazol Normogenwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pantoprazol may affect the efficacy of other medicines. Tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections), as Pantoprazol Normogen may make these and other medicines not work properly.

• Warfarin and phenprocoumon, which affect blood clotting. You may need additional checks.

• Medicines used to treat HIV infection, such as atazanavir.

• Methotrexate used to treat rheumatoid arthritis, psoriasis, and cancer. If you are taking methotrexate, your doctor may temporarily stop treatment with Pantoprazol Normogen, as pantoprazol may increase methotrexate levels in the blood.

• Fluvoxamine (used to treat depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce your dose.

• Rifampicin (used to treat infections).

• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking Pantoprazol Normogen if you need to have a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breast-feeding, and fertility

There is not enough data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human breast milk. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol Normogen has no or negligible influence on the ability to drive or use machines.

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Pantoprazol Normogencontains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

3. How to use Pantoprazol Normogen

Your nurse or doctor will administer the daily dose as an injection into a vein over a period of 2-15 minutes.

The recommended dose is:

Adults

For the treatment of gastric ulcers, duodenal ulcers, and reflux esophagitis.

One vial (40 mg of pantoprazol) per day.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increased secretion of stomach acid.

Two vials (80 mg of pantoprazol) per day.

Subsequently, your doctor may adjust your dose, depending on the amount of acid secretion you produce. If you are prescribed more than two vials (80 mg) per day, the injections will be administered in equal doses. Your doctor may prescribe a dose of more than four vials (160 mg) per day for a short period. If you need to quickly control your stomach acid levels, an initial dose of 160 mg (four vials) should be sufficient to significantly reduce the amount of stomach acid.

Patients with liver problems

If you have severe liver problems, the daily injection should be only 20 mg (half a vial).

Use in children and adolescents

The use of these injections is not recommended in children and adolescents under 18 years of age.

If you use more Pantoprazol Normogen than you should

This medicine is controlled with caution by your nurse or doctor, so it is very unlikely that you will receive more than you should.

There are no known symptoms of overdose.

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

4. Possible side effects

Like all medicines, Pantoprazol Normogen can cause side effects, although not everybody gets them.

If you experience any of the following side effects, talk to your doctor or pharmacist.

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known;frequency cannot be estimated from the available data):you may notice one or more of the following - blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or symptoms similar to flu, fever, swollen glands (e.g. in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-like red spots on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, high body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size, sometimes with pain when urinating or back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Frequent(may affect up to 1 in 10 patients)

Inflammation of the vein wall and blood clots (thrombophlebitis) at the injection site, benign stomach polyps.

• Uncommon(may affect up to 1 in 100 patients)

Headache, dizziness, diarrhea, feeling of dizziness, vomiting, swelling, and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruption, tingling, feeling of weakness, fatigue, or general malaise, sleep disturbances, hip, wrist, and spine fractures.

• Rare(may affect up to 1 in 1,000 patients)

Alteration or complete loss of taste, vision disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling in the limbs (peripheral edema), allergic reactions, depression, breast enlargement in men.

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

Disorientation.

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

Hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 patients)

Increased liver enzymes.

• Rare(may affect up to 1 in 1,000 patients)

Increased bilirubin, increased fat in the blood, sharp drop in white blood cells, associated with high fever.

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

Reduced platelet count, which may cause bleeding or more bruising than usual, reduced white blood cell count, which may lead to more frequent infections, abnormal reduction in the balance between red and white blood cell and platelet counts.

Frequency not known(cannot be estimated from the available data) decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Normogen

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Store the vial in the original packaging to protect it from light.

After reconstitution, or reconstitution and dilution, physical and chemical stability has been demonstrated for 12 hours at a temperature below 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage time and conditions are the responsibility of the user and normally should not exceed 12 hours at a temperature above 25°C.

Do not use Pantoprazol Normogen 40 mg intravenously if you notice that the appearance has changed (e.g. if you notice turbidity or precipitation)

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition ofPantoprazol Normogen

The active ingredient is pantoprazol. Each vial contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).

The other components are: disodium edetate and sodium hydroxide (to adjust the pH).

Appearance of the Product and Container Content

Pantoprazol Normogen is a white or off-white lyophilized powder with a porous appearance for injectable solution. It is presented in a type I transparent glass vial closed with a chlorobutyl plug and sealed with an aluminum cap containing 40 mg of powder for injectable solution.

Pantoprazol Normogen is available in the following package sizes:

Package with 1 vial of powder for injectable solution.

Clinical package with 50 (50x1) vials of powder for injectable solution.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the Last Revision of this Prospectus: March2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85854/P_85854.html

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This information is intended solely for doctors or healthcare professionals:

The solution for immediate use is prepared by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride injectable solution into the vial containing the powder. This solution can be administered directly or diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride injectable solution or 55 mg/ml (5%) glucose injectable solution. For dilution, type II glass vials or polyethylene perfusion bags with twist-off should be used.

Pantoprazol Normogen should not be prepared or mixed with solvents other than those specified.

After reconstitution, the solution can be used within 12 hours, although from a microbiological point of view, the product should be used immediately. If not, the conservation within the time and conditions of use is the responsibility of the user and should not normally exceed 12 hours and 25°C.

The medication will be administered intravenously over 2-15 minutes.

The content of the vial is for single use. Any remaining product in the vial or any vial in which a change in its visual appearance is detected (e.g., if turbidity or precipitations are observed) should be discarded.