Prospecto: Information for the User

Pantoprazol Normogen 40 mg powder for injectable solution EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.Pantoprazol Normogen and its use

1. What you need to know before starting to use Pantoprazol Normogen
2. How to use Pantoprazol Normogen

4.Possible adverse effects

5Storage of Pantoprazol Normogen

6.Contents of the package and additional information

Pantoprazol Normogen contains the active substance pantoprazol.

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

Pantoprazol Normogen is used for the treatment:

-Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus(the tube that connects your throat with your stomach)accompanied by acid regurgitation from the stomach.

-Stomach and duodenal ulcers.

-Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not use Pantoprazol Normogen

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components 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

Consult your doctor, pharmacist or nurse before starting to use Pantoprazol Normogen:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently. If liver enzyme levels increase, treatment should be interrupted.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
• Using a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you are using Pantoprazol Normogen for more than three months, it is possible that 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, see your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform blood tests periodically to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a similar medicine to Pantoprazol Normogen to reduce stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt 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 (Cromogranin A).

Inform 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, particularly if repeated.
• Blood in the vomit: it may appear as a dark brown powder 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.

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

Children and adolescents

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

Other medicines and Pantoprazol Normogen

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including medicines purchased without a prescription.

Pantoprazole may affect the efficacy of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Normogen may make these and other medicines not work correctly.

• Warfarin and fenprocoumon, which affect blood clotting. You may need additional monitoring.

• 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 interrupt treatment with Pantoprazol Normogen temporarily, as pantoprazole 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.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women.Pantoprazole is excreted in human breast milk.If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and operating machinery

Pantoprazol Normogen has no influence or has a negligible influence on the ability to drive or operate machinery.

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

Important information about some of the components of Pantoprazol Normogen

This medicine contains less than 1 mmol of sodium (23 mg), so it is essentially "sodium-free".

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

Therecommended 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 increase in stomach acid production.

Two vials (80 mg of pantoprazol) per day.

Your doctor may then adjust your dose, depending on the amount of stomach acid 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 temporarily prescribe a dose of more than four vials (160 mg) per day. If you need to quickly controlrapidlystomach acid levels, an initial dose of 160 mg (four vials) should be sufficient to significantly reduce stomach acid levels.

Patients with liver problems

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

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 18 years old.

If you use more Pantoprazol Normogen than you should

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

No known symptoms of overdose exist.

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

Like all medications, Pantoprazol Normogen may cause side effects, although not everyone will experience them.

If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this leaflet, inform 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, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and excessive sweating.

• Severe skin disorders (frequency unknown; its frequency cannot be estimated with the available data):Blisters on the skin and a rapid deterioration of overall conditions, erosion (including light bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.

• Other serious conditions (frequency unknown):Yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size sometimes with painful urination or lower back pain (severe kidney inflammation), possibly leading to renal failure.

Other side effects are:

• Frequent(may affect 1 in 10 patients)

Phlebitis and blood clots in the vein at the site of medication injection, benign polyps in the stomach.

• Infrequent(may affect 1 in 100 patients)

Headache, dizziness, diarrhea, sensation of dizziness, vomiting, bloating and flatulence (gas), constipation, dry mouth, abdominal pain and discomfort, hives on the skin, exanthema, rash, tingling, feeling of weakness, fatigue or general discomfort, sleep disturbances, hip, wrist, and spinal column fractures.

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

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

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

Disorientation.

• Frequency unknown(cannot be estimated from the available data)

Illusion, confusion (especially in patients with a history of these symptoms), decrease in sodium levels in the blood, decrease in magnesium levels in the blood (see section 2), sensation of tingling, pinpricks, numbness, burning or numbness, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Infrequent(may affect 1 in 100 patients)

Increased liver enzymes.

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

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

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

Reduction in the number of platelets that could cause bleeding or more frequent bruising, reduction in the number of white blood cells that could lead to more frequent infections, abnormal imbalance between the number of red and white blood cells, as well as platelets.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation.

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

After reconstitution, or reconstitution and dilution, physical and chemical stability in use has been demonstrated for 12 hours stored below25ºC.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time in use and the conditions prior to its use are the responsibility of the user and should normally not exceed 12 hours at a temperature above25ºC.

Do not use Pantoprazol Normogen 40 mg intravenously if you observe a change in appearance (for example: if turbidity or precipitates are observed)

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. In this way, you will help protect the environment.

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:sodium edetate and sodium hydroxide (to adjust the pH).

Appearance of the product and contents of the package

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

Pantoprazol Normogen is available in the following package sizes:

Package with 1 vial with powder for injectable solution.

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

Marketing authorization holder and responsible manufacturer

Laboratorios Normon, S.A.

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

Last review date of this leaflet: March 2021

Detailed and updated information on 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 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/85854/P_85854.html

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This information is intended solely for medical professionals or healthcare professionals:

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

Pantoprazol Normogen should not be prepared or mixed with other solvents different from 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, storage within the time and conditions of use are the responsibility of the user and are normally not greater than 12 hours and25°C.

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

The contents of the vial are for single use. Any remaining product in the vial or any vial showing a change in its visual appearance (e.g., if turbidity or precipitates are observed) should be discarded.