PROSPECTO : INFORMATION FOR THE USER

Pantoprazol NORMON 40 mg powder for injectable solution EFG

Read this prospect carefully before starting to take the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor.

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

1. Before using Pantoprazol NORMON

3.How to use Pantoprazol NORMON

4.Possible adverse effects

5Storage of Pantoprazol NORMON

6.Additional information

Pantoprazol NORMON is 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 NORMON 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 regurgitation of acid 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 NORMON

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of Pantoprazol NORMON (see section 6)
• If you are allergic to medications that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Take special care with Pantoprazol NORMON

• 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 your liver enzymes increase, treatment should be interrupted. Consult your doctor if you are taking any medication containing atazanavir (for HIV treatment) at the same time as pantoprazole.
• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol NORMON for reducing 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 NORMON. Remember to mention any other symptoms you may notice, such as joint pain.

Inform your doctor immediatelyif you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in your vomit
• Pale appearance and feeling of weakness (anemia)
• Blood in your stools

• Severe or persistent diarrhea, as Pantoprazol NORMON 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 cancer symptoms and delay its diagnosis. If your symptoms persist despite treatment, additional investigations will be performed.

Use of other medications

Pantoprazol NORMON 40 mg I.V. injections may affect the efficacy of other medications, soinform your doctor if you are taking

• Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol NORMON may make these and other medications not work correctly.

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

• Atazanavir (used for HIV treatment).

Informyour doctor or pharmacist if you are using, or have recently used, other medications,includingthose purchasedwithout a prescription.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take pantoprazole:

• You are scheduled to have a specific blood test (Cromogranina A).
• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in your blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may cause a decrease in potassium and calcium levels in your blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

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 think you may be pregnant, or if you are breastfeeding, you should only use this medication if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Pantoprazol NORMON contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; 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.

Theusualdose

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.

Special patient groups:

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

• Children (under 18 years), the use of these injections is not recommended in children.

If you use more Pantoprazol NORMON than you should

Inform your doctor or pharmacist, indicating the medication and the amount ingested.No known symptoms of overdose.

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

Like all medications, Pantoprazol NORMON may have side effects, although not everyone will experience them.

The frequency of the possible side effects described below is classified as follows:

Very common (affects more than one patient in every 10)

Common (affects between 1 and 10 patients in every 100)

Uncommon (affects between 1 and 10 patients in every 1,000)

Rare (affects between 1 and 10 patients in every 10,000)

Very rare (affects fewer than 1 patient in every 10,000)

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

• Severe allergic reactions (rare): 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 not known):skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.

• Other severe conditions (frequency not known):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys sometimes with painful urination or lower back pain (severe kidney inflammation)

Other side effects are:

• Common(affects between 1 and 10 patients in every 100)

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

• Uncommon(affects between 1 and 10 patients in every 1,000)

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 malaise; sleep disturbances

If you are taking proton pump inhibitors such as Pantoprazol NORMON, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal column fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

• Rare(affects between 1 and 10 patients in every 10,000)

vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

• Very rare(affects fewer than 1 patient in every 10,000)

disorientation

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

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, skin rash, possibly with joint pain, tingling, paresthesia (tingling), burning or numbness and inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(affects between 1 and 10 patients in every 1,000)

increased liver enzymes

• Rare(affects between 1 and 10 patients in every 10,000)

increased bilirubin; increased fat in the blood

• Very rare(affects fewer than 1 patient in every 10,000)

reduced platelet count which could cause bleeding or more frequent bruising; reduced white blood cell count which could lead to more frequent infections.

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

If you are taking Pantoprazol NORMON for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, seek medical attention immediately. Low magnesium levels can also cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

Store the unreconstituted vial in the outer packaging. Do not store at a temperature above30°C

Use the reconstituted solution within 12 hours

Use the reconstituted and diluted solution within 12 hours

From a microbiological standpoint, 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 NORMON 40 mg i.v. if you observe a change in appearance (e.g., if turbidity or precipitates are observed)

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and medicines that you do not need at the SIGREcollection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition ofPantoprazol NORMON

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

The other components are:edetate disodium.

Appearance of the product and contents of the package

Pantoprazol NORMON is a white or off-white powder for injectable solution. It is presented ina glass vial with an aluminum cap and stopper containing 40 mg of powder for injectable solution.

Pantoprazol NORMON is available in the following package sizes:

Package with 1 vial

Clinical package with 50 (50x1) 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 July 2019

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

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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 sodium chloride injectable solution (0.9%) into the vial containing the powder.This solution may 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 or plastic containers should be used.

Pantoprazol NORMON should not be prepared or mixed with other solvents different from those specified.

After reconstitution, the solution may be used within 12 hours, although from a microbiological point of view, the product should be used immediately.If not, conservation within the time and conditions of use are the responsibility of the user and are normally not greater than 12 hours and25°C.

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

The contents of the vial are for a single intravenous 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.