PANTOPRAZOL NORMON 40 mg POWDER FOR INJECTABLE SOLUTION

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

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

Pantoprazole NORMON is used for the treatment:

• Reflux esophagitis. It 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. BEFORE USING Pantoprazole NORMON

Do not use Pantoprazole NORMON

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

Be careful with Pantoprazole NORMON

• If you have severeliver problems. Inform your doctor if you have ever had liver problems. He will perform more frequent monitoring of liver enzymes. In case of an increase in liver enzymes, treatment should be discontinued. Consult your doctor if you are taking any medication that contains atazanavir (for HIV infection treatment) at the same time as pantoprazole.

If you suffer a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole 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 the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools

• severe or persistent diarrhea, as Pantoprazole 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 because pantoprazole can alleviate cancer symptoms and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

Use of other medications

Pantoprazole NORMON 40 mg I.V. injections may influence the effectiveness of other medications, so inform your doctor if you are taking

• Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazole NORMON may cause these and other medications to not work properly.

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

• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are using or have recently used other medications, includingthose without a prescription.

Warnings and precautions

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

• A specific blood test (Chromogranin A) is scheduled.
• If you take pantoprazole for more than three months, you may suffer a decrease in magnesium levels in your blood. The symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have 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 whether to perform periodic blood tests to monitor magnesium levels.

Pregnancy and lactation

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk. If you are pregnant, think you may be pregnant, or are breastfeeding, you should only use this medication if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Pantoprazole NORMON contains sodium

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

3. HOW TO USE Pantoprazole NORMON

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

The normal dose is:

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

One vial (40 mg of pantoprazole) per day.

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

Two vials (80 mg of pantoprazole) per day.

Subsequently, your doctor may adjust the 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.

Special patient groups:

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

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

If you use more Pantoprazole NORMON than you should

Inform your doctor or pharmacist, indicating the medication and the amount taken. There are no known symptoms of overdose.

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

4. Possible adverse effects

Like all medications, Pantoprazole NORMON can have adverse effects, although not all people experience them.

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

very frequent (affects more than 1 patient in 10)

frequent (affects between 1 and 10 patients in 100)

uncommon (affects between 1 and 10 patients in 1,000)

rare (affects between 1 and 10 patients in 10,000)

very rare (affects less than 1 patient in 10,000)

frequency not known (cannot be estimated from the available data).

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's edema), intense dizziness with rapid heartbeats and excessive sweating.

• Severe skin disorders (frequency not known): blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

• Other severe conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size sometimes with pain when urinating or pain in the lower back (severe kidney inflammation)

Other adverse effects are:

• Frequent(affects between 1 and 10 patients in 100)

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

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

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

If you are taking proton pump inhibitors like Pantoprazole NORMON, especially for a period of 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).

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

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

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

disorientation

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

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

Adverse effects identified through blood tests:

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

increase in liver enzymes

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

increase in bilirubin; increase in blood fats

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

reduction in platelet count, which could lead to bleeding or more bruising than usual; reduction in white blood cell count, which could lead to more frequent infections.

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

If you are taking Pantoprazole NORMON for more than three months, your 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 have any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in 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 adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Conservation of PANTOPRAZOL NORMON

Keep out of the reach and sight of children.

Do not use Pantoprazole 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 above 30°C

Use the reconstituted solution within 12 hours

Use the reconstituted and diluted solution within 12 hours

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

Do not use Pantoprazole NORMON 40 mg i.v. if you observe that the visual appearance has changed (e.g., if turbidity or precipitates are observed)

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Pantoprazole NORMON

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

The other components are: disodium edetate.

Appearance of the product and packaging content

Pantoprazole NORMON is a white or off-white powder for injectable solution. It is presented in a glass vial with an aluminum cap and stopper that contains 40 mg of powder for injectable solution.

Pantoprazole NORMON is available in the following packaging sizes:

Package with 1 vial

Clinical package with 50 (50x1) vials

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

This prospectus was revised in July 2019

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/

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This information is intended only 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, glass or plastic containers should be used.

Pantoprazole NORMON 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 used immediately, the storage time and conditions prior to use are 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 contents of the vial are for single intravenous use. Any remaining product in the vial or any vial in which a change in visual appearance is detected (e.g., if turbidity or precipitates are observed) should be discarded.