Pantoprazole Normogen 40 mg powder for solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pantoprazole Normogen 40 mg powder for solution for injection EFG

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before using Pantoprazole Normogen

3. How to use Pantoprazole Normogen

4. Possible side effects

5. How to store Pantoprazole Normogen

6. Contents of the pack and other information

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

Pantoprazol Normogen contains the active substance pantoprazol.

Pantoprazol Normogen is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of acid-related disorders of the stomach and intestine. This medicine is administered by intravenous injection and will only be given to you if your doctor considers that an injection of pantoprazol is, at this time, more suitable for you than pantoprazol tablets. The tablets will replace the injections as soon as your doctor considers it appropriate.

Pantoprazol Normogen is used for the treatment in adults of:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you need to know before starting to use Pantoprazole Normogen

Do not use Pantoprazole Normogen

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to medicines containing other proton pump inhibitors (for example, omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Pantoprazole Normogen:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently. If liver enzymes increase, treatment should be discontinued.
• Consult your doctor if you are taking protease inhibitors for HIV, such as atazanavir (used to treat HIV infection), at the same time as pantoprazole.
• Taking a proton pump inhibitor such as pantoprazole, especially for over a year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).
• If you are taking Pantoprazole Normogen for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Normogen used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole 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).

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

• Unintentional weight loss.

• Vomiting, particularly if repeated.

• Blood in vomit: it may appear as dark coffee-ground-like specks in your vomit.

• Blood in your stools, which may appear black or tarry (melena).

• Difficulty swallowing, or pain when swallowing.

• Pale appearance and feeling weak (anemia).

• Chest pain.

• Stomach pain.

• Severe or persistent diarrhea, as Pantoprazole Normogen has been associated with a slightly increased risk of infectious diarrhea.

• Serious skin reactions have been reported with Pantoprazole Normogen treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazole Normogen and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.

Your doctor will decide whether additional tests are needed to rule out malignant disease, as pantoprazole may relieve cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

Children and adolescents

The use of pantoprazole is not recommended in children, as it has not been studied in individuals under 18 years of age.

Using Pantoprazole Normogen with other medicines

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

Pantoprazole may affect the effectiveness of other medicines. Inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections), as Pantoprazole Normogen may reduce the effectiveness of these and other medicines.

• Warfarin and phenprocoumon, which affect blood clotting. You may require 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 temporarily discontinue treatment with Pantoprazole Normogen, as pantoprazole may increase methotrexate levels in the blood.

• Fluvoxamine (used to treat depression and other psychiatric conditions). 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 Pantoprazole Normogen if you are due to undergo a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and using machines

Pantoprazole Normogen has no effect or a negligible effect on the ability to drive or use machines.

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

Pantoprazole Normogen contains sodium

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

3. How to use Pantoprazol Normogen

Your nurse or doctor will administer the daily dose as an intravenous injection 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 pantoprazole) per day.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion.

Two vials (80 mg of pantoprazole) per day.

Subsequently, your doctor may adjust your dose depending on the amount of gastric acid you produce. If more than two vials (80 mg) per day are prescribed, the injections will be given in equal divided doses. Your doctor may temporarily prescribe a dose exceeding four vials (160 mg) per day. If rapid control of stomach acid levels is required, an initial dose of 160 mg (four vials) should be sufficient to considerably reduce gastric acid production.

Patients with liver problems

If you have severe liver impairment, 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 carefully controlled 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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Pantoprazole Normogen may cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

• Severe skin disorders (frequency not known; frequency cannot be estimated from available data): you may notice one or more of the following – skin blisters and rapid deterioration in general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, 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's syndrome, erythema multiforme), subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, peeling, ulcers in mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys sometimes with pain on urination and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse effects are:

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

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

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

Headache, dizziness, diarrhoea, feeling of dizziness, vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruption, tingling, sensation of weakness, fatigue or malaise, sleep disturbances, fractures of the hip, wrist and spine.

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

Altered or complete loss of taste sensation, vision disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling in the limbs (peripheral oedema), 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 available data)

Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or stinging, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse 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 blood fat levels, sudden drop in granular white blood cells in circulation, associated with high fever.

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

Reduction in the number of platelets which could lead to bleeding or more bruising than usual, reduction in the number of white blood cells which could lead to more frequent infections, abnormal decrease in the balance between red blood cells, white blood cells, and platelets.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

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

5. Storage of Pantoprazole Normogen

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Keep the vial in its 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 when stored below 25°C.

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

Do not use Pantoprazole Normogen 40 mg for intravenous use if you notice any change in its appearance (for example: cloudiness or precipitation).

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at 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

Composition of Pantoprazol Normogen

The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).

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

Appearance of the product and contents of the pack

Pantoprazol Normogen is a white or almost white, porous-appearing lyophilized powder for injectable solution. It is supplied in a clear type I glass vial closed with a chlorobutyl rubber stopper and sealed with an aluminium cap containing 40 mg of powder for injectable solution.

Pantoprazol Normogen is available in the following pack sizes:

Pack containing 1 vial with powder for injectable solution.

Clinical pack containing 50 (50x1) vials with 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 most recent revision of this summary: March 2025

Detailed and up-to-date information on this medicine 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 updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85854/P_85854.html

This information is intended for healthcare professionals only:

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

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

After reconstitution, the solution may be used within 12 hours; however, from a microbiological standpoint, the product should be used immediately. If not used immediately, storage during the period and under conditions of use is the responsibility of the user and should normally not exceed 12 hours at 25°C.

The medicine is to be administered intravenously over 2–15 minutes.

The vial contents are for single use only. Any unused portion remaining in the vial or any vial in which a change in visual appearance is observed (e.g., cloudiness or precipitation) must be discarded.