Nolpaza

Package Leaflet: Information for the User

Nolpaza, 40 mg, Powder for Solution for Injection

Pantoprazole

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get 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 Nolpaza is and What It is Used For
• 2. Before You Use Nolpaza
• 3. How to Use Nolpaza
• 4. Possible Side Effects
• 5. How to Store Nolpaza
• 6. Contents of the Pack and Other Information

1. What Nolpaza is and What It is Used For

Nolpaza contains the active substance pantoprazole. Nolpaza is a selective “proton pump inhibitor”, a medicine that reduces the amount of acid produced in the stomach. Nolpaza is used to treat diseases of the stomach and intestines, related to acid production. The medicine is given intravenously when, in the doctor's opinion, this route of administration is more appropriate than oral administration with pantoprazole tablets. Injections will be replaced with tablets as soon as the doctor considers it appropriate.

Nolpaza is Used in Adults for the Treatment of:

• Gastroesophageal reflux disease. Esophagitis (inflammation of the esophagus), which is accompanied by acid reflux.
• Peptic ulcer disease and duodenal ulcer.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.

2. Before You Use Nolpaza

When Not to Use Nolpaza

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• If you have been diagnosed with an allergy to medicines containing other proton pump inhibitors.

Warnings and Precautions

Before taking Nolpaza, you should discuss it with your doctor, pharmacist, or nurse.

• If you have severe liver problems. You should inform your doctor about any liver diseases you have had. Your doctor will perform more frequent liver enzyme tests, and if their levels increase, therapy will be discontinued.
• If you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection) at the same time as pantoprazole, you should ask your doctor for detailed advice.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis (decreased bone density) or if your doctor has informed you that you are at risk of osteoporosis (for example, if you are taking steroid medications).
• If you take Nolpaza for more than three months, you may experience a decrease in blood magnesium levels, which can cause fatigue, tremors, disorientation, seizures, dizziness, and cardiac arrhythmias. If you experience any of these symptoms, you should inform your doctor. Low blood magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to periodically check your blood magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid production.
• If you get a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Nolpaza. You should also tell your doctor about any other side effects, such as joint pain.
• Severe skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. You should stop taking pantoprazole and seek medical advice immediately if you notice any symptoms related to these serious skin reactions described in section 4.
• About a planned specific blood test (chromogranin A levels).

You should immediately inform your doctorbefore or during treatment with Nolpaza if you experience any of the following symptoms, which may be signs of a more serious disease:

• Unintentional weight loss;
• Vomiting, especially if it is repeated;
• Bloody vomiting, which may look like coffee grounds;
• Blood in the stool, black or tarry stools;
• Difficulty swallowing or pain when swallowing;
• Pale skin and weakness (anemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhea, as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.

Children and Adolescents

Nolpaza is not recommended for use in children.

Nolpaza and Other Medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
Since pantoprazole given by injection may affect the effectiveness of other medicines, you should 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 Nolpaza may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood density and prevent blood clots. Further tests may be necessary.
• 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 the use of Nolpaza, as pantoprazole may increase the level of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may prescribe a lower dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before taking pantoprazole, you should discuss it with your doctor if you are going to have a specific urine test (for tetrahydrocannabinol (THC)).
You should tell your doctor or nurse about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.

Pregnancy, Breast-Feeding, and Fertility

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.
There is limited data on the use of pantoprazole in pregnant women. It has been found that the medicine passes into the breast milk of nursing mothers.
The medicine may be used in pregnant women or women who are breast-feeding only if the doctor considers that the benefit of the treatment is greater than the potential risk to the unborn child or infant.

Driving and Using Machines

Nolpaza has no or negligible influence on the ability to drive and use machines.
Patients who experience side effects such as dizziness and visual disturbances should not drive or operate machinery.

Nolpaza Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that it is essentially “sodium-free”.

3. How to Use Nolpaza

The medicine is given intravenously in a single daily dose over a period of 2 to 15 minutes by a doctor or nurse.
Recommended dosage:

Adults

In case of stomach ulcers, duodenal ulcers, and gastroesophageal reflux disease
One vial (40 mg of pantoprazole) per day.
In case of long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid production
Two vials (80 mg of pantoprazole) per day.
In the future, your doctor may adjust the dose based on the amount of acid produced in the stomach. If your doctor prescribes doses greater than two vials (80 mg) per day, the medicine will be given in two equal divided doses. Periodically, your doctor may prescribe a dose of more than four vials (160 mg) per day. For rapid control of acid production, an initial dose of 160 mg (four vials) should be sufficient to reduce acid production.

Special Patient Groups:

• In patients with severe liver disease, the daily dose should be only 20 mg (half a vial).

Use in Children and Adolescents

Nolpaza injections are not recommended for use in children under 18 years of age.

Overdose of Nolpaza

Your doctor or nurse will carefully check the dosage, so overdosing is unlikely.
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 Side Effects

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

If You Experience Any of the Following Side Effects, Contact Your Doctor or Go to the Nearest Hospital Immediately:

• Severe allergic reactions (rare: less than 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema/anaphylactic shock), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from available data):
• you may notice one or more of the following symptoms - blisters and severe worsening of general health, erosion (including mild bleeding) of the eyes, nose, mouth/lips, or genitals, or rash, especially on sun-exposed skin areas. You may also experience joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., under the arms), and changes in some white blood cells or liver enzymes in blood tests.
• red, non-raised spots or circular patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known):yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlarged kidneys, sometimes accompanied by pain when urinating and pain in the lower back (severe kidney inflammation); may lead to kidney failure.

Other side effects include:

• Common(may affect up to 1 in 10 people): Inflammation of the vein wall and blood clotting (thrombophlebitis) at the injection site; mild stomach polyps.
• Uncommon(may affect up to 1 in 100 people): Headache; dizziness; diarrhea; nausea; vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash; exanthema, skin eruptions; itching; fractures of the hip, wrist, or spine; weakness; fatigue or general feeling of being unwell; sleep disturbances.
• Rare(may affect up to 1 in 1000 people): Disturbances or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; peripheral edema (peripheral swelling); allergic reactions, depression; gynecomastia (breast enlargement in men).
• Very Rare(may affect up to 1 in 10,000 people): Disorientation.
• Not Known(frequency cannot be estimated from available data): Hallucinations, confusion (especially in patients who have had these symptoms before); feeling of tingling, prickling, burning, or numbness; rash that may be accompanied by joint pain; colitis (inflammation of the colon), which can cause persistent watery diarrhea.

Side Effects Identified in Blood Tests:

• Uncommon(may affect up to 1 in 100 people): Increased liver enzyme activity.
• Rare(may affect up to 1 in 1000 people): Increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very Rare(may affect up to 1 in 10,000 people): Decreased platelet count, which can cause abnormal bleeding or bruising; decreased white blood cell count, which can cause more frequent infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.
• Not Known(frequency cannot be estimated from available data): Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Nolpaza

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 and vial after “EXP”. The expiry date refers to the last day of that month.
Batch number is stated on the packaging after “Lot”.
Do not store above 25°C.
The vial should be kept in the outer packaging to protect it from light.
The reconstituted or reconstituted and diluted solution has a chemical and physical stability of 12 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the medical personnel are responsible for the storage time and conditions before use.
Do not use Nolpaza if it has changed appearance (e.g., if the solution has become cloudy or precipitated).
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. Contents of the Pack and Other Information

What Nolpaza Contains

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: mannitol, sodium citrate dihydrate, sodium hydroxide for pH adjustment.

What Nolpaza Looks Like and Contents of the Pack

Nolpaza is a white or almost white, uniform, porous mass.
Packaging: 1 glass vial, in a cardboard box.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Sofarimex – Indústria Química e Farmacêutica, S.A, Av. Das Indústrias-Alto do Colaride, Cacém
2735-213, Portugal
LABORATORIOS ALCALA FARMA, S.L., Avenida de Madrid, 82, Alcala de Henares, 28802
Madrid, Spain
Date of Last Revision of the Leaflet:29.12.2024
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The following information is intended for healthcare professionals only:
The ready-to-use solution is prepared by injecting 10 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0.9%) into the vial containing the lyophilized powder. The solution may be administered directly or after mixing with 100 ml of sodium chloride injection solution at a concentration of 9 mg/ml (0.9%) or glucose injection solution at a concentration of 50 mg/ml (5%). Only glass or plastic containers should be used for dilution.
Nolpaza should not be prepared or mixed with solvents other than those mentioned above.
After reconstitution or reconstitution and dilution, the medicine retains its chemical and physical stability for 12 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the medical personnel are responsible for the storage time and conditions before use.
The medicine should be administered intravenously over a period of 2 to 15 minutes.
The contents of the vial are intended for single use only. Any amount of the medicine remaining in the vial or the medicine whose appearance has changed (e.g., if cloudiness or precipitation occurs) should be discarded.