Nolpaza

Package leaflet: Information for the user

Nolpaza, 40 mg, powder for solution for injection
pantoprazole
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Nolpaza is and what it is used for
2. What you need to know 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 hydrochloric acid produced in the stomach. Nolpaza is used in the treatment of stomach and intestinal disorders related to the secretion of hydrochloric acid.
Nolpaza is administered intravenously when, in the opinion of the doctor, this route of administration is more appropriate than giving pantoprazole in tablet form. Injections will be replaced by tablets as soon as the doctor considers it appropriate.
Nolpaza is used in adults for the treatment of:

• Gastroesophageal reflux disease. Inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with backflow of stomach acid.
• Gastric and duodenal ulcer disease.
• Zollinger-Ellison syndrome and other medical conditions associated with excessive secretion of hydrochloric acid in the stomach.

2. Important information before using Nolpaza

When not to use Nolpaza

• if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Nolpaza, discuss this with your doctor, pharmacist, or
nurse.

• If the patient has severe liver problems. Inform the doctor about any previous liver diseases. The doctor will perform more frequent liver enzyme tests, and if their levels increase, treatment will be discontinued.
• If the patient is taking HIV protease inhibitors, such as atazanavir (used in the treatment of HIV infection), together with pantoprazole, they should seek detailed advice from their doctor.
• The use of a proton pump inhibitor such as pantoprazole, especially for periods longer than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (for example, if the patient is taking steroid medicines).
• If the patient takes Nolpaza for longer than three months, they may experience reduced magnesium levels in the blood, which may lead to fatigue, tetany, disorientation, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, the patient should inform their doctor. Low magnesium levels in the blood may also lead to reduced potassium and calcium levels. The doctor may decide that periodic monitoring of magnesium levels in the patient's blood is necessary.
• If the patient has ever had a skin reaction while taking a medicine similar to Nolpaza that reduces gastric acid secretion.
• If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue Nolpaza. The patient should also report any other adverse effects, such as joint pain.
• Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. The patient should stop taking pantoprazole and seek immediate medical advice if they notice any symptoms related to these serious skin reactions described in section 4.
• Regarding a planned specific blood test (chromogranin A levels).

The patient should immediately inform their doctor before starting or during treatment with the medicine,
if any of the following symptoms occur, as they may indicate another, more serious
condition:

• unintentional weight loss;
• vomiting, particularly recurrent;
• vomiting blood, which may look like dark coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain during swallowing;
• pallor and weakness (anaemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhoea, as use of this medicine is associated with a slight increase in the risk of infectious diarrhoea.

The doctor may decide that tests are necessary to rule out an underlying tumour, because treatment with pantoprazole may relieve symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Children and adolescents
Nolpaza is not recommended for use in children.
Nolpaza and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Because pantoprazole administered by injection may affect the effectiveness of other
medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Nolpaza may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further testing may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer conditions) – when methotrexate is used, the doctor may temporarily discontinue Nolpaza, because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend reducing the dose.
• Rifampicin (used to treat infections).
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Before starting pantoprazole, discuss this with your doctor if the patient is scheduled for a specific urine test [for tetrahydrocannabinol (THC)].
Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of pantoprazole in pregnant women. It has been shown that the drug passes into breast milk.
The medicine may be used in pregnant women, women in whom pregnancy cannot be excluded, or women who are breastfeeding only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.
Driving and operating machinery
Nolpaza has no effect or has a negligible effect on the ability to drive motor vehicles
and operate mechanical equipment.
Patients who experience adverse effects such as dizziness or visual disturbances
should not drive or operate machinery.
Nolpaza contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning that the medicine is considered "sodium-free".

3. How to use Nolpaza

The medicine is administered intravenously as a single daily dose over 2 to 15 minutes by a doctor or nurse.

Recommended dosage:

Adults

For gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease
One vial (40 mg of pantoprazole) per day.

For long-term treatment of Zollinger-Ellison syndrome and other medical conditions associated with excessive hydrochloric acid secretion
Two vials (80 mg of pantoprazole) per day.

Later, your doctor may adjust the dose depending on gastric acid secretion. If your doctor prescribes a dose higher than two vials (80 mg) per day, the medicine will be given in two equal divided doses. Periodically, your doctor may recommend a dose exceeding four vials (160 mg) per day. To achieve rapid control of acid secretion, an initial dose of 160 mg (four vials) should be sufficient to reduce acid secretion.

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
Injections are not recommended for children under 18 years of age.

Accidental overdose of Nolpaza
The doctor or nurse carefully checks the dosage, so overdose is unlikely.
Symptoms of overdose are unknown.

If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the listed adverse reactions occur, you should
immediately contact your doctor or go to the nearest hospital:

• Severe allergic reactions (rare: no more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle rash), breathing difficulties, angioedema of the face (Quincke’s edema/angioedema), severe central vertigo accompanied by rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data):
• the patient may notice one or more of the following symptoms – skin blistering and sudden worsening of general health, erosions (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• red, non-elevated spots or circular lesions on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genitals and eyes. The onset of such severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency unknown): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation); potentially leading to kidney failure.

Other adverse reactions include:

• Common (may affect up to 1 in 10 patients): Inflammation of the vein wall and blood clotting (thrombophlebitis) at the injection site; benign gastric polyps.
• Uncommon (may affect up to 1 in 100 patients): Headache; central vertigo; diarrhoea; nausea; vomiting; flatulence and gas; constipation; dryness of the mouth; pain and discomfort in the abdomen; skin rash; hives, skin eruptions; itching; fractures of the hip, wrist or spine; weakness; fatigue or general malaise; sleep disturbances.
• Rare (may affect up to 1 in 1,000 patients): Disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated temperature; high fever; limb swelling (peripheral oedema); allergic reactions, depression; breast enlargement in males.
• Very rare (may affect up to 1 in 10,000 patients): Disorientation.
• Unknown (frequency cannot be estimated from available data): Hallucinations, confusion (particularly in patients who have previously experienced such symptoms); sensations of tingling, pricking, burning or numbness; rash possibly associated with joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified in blood tests:

• Uncommon (may affect up to 1 in 100 patients): Increased liver enzyme activity.
• Rare (may affect up to 1 in 1,000 patients): Increased bilirubin levels; increased blood lipid levels; fever-related sudden decrease in circulating granulocytes – white blood cells.
• Very rare (may affect up to 1 in 10,000 patients): Decreased platelet count, which may lead to abnormal bleeding or bruising; decreased white blood cell count, which may lead to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets.
• Unknown (frequency cannot be estimated from available data): Decreased concentration of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicinal product Nolpaza

The medicinal product should be stored in a place inaccessible and out of sight of children.
Do not use this medicinal product after the expiry date stated on the carton and vial after the abbreviation "EXP". The expiry date refers to the last day of the stated month. The batch number is indicated on the packaging after the abbreviation "Lot".
Do not store above 25°C.
The vial should be stored in the outer packaging to protect from light.
The solution after reconstitution or after reconstitution and dilution maintains its chemical and physical stability for 12 hours at 25°C.
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, it is the responsibility of the medical personnel to ensure the storage conditions and duration prior to use.
Do not use the medicinal product Nolpaza if there are any changes in its appearance (e.g. if the solution becomes cloudy or a precipitate forms).
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 sodium pantoprazole sesquihydrate).
• Other ingredients are: mannitol, disodium citrate dihydrate, sodium hydroxide for pH adjustment.

What Nolpaza looks like and contents of the pack
Nolpaza is a white or almost white, homogeneous, porous mass.
Packaging: 1 glass vial in a cardboard box.
Marketing Authorisation 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

The following information is intended exclusively for healthcare professionals:

A ready-to-use solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) injection solution into a vial containing the lyophilized powder. The solution may be administered directly or after mixing with 100 ml of sodium chloride 9 mg/ml (0.9%) injection solution or glucose 50 mg/ml (5%) injection solution. Glass or plastic containers should be used for dilution.
Nolpaza must not be prepared or mixed with solvents other than those previously mentioned.
After reconstitution or reconstitution and dilution, the medicinal product maintains chemical and physical stability for 12 hours at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the healthcare professional is responsible for the storage duration and conditions prior to use.
The medicinal product should be administered intravenously over 2 to 15 minutes.
The vial content is intended for single use only. Any unused portion of the medicinal product remaining in the vial or any solution that has changed appearance (e.g. cloudiness or precipitation) must be discarded.