Pantoprazole Noridem

Package leaflet: Information for the user

Pantoprazole Noridem 40 mg powder for injectable solution

pantoprazole
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any 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.

The name of this medicine is:

• Pantoprazole Noridem 40 mg powder for injectable solution

Throughout the remainder of this package leaflet, the medicine will be referred to as Pantoprazole Injection.
Contents of this leaflet:

1. What Pantoprazole Injection is and what it is used for
2. What you need to know before using Pantoprazole Injection
3. How to use Pantoprazole Injection
4. Possible side effects
5. How to store Pantoprazole Injection
6. Contents of the pack and other information

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

Pantoprazole Injection contains the active substance pantoprazole (as sodium sesquihydrate). Pantoprazole Injection is a selective "proton pump inhibitor," a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.
This preparation is injected intravenously and will be administered to you only if your doctor considers that injectable pantoprazole is currently more appropriate than pantoprazole tablets. Tablets will replace injections as soon as your doctor deems it appropriate.
Pantoprazole Injection is used for the treatment in adults of:

• Reflux esophagitis. An inflammation of the esophagus (the tube connecting the throat to the stomach) associated with gastric acid reflux.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

2. What you should know before using Pantoprazole Injection

Do not take Pantoprazole Injection

• 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.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pantoprazole Injection

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will arrange for more frequent monitoring of your liver enzymes. If liver enzymes increase, treatment must be discontinued.
• If you are taking protease inhibitors for HIV, such as atazanavir (for the treatment of HIV infection), consult your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine.
• Inform your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of developing osteoporosis (for example, if you are taking steroids).
• If you have been taking Pantoprazole Injection for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Injection that reduces gastric acidity.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue therapy with Pantoprazole Injection. Remember to also report any other adverse effects such as joint pain.
• If you need to undergo a specific blood test (Chromogranin A).

Inform your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which could be signs of a more serious condition:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Presence of blood in vomit; this may appear as dark coffee-ground-like material in the vomit
• Appearance of blood in stools, which may appear dark or tarry
• Difficulty swallowing or pain when swallowing
• Looking pale and feeling weak (anemia)
• Chest pain
• Stomach pain
• Severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea.

Your doctor may decide that you need further tests to rule out a malignant condition, as pantoprazole can relieve symptoms of cancer and may delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.

Children and adolescents
The use of Pantoprazole Injection is not recommended in children, as efficacy has not been demonstrated in children under 18 years of age.

Other medicines and Pantoprazole Injection
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Pantoprazole Injection may affect the effectiveness of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazole Injection may prevent these and other medicines from working properly.
• Warfarin and fenprocoumon, which affect blood clotting. You may need 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 Injection, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John’s wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human milk has been reported.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers the benefit to you greater than the potential risk to the fetus or infant.

Driving and using machines
Pantoprazole Noridem does not affect or has a negligible effect on the ability to drive and use machinery.
If you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

Pantoprazole Noridem contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially “sodium-free”.

3. How to take Pantoprazole Injection

The nurse or doctor will administer your daily dose as an intravenous injection over a period of 2–15 minutes.
The recommended dose is:
Adults

• For gastric, duodenal ulcers, and reflux esophagitis: One vial (40 mg of pantoprazole) per day.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive stomach acid production: Two vials (80 mg of pantoprazole) per day. Subsequently, your doctor may adjust the dose according to your gastric acid secretion levels. If more than two vials (80 mg) per day are prescribed, the injections will be divided into two equal doses. Your doctor may temporarily prescribe a dose higher than four vials (160 mg) per day. If rapid control of gastric acidity is required, an initial dose of 160 mg (four vials) will be sufficient to adequately reduce stomach acid levels.

Patients with liver problems
If you have severe liver problems, the daily injection should be only 20 mg (half a vial).
Use in children and adolescents
These injections are not recommended for use in children and adolescents under 18 years of age.
If you take more Pantoprazole Noridem than you should
Doses are carefully controlled by the nurse or doctor, so overdose is very unlikely. Symptoms of overdose are not known.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, consult your doctor immediately, or contact the nearest
hospital emergency department:

• Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (angioedema/Quincke's edema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): you may notice one or more of the following symptoms – appearance of skin blisters and rapid deterioration of your general condition, erosion (including mild 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. under the arm), and blood tests may show changes in the count of 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).
• Other serious disorders (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash, and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to possible 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; benign gastric polyps.
• Uncommon (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; skin rash, exanthema, eruption; itching; feeling of weakness, fatigue or general malaise; sleep disorders; fractures of the hip, wrist or spine.
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with a history of these symptoms); tingling sensation, pins and needles, burning or numbness; erythema; possible joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased blood lipid levels; rapid decrease in circulating granulocytes, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause bleeding or bruising more than normal; reduced white blood cell count, which may lead to more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells and platelets.
• Not known (frequency cannot be estimated from the available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Injection

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the glass container (vial) after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the container in the outer packaging to protect the medicine from light.
Use the reconstituted solution within 12 hours. Use the reconstituted and diluted solution within 12 hours.
Note: the storage times for the reconstituted solution and for the diluted solution after reconstitution are not cumulative.
From a microbiological point of view, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 12 hours at a temperature not exceeding 25°C.
Do not use Pantoprazole Injection if it appears altered (e.g. if cloudiness or precipitate is observed).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pantoprazole Injection contains

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

Description of the appearance of Pantoprazole Injection and contents of the pack
Pantoprazole Injection is a white to almost white powder for injectable solution. It is supplied in a 10 mL
clear glass vial sealed with an aluminium/plastic flip-off cap and a rubber stopper.
Pantoprazole Injection is available in the following pack sizes:
Pack of 1 vial.
Pack of 5 vials.
Pack of 10 vials.
Pack of 20 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3, Office 115
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens–Lamia,
14568 Krioneri, Attiki, Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Ireland Pantoprazole Noridem 40mg Powder for Solution for Injection
Austria Pantoprazol Noridem 40mg Pulver zur Herstellung einer Injektionslösung
Germany Pantoprazol Noridem 40mg Pulver zur Herstellung einer Injektionslösung
Czech Republic Pantoprazole Noridem
Denmark Pantoprazole Noridem
Spain Pantoprazol Noridem 40 mg polvo para solución inyectable EFG
Finland Pantoprazole Noridem 40 mg injektiokuiva-aine, liuosta varten
France Pantoprazol Noridem 40 mg poudre pour solution injectable
Hungary Pantoprazol Noridem 40 mg por oldatos injekcióhoz
Italy Pantoprazolo Noridem
Netherlands Pantoprazol Noridem 40 mg poeder voor oplossing voor injectie
Norway Pantoprazole Noridem
Poland Pantoprazol Noridem
Portugal Pantoprazol Noridem
Romania Pantoprazol Noridem 40 mg pulbere pentru soluţie injectabilă
Sweden Pantoprazole Noridem
Slovakia Pantoprazole Noridem 40 mg prášok na injekčný roztok
Cyprus Pantoprazole Noridem 40 mg κόνις για ενέσιμο διάλυμα

The following information is intended exclusively for medical professionals or healthcare providers:
The solution for administration should be prepared by injecting 10 mL of sodium chloride 9 mg/mL (0.9%)
injectable solution into the vial containing the powder. After reconstitution, the product appears as a clear,
colourless solution. This solution may be administered directly or after dilution with 100 mL of sodium
chloride 9 mg/mL (0.9%) injectable solution or glucose 50 mg/mL (5%) injectable solution. For dilution, glass
or plastic containers should be used.
After reconstitution, or reconstitution and dilution, chemical and physical stability has been demonstrated for
12 hours at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, storage
conditions and duration prior to use are the responsibility of the user and should normally not exceed 12 hours
at a maximum of 25°C.
Pantoprazole Noridem must not be prepared or mixed with solvents other than those specified above. The
medicinal product must be administered intravenously over 2 to 15 minutes.
The contents of the vial are intended for single intravenous use only. Any unused solution remaining in the
container or showing any change in appearance (e.g., cloudiness or precipitation) must be discarded.