PANTOPRAZOLO 40 mg Powder For Injectable Solution

Зміст інструкції

1. Pantoprazolo Noridem 40 mg powder for injectable solution
   1. What is Pantoprazolo Injection and what is it used for
   2. What you need to know before using Pantoprazolo Injection
   3. How to administer Pantoprazolo Injection
   4. Possible side effects
   5. How to store Pantoprazolo Iniezione
   6. Package Contents and Other Information

Pantoprazolo Noridem 40 mg powder for injectable solution

pantoprazolo

Generic medicine

Readcarefullythisleafletbeforeusingthismedicinebecauseitcontainsimportant
informationforyou.

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

The name of the medicine is as follows:

• Pantoprazolo Noridem 40 mg powder for injectable solution

Contentsofthisleaflet:

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

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

Pantoprazolo Iniezione contains the active ingredient pantoprazole (as sesquihydrate sodium). Pantoprazolo
Iniezione 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 into a vein and will only be administered to you if the doctor believes that pantoprazolo
injectable is at the moment more suitable than pantoprazolo tablets. The tablets will replace the injections
as soon as the doctor deems it appropriate.

Pantoprazolo Iniezioneisusedforthetreatmentofadultswith:

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

2. What you need to know before using Pantoprazolo Injection

DonottakePantoprazolo 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.

Warningsandprecautions
Talk to your doctor, pharmacist or nurse before taking Pantoprazolo Injection

• If you have severe liver problems. Tell 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, the

treatment must be stopped.

• If you are simultaneously taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for a period longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine.
• Tell your doctor if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of developing osteoporosis (for example, if you are taking steroids).
• If you are taking Pantoprazolo Injection for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low levels of magnesium can also lead to a reduction in potassium or calcium levels 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 Pantoprazolo Injection that reduces stomach acid.
• If you notice the appearance of a rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop therapy with Pantoprazolo Injection. Remember to also report any other unwanted effects such as joint pain.
• If you are to undergo a specific blood test (Chromogranin A).

Tellyourdoctorimmediatelybefore or after taking this medicine, if you notice any of the
following symptoms, which may be a sign of a more serious illness:

• an unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit; this may appear as dark coffee grounds in the vomit
• appearance of blood in the stools which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appear pale and feel weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a malignant disease as
pantoprazole also relieves the symptoms of cancer and may cause a delay in diagnosis. If your symptoms
persist despite treatment, further investigations should be considered.

Childrenandadolescents
The use of Pantoprazolo Injection is not recommended in children, given that its efficacy has not been demonstrated
in children under 18 years of age.

OthermedicinesandPantoprazolo Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines.
Pantoprazolo Injection can affect the effectiveness of other medicines, so tell your doctor if you are
taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) as Pantoprazolo Injection may prevent these and other medicines from working properly.
• Warfarin and phenprocoumone, which affect the thickening, or thinning of the blood. You may need further checks.
• 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 suspend treatment with Pantoprazolo Injection because pantoprazole may increase the levels of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John's Wort ( Hypericumperforatum) (used to treat mild depression).

Pregnancyandbreastfeedingandfertility
There are no adequate data regarding the use of pantoprazole in pregnant women. Excretion into human breast milk has been reported.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
You should only use this medicine if the doctor considers the benefit for you greater than the potential risk
to the fetus or the baby.

Drivingandusingmachines
Pantoprazolo Noridem does not alter or alters negligibly the ability to drive vehicles and use
machinery.
If you experience side effects such as dizziness or visual disturbances, you should not drive vehicles or use
machinery.

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

3. How to administer Pantoprazolo Injection

The nurse or doctor will administer the daily dose as an intravenous injection over an interval of
2 - 15 minutes.
The recommended dose is:

Adults

• For gastriculcers,duodenalulcersandrefluxesophagitis.One vial (40 mg of pantoprazolo) per day.
• For long-termtreatmentofZollinger-Ellisonsyndromeandotherconditionsinwhichtoomuchacidisproducedinthestomach.Two vials (80 mg of pantoprazolo) per day. Subsequently, the doctor may adjust the dosage based on the amount of your gastric acid secretion. If more than two vials (80 mg) per day are prescribed, the injections will be divided into two equal administrations. The doctor may temporarily prescribe a dosage 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 acid levels in the stomach.

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

Useinchildrenandadolescents
These injections are not recommended for use in children and adolescents under 18 years of age.

IfyoutakemorePantoprazolo Noridemthanyoushould
The dosages are carefully controlled by the nurse or doctor, therefore an overdose is very
unlikely. No symptoms of overdose are known.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

Ifyouexperienceanyofthefollowingsideeffects,seekmedicalattentionimmediately,orcontactthenearest
hospitalemergencyroom:

• Severeallergicreactions(rarefrequency: may affect up to 1 in 1,000 ): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severeskinconditions(frequencynotknown: frequency cannot be estimated based on available data ): you may notice one or more of the following manifestations - 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, especially in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g. under the armpit) and blood tests may show changes in the count of some white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, multiforme erythema, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Othersevereconditions(frequencynotknown:frequency cannot be estimated based on available data): yellowing of the skin or the whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlargement of the kidneys sometimes with pain when urinating, and lower back pain (severe kidney inflammation) that can lead to possible kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 people) : Inflammation of the vein wall and blood clotting (thrombophlebitis) at the injection site of the medicine; benign polyps in the stomach.
• Uncommon(may affect up to 1 in 100): headache; dizziness; diarrhea; nausea; vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and feeling unwell; rash, exanthema, eruption; itching; feeling weak, tired or generally unwell; sleep disorders; hip, wrist or spine fractures.
• Rare(may affect up to 1 in 1,000): alteration or complete loss of taste; visual disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions; depression; increased breast volume in men.
• VeryRare(may affect up to 1 in 10,000): disorientation.
• NotKnown(frequency cannot be estimated based on available data): hallucinations, confusion (especially in patients with a history of these symptoms); tingling, prickling and pins and needles sensation, burning or numbness, erythema, possible joint pain, inflammation of the large intestine, causing persistent watery diarrhea.

Side effects identified through blood tests:

• Notcommon(may affect up to 1 in 100) an increase in liver enzymes.
• Rare(may affect up to 1 in 1,000) an increase in bilirubin; increased levels of fats in the blood; rapid decrease in circulating granulocytes, associated with high fever.
• VeryRare(may affect up to 1 in 10,000) a reduction in the number of platelets, which can cause bleeding or bruising more than normal; a reduction in the number of white blood cells, which can lead to more frequent infections; concurrent abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.
• NotKnown(frequency cannot be estimated based on available data) decrease in the level of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reportingofsideeffects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 Pantoprazolo Iniezione

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 package 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 at a temperature 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 of the reconstituted solution and the diluted solution after reconstitution are not
cumulative.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions before use are the responsibility of the
user and should normally not exceed 12 hours at no more than 25°C.
Do not use Pantoprazolo Iniezione if you notice an altered appearance (e.g. if turbidity or precipitate is observed).
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

WhatPantoprazolo Iniezionecontains

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

DescriptionofPantoprazolo Iniezioneappearanceandpackagecontents
Pantoprazolo Iniezione is a powder for injectable solution from white to almost white. It is available in a
10 mL transparent glass vial closed with a tear-off aluminum/plastic capsule and a
rubber stopper.
Pantoprazolo Iniezione is available in the following packs:
Pack of 1 vial.
Pack of 5 vials.
Pack of 10 vials.
Pack of 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation 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

ThismedicinalproductisauthorisedintheMemberStatesoftheEuropeanEconomicAreawiththefollowing
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

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Thefollowinginformationisintendedexclusivelyforhealthcareprofessionalsorhealthcareoperators:
The solution ready for use should be prepared by injecting 10 mL of sodium chloride injectable solution
9 mg/mL (0.9%) into the vial containing the powder. The appearance of the product after reconstitution is a
clear and colourless solution. This solution can be administered directly or after dilution
with 100 mL of sodium chloride injectable solution 9 mg/mL (0.9%) or glucose injectable solution
50 mg/mL (5%). Glass or plastic containers should be used for dilution.
After reconstitution, or reconstitution and dilution, chemical and physical stability has been demonstrated for 12 hours at
25°C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions before use are the responsibility of
the user and should not normally exceed 12 hours, at no more than 25°C.
Pantoprazolo Noridem should not be prepared or mixed with solvents other than those indicated above. The
medicinal product must be administered intravenously in 2 - 15 minutes.
The contents of the vial are exclusively for a single intravenous administration. Any product
remaining in the container or with altered appearance (e.g. if turbidity or precipitate is observed) must
be discarded.