PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance: PANTOPRAZOLE SODIUM SESQUIHYDRATE

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IBI Pantoprazole 40mg powder for solution for injection/infusion
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VICTOR DESIGN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole 40mg powder for solution
for injection/infusion
Pantoprazole
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Pantoprazole is and what it is used for
2. What you need to know before you use Pantoprazole
3. How to take Pantoprazole
4. Possible side effects
5. How to store Pantoprazole
6. Conents of the pack and other information
1 WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR
Pantoprazole is a selective “proton pump inhibitor”, a medicine which
reduces the amount of acid produced in your stomach. It is used for
treating acid-related diseases of the stomach and intestine.
This medicine is administered into a vein and will only be given to you if
your doctor thinks pantoprazole injections or infusions are more
suitable for you at the moment than pantoprazole tablets. Tablets will
replace your injections or infusions as soon as your doctor sees fit.
Pantoprazole is used for treating:
• Reflux oesophagitis. An inflammation of your oesophagus (the
tube which connects your throat to your stomach) accompanied
by the regurgitation of stomach acid.
• Stomach and duodenal ulcers.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE PANTOPRAZOLE
Do not use Pantoprazole
• If you are allergic (hypersensitive) to pantoprazole or any of the
other ingredients of this medicine (see section 6).
• If you are allergic to medicines containing other proton pump
inhibitors.
Warnings and precautions
• If you have severe liver problems. Please tell your doctor if you
ever had problems with your liver in the past. He will check your
liver enzymes more frequently. In the case of a rise of liver
enzymes, the treatment should be stopped.
• If you are taking a medicine containing atazanavir (for the
treatment of HIV-infection) at the same time as pantoprazole,
ask your doctor for specific advice.
Tell your doctor immediately if you notice any of the following
symptoms:
• an unintentional loss of weight
• repeated vomiting
The following information is intended for medical or healthcare
professionals only:
A ready-to-use solution is prepared by injecting 10 ml of sodium
chloride 9 mg/ml (0.9 %) solution for injection into the vial
containing the dry powder.
This solution may either be administered directly or after mixing it
with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection







3

difficulty in swallowing
vomiting blood
you look pale and feel weak (anaemia)
you notice blood in your stools
severe and/or persistent diarrhoea, as Pantoprazole has been
associated with a small increase in infectious diarrhoea.

Your doctor may decide that you need some tests to rule out malignant
disease because pantoprazole also alleviates the symptoms of cancer
and could cause delay in diagnosing it. If your symptoms continue in
spite of your treatment, further investigations will be considered.
If you are on Pantoprazole for more than three months it is possible
that the levels of magnesium in your blood may fall. Low levels of
magnesium can be seen as fatigue, involuntary muscle contractions,
disorientation, convulsions, dizziness, increased heart rate. If you get
any of these symptoms, please tell your doctor promptly. 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 levels of magnesium.
Taking a proton pump inhibitor like Pantoprazole, especially over a
period of more than one year, may slightly increase your risk of fracture
in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if
you are taking corticosteroids (which can increase the risk of
osteoporosis).
Other medicines and Pantoprazole
Pantoprazole injection/infusion may influence 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 certain types
of cancer) because Pantoprazole may stop these and other
medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening, or
thinning of the blood. You may need further checks.
• Atazanavir (used to treat HIV-infection).
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained 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 are no adequate data from the use of pantoprazole in pregnant
women. Excretion into human milk has been reported.
Driving and using machines
If you experience side effects like dizziness or disturbed vision, you
should not drive or operate machines.
Important information about some of the ingredients of Pantoprazole
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. is
essentially ‘sodium free’.
3. HOW TO USE PANTOPRAZOLE
Your nurse or your doctor will administer the daily dose to you as an
injection or infusion into a vein over a period of 2 - 15 minutes.
The usual dose is:
One vial (40 mg pantoprazole) once a day.

or glucose 55 mg/ml (5 %) solution for injection. The appearance of
the product after reconstitution is a clear brownish solution. Do not
use if any particles are present in the reconstituted solution.
Pantoprazole should not be prepared or mixed with solvents other
than those stated.
The reconstituted solution of 40 mg/10 ml is stable for a period of
24 hours after initial puncture of stopper.

Special patient groups:
If you suffer from severe liver problems, the daily injection/infusion
should be only 20 mg (half a vial).
Children (under 18 years). These injections/infusions are not
recommended for use in children.
If you use more Pantoprazole than you should
These doses are carefully checked by your nurse or your doctor so an
overdose is extremely unlikely. There are no known symptoms of
overdose.
If you have any further questions about the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pantoprazole can cause side effects, although not
everybody gets them.
If you get any of the following side effects, tell your doctor
immediately, or contact the casualty department at your nearest
hospital:
• Serious allergic reactions (frequency rare): swelling of the tongue
and/or throat, difficulty in swallowing, hives (nettle rash), difficulties
in breathing, allergic facial swelling (Quincke’s oedema / angioedema),
severe dizziness with very fast heartbeat and heavy sweating.
• Serious skin conditions (frequency not known): blistering of the skin
and rapid deterioration of your general condition, erosion (including
slight bleeding) of eyes, nose, mouth/lips or genitals (StevensJohnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and
sensitivity to light.
• Other serious conditions (frequency not known): yellowing of the
skin or whites of the eyes (severe damage to liver cells, jaundice)
or fever, rash, and enlarged kidneys sometimes with painful
urination and lower back pain (serious inflammation of the kidneys).
Other side effects are:
Common side effects (may affect up to 1 in 10 patients):
Inflammation of the wall of the vein and blood clotting
(thrombophlebitis) where the medicine is injected.
Uncommon side effects (may affect up to 1 in 100 patients):
Headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and
flatulence (wind); constipation; dry mouth; abdominal pain and
discomfort; skin rash, exanthema, eruption; itching; feeling weak,
exhausted or generally unwell; sleep disorders.
Rare side effects (may affect up to 1 in 1,000 patients):
Disturbances in vision such as blurred vision; hives; pain in the joints;
muscle pains; weight changes; raised body temperature; swelling of
the extremities (peripheral oedema); allergic reactions; depression;
breast enlargement in males; distortion or complete lack of sense of
taste.

Uncommon side effects (may affect up to 1 in 10 patients)
An increase in liver enzymes.
Rare side effects (may affect up to 1 in 1,000 patients)
An increase in bilirubin; increased fat levels in blood; sharp drop in
circulating granular white blood cells, associated with high fever.
Very rare side effects (may affect fewer than 1 in 10,000 patients)
A reduction in the number of blood platelets, which may cause you to
bleed or bruise more than normal; a reduction in the number of white
blood cells, which may lead to more frequent infections; coexisting
abnormal reduction in the number of red and white blood cells, as well
as platelets.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE PANTOPRAZOLE
Keep this medicine out of the sight and reach of children.
Do not use Pantoprazole after the expiry date, which is stated on the
carton and the vial after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the vial in the outer carton in order to
protect it from light.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Pantoprazole contains
The active substance is pantoprazole. Each vial contains 40 mg of
pantoprazole (as sodium sequihydrate). The other ingredients are:
sodium hydroxide (for pH adjustment).
What Pantoprazole looks like and contents of the pack
Pantoprazole is a white to off-white powder for solution for
injection/infusion. It comes in a 10 ml clear glass vial closed with an
aluminium cap and grey rubber stopper containing 40 mg powder for
solution for injection/infusion.
Pantoprazole is available in the following pack sizes:
Pack with 1, 5, 10, 20 vials.
Not all pack sizes may be marketed.

Very rare side effects (may affect fewer than 1 in 10,000 patients):
Disorientation.

Marketing Authorisation Holder
Laboratórios Azevedos – Indústria Farmacêutica, S.A.
Estrada Nacional 117-2 Alfragide, 2614-503 Amadora
Portugal

Side effects with unknown frequency (frequency cannot be estimated
from the available data):
Hallucination, confusion (especially in patients with a history of these
symptoms); decreased sodium level in blood; decreased magnesium
level in blood.

Manufacturer
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias – Alto do Colaride; Agualva
2735-213 CACÉM
Portugal

Side effects identified through blood tests:

This leaflet was last revised in 02/2014

Chemical and physical in-use stability has been demonstrated for
12 hours at 25ºC after dilution with sodium chloride 9 mg/ml (0.9%)
solution and with glucose 50 mg/ml (5%) solution.
The diluted solutions with sodium chloride 9 mg/ml (0.9%) solution
and with dextrose 50 mg/ml (5%) solution at concentrations of 80
and 160mg doses should be administered within the infusion time
of 15 minutes.

From a microbiological point of view, the product should be used
immediately.
The medicine should be administered intravenously over 2 - 15
minutes.
Any product that has remained in the container must be discarded.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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