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IBI Pantoprazole 40mg powder for solution for injection/infusion

What is in this leaflet:
1. What Pantoprazole is and what it is used for
2. What you need to know before you use
3. How to use Pantoprazole
4. Possible side effects
5. How to store Pantoprazole
6. Contents of the pack and other information
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.
• Zollinger-Ellison-Syndrome and other conditions
producing too much acid in the stomach.
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
• People who take multiple daily doses of proton
pump inhibitor medicines for a long period of time
(a year or longer) may have an increased risk of
fractures of the hip, wrist or spine. Talk to your
doctor about your risk of bone fracture if you take
• If you have low magnesium levels in your body.
This problem can be serious. Low magnesium can
happen in some people who take proton pump
inhibitor medicine for at least 3 months. If low
magnesium levels happen, it is usually after a year
of treatment. You may or may not have symptoms
of low magnesium.
Talk to your doctor before taking Pantoprazole:
• if you have ever had a skin reaction after treatment
with a medicine similar to Pantoprazole that
reduces stomach acid.
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 or glucose 50 mg/ml (5 %) solution

Patients with liver problems:
If you suffer from severe liver problems, the daily
injection/infusion should be only 20 mg (half a vial).
Use in children and adolescents:
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, pharmacist or nurse.

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

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

Children and adolescents
Pantoprazole is not recommended for use in children
as it has not been proven to work in children below 18
years of age.

• 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
• 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
(Stevens-Johnson-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

If you get any of the following side effects, tell your
doctor immediately, or contact the casualty
department at your nearest hospital:

Other medicines and Pantoprazole
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
• 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).
• Methotrexate (used to treat rheumatoid arthritis,
psoriasis and cancer) – if you are taking
methotrexate your doctor may temporarily stop
your Pantoprazole treatment because
pantoprazole can increase levels of methotrexate
in the blood.

Other side effects are:
Common side effects (may affect up to 1 in 10
Inflammation of the wall of the vein and blood clotting
(thrombophlebitis) where the medicine is injected.

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
There are no adequate data from the use of
pantoprazole in pregnant women. Excretion into
human milk has been reported.
You should use this medicine only if your doctor
considers the benefit for you greater than the
potential risk for your unborn child or baby.

Uncommon side effects (may affect up to 1 in 100
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.
Taking proton pump inhibitors 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).

Driving and using machines
If you experience side effects like dizziness or
disturbed vision, you should not drive or operate

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.

Pantoprazole contains less than 1 mmol sodium
(23 mg) per vial, i.e. is essentially ‘sodium free’.
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.

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

The recommended dose is:
Adults - For gastric ulcers, duodenal ulcers and
reflux oesophagitis:
One vial (40 mg pantoprazole) once a day.

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, rash,
possibly with pain in the joints, feeling of tingling,
prickling, pins and needles, burning sensation or
numbness, low levels of potassium which can cause
muscle weackness, twitching or abnormal heart
rhythm, muscle spams or cramps, low levels of

Adults - For the long-term treatment of ZollingerEllison syndrome and other conditions in which too
much stomach acid is produced: Two vials (80 mg
pantoprazole) a day.
Your doctor may adjust the dose, depending on the
amount of stomach acid you produce. If you are
prescribed more than two vials (80 mg) a day, the
injections will be given in two equal doses.

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.

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 glucose 50 mg/ml (5%) solution
at concentrations of 80 and 160 mg doses should be
administered within the infusion time of 15 minutes.

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 (see section 2).


Tell your doctor immediately if you notice any of the
following symptoms:
• an unintentional loss of weight
• vomiting, particularly if repeated
• difficulty in swallowing or pain when swallowing
• vomiting blood; this may appear as dark coffee
grounds in your vomit
• you look pale and feel weak (anaemia)
• you notice blood in your stools, which may be
black or tarry in appearance
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as
Pantoprazole has been associated with a small
increase in infectious diarrhoea.


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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• 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.

Your doctor may prescribe a temporary dose of more
than four vials (160 mg) a day. If your stomach acid
level needs to be controlled rapidly, a starting dose of
160 mg (four vials) should be enough to lower the
amount of stomach acid sufficiently.



If you get a rash on your skin, especially in areas
exposed to the sun tell your doctor as soon as you
can, as you may need to stop your treatment with
Pantoprazole. Remember to also mention any other
ill-effects like pain in your joints.


Pantoprazole 40mg powder for
solution for injection/infusion

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Side effects identified through blood tests:
Uncommon side effects (may affect up to 1 in 100
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: UK: the Yellow Card Scheme
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website:; E-mail:
By reporting side effects you can help provide more
information on the safety of this medicine.
Keep this medicine out of the sight and reach of
Do not use this medicine 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.
What Pantoprazole contains
The active substance is pantoprazole. Each vial
contains 40 mg of pantoprazole (as sodium
sesquihydrate). The other ingredient is sodium
hydroxide (for pH adjustment).
What Pantoprazole looks like and contents of the
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.
Marketing Authorisation Holder
Laboratórios Azevedos – Indústria Farmacêutica, S.A.
Estrada Nacional 117-2 Alfragide,
Amadora, Portugal
Sofarimex – Indústria Química e Farmacêutica, Lda
Av. das Indústrias – Alto do Colaride;
2735-213 CACÉM, Portugal

This leaflet was last revised in 06/2016
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
Do not use this medicine if you notice any particles are
present in the reconstituted solution.

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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.