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PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): PANTOPRAZOLE SODIUM SESQUIHYDRATE / PANTOPRAZOLE SODIUM SESQUIHYDRATE / PANTOPRAZOLE SODIUM SESQUIHYDRATE

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IBI Pantoprazole 40mg powder for solution for injection/infusion
Version 1 Created 25.03.13
Font: VAG Rounded Light & Bold 8.8 pt
NOW Version- 10A (IRL) created 12.12.16
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(profile advised by manufacturer 07.12.16)

10A Ireland
Use in children and adolescents:
Children (under 18 years). These
injections/infusions are not recommended
for use in children.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole 40mg powder for solution for injection/infusion

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.
• Zollinger-Ellison-Syndrome and other
conditions producing too much acid in
the stomach.
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.
• 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 Pantoprazole.
• 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.
• if you are due to have a specific blood
test (Chromogranin A).
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.
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
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 for injection.

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.
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.
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.
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.
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.
Driving and using machines
If you experience side effects like dizziness
or disturbed vision, you should not drive or
operate machines.
Pantoprazole 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 recommended dose is:
Adults - For gastric ulcers, duodenal
ulcers and reflux oesophagitis:
One vial (40 mg pantoprazole) once a day.
Adults - For the long-term treatment of
Zollinger-Ellison 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.
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 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.
4. POSSIBLE SIDE EFFECTS

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• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as
Pantoprazole has been associated with a
small increase in infectious diarrhoea.

30

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 use Pantoprazole
4. Possible side effects
5. How to store Pantoprazole
6. Contents of the pack and other
information

60

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.

Laetus reading direction

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Code

30

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60

Pantoprazole

Like all medicines, this medicine 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
(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 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.
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).
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.
Very rare side effects (may affect fewer
than 1 in 10,000 patients):
Disorientation.
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
weakness, twitching or abnormal heart
rhythm, muscle spams or cramps, low
levels of calcium.

Patients with liver problems:
If you suffer from severe liver problems, the
daily injection/infusion should be only 20 mg
(half a vial).

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

The appearance of the product after
reconstitution is a clear brownish solution.
Do not use if any particles are present in the
reconstituted solution.

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.

Pantoprazole should not be prepared or mixed
with solvents other than those stated.

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.

The reconstituted solution of 40 mg/10 ml is
stable for a period of 24 hours after initial
puncture of stopper.

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).
Side effects identified through blood
tests:
Uncommon side effects (may affect up to 1
in 100 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: UK: the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
Ireland: HPRA Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
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 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.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
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 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.
Marketing Authorisation Holder
Laboratórios Azevedos – Indústria
Farmacêutica, S.A.
Estrada Nacional 117-2 Alfragide,
2614-503
Amadora,
Portugal
Manufacturer
Sofarimex – Indústria Química e
Farmacêutica, Lda
Av. das Indústrias – Alto do Colaride;
Agualva,
2735-213 CACÉM,
Portugal
This leaflet was last revised in 09/2016

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 discarded.
Do not use this medicine if you notice any
particles are present in the reconstituted
solution.
200244.03

Expand Transcript

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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