PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION

Active substance: PANTOPRAZOLE SODIUM SESQUIHYDRATE

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Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it
again
• If you have any further questions, ask your
doctor or pharmacist.
• If any side effects get serious, or if you notice
any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Pantoprazole 40 mg powder for
solution for injection is and what it is used for
2. Before you use Pantoprazole 40 mg powder
for solution for injection
3. How to use Pantoprazole 40 mg powder for
solution for injection
4. Possible side effects
5. How to store Pantoprazole 40 mg powder for
solution for injection
6. Further information

1. What Pantoprazole 40mg powder
for solution for injection is and
what it is used for
Pantoprazole 40mg powder for solution for
injection 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 preparation is injected into a vein and
will only be given to you if your doctor thinks
pantoprazole injections are more suitable for
you at the moment than pantoprazole tablets.
Tablets will replace your injections as soon as
your doctor sees fit.
Pantoprazole 40mg powder for solution for
injection 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 your
stomach.

2. Before you use Pantoprazole 40mg
powder for solution for injection
Do not use Pantoprazole 40mg powder for
solution for injection
• If you are allergic (hypersensitive) to
pantoprazole or any of the other ingredients
of Pantoprazole 40 mg powder for solution for
injection (see section 6).
• If you are allergic to medicines containing
other proton pump inhibitors.
Take special care with Pantoprazole 40 mg
powder for solution for injection.
• 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 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 weight loss
• repeated vomiting
• 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.
Taking other medicines
Pantoprazole injections 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 nurse if you are taking,
or have recently taken, any other medicines,
including medicines obtained without a
prescription.
Pregnancy and breast-feeding
There are no adequate data from the use of
pantoprazole in pregnant women. Excretion
into human milk has been reported. If you are
pregnant or think you may be pregnant, or if
you are breast-feeding you should not be given
this medicine unless your doctor considers the
benefit for you greater than the potential risk for
your unborn child or baby.
Ask your doctor or pharmacist for advice before
taking any medicine
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 40 mg powder for
solution for injection
This medicinal product contains less than 1
mmol of sodium (23 mg) per dose, i.e. essentially
“sodium-free”.

3. How to use Pantoprazole 40mg
powder for solution for injection
Your doctor or nurse will administer the daily
dose to you as an injection into a vein over a
period of 2-15 minutes.
The usual dose is:
For gastric ulcers, duodenal ulcers and reflux
oesophagitis
One vial (40 mg pantoprazole) a day.
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 later adjust the dose depending
on the amount of stomach acid you produce. If
you are prescribed more than two vials (80mg)
a day, the injections will be in two equal doses.
Your doctor may prescribe a temporary dose
of more than four vials (160mg) 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.
Special patient groups:
• If you have severe liver problems the daily
injection should be only 20 mg (half a vial).
• Children (under 18 years). These injections are
not recommended for use in children.
If you use more Pantoprazole 40 mg powder
for solution for injection than you should
These doses are carefully checked by your nurse
or doctor so an overdose is extremely unlikely.
There are no known symptoms of overdose.
If you have any further questions on the use of
this product ask your doctor or nurse.
Continued overleaf

TECHNICAL PRESCRIBING INFORMATION

D02195

Pantoprazole 40 mg powder for solution for injection
The following information is intended for medical
or healthcare staff only:
A ready-to-use intravenous solution is prepared
by injecting 10 ml of sodium chloride 9 mg/ml
(0.9%) solution for injection into the vial
containing the lyophilised powder. The solution
may either be administered directly or after
mixing it with 100 ml of sodium chloride 9 mg/ml
(0.9%) solution for injection or glucose 50 mg/ml

(5%) solution for injection. Glass or plastic
containers should be used for dilution.
Pantoprazole 40 mg, powder for solution for
injection should not be prepared or mixed with
solvents other than those stated.
After reconstitution, or reconstitution and
dilution, chemical and physical in-use stability
has been demonstrated for 12 hours at 25ºC.

4. Possible side effects
Like all medicines, Pantoprazole 40mg powder
for solution for injection can cause side effects,
although not everybody gets them.
The frequency of possible side effects listed
below is defined using the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from
the available data).
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), difficulty 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 the whites of
your 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 (affects 1 to 10 users in 100):
inflammation of the wall of the vein and
blood clotting (thrombophlebitis) where the
medicine is injected.
• Uncommon (affects 1 to 10 users in 1,000)
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 a proton pump inhibitor like
Pantoprazole 40mg powder for solution for
injection, 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 (affects 1 to 10 users in 10,000)
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.
• Very rare (affects less than 1 user in 10,000)
disorientation
• Not known (frequency cannot be estimated
from the available data) hallucination,
confusion (especially in patients with a history
of these symptoms); decreased sodium level
in blood.
If you are on Pantoprazole 40mg powder for
solution for injection 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.
Side effects identified through blood tests:
• Uncommon (affects 1 to 10 users in 1,000)
an increase in liver enzymes
• Rare (affect 1 to 10 users in 10,000)
an increase in bilirubin; increased fats in the
blood.

From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user.

• Very rare (affects less than 1 user in 10,000)
a reduction in the number of blood platelets,
which may cause you to bleed or bruise more
than normal; a reduction in white cells in your
blood which may lead to more frequent
infections.
If any of the side effects get serious or if you
notice any side effects not listed in the leaflet,
please tell your doctor or nurse.

5. How to store Pantoprazole 40mg
powder for solution for injection
Keep out of the reach and sight of children.
Do not use Pantoprazole 40 mg powder for
solution for injection after the expiry date which
is stated on the carton and the vial after EXP.
The expiry date refers to the last day of the
month.
Do not store above 25ºC.
Keep the vial in the outer carton in order to
protect from light.
After reconstitution, or reconstitution and
dilution, chemical and physical in-use stability
has been demonstrated for 12 hours at 25ºC.
From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user.
Do not use Pantoprazole 40 mg powder for
solution for injection if you notice that the visual
appearance has changed (e.g. if cloudiness or
precipitation is observed).
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Further Information
What Pantoprazole 40 mg powder for solution
for injection contains
• The active substance is pantoprazole. Each
vial contains 40 mg of pantoprazole (as
sodium sesquihydrate)
• The other ingredients are:
- mannitol,
- sodium citrate dihydrate
- sodium hydroxide for pH adjustment
What Pantoprazole 40 mg powder for solution
for injection looks like and contents of the
pack
Pantoprazole 40 mg powder for solution for
injection is a white or almost white uniform
porous cake.
It comes in packs of 1, 5, 10 and 20 glass vials.
Not all packs may be marketed.
Marketing Authorisation Holder:
Martindale Pharmaceuticals Limited,
Bampton Road,
Harold Hill,
Romford,
Essex,
United Kingdom.
RM3 8UG.
Manufacturers:
Laboratorios Alcalá Farma, S.L
Carretera M-300 Km 29,920
Apartado de correos 37
28802 Alcalá de Henares (Madrid)
Tel: 0034 91 889 06 00
Fax: 0034 91 889 05 02
Valdepharm
Parc Industriel d’incarville - BP 606
27106 val de Reuil Cedex
France
Tel: 0033 232 25 70 70
Fax: 0033 232 25 70 26
This leaflet was last approved in April 2012
PL 00156/0338

D02195

D02195

Pantoprazole 40 mg powder for solution for injection
Pantoprazole

PL 00156/0338

The medicine should be administered
intravenously over 2 – 15 minutes.
The content of the vial is for single intravenous
use only. Any product that has remained in the
container or the visual appearance of which has
changed (e.g. if cloudiness or precipitation is
observed) must be discarded.

D02195

PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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