PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION

Active substance: PANTOPRAZOLE SODIUM SESQUIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pantoprazole 40 mg Powder for Solution for Injection or Infusion

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.
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 any of the side effects gets 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 is and what it is used for
2.
Before you use Pantoprazole
3.
How to use Pantoprazole
4.
Possible side effects
5.
How to store Pantoprazole
6.
Further information

1

WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR

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 is used for treating:

to your stomach) accompanied by the regurgitation of stomach acid.
-Ellison-Syndrome and other conditions producing too much acid in the stomach.
2

BEFORE YOU USE PANTOPRAZOLE

Do not use Pantoprazole :
Pantoprazole (see section 6).

Take special care with Pantoprazole :
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.
-infection) at the
same time as pantoprazole, ask your doctor for specific advice.
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).Tell your doctor immediately if you notice any of the following symptoms:

eak (anaemia)

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
or erlotinib (used for certain types of cancer) because pantoprazole may stop these and other
medicines from working properly.
need further checks.
-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 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 use this medicine only if 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
This medicine c

3

-

HOW TO USE PANTOPRAZOLE

Your nurse or your doctor 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 Zollinger-Ellison 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 (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.
Special patient groups:
e liver problems, the daily injection should be only 20 mg (half a vial).

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 regarding the use of your medicine, ask your doctor or a
pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines pantoprazole sodium 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:

swelling of the tongue and/or throat, difficulty in
swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling
oedema / angioedema), severe dizziness with very fast heartbeat and heavy sweating.
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.
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:
(affects 1 to 10 users in 100)
inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is
injected.
(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; fracture of hip, wrist or spine.
(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.
(affects less than 1 user in 10,000)
disorientation.
(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 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:
(affects 1 to 10 users in 1,000)
an increase in liver enzymes.
(affect 1 to 10 users in 10,000)
an increase in bilirubin; increased fats in the blood.
(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 the number of white blood cells, which may lead to more frequent
infections.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5.

HOW TO STORE PANTOPRAZOLE

Keep out of the reach and sight of children.
Do not take your medicine after the expiry date which is stated on the carton and 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 from light
Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C. From a
microbiological point of view, the reconstituted / diluted solution should be used immediately. If
not used immediately, in-use storage times and conditions prior to use are the responsibility of
the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken
place in controlled and validated aseptic conditions.
The reconstituted solution should be inspected visually prior to use. It should only be used if the
solution is clear and practically free from particles
Do not use pantoprazole 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 contains:
The active ingredient is pantoprazole. Each vial contains 40 mg pantoprazole (as pantoprazole
sodium),
The other ingredient is disodium edetate.
What Pantoprazole looks like and contents of the pack
Pantoprazole is a white to almost white dry powder in a clear glass vial with a rubber stopper
and sealed with aluminium caps fitted with plastic flip-off discs. Each package contains 1
injection bottle.
Pantoprazole 40 mg Powder for solution for injection or infusion is available in packs of 1, 5 and
10 vials:
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited
Brampton Road,
Hampden Park,

Eastbourne,
East Sussex BN22 9AG
UNITED KINGDOM
Manufacturer
TEVA Pharmaceutical Works Private Limited Company
HHungary
This leaflet was last revised in May2013.
PL 00289/1141
----------------------------------------------------------------------------------------------------------------Pantoprazole 40 mg Powder for Solution for Injection or Infusion

The following information is intended for medical or healthcare professionals only:
(Please note this is a Prescriber Information Leaflet NOT the SPC. For full details
regarding this product please refer to the SPC).

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 55 mg/ml (5 %) solution for injection.
The reconstituted solution should be inspected visually prior to use. It should only be used if the
solution is clear and practically free from particles
Pantoprazole should not be prepared or mixed with solvents other than those stated.
After preparation, the solution must be used within 12 hours. 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 and would normally not be longer than
24 hours at 2 to 8ºC.
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 whose visual appearance has changed (e.g. if cloudiness or precipitation is observed)
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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