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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
Pantoprazole

Read all of this leaflet carefully before you start using 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.

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.

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

1.

What Pantoprazole is and what it is used for

Pantoprazole contains the active substance pantoprazole (as sodium sesquihydrate). 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 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:
-

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 to pantoprazole sodium or to any of the other ingredients of this medicine (listed in
section 6).
- If you are allergic to medicines containing other proton pump inhibitors.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Pantoprazole
- 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.

1

-

-

People who use 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 use Pantoprazole.
If you have low magnesium levels in your body. This problem can be serious. Low magnesium can
happen in some people who use a 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.

Tell your doctor immediately, before or after using this medicine, if you notice any of the following
symptoms, which could be a sign of another, more serious, disease:
- an unintentional loss of weight (not related to a diet or an exercise programme)
- vomiting, particularly if repeated
- vomiting blood; this may appear as dark coffee grounds in your vomit
- you notice blood in your stools; which may be black or tarry in appearance
- difficulty in swallowing or pain when swallowing
- you look pale and feel weak (anaemia)
- chest pain
- stomach pain
- severe and/or persistent diarrhoea, because this medicine 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.
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, have recently taken or might take 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) and other medicines used to treat HIV.
- 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 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 breast feeding, think you may be pregnant, or are planning to have a
baby ask your doctor or pharmacist for advice before using this medicine. 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 sodium
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 into a vein over a period of 2
- 15 minutes.
The recommended 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.
Patients with liver problems
If you suffer from severe liver problems, the daily injection should be only 20 mg (half a vial).
Use in children and adolescents
These injections are not recommended for use in children and adolescents under 18 years.
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
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 may affect up to 1 in 1,000 people): 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 frequency cannot be estimated from the available
data): 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 frequency cannot be estimated from the available
data): 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 (may affect up to 1 in 10 people)
Inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is
injected.

-

Uncommon (may affect up to 1 in 100 people)

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, 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 (may affect up to 1 in 1,000 people)
Distortion or complete lack of the sense of taste; 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 (may affect up to 1 in 10,000 people)
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, 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 spasm or
cramps; low levels of calcium.
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).

-

Side effects identified through blood tests:
- Uncommon (may affect up to 1 in 100 people)
an increase in liver enzymes.
- Rare (may affect up to 1 in 1,000 people)
an increase in bilirubin; increased fats in the blood; sharp drop in circulating granular white blood cells,
associated with high fever.
- Very Rare (may affect up to 1 in 10,000 people)
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 this 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 6 hours at 25°C and for 24 hours at 2-8°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 colourless or slightly brownish, 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).
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 protect the environment.
6. Contents of the pack and other information
What Pantoprazole contains:
- The active substance 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.
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
H-2100 Gödöllő, Táncsics Mihály út 82
Hungary
This leaflet was last revised in April 2015
PL 00289/1141
----------------------------------------------------------------------------------------------------------------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 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 colourless or slightly brownish, 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 6 hours if it is stored at 25ºC or within 24 hours at 2-8ºC.
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse 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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