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Pantoprazole 40 mg

Pantoprazole 40 mg
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P15XXXXX
Package leaflet: Information for the user Tell your doctor immediately, before or after taking this medicine,
if you notice any of the following symptoms, which could be a sign
Pantoprazole 40 mg of another, more serious, disease:
powder for solution for injection - an unintentional loss of weight
- vomiting, particularly if repeated
Pantoprazole sodium sesquihydrate
- vomiting blood; this may appear as dark coffee grounds in your
Read all of this leaflet carefully before you start using this vomit
medicine because it contains important information for you. - you notice blood in your stools; which may be black or tarry in
- Keep this leaflet. You may need to read it again. appearance
- If you have any further questions, ask your doctor, pharmacist - difficulty in swallowing or pain when swallowing
or nurse. - you look pale and feel weak (anaemia)
- This medicine has been prescribed for you only. Do not pass it - chest pain
on to others. It may harm them, even if their signs of illness are - stomach pain
the same as yours. - severe and/or persistent diarrhoea, because this medicine has
- If you get any side effects, talk to your doctor, pharmacist or been associated with a small increase in infectious diarrhoea.
nurse. This includes any possible side effects not listed in this Your doctor may decide that you need some tests to rule out
leaflet. See section 4. malignant disease because Pantoprazole also alleviates the
What is in this leaflet symptoms of cancer and could cause delay in diagnosing it. If your
1. What Pantoprazole is and what it is used for symptoms continue in spite of your treatment, further investigations
2. What you need to know before you use Pantoprazole will be considered.
3. How to use Pantoprazole Children and adolescents
4. Possible side effects Pantoprazole is not recommended for use in children as it has not
5. How to store Pantoprazole been proven to work in children below 18 years of age.
6. Contents of the pack and other information
Other medicines and Pantoprazole
1. What Pantoprazole is and what it is used for Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including medicines obtained
Pantoprazole contains the active substance pantoprazole sodium without a prescription.
sesquihydrate .Pantoprazole is a selective “proton pump inhibitor”, This is because Pantoprazole may influence the effectiveness of
a medicine which reduces the amount of acid produced in your other medicines, so tell your doctor if you are taking:
stomach. It is used for treating acid related diseases of the stomach - Medicines such as ketoconazole, itraconazole and
and intestine. posaconazole (used to treat fungal infections) or erlotinib (used
This preparation is injected into a vein and will only be given to you for certain types of cancer) because Pantoprazole may stop
if your doctor thinks Pantoprazole injections are more suitable for these and other medicines from working properly.
you at the moment than Pantoprazole tablets. Tablets will replace - Warfarin and phenprocoumon, which affect the thickening, or
your injections as soon as your doctor sees fit. thinning of the blood. You may need further checks.
Pantoprazole is used for treating: - Medicines used to treat HIV-infection, such as atazanavir.
- Reflux oesophagitis. An inflammation of your oesophagus (the - Methotrexate (used to treat rheumatoid arthritis, psoriasis,
tube which connects your throat to your stomach) accompanied and cancer) – if you are taking methotrexate your doctor
by the regurgitation of stomach acid. may temporarily stop your Pantoprazole treatment because
- Stomach and duodenal ulcers. Pantoprazole can increase levels of methotrexate in the blood.
- Zollinger-Ellison-Syndrome and other conditions producing too - Fluvoxamine (used to treat depression and other psychiatric
much acid in the stomach. diseases – if you are taking fluvoxamine your doctor may
reduce the dose.
2. What you need to know before you take Pantoprazole - Rifampicin (used to treat infections
- St John’s wort (Hypericum perforatum) (used to treat mild
Do not use Pantoprazole depression)
- If you are allergic to pantoprazole or to any of the other
Pregnancy and breast-feeding
ingredients of this medicine (listed in section 6).
There are no adequate data from the use of Pantoprazole in
- If you are allergic to medicines containing other proton pump
pregnant women. Excretion into human milk has been reported.
inhibitors.
If you are pregnant or breast feeding, think you may be pregnant,
Warnings and precautions or are planning to have a baby, ask your doctor or pharmacist for
Talk to your doctor, pharmacist or nurse before taking Pantoprazole advice before taking this medicine.
- If you have severe liver problems. Please tell your doctor if you
ever had problems with your liver in the past. He will check You should use this medicine, only if your doctor considers the
your liver enzymes more frequently. In the case of a rise of liver benefit for you greater than the potential risk for your unborn child
enzymes the treatment should be stopped. or baby.
- If you are taking HIV protease inhibitors such as atazanavir Driving and using machines
(for the treatment of HIV-infection) at the same time as Pantoprazole has no or negligible influence on the ability to drive
Pantoprazole, ask your doctor for specific advice. and use machines.
- Taking a proton pump inhibitor like Pantoprazole, especially If you experience side effects like dizziness or disturbed vision, you
over a period of more than one year, may slightly increase your should not drive or operate machines.
risk of fracture in the hip, wrist or spine. Tell your doctor if you
have osteoporosis or if you are taking corticosteroids (which Important information about some of the ingredients of
can increase the risk of osteoporosis). Pantoprazole
- If you are on Pantoprazole for more than three months it is This medicine contains less than 1 mmol sodium (23 mg) per vial,
possible that the levels of magnesium in your blood may fall. i.e. is essentially ‘sodium- free’.
Low levels of magnesium can be seen as fatigue, involuntary
muscle contractions, disorientation, convulsions, dizziness, 3. How to take Pantoprazole
increased heart rate. If you get any of these symptoms, please Your nurse or your doctor will administer the daily dose to you as
tell your doctor promptly. Low levels of magnesium can also an injection into a vein over a period of 2 - 15 minutes.
lead to a reduction in potassium or calcium levels in the blood.
Your doctor may decide to perform regular blood tests to The recommended dose is:
monitor your levels of magnesium. Adults
- If you have ever had a skin reaction after treatment with a - For gastric ulcers, duodenal ulcers and reflux oesophagitis.
medicine similar to Pantoprazole that reduces stomach acid. One vial (40 mg Pantoprazole) a day.
- If you get a rash on your skin, especially in areas exposed to - For the long-term treatment of Zollinger-Ellison syndrome and
the sun tell your doctor as soon as you can, as you may need other conditions in which too much stomach acid is produced.
to stop your treatment with Pantoprazole. Remember to also Two vials (80 mg Pantoprazole) a day.
mention any other ill-effects like pain in your joints.
- If you are due to have a specific blood test (Chromogranin A)

The following information is intended for medical or healthcare Diluted Solution:

professionals only: The vial containing the powder is reconstituted with 10 ml of sodium
Reconstituted Solution: chloride (0.9 %) solution for injection, which is further diluted with
A ready-to-use solution is prepared by injecting 10 ml of sodium 100ml of 0.9% Sodium Chloride Injection or 5% Dextrose Injection
chloride (0.9 %) solution for injection into the vial containing (i.e. concentration level of about 0.4mg/ml).
the powder. This solution can be administered directly. The The reconstituted and diluted solution of drug product thus obtained
reconstituted solution for injection is physically and chemically is physically compatible and chemically stable over a period of
stable over a period of 24 hours at 25 °C. 12 hours with 0.9% Sodium Chloride Injection and 5% Dextrose
Injection at 25°C. Plastic containers should be used for dilution.

Black A/s: 210 X 420 mm

Your doctor may later adjust the dose, depending on the amount - Very Rare (may affect up to 1 in 10,000 people) a reduction
of stomach acid you produce. If you are prescribed more than two in the number of blood platelets, which may cause you to
vials (80 mg) a day, the injections will be given in two equal doses. bleed or bruise more than normal; a reduction in the number of
Your doctor may prescribe a temporary dose of more than four vials white blood cells, which may lead to more frequent infections;
(160 mg) a day. If your stomach acid level needs to be controlled coexisting abnormal reduction in the number of red and white
rapidly, a starting dose of 160 mg (four vials) should be enough to blood cells, as well as platelets.
lower the amount of stomach acid sufficiently. Reporting of side effects
Patients with liver problems If you get any side effects, talk to your doctor, pharmacist or nurse.
If you suffer from severe liver problems, the daily injection should This includes any possible side effects not listed in this leaflet. You
be only 20 mg (half a vial). can also report side effects directly via
Use in children and adolescents www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in
These injections are not recommended for use in children and the Google Play or Apple App Store.
adolescents under 18 years. By reporting side effects you can help provide more information on
the safety of this medicine.
If you use more Pantoprazole than you should
These doses are carefully checked by your nurse or your doctor so 5. How to store Pantoprazole
an overdose is extremely unlikely. There are no known symptoms Keep this medicine out of the sight and reach of children.
of overdose.
Do not use this medicine after the expiry date, which is stated on
If you have any further questions about the use of this medicine, the carton and the vial after EXP. The expiry date refers to the last
ask your doctor, pharmacist or nurse. day of that month.
Store below 30 °C.
4. Possible side effects
Store in the original package in order to protect from light.
Like all medicines, this medicine can cause side effects, although After preparation, the reconstituted solution must be used within 12
not everybody gets them. hours if it is diluted or within 24 hours if it is not further diluted.
If you get any of the following side effects, tell your doctor From a microbiological point of view, the product should be used
immediately, or contact the casualty department at your immediately. If not used immediately, in-use storage times and
nearest hospital: conditions prior to use are the responsibility of the user and would
- Serious allergic reactions (frequency rare: may affect up to 1 normally not be longer than 24 hours at 2-8 °C.
in 1,000 people): swelling of the tongue and/or throat, difficulty Do not use Pantoprazole if you notice that the visual appearance
in swallowing, hives (nettle rash), difficulties in breathing, has changed (e.g. if cloudiness or precipitation is observed).
allergic facial swelling (Quincke’s oedema / angioedema),
severe dizziness with very fast heartbeat and heavy sweating. Do not throw away any medicines via wastewater or household
- Serious skin conditions (frequency not known: frequency waste. Ask your pharmacist how to throw away medicines you no
cannot be estimated from the available data): blistering of the longer use. These measures will help to protect the environment.
skin and rapid deterioration of your general condition, erosion 6. Contents of the pack and other information
(including slight bleeding) of eyes, nose, mouth/lips or genitals
(Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema What Pantoprazole contains
multiforme), and sensitivity to light. - The active substance is pantoprazole. Each vial contains 40 mg
- Other serious conditions (frequency not known: frequency of pantoprazole (as sodium sesquihydrate).
cannot be estimated from the available data): yellowing of
the skin or whites of the eyes (severe damage to liver cells, What Pantoprazole looks like and contents of the pack
jaundice) or fever, rash, and enlarged kidneys sometimes with Powder for solution for injection.
painful urination, and lower back pain (serious inflammation of White to off-white powder in 10 ml Type-I clear glass vial with
the kidneys), possibly leading to kidney failure. bromobutyl rubber stopper and sealed with aluminum seal having
Other side effects are: polypropylene disc.
- Common (may affect up to 1 in 10 people) Inflammation of Pack sizes of 1 vial and 5 (5x1) vials, 10 (10x1) vials and 20 (20x1)
the wall of the vein and blood clotting (thrombophlebitis) where vials with powder for solution for injection.
the medicine is injected. Not all pack sizes may be marketed.
- Benign polyps in the stomach
- Uncommon (may affect up to 1 in 100 people) Marketing Authorisation Holder
Headache; dizziness; diarrhoea; feeling sick, vomiting; bloating Milpharm Limited
and flatulence (wind); constipation; dry mouth; abdominal pain Ares Block, Odyssey Business Park
and discomfort; skin rash, exanthema, eruption; itching; feeling West End Road
weak, exhausted or generally unwell; sleep disorders; fracture Ruislip HA4 6QD
in the hip, wrist or spine. United Kingdom
- Rare (may affect up to 1 in 1,000 people) Manufacturer
Distortion or complete lack of the sense of taste; disturbances APL Swift Services (Malta) Limited
in vision such as blurred vision; hives; pain in the joints; HF26, Hal Far Industrial Estate, Hal Far
muscle pains; weight changes; raised body temperature; high Birzebbugia, BBG 3000
fever; swelling of the extremities (peripheral oedema); allergic Malta
reactions; depression; breast enlargement in males.
- Very Rare (may affect up to 1 in 10,000 people) or
Disorientation. Milpharm Limited
- Not known (frequency cannot be estimated from the Ares Block, Odyssey Business Park
available data) West End Road
Hallucination, confusion (especially in patients with a history of Ruislip HA4 6QD
these symptoms); decreased sodium level in blood, decreased United Kingdom
magnesium level in blood (see section 2), feeling of tingling,
This leaflet was last revised in 08/2019.
prickling, pins and needles, burning sensation or numbness ,
rash, possibly with pain in the joints, inflammation in the large
bowel, that causes persistent watery diarrhoea.
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 fat levels in blood; sharp drop
in circulating granular white blood cells, associated with high
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fever.

Pantoprazole should not be prepared or mixed with solvents other The content of the vial is for single intravenous use only. Any
than those stated. product that has remained in the container or whose visual
After preparation, the reconstituted solution must be used within appearance has changed (e.g. if cloudiness or precipitation is
12 hours if it is diluted or within 24 hours if it is not further diluted. observed) must be discarded.
From a microbiological point of view, the product should be used The appearance of the product after reconstitution is a clear
immediately. If not used immediately, in-use storage times and colourless to yellowish colour solution.
conditions prior to use are the responsibility of the user and would
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normally not be longer than 24 hours at 2-8 °C.

The medicine should be administered intravenously over 2 - 15
minutes.