Pantoprazole 40 Mg Powder For Solution For Injection
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Package leaflet: Information for the user
Pantoprazole 40 mg
powder for solution for injection
Pantoprazole
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.
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 or pharmacist or nurse.
• If you get any side effects, talk to your doctor or 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 40 mg powder for solution for injection is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. What Pantoprazole 40 mg powder for solution for injection is and what it is used for
Pantoprazole 40 mg powder for solution for injection is a selective “proton pump inhibitor”, a medicine which reduces the amount of
Pantoprazole 40 mg 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. What you need to know before you use Pantoprazole 40 mg powder for solution for injection
Do not use Pantoprazole 40mg powder for solution for injection
• If you are allergic to pantoprazole or 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 or pharmacist or nurse before using Pantoprazole.
• If you have severe liver problems. Please tell you 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 you symptoms continue in spite of your treatment, further investigations will be considered.
Taking a proton pump inhibitor like Pantoprazole 40 mg 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). Children and adolescents
These injections are not recommended for use in children.
Other medicines and Pantoprazole 40 mg powder for solution for injection
Pantoprazole injections may influence the effectiveness of other medicines, so tell you 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).
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer).
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 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. If you are pregnant or think you may be pregnant, or if you breastfeeding you should not be given this medicine unless you 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 40 mg powder for solution for injection contains sodium.
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
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 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 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:
• If you have severe liver problems the daily injection should be only 20 mg (half a vial).
Use in children and adolescents
Children (under 18 years).
• These injections are not recommended for use in children.
If you receive 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 medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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The frequency of possible side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
If you get any of the following side effects, tell you 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).
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.
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; fracture of the hip, wrist or spine; feeling weak; exhausted or generally unwell; sleep disorders.
• Rare (may affect up to 1 in 1,000 people):
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; taste disorders.
• 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; decreased calcium level in blood; decreased potassium level in blood; tingling or numbness in the hands or feet; muscle spasm.
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; severe reduction in number of white blood cells which makes infections more likely.
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 white cells in your blood which may lead to more frequent infections; severe reduction in blood cells which can cause weakness, bruising or make infections more likely.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: 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 40 mg powder for solution for injection
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 from light.
After reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25°C.
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 appears 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 40 mg powder for solution for injection contais
• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other ingredients (excipients) are mannitol (E421), sodium citrate dehydrate and 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.
Pantoprazole 40 mg powder for solution for injection is available in packs of 1, 5, 10 and 20 glass vials.
Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
This leaflet was last revised in: 06/2014
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 25°C.
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.
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.
The following information is intended for healthcare professionals 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
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