Each vial contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The reconstituted solution should be colourless to faintly yellow and free from visible particle.
Excipients/Inactive Ingredients: tetrasodium edetate, mannitol, trometamol.
Pantosala 40 mg is a selective "proton pump inhibitor", a medicine which reduces the amount of acid produced in the 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 the patient if the doctor thinks pantoprazole injections are more suitable at the moment than pantoprazole tablets. Tablets will replace the injections as soon as the doctor sees fit.
Reflux oesophagitis. An inflammation of the oesophagus (the tube which connects the throat to the 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.
The nurse or the doctor will administer the daily dose to the patient 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.
The doctor may later adjust the dose, depending on the amount of stomach acid the patient produces. If the patient is prescribed more than two vials (80 mg) a day, the injections will be given in two equal doses. The doctor may prescribe a temporary dose of more than four vials (160 mg) a day. If the 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.
Use in children (under 18 years): These injections are not recommended for use in children.
Special patient groups: If the patient suffers from severe liver problems, the daily injection should be only 20 mg (half a vial).
If the patient uses more Pantosala 40 mg than they should: These doses are carefully checked by the nurse or the doctor so an overdose is extremely unlikely.
There are no known symptoms of overdose.
If there are any further questions on the use of this product, ask the doctor or pharmacist.
Do not use Pantosala 40 mg: If allergic to pantoprazole or any of the other ingredients of this medicine (listed in Description); If allergic to medicines containing other proton pump inhibitors.
Talk to the doctor before using Pantosala 40 mg: If there is severe liver problems. Please tell the doctor if there ever were problems with the liver in the past. The doctor will check the liver enzymes more frequently. In the case of a rise of liver enzymes the treatment should be stopped.
If taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask the doctor for specific advise.
Taking a proton pump inhibitor like Pantosala 40 mg, especially over a period of more than one year, may slightly increase the risk of fracture in the hip, wrist or spine. Tell the doctor if osteoporosis is present or if corticosteroids (which can increase the risk of osteoporosis) are being taken.
If there had ever been a skin reaction after treatment with a medicine similar to pantoprazole that reduces stomach acid.
If the patient gets a rash on the skin, especially in areas exposed to the sun the doctor must be told as soon as possible, as there may be a need to stop the treatment with pantoprazole. Remember to also mention any other ill-effects like pain in the joints.
Tell the doctor immediately if any of the following symptoms is noticed: an unintentional loss of weight; repeated vomiting; difficulty in swallowing; vomiting blood; looking pale and feeling weak (anaemia); noticing blood in the stools; severe and/or persistent diarrhoea, as pantoprazole has been associated with a small increase in infectious diarrhoea.
The doctor may decide that the patient needs some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If the symptoms continue in spite of the treatment, further investigations will be considered.
Pantosala 40 mg contains Sodium: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially 'sodium-free'.
Driving and using machines: If the patient experiences side effects like dizziness or disturbed vision, the patient should not drive or operate machines.
There are no adequate data from the use of pantoprazole in pregnant women.
Excretion into human milk has been reported. If the patient is pregnant, or thinks they may be pregnant, or if the patient is breast-feeding, the patient should use this medicine only if the doctor considers the benefit for the patient greater than potential risk for the unborn child or baby.
Ask the doctor or pharmacist for advice before taking any medicine.
Like all medicines, Pantosala 40 mg can cause side effects, although not everybody gets them.
The frequency of possible side effects listed as follows 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 any of the following side effects is present, tell the doctor immediately, or contact the casualty department at the nearest hospital: Serious allergic reactions (frequency rare): 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): blistering of the skin and rapid deterioration of the general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme), sensitivity to light, rash, possibly with pain in the joints.
Other serious conditions (frequency not known): 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 (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, especially over a period of more than one year, may slightly increase the risk of fracture in the hip, wrist or spine. Tell the doctor if osteoporosis is present or if corticosteroids (which can increase the risk of osteoporosis) are being taken.
Rare (affects 1 to 10 users in 10,000): 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; high fever; 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; decreased magnesium level in blood.
If the patient is on Pantoprazole for more than three months it is possible that the levels of magnesium in the blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If any of the symptoms is present, please tell the doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor the levels of magnesium.
Side effects identified through blood tests: Uncommon (affects 1 to 10 users in 1,000): an increase in liver enzymes.
Rare (affects 1 to 10 users in 10,000): an increase in bilirubin; increased fats in the blood; sharp drop in circulating granular white blood cells, associated with high fever.
Very Rare (affects less than 1 user in 10,000): a reduction in the number of blood platelets, which may cause the patient 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 white and red blood cells, as well as platelets.
Reporting of side effects: If any of the side effects are present, talk to the doctor or pharmacist.
By reporting side effects the patient can help provide more information on the safety of Pantosala 40 mg.
Pantoprazole injections may influence the effectiveness of other medicines, so tell the doctor if the patient is taking: Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantosala 40 mg may stop these and other medicines from working properly.
Warfarin and phenprocoumon, which affect the thickening or thinning of the blood. The patient may need further checks.
Atazanavir (used to treat HIV-infection).
Methotrexate (used to treat cancer or psoriasis). If the patient is taking methotrexate the doctor may temporarily stop the Pantosala 40 mg treatment.
Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines.
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 50 mg/ml (5 %) solution for injection. Glass or plastic containers should be used for dilution.
Pantosala 40 mg should not be prepared or mixed with solvents other than those stated.
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 in accordance with local requirements.
Do not use this medicine if noticing 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 the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
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 and 24 hours at 5±3°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 2-8 °C.
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Powd for soln for inj (vial) 40 mg (white to off-white) x 1 x 10's.
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