Pantoprazole 40 Mg Powder For Solution For Injection
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pantoprazole 40mg powder for solution for injection/infusion
Pantoprazole
Read all of this leaflet carefully before you start taking 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.
• 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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. Howto take Pantoprazole
4. Possible side effects
5. Howto store Pantoprazole
6. Conents of the pack and other information
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 medicine is administered into a vein and will only be given to you if your doctor thinks pantoprazole injections or infusions are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections or infusions as soon as your doctor sees fit.
Pantoprazole is used for treating:
• Reflux oesophagifis. An inflammafion of your oesophagus (fhe fube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
• Stomach and duodenal ulcers.
Do not use Pantoprazole
• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors.
Warnings and precautions
• 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.
Tell your doctor immediately if you notice any of the following symptoms:
• an unintentional loss of weight
• repeated vomiting
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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
• 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 your symptoms continue in spite of your treatment, further investigations will be considered.
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.
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).
Other medicines and Pantoprazole
Pantoprazole injection/infusion may influence the effectiveness of other medicines, so tell your 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).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, 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.
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 contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially 'sodium free'.
Your nurse or your doctor will administer the daily dose to you as an injection or infusion into a vein over a period of 2 -15 minutes.
The usual dose is:
One vial (40 mg pantoprazole) once a day.
or glucose 55 mg/ml (5 %) solution for injection. The appearance of the product after reconstitution is a clear brownish solution. Do not use if any particles are present in the reconstituted solution. Pantoprazole should not be prepared or mixed with solvents other than those stated.
The reconstituted solution of 40 mg/10 ml is stable for a period of 24 hours after initial puncture of stopper.
Special patient groups:
If you suffer from severe liver problems, the daily injection/infusion should be only 20 mg (half a vial).
Children (under 18 years). These injections/infusions are not recommended for use in children.
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 or pharmacist.
Like all medicines, Pantoprazole 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): 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 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 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 side effects (may affect up to 1 in 10 patients):
Inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected.
Uncommon side effects (may affect up to 1 in 100 patients):
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.
Rare side effects (may affect up to 1 in 1000 patients):
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; distortion or complete lack of sense of taste.
Very rare side effects (may affect fewer than 1 in 10.000 patients): Disorientation.
Side effects with unknown frequency (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.
Side effects identified through blood tests:
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Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C after dilution with sodium chloride 9 mg/ml (0.9%) solution and with glucose 50 mg/ml (5%) solution.
The diluted solutions with sodium chloride 9 mg/ml (0.9%) solution and with dextrose 50 mg/ml (5%) solution at concentrations of 80 and 160mg doses should be administered within the infusion time of 15 minutes.
Uncommon side effects (may affect up to 1 in 10 patients)
An increase in liver enzymes.
Rare side effects (may affect up to 1 in 1.000 patients)
An increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever.
Very rare side effects (may affect fewer than 1 in 10.000 patients)
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.
Keep this medicine out of the sight and reach of children.
Do not use Pantoprazole 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 it from light.
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 to protect the environment.
What Pantoprazole contains
The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sequihydrate). The other ingredients are: sodium hydroxide (for pH adjustment).
What Pantoprazole looks like and contents of the pack
Pantoprazole is a white to off-white powder for solution for injection/infusion. It comes in a 10 ml clear glass vial closed with an aluminium cap and grey rubber stopper containing 40 mg powder for solution for injection/infusion.
Pantoprazole is available in the following pack sizes:
Pack with 1,5,10,20 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratories Azevedos - Industria Farmaceutica, S.A.
Estrada Nacional 117-2 Alfragide, 2614-503 Amadora Portugal
Manufacturer
Sofarimex - Industria Qulmica e Farmaceutica, S.A.
Av. das Industrias—Alto do Colaride; Agualva
2735-213 CACEM
Portugal
This leaflet was last revised in 02/2014
From a microbiological point of view, the product should be used immediately.
The medicine should be administered intravenously over 2 -15 minutes.
Any product that has remained in the container must be discarded.