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PRAZOLPAN 40 mg. 1 vial

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WHAT PRAZOLPAN AND WHAT IT IS USED
Pantoprazole is a selective "proton pump inhibitor", a drug which reduces the amount of separated into your stomach acid. Used for the treatment of diseases with increased acidity of the stomach and intestines.
This product is administered into a vein and will only be prescribed if your doctor believes that pantoprazole injections are more suitable for you at the moment than pantoprazole tablets. The tablets will replace injections as soon as the doctor determines that your condition is better.

Pantoprazole is used for treatment of:
Reflux - esophagitis. Inflammation of the esophagus (the tube that connects the throat to the stomach) accompanied by a return of gastric acid;
Ulcers of the stomach and duodenum;
Syndrome Zollinger-Ellison and other conditions which emit very large amount of acid in your stomach.

2. BEFORE YOU ARE GIVEN PRAZOLPAN
Do not use PRAZOLPAN:
if you are allergic (hypersensitive) to pantoprazole sodium or any of the other ingredients of PRAZOLPAN (see section 6);
if you are allergic to other medicines containing proton pump inhibitors.
Take special care with PRAZOLPAN:
If you have severe liver disease. Tell your doctor even if you have ever had liver problems. He will appoint more frequent testing of liver enzymes you. If values ​​rise, the treatment will be terminated;
If you are taking a medicine containing atazanavir (for the treatment of HIV infection) with pantoprazole, ask your doctor for advice;
Taking proton pump inhibitors such as pantoprazole, particularly for a period longer than one year may slightly increase the risk of fractures of 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).
Immediately tell your doctor if you notice any of the following symptoms:
unexplained weight loss;
repeated vomiting;
difficulty swallowing;
vomiting blood;
look pale / and or feel tired (anemia);
notice blood in the stool;
severe and / or persistent diarrhea, as pantoprazole is rarely accompanied by an increased incidence of infectious diarrhea.
Your doctor may decide that you need to conduct some tests to rule out malignant disease because pantoprazole and relieves the symptoms of cancer and its application could delay diagnosis. If, despite your complaints continue treatment should discuss the need for additional research.

Taking other medicines
PRAZOLPAN injections may influence the effectiveness of other medicines, so tell your doctor if you take:
Drugs such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer) because pantoprazole can suppress the effects of these and other drugs;
Warfarin and phenprocoumon used to thin the blood. It will require more frequent surveys;
Atazanavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and lactation
There are no adequate data on the use of pantoprazole in pregnant women. There are reports of excretion of pantoprazole in breast milk. If you are pregnant or think you may be pregnant or breast-feeding, use this medicine if your doctor has determined that the benefit to you is greater than the risk to your unborn child or baby.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
If you get side effects such as dizziness or visual impairment, you should not drive or operate machinery.

Important information about some of the ingredients of PRAZOLPAN
This product contains less than 1 mmol sodium (23 mg) per vial, i.e. in practice it does not contain sodium.

3. HOW YOU WILL BE ADMINISTERED PRAZOLPAN
Your nurse or doctor will apply a daily dose by injection into a vein over a period of 2 to 15 minutes.

The usual dose is:
For gastric ulcer, duodenal ulcer and reflux esophagitis:
One vial (40 mg pantoprazole) a day.

For long-term treatment of the syndrome of Zollinger-Ellison and other condition associated with an increased secretion of gastric acid:
Two vials (80 mg pantoprazole) a day.

Your doctor may decide to change the dose later depending on the amount of emitted by your stomach acid. If you have been prescribed more than two vials (80 mg) per day, injections should be divided into two equal doses. Your doctor may temporarily prescribe more than four vials (160 mg) per day. If the level of acid in your stomach requires rapid control dose of 160 mg (four vials) should be enough
If any of these side effects, tell your doctor immediately or call an emergency room of the nearest hospital:
Serious allergic reactions (rare): swelling of the tongue and / or throat, difficulty swallowing, hives, shortness of breath, allergic facial swelling (edema Quincke / angioedema), severe dizziness with very rapid heart beat and sweating;
Severe skin reactions (frequency not known): blistering of the skin and rapid deterioration of general condition, erosion (including slight bleeding) in the eyes, nose, mouth / lips or vulva (syndrome Stevens-Johnson, syndrome Lyell, erythema multiforme) and sensitivity to light;
Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (signs of serious damage to liver cells, jaundice) or fever, rash, sometimes increase the size of the kidney with painful urination and lower back pain (severe inflammation kidneys).
Other side effects are:
Common (affects 1 to 10 users in 100):
Inflammation of the vein walls and blood clots (thrombophlebitis) in place of dosing.
Uncommon (affects 1 to 10 users in 1000):
Headache, dizziness, diarrhea, nausea, vomiting; bloating and flatulence (flatulence), constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruptions, itching, tiredness, exhaustion or malaise, sleep disorders.
Rare (affects 1 to 10 users in 10,000):
Visual disturbances such as blurred vision, hives, joint pain, muscle pain, changes in body weight, fever, swelling of the extremities (peripheral edema), allergic reactions, depressed mood, breast enlargement in males.
Very rare (affects less than 1 user in 10 000):
Disorientation.
Not known (estimates of frequency can not be made from available data):
Hallucinations, confusion (especially in patients who have already received such symptoms), reduced level of sodium in the blood.
If you are treated with pantoprazole for a period longer than three months it is possible to decrease the levels of magnesium in your blood. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you get any of these symptoms, please inform your doctor immediately. Furthermore, the low magnesium levels can lead to decreases in potassium or calcium in the blood. Your doctor may decide for regular blood tests to monitor levels of magnesium in your body.

Adverse reactions that were observed in blood tests:
Uncommon (affects 1 to 10 users in 1000):
Elevated liver enzymes.
Rare (affects 1 to 10 users in 10,000):
Elevated bilirubin and blood fat.
Very rare (affects less than 1 user in 10 000):
Low numbers of platelets that may lead to bleeding or bruising more frequently than normal; low white blood cells which can lead to more frequent infections.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE PRAZOLPAN
Do not use PRAZOLPAN after the expiry date stated on the carton and vial label after "EXP". The expiry date refers to the last day of that month.
Keep out of reach of children.
Do not store above 25 ° C.
Store in the original container to protect from light.
The chemical and physical stability of the product ready for use 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 product should be used immediately. If not used immediately, time and storage conditions of the product ready for use are the responsibility of the user and normally should not exceed 24 hours at 2 to 8 ° C, unless dilution has taken place in controlled and validated aseptic conditions.
The reconstituted product should be inspected visually before use. It should only be used if the solution is clear and practically free from particles.
Do not use PRAZOLPAN if you notice a change in appearance (eg occurrence of turbidity or sediment).
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What PRAZOLPAN
The active substance is pantoprazole (pantoprazole). One vial contains 40 mg of pantoprazole (pantoprazole sodium).
The other ingredient is disodium edetate.

PRAZOLPAN looks like and contents of the pack
PRAZOLPAN is white to off-white dry powder in a clear glass vial with a rubber stopper and an aluminum seal closed with plastic flip off disc. Each pack contains one vial for injection.
PRAZOLPAN 40 mg powder for injection or infusion is available in packs of 1, 5 or 10 vials.
Not all pack sizes may be marketed.

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