1. What Toprazole is and what it is used for
Toprazole 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 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.
Toprazole 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 the stomach.

2. Before you are given Toprazole
Do not use Toprazole 
- If you are allergic to pantoprazole or any of the other ingredients of this medicine.
- If you are allergic to medicines containing other proton pump inhibitors.
Take special care with Toprazole
Talk to your doctor, pharmacist or nurse before you are given Toprazole:
-  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.
-  Difficulty in swallowing
-  Vomiting blood
-  You look pale and feel weak (anaemia)
-  You notice blood in your stools
- Severe and/or persistent diarrhea, as Toprazole has been associated with a small increase in infectious diarrhea.
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.
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).
Taking other medicines
Toprazole 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 Toprazole 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).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
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 are breast-feeding, you should use this medicine only if your 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.
Important information about some of the ingredients of Toprazole
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially ‘sodium-free’ 

3. How Toprazole is given 
Your nurse or your doctor 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 given 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 suffer from severe liver problems, the daily injection should be only 20 mg (half a vial)
- Children (under 18 years). These injections are not   recommended for use in children.
If you have more Toprazole 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 on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine 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, may affect less   than 1 in 1,000 people): 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, frequency cannot be estimated from the available data): 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, frequency cannot be estimated from the available data): 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 (may affect less than 1 in 10 people) 
Inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected.
-  Uncommon (may affect less than 1 in 100 people)
Headache; dizziness; diarrhea; 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 (may affect less than 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.
Very rare (may affect less than 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.
 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.
Side effects identified through blood tests
- Uncommon (may affect less than 1 in 100 people)
An increase in liver enzymes
- Rare (may affect less than 1 in 1,000 people)
An increase in bilirubin; increased fats in the blood
- Very rare (may affect less than 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 the number of white blood cells, which may lead to more frequent infections.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

5. How to store Toprazole 
Keep out of reach of children.
Store below 25°C.
Keep in original pack to protect from light.
From a microbiological point of view the reconstituted or diluted solution should be used immediately. If not used immediately, in-use storage conditions are the responsibility of the user and would normally not be longer than 12 hours at 25°C.
The appearance after reconstitution is a clear colorless solution to pale yellow.
Do not use beyond the expiry date or if the product shows any sign of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.