Product Details

Product Information of Protium 40mg IV Injection

What you need to know before you take Protium

Do not use Protium – If you are allergic to pantoprazole or to 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, pharmacist or nurse before taking Protium – 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 HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice. 2 – 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). – If you are on Protium 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 or 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. – If you have ever had a skin reaction after treatment with a medicine similar to Protium that reduces stomach acid. – If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Protium. Remember to also mention any other illeffects like pain in your joints. – If you are due to have a specific blood test (Chromogranin A). Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: – an unintentional loss of weight – vomiting, particularly if repeated – vomiting blood; this may appear as dark coffee grounds in your vomit – you notice blood in your stools; which may be black or tarry in appearance – difficulty in swallowing or pain when swallowing – you look pale and feel weak (anaemia) – chest pain – stomach pain – severe and/or persistent diarrhoea, because this medicine 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. Children and adolescents Protium is not recommended for use in children as it has not been proven to work in children below 18 years of age. Other medicines and Protium Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Protium 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 Protium 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. – Medicines used to treat HIV-infection, such as atazanavir. – Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate your doctor may temporarily stop your Protium treatment because pantoprazole can increase levels of methotrexate in the blood. 3 – Fluvoxamine (used to treat depression and other psychiatric diseases) – if you are taking fluvoxamine your doctor may reduce the dose. – Rifampicin (used to treat infections) – St John’s wort (Hypericum perforatum) (used to treat mild depression) Pregnancy and breast-feeding 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 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. 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 Protium has no or negligible influence on the ability to drive and use 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 Protium This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially ‘sodium- free’.