Proton IV 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.  

Proton IV 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.  

Do not use Proton IV  

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6)  

• if you are allergic to medicines containing other Proton IV pump inhibitors.  

Warnings and precautions  

Talk to your doctor, pharmacist or nurse before you are given Proton IV  

• 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.  

• if you have ever had a skin reaction after treatment with a medicine similar to Proton IV that reduces stomach acid.  

• if you are due to have a specific blood test (Chromogranin A). 

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  

• chest pain  

• stomach pain  

• severe and/or persistent diarrhoea, as Proton IV has been associated with a small increase in infectious diarrhoea.  

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 Proton IV. Remember to also mention any other ill-effects like pain in your joints.  

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 Proton IV, 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).  

Children and adolescents  

Proton IV 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 Proton IV  

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Proton IV 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 Proton IV 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 and other medicines used to treat HIV-infection  

• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate your doctor may temporarily stop your Proton IV treatment because pantoprazole can increase levels of methotrexate in the blood  

• 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, 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. 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  

Proton IV 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.  

Proton IV contains sodium  

This medicine contains less than 1 mmol sodium (23 mg) per maximum daily dose, that is to say ‘sodium- free’.  

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.  

Patients with liver problems  

If you suffer from severe liver problems, the daily injection should be only 20 mg (half a vial).  

Use in children and adolescents  

These injections are not recommended for use in children and adolescents under 18 years.  

If you use more Proton IV 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.  

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) possibly leading to kidney failure.  

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; benign polyps in the stomach. 

• Uncommon (may affect less than 1 in 100 people) 

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 (may affect less than 1 in 1,000 people)  

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 (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, feeling of tingling, prickling, pins and needles, burning sensation or numbness; low levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm; muscle spasm or cramps; low levels of calcium; rash, possibly with pain in the joints.  

If you are on Proton IV 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, sharp drop in circulating granular white blood cells, associated with high fever. 

• 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, 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 National Pharmacovigilance and Drug Safety Centre (NPC). By reporting side effects you can help provide more information on the safety of this medicine.  

• Keep out of the reach and sight of children.  

• Do not use this medicine 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 30°C. 

• After the reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25°C. From a microbiological point of view, unless the method of opening and dilution precludes the risk of microbial contamination, the product should be used immediately.  

• Do not use this medicine if you notice 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 your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.