Protium 40 mg i.v. Powder for Solution for Injection

Read all of this leaflet carefully before you start using 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.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Protium is and what it is used for
2. What you need to know before you use Protium
3. How to use Protium
4. Possible side effects
5. How to store Protium
6. Contents of the pack and other information

Protium 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 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.
• 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, 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 ill-effects 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.
• 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’.

Adults

• 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 Protium 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 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 up to 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 up to 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 up to 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; fracture in the hip, wrist or spine.
• Rare (may affect up to 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 up to 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, decreased magnesium level in blood (see section 2), feeling of tingling, prickling, pins and needles, burning sensation or numbness , rash, possibly with pain in the joints.

Side effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people)
  an increase in liver enzymes.
• Rare (may affect up to 1 in 1,000 people)
  an increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever.
• Very Rare (may affect up to 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 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.

What Protium contains

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole.
• The other ingredients are: disodium edetate and sodium hydroxide (for pH adjustment).

What Protium looks like and contents of the pack

Protium is a white to off-white powder for solution for injection. 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.

Protium is available in the following pack sizes:

Pack with 1 vial.

Pack with 5 (5x1) vials.

Hospital pack with 1 vial.

Hospital pack with 5 (5x1) vials.

Hospital pack with 10 (10x1) vials.

Hospital pack with 20 (20x1) vials.

Not all pack sizes may be marketed.

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