Pantoprazole 40 mg powder for solution for injection

• 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.

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

• 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.

• 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 pump inhibitors.

Talk to your doctor, pharmacist or nurse before you are given Pantoprazole:

• if you have severe liver problems. Please tell your doctor if you have ever had problems with your liver in the past. Your doctor 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 (reduced bone density) or if you have been told that you are at risk of getting osteoporosis (for example, if you are taking steroids).
• 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 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 Pantoprazole 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 Pantoprazole. Remember to also mention any other ill-effects like pain in your joints.
• Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and Erythema multiforme have been reported in association with pantoprazole treatment. Stop using pantoprazole and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• 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 (not related to a diet or an exercise programme)
• 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.

Pantoprazole is not recommended for use in children and adolescents as it has not been proven to work in children and adolescents below 18 years of age.

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 Pantoprazole 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 Pantoprazole 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 Pantoprazole 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).

Talk to your doctor before taking pantoprazole if you are due to have a specific urine test (for THC; Tetrahydrocannabinol).

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.

Pantoprazole 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.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium free’.

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

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

These doses are carefully checked by your nurse or your doctor so an overdose is extremely unlikely.

There are no known symptoms of overdose.

• 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): you may notice one or more of the following - blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals or skin sensitivity/rash, particularly in areas of skin exposed to light/the sun. You may also have joint pain or flu-like symptoms, a fever, swollen glands (e.g. in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes. Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson-syndrome, toxic epidermal necrolysis). Lyell-syndrome, Erythema multiforme, Subacute cutaneous lupus erythematosus. Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Photosensitivity.
• 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.

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)

• Rash, possibly with pain in the joints
• Inflammation in the large bowel, that causes persistent watery diarrhoea
• Hallucination, confusion (especially in patients with a history of these symptoms); 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.

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.

Not known (frequency cannot be estimated from the available data)

• Decreased level of sodium, magnesium, calcium or potassium in blood (see section 2).

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 MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other ingredients are: disodium edetate.

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

The medicinal product is available in one glass vial closed with a stopper and sealed by aluminium cap containing 40 mg powder for solution for injection.

Pantoprazole is available in the following pack sizes:

Pack with 1, 5, 10 or 50 vials.

Not all pack sizes may be marketed.

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