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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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 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 SUN, 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 SUN. 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 if you notice any of the following symptoms:

• an unintentional loss of weight
• vomiting, particularly if repeated
• difficulty in swallowing or pain when swallowing
• vomiting blood; this may appear as dark coffee grounds in your vomit
• you look pale and feel weak (anaemia)
• you notice blood in your stools; which may be black or tarry in appearance
• 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 as it has not been proven to work in children below 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 (a type of rheumatism), psoriasis (a skin disease. The skin is red and dry with flakes), 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).

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 dose, 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 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): 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 (Stevens-Johnson-Syndrome, Lyell-Syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), 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.

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; fracture in the hip, wrist or spine.
• 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); feeling of tingling, prickling, pins and needles, burning sensation or numbness; rash, possibly with pain in the joints, inflammation in the large bowel, that causes persistent watery diarrhoea.

• 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.
• 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 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 sodium sesquihydrate. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).

Pantoprazole is a white to almost white powder for solution for injection. It comes in a 10 ml clear glass vial closed with a red aluminium seal and grey rubber stopper containing 40 mg powder for solution for injection.

Pantoprazole is available in the following pack sizes:

Packs with 1, 5, 10 and 50 vial(s).

Not all pack sizes may be marketed.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung

Belgium: Pantoprazol SUN 40 mg poeder voor oplossing voor injectie

Pantoprazol SUN 40 mg poudre pour solution injectable

Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung

Denmark: Pantoprazol SUN

Germany: Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung

Finland: Pantoprazol SUN 40 mg injektiokuiva-aine, liuosta varten

France: Pantoprazole SUN 40 mg poudre pour solution injectable

Italy: Pantoprazolo SUN 40 mg polvere per soluzione iniettabile

The Netherlands: Pantoprazol SUN 40 mg poeder voor oplossing voor injectie

Norway: Pantoprazol SUN 40 mg pulver til injeksjonsvæske, oppløsning

Poland: Pantoprazol SUN 40 mg proszek do sporządzania roztworu do wstrzykiwań

Romania: Pantoprazol SUN 40 mg pulbere pentru soluţie injectabilă

Sweden: Pantoprazol SUN 40 mg pulver till injektionsvätska, lösning

United Kingdom (Northern Ireland): Pantoprazole 40 mg powder for solution for injection