Pantoprazole Sun Pharmaceutical Industries Europe BV

Package leaflet: Information for the user

Pantoprazole Sun Pharmaceutical Industries Europe BV 40 mg powder for concentrate for solution for infusion
pantoprazole
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, as 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, including side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

What is in this leaflet

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

1. What Pantoprazole Sun Pharmaceutical Industries Europe BV is and what it is used for

Pantoprazole Sun Pharmaceutical Industries Europe BV contains the active substance pantoprazole.
Pantoprazole Sun Pharmaceutical Industries Europe BV is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is indicated for the treatment of acid-related diseases of the stomach and intestine.
This preparation is administered by intravenous infusion and will be prescribed only if your doctor considers that pantoprazole injections are currently more suitable for you than pantoprazole tablets. The tablets will replace the injections as soon as your doctor considers it appropriate.
Pantoprazole Sun Pharmaceutical Industries Europe BV is used in adults for the treatment of:

• Gastro-oesophageal reflux disease (GORD), which is inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with regurgitation of gastric acid.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.

2. What you need to know before using Pantoprazole Sun Pharmaceutical Industries Europe BV

Do not use Pantoprazole Sun Pharmaceutical Industries Europe BV

• 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 using Pantoprazole Sun Pharmaceutical Industries Europe BV

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzyme levels more frequently. If your liver enzymes increase, treatment should be discontinued.
• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole, consult your doctor for specific advice.
• Taking a proton pump inhibitor such as pantoprazole, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. If you have osteoporosis (reduced bone density) or have been told that you may be at risk of osteoporosis (for example, if you are taking steroids), consult your doctor.
• If you are taking Pantoprazole Sun Pharmaceutical Industries Europe BV for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Sun Pharmaceutical Industries Europe BV that reduces gastric acidity.
• Serious skin reactions such as 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 contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• If you are scheduled to undergo a specific blood test (Chromogranin A).

Inform your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be signs of a more serious underlying condition:

• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in vomit, which may appear as dark coffee-ground-like material
• appearance of blood in stools, which may look dark or tarry
• difficulty swallowing or pain when swallowing
• looking pale and feeling weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea
• If you develop a skin rash, particularly in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole Sun Pharmaceutical Industries Europe BV. Remember to also report any other adverse effects such as joint pain.

Your doctor may decide that you need certain tests to rule out malignancy, as pantoprazole can relieve symptoms of cancer and might delay diagnosis. If your symptoms persist despite treatment, further investigations should be considered.

Children and adolescents
The use of Pantoprazole Sun Pharmaceutical Industries Europe BV is not recommended in children, as its efficacy has not been demonstrated in individuals under 18 years of age.

Other medicines and Pantoprazole Sun Pharmaceutical Industries Europe BV
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.

This is because Pantoprazole Sun Pharmaceutical Industries Europe BV may affect the effectiveness of other medicines. Therefore, inform 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), as Pantoprazole Sun Pharmaceutical Industries Europe BV may prevent these and other medicines from working properly
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need additional monitoring
• 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 discontinue treatment with Pantoprazole Sun Pharmaceutical Industries Europe BV because pantoprazole may increase methotrexate levels in the blood
• Fluvoxamine (used to treat depression and other psychiatric conditions). 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 Sun Pharmaceutical Industries Europe BV if you are scheduled to undergo a specific urine test (for THC; tetrahydrocannabinol).

Pregnancy and breastfeeding
There are not adequate data available on the use of pantoprazole in pregnant women. Excretion into human breast milk has been reported.

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

You should use this medicine only if your doctor considers the benefit to you to outweigh the potential risk to the fetus or infant.

Driving and using machines
Pantoprazole Sun Pharmaceutical Industries Europe BV does not affect or affects negligibly the ability to drive and use machines. However, if you experience adverse effects such as dizziness or visual disturbances, you should not drive or operate machinery.

Pantoprazole Sun Pharmaceutical Industries Europe BV contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.

3. How to use Pantoprazole Sun Pharmaceutical Industries Europe BV

The nurse or doctor will administer your daily dose as an intravenous injection over a period of 2–15 minutes.
The recommended dose is:
Adults
For gastric ulcers, duodenal ulcers and reflux esophagitis
1 vial (40 mg of pantoprazole) per day.
For long-term treatment of Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced
2 vials (80 mg of pantoprazole) per day.
Your doctor may adjust the dose depending on the amount of acid produced by your stomach. If you have been prescribed more than 2 vials (80 mg) per day, the injections will be divided into two equal doses. Your doctor may temporarily prescribe a dose of more than 4 vials (160 mg) per day. If rapid control of stomach acid levels is required, an initial dose of 160 mg (4 vials) will be sufficient to adequately reduce stomach acid production.
Patients with liver problems
If you have severe liver problems, the daily injected dose will 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 of age.
If you use more Pantoprazole Sun Pharmaceutical Industries Europe BV than you should
These doses have been carefully determined by your nurse or doctor, so overdose is extremely unlikely. Symptoms of overdose are not known.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

If you experience any of the following side effects, contact your doctor immediately or go to the nearest hospital emergency department:

• Severe allergic reactions (rare frequency, up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic facial swelling (Quincke's edema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Serious skin disorders (frequency not known, frequency cannot be estimated from available data): you may notice one or more of the following symptoms – appearance of skin blisters 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/sunlight. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arm), and blood tests may show changes in white blood cell count or liver enzymes (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• Reddish, flat spots, circular or target-shaped, on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash and kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

• Common (may occur in up to 1 in 10 people): Inflammation of the vein wall and blood clot formation (thrombophlebitis) at the injection site; benign stomach polyps.
• Uncommon (may occur in up to 1 in 100 people): Headache, dizziness, diarrhoea, nausea, vomiting, bloating and flatulence (gas), constipation, dry mouth, abdominal pain and feeling unwell, skin rash, exanthema, eruption, itching, feeling of weakness, fatigue or general malaise, sleep disorders, hip, wrist or spinal fractures.
• Rare (may occur in up to 1 in 1,000 people): Altered or complete loss of taste, vision disorders such as blurred vision, hives, joint pain, muscle pain, weight changes, increased body temperature, high fever, swelling of the extremities (peripheral oedema), allergic reactions, depression, breast enlargement in men.
• Very rare (may occur in up to 1 in 10,000 people): Disorientation.
• Frequency not known (frequency cannot be estimated from available data): Hallucinations, confusion (especially in patients with a history of these symptoms), tingling sensation, pins and needles, burning or numbness, erythema, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests

• Uncommon (may occur in up to 1 in 100 people): increased liver enzymes.
• Rare (may occur in up to 1 in 1,000 people): increased bilirubin, increased blood fat levels, drastic decrease in circulating granulocytes in the blood associated with high fever.
• Very rare (may occur in up to 1 in 10,000 people): reduced platelet count, which may cause increased bleeding or bruising; reduced white blood cell count, which may lead to more frequent infections; marked abnormal reduction in red and white blood cells as well as platelets.
• Not known (frequency cannot be estimated from available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazolo Sun Pharmaceutical Industries Europe BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cardboard box and on the vial after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Store the vial in the outer cardboard box to protect the medicine from light.
Use the reconstituted solution within 12 hours.
Use the reconstituted and diluted solution within 12 hours.
From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 12 hours at not more than 25°C.
After reconstitution, or after reconstitution and dilution, store the vial in the outer cardboard box to protect the medicine from light.
Do not use this medicine if you notice any changes in appearance (for example, if cloudiness or precipitation is observed).
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6 Contents of the pack and other information

What Pantoprazolo Sun Pharmaceutical Industries Europe BV contains

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

Description of the appearance of Pantoprazolo Sun Pharmaceutical Industries Europe BV and contents of the pack
Pantoprazolo Sun Pharmaceutical Industries Europe BV is a white to almost white powder for injectable solution. It is supplied as a 10 mL transparent glass vial closed with an aluminum cap and a chlorobutyl rubber stopper, containing 40 mg of powder for injectable solution.
Pantoprazolo Sun Pharmaceutical Industries Europe BV is available in the following pack sizes:
Pack containing 1 vial and pack containing 10 vials (10x1).
Multiple pack containing 50 vials (2 packs of 25).
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for doctors or healthcare professionals:
The ready-to-use solution should be prepared by injecting 10 mL of sodium chloride 9 mg/mL (0.9%) injection solution into the vial containing the dry powder. This solution may be administered directly or after dilution with 100 mL of sodium chloride 9 mg/mL (0.9%) injection solution or glucose 55 mg/mL (5%) injection solution. For dilution, use containers made of glass or plastic.
Pantoprazole Sun Pharmaceutical Industries Europe BV must not be prepared or diluted with solvents other than those mentioned.
After preparation, use the solution within 12 hours. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and must not exceed 12 hours at a temperature not exceeding 25°C.
Administer the medicinal product intravenously over 2-15 minutes.
The contents of the vial are intended solely for a single intravenous administration. Any unused product remaining in the container or with altered appearance (e.g. cloudiness or precipitation) should be discarded.