Pantoprazole Sun Pharma: detailed information

Package leaflet: Information for the user

Pantoprazole SUN Pharma 40 mg powder for injectable solution

sodium pantoprazole sesquihydrate
Equivalent medicine
Please read this leaflet carefully before you are given this medicine because it
contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Pantoprazole SUN Pharma is and what it is used for
What you need to know before you are given Pantoprazole SUN Pharma
How Pantoprazole SUN Pharma is administered
Possible side effects
How to store Pantoprazole SUN Pharma
Contents of the pack and other information

1. What is Pantoprazole SUN Pharma and what is it used for?

Pantoprazole SUN Pharma contains the active substance pantoprazole. Pantoprazole SUN Pharma 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 injection and will be prescribed to you only if your doctor considers that pantoprazole injections are currently more suitable for you than pantoprazole tablets. Tablets will replace injections as soon as your doctor deems it appropriate.
Pantoprazole SUN Pharma is indicated for the treatment of

reflux esophagitis. This is inflammation of the esophagus (the tube connecting the throat to the stomach) associated with acid regurgitation from the stomach.
stomach and duodenal ulcers
Zollinger-Ellison syndrome and other conditions characterized by excessive acid production in the stomach.

2. What you should know before being given Pantoprazole SUN Pharma

Pantoprazole SUN Pharma must not be given to you

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 being given Pantoprazole SUN Pharma

if you have severe liver problems. Inform your doctor if you have had liver problems in the past. Your doctor may want to monitor your liver enzymes more frequently. If these levels rise, 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 SUN Pharma, consult your doctor for advice.
if you are taking a proton pump inhibitor such as Pantoprazole SUN Pharma, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you have osteoporosis (reduction in bone density) or have been told you may be at risk of osteoporosis (for example, if you are taking corticosteroids), consult your doctor.
if you have been taking Pantoprazole SUN Pharma for more than three months, your blood magnesium levels may decrease. Inform your doctor immediately if you experience any of the following symptoms of low magnesium levels, such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. Low magnesium levels may also lead to reduced levels of potassium or calcium 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 Pharma that reduces gastric acidity.
Inform your doctor as soon as possible if you notice the appearance of a skin rash, especially in sun-exposed areas, as it may be necessary to discontinue treatment with Pantoprazole SUN Pharma. Remember to also report any other adverse effects such as joint pain.
if you need to undergo a specific blood test (Chromogranin A).

Treatment with Pantoprazole SUN Pharma may mask symptoms of a more serious stomach condition such as cancer:
Inform your doctor immediately, before and after taking the medicine, if you notice any of the following symptoms, which could indicate a more serious underlying disease:

unintentional weight loss
vomiting, especially if repeated
vomiting blood, which may appear as dark coffee-ground material in vomit
blood in the stool, which may appear black or tarry
difficulty swallowing or pain when swallowing
paleness and weakness (anaemia)
chest pain
stomach pain
severe and/or persistent diarrhoea, as Pantoprazole SUN Pharma has been associated with a slight increase in infectious diarrhoea.

Your doctor may decide to perform certain tests to rule out the presence of a malignant disease, since pantoprazole can relieve symptoms of cancer and may therefore delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.
Children and adolescents
Pantoprazole SUN Pharma is not recommended in children, as efficacy has not been demonstrated in individuals under 18 years of age.
Other medicines and Pantoprazole SUN Pharma
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
This is because Pantoprazole SUN Pharma 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 to treat certain types of cancer): Pantoprazole SUN Pharma may prevent these and other medicines from working properly
warfarin and fenprocoumon, which affect blood clotting. You may require additional monitoring
medicines used to treat HIV infection, such as atazanavir
methotrexate (used to treat rheumatoid arthritis (a type of rheumatism), psoriasis (a skin disease where the skin is red, dry, and scaly), and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole SUN Pharma, as 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).

Pregnancy and breastfeeding
There are insufficient adequate data on the use of pantoprazole during pregnancy. Pantoprazole has been reported to be excreted in human breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before being given this medicine.
This medicine should only be administered if your doctor considers that the benefit to you outweighs the potential risk to the unborn child.
Driving and using machines
Pantoprazole SUN Pharma does not affect or has negligible effect on the ability to drive or use machines. However, if you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.
Pantoprazole SUN Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.

3. How Pantoprazolo SUN Pharma is administered

The nurse or doctor will administer your daily dose as an intravenous injection over 2–15 minutes.

Recommended dose
Adults

Gastric ulcers, duodenal ulcers and reflux esophagitis: 1 vial (40 mg of pantoprazole) per day.
Long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive stomach acid production: 2 vials (80 mg of pantoprazole) per day.

Your doctor may adjust the dose depending on the amount of acid your stomach produces. If you have been prescribed more than 2 vials (80 mg) per day, the injections will be given in two equal doses. Your doctor may prescribe a temporary 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 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
The use of these injections is not recommended in children and adolescents under 18 years of age.

If you are given more Pantoprazolo SUN Pharma than you should
These doses have been carefully controlled by your nurse or doctor; therefore, overdose is extremely unlikely. Symptoms of overdose are not known.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
If you notice any of the following side effects, contact your doctor or the nearest hospital emergency department immediately

Severe allergic reactions (rare frequency, may occur in up to 1 person in 1000): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's oedema / angioedema), severe dizziness with very rapid heartbeat and profuse sweating
Severe skin conditions (frequency not known, frequency cannot be determined from available data):
you may notice one or more of the following symptoms: blisters on the skin and rapid deterioration in general condition, erosion (even mild) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show abnormalities in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's 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 determined from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and kidney enlargement sometimes with painful urination and lower back pain (severe kidney inflammation).

Other side effects

Common (may occur in up to 1 in 10 people): inflammation of the vein walls 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, malaise, vomiting, bloating and flatulence (gas), constipation, dryness of the mouth, abdominal pain and tenderness, rash, exanthema, eruption, itching, feeling of weakness, exhaustion or general fatigue, sleep disorders, hip, wrist or spinal fractures
Rare (may occur in up to 1 in 1,000 people): distortion or complete loss of taste sensation, 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 determined from available data): hallucinations, confusion (particularly in patients with a history of such symptoms), tingling, prickling, stinging, burning sensation or numbness, skin rash, 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 fats, sudden drop in circulating neutrophils in the blood associated with high fever
Very rare (may occur in up to 1 in 10,000 people): reduction in platelet count which may lead to bleeding or more frequent bruising than normal, reduction in white blood cell count which may lead to more frequent infections, concurrent abnormal reduction in red blood cells 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, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Pantoprazolo SUN Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "Exp".
The expiry date refers to the last day of the month.
Store below 30°C. Keep the vials in their outer packaging 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 standpoint, the product should be used immediately; storage times and conditions during use are the responsibility of the user and normally should not exceed 12 hours at a temperature not exceeding 25°C.
The reconstituted solution is clear, transparent, colourless or slightly yellowish. Do not use this medicine if you notice any changes in its appearance (e.g., cloudiness or formation of precipitates).
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information
What Pantoprazolo SUN Pharma contains

The active substance is sodium pantoprazole sesquihydrate. One vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
The other ingredient is edetate disodium.

Description of the appearance of Pantoprazolo SUN Pharma and package contents
Pantoprazolo SUN Pharma is a white to almost white powder for injectable solution. It is available in a 10 ml clear glass vial closed with an aluminium red cap and grey rubber stopper, containing 40 mg of powder for injectable solution.
Pantoprazolo SUN Pharma is available in the following pack sizes:
Carton containing 1 vial.
Carton containing 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milan
Italy
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Legal representative in Italy:
Sun Pharma Italia S.r.l. - Viale Giulio Richard, 3 - 20143 Milan

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

This medicine is authorised in the European Economic Area countries under the following names:
Germany: Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung
France: Pantoprazole SUN Pharma 40 mg poudre pour solution injectable
Italy: Pantoprazolo SUN Pharma 40 mg polvere per soluzione iniettabile
The Netherlands: Pantoprazol SUN Pharma 40 mg poeder voor oplossing voor injectie

The following information is intended exclusively for healthcare professionals:
Prepare the ready-to-use solution by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride injectable solution into the vial containing the dry powder. This solution may be administered directly or after mixing with 100 ml of 9 mg/ml (0.9%) sodium chloride injectable solution or 55 mg/ml (5%) glucose injectable solution. For dilution, use containers made of glass or plastic.
Pantoprazolo SUN Pharma must not be prepared or mixed with solvents other than those specified.
After preparation, use the solution within 12 hours. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage time and conditions prior to use are the responsibility of the user and must not exceed 12 hours at a temperature not exceeding 25°C.
Administer the medicine intravenously over 2–15 minutes.
The vial contains a single intravenous dose. The reconstituted solution is clear, transparent, colourless or slightly yellowish. Any unused solution or solution with altered appearance (e.g., cloudiness or precipitate formation) must be discarded.