Pantoprazole Aurobindo Pharma Italia

Package leaflet: Information for the user

Pantoprazole Aurobindo Pharma Italia 40 mg powder for injectable solution

Generic medicine
Please read this leaflet carefully before using 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Pantoprazolo Aurobindo Pharma Italia is and what it is used for

Pantoprazolo Aurobindo Pharma Italia contains the active substance pantoprazole sodium sesquihydrate.
Pantoprazolo Aurobindo Pharma Italia is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat conditions related to stomach and intestinal acidity.
This preparation is administered by intravenous injection and will be prescribed to you only if your doctor considers that injections of Pantoprazolo Aurobindo Pharma Italia are currently more suitable for you than pantoprazole tablets. Tablets will replace the injections as soon as your doctor deems it appropriate.
Pantoprazolo Aurobindo Pharma Italia is used in the treatment of adults with:

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

2. What you need to know before using Pantoprazolo Aurobindo Pharma Italia

Do not use Pantoprazolo Aurobindo Pharma Italia

• 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 Pantoprazolo Aurobindo Pharma Italia.

• if you have severe liver problems. Inform your doctor if you have previously had liver problems. Your doctor will check your liver enzyme levels more frequently. If these levels increase, treatment should be discontinued;

• if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) concomitantly with Pantoprazolo Aurobindo Pharma Italia, consult your doctor for specific advice;

• taking a proton pump inhibitor such as Pantoprazolo Aurobindo Pharma Italia, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine.

• if you have osteoporosis (reduced bone density) or if your doctor tells you that you are at risk of osteoporosis (for example, if you are taking steroids), inform your doctor;

• if you have been taking Pantoprazolo Aurobindo Pharma Italia for more than 3 months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium and 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 Pantoprazolo Aurobindo Pharma Italia that reduces gastric acidity.

• if you develop a skin rash, particularly in sun-exposed areas, inform your doctor as soon as possible, as you may need to stop treatment with pantoprazole. Remember to also report any other adverse effects such as joint pain;

• if you need 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 could be signs of a more serious underlying condition:

• unintentional weight loss;
• vomiting, especially if repeated;
• vomiting blood; this may appear as dark clumps resembling coffee grounds in the vomit;
• if you notice blood in your stools, which may appear black or dark;
• difficulty swallowing or pain when swallowing;
• paleness and feeling weak (anaemia);
• chest pain;
• stomach pain;
• severe and/or persistent diarrhoea, as this medicine 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 Pantoprazolo Aurobindo Pharma Italia also relieves symptoms of cancer and could therefore delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.
Children and adolescents
The use of Pantoprazolo Aurobindo Pharma Italia is not recommended in children, as its efficacy has not been demonstrated in individuals under 18 years of age.
Other medicines and Pantoprazolo Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
This is because Pantoprazolo Aurobindo Pharma Italia 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), as Pantoprazolo Aurobindo Pharma Italia may prevent these and other medicines from working properly;
• warfarin and fenprocoumon, which affect blood clotting or thinning. You may require additional tests;
• 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 Pantoprazolo Aurobindo Pharma Italia because pantoprazole may increase methotrexate levels in the blood;
• fluvoxamine (used to treat depression and other psychiatric disorders) – 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
Adequate data on the use of Pantoprazolo Aurobindo Pharma Italia during pregnancy are not available. Excretion of pantoprazole into breast milk has been reported.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should use this medicine only if your doctor considers that the benefit to you outweighs the potential risk to the fetus or newborn.
Driving and using machines
Pantoprazolo Aurobindo Pharma Italia does not affect or affects negligibly the ability to drive or use machines.
However, if you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.
Important information about certain ingredients of Pantoprazolo Aurobindo Pharma Italia
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically 'sodium-free'.

3. How to take Pantoprazolo Aurobindo Pharma Italia

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 Pantoprazolo Aurobindo Pharma Italia) per day.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced: 2 vials (80 mg of Pantoprazolo Aurobindo Pharma Italia) per day.

Your doctor may later 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
These injections are not recommended for children and adolescents under 18 years of age.
If you use more Pantoprazolo Aurobindo Pharma Italia than you should
These doses are carefully monitored by the nurse or doctor, so 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 gets them.

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

• Severe allergic reactions (uncommon frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin conditions (frequency not known: frequency cannot be estimated from the available data): you may notice one or more of the following symptoms – blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, skin sensitivity/rash, particularly in areas of skin exposed to light/sun. 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'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 estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash and enlarged kidneys, sometimes with pain when urinating and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects include:

• Common (may affect 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 affect up to 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; bloating and flatulence (gas); constipation; dry mouth, abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling of weakness, exhaustion or general fatigue; sleep disorders; hip, wrist or spinal fractures.
• Rare (may affect up to 1 in 1,000 people): altered or complete loss of taste; visual disturbances such as blurred vision; urticaria; 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 affect up to 1 in 10,000 people): disorientation.
• Not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with prior history of such symptoms); tingling, pricking or pins and needles sensation, burning or numbness; erythema, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Side effects identified through blood tests

• Uncommon (may affect up to 1 in 100 people): increased liver enzymes.
• Rare (may affect up to 1 in 1,000 people): increased bilirubin; increased blood lipids; sudden drop in circulating neutrophils in the blood, associated with high fever.
• Very rare (may affect up to 1 in 10,000 people): reduced platelet count, which may cause bleeding or bruising more frequently than normal; reduced white blood cell count, which may lead to more frequent infections; abnormal concurrent reduction in red blood cells, white blood cells, and platelets.
• Not known (frequency cannot be estimated from the 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 effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://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 Aurobindo Pharma Italia

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 that month.
Store below 30 °C.
Keep in the original packaging to protect the medicine from light.
After preparation, the reconstituted solution must be used within 12 hours after dilution or within 24 hours if not further diluted.
From a microbiological point of view, the product should be used immediately. If not used immediately, the duration and conditions of storage in use are the responsibility of the user.
Do not use Pantoprazolo Aurobindo Pharma Italia if you notice any change in its appearance (e.g. if cloudiness or precipitates are observed).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Aurobindo Pharma Italia 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.

Description of the appearance of Pantoprazolo Aurobindo Pharma Italia and contents of the pack
Powder for injectable solution.
White to almost white powder in a 10 ml colourless, type I glass vial with a bromobutyl rubber stopper, sealed with an aluminium cap having a polypropylene disc.
Pack sizes: 1 or 5 (5x1) vials, 10 (10x1) vials, and 20 (20x1) vials of powder for injectable solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia,
BBG 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Pantoprazol Eugia 40 mg poeder voor oplossing voor injectie / poudre pour solution injectable / Pulver zur Herstellung einer Injektionslösung
Germany: Pantoprazol PUREN 40 mg Pulver zur Herstellung einer Injektionslösung
Italy: Pantoprazolo Aurobindo Pharma Italia
Netherlands: Pantoprazol Eugia 40 mg, poeder voor oplossing voor injectie
Poland: Pantoprazole Eugia
Portugal: Pantoprazol Aurobindo
Spain: Pantoprazol Aurovitas 40 mg polvo para solución inyectable EFG

The following information is intended exclusively for physicians or healthcare professionals:
Reconstituted solution:
The ready-to-use solution is prepared by injecting 10 ml of sodium chloride 0.9% injectable solution into the vial containing the powder. This solution can be administered directly. The reconstituted solution is physically and chemically stable for 24 hours at 25 °C.

Diluted solution:
The powder vial is reconstituted with 10 ml of sodium chloride 0.9% injectable solution and further diluted with 100 ml of either 0.9% sodium chloride injection solution or 5% dextrose injection solution (resulting in a concentration of approximately 0.4 mg/ml).
The resulting reconstituted and diluted medicinal solution is physically compatible and chemically stable for 12 hours with 0.9% sodium chloride injectable solution and 5% dextrose injection solution at 25 °C. Dilution must be performed using plastic containers.
Pantoprazolo Aurobindo Pharma Italia must not be prepared or mixed with solvents other than those mentioned above.
After preparation, the reconstituted solution must be used within 12 hours after dilution, or within 24 hours if not further diluted.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage conditions and duration of stability during use are the responsibility of the user.

Administer the medicinal product intravenously over 2 to 15 minutes.
The vial is for single use only. Any unused product or product showing changes in appearance (e.g. cloudiness or precipitation) must be discarded.
The appearance of the product after reconstitution is a clear, colourless to yellowish solution, free from particles.