Pantoprazole Sandoz GmbH

Package leaflet: Information for the patient

Pantoprazole Sandoz GmbH 40 mg powder for concentrate for solution for infusion

Read all of this leaflet carefully before this medicine is administered to you 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:
1 What Pantoprazole Sandoz GmbH powder for concentrate for solution for infusion is and what it is used for
2 What you need to know before using Pantoprazole Sandoz GmbH powder for concentrate for solution for infusion
3 How to use Pantoprazole Sandoz GmbH powder for concentrate for solution for infusion
4 Possible side effects
5 How to store Pantoprazole Sandoz GmbH powder for concentrate for solution for infusion
6 Contents of the pack and other information

1. What Pantoprazolo Sandoz GmbH is and what it is used for

Pantoprazolo Sandoz GmbH contains the active substance pantoprazole. Pantoprazolo Sandoz GmbH
is a "selective proton pump inhibitor", a medicine that reduces the amount of acid
produced by the stomach. It is used to treat stomach and intestinal disorders related to
acidity. This preparation is administered intravenously and will be given to you only if your doctor
considers the intravenous form, for the time being, more suitable than the tablet form.
As soon as your doctor deems it appropriate, the tablet form will replace the intravenous form.
Pantoprazolo Sandoz GmbH is used to treat:

• reflux esophagitis; this is inflammation of the esophagus (the "tube" connecting the throat to the stomach) accompanied by regurgitation of gastric acid
• gastric and duodenal ulcers
• Zollinger-Ellison syndrome and other disorders causing excessive acid production in the stomach.

2. What you need to know before taking Pantoprazole Sandoz GmbH

Do not use Pantoprazole Sandoz GmbH

• 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 Pantoprazole Sandoz GmbH.

• if you have severe liver problems. If you have previously had liver problems, inform your doctor; they will check your enzyme levels more frequently. If your enzyme levels increase, treatment must be discontinued
• if you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infections) concomitantly with pantoprazole, consult your doctor.
• taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine.
• Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• if you take Pantoprazole Sandoz GmbH for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may 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 need to undergo a specific blood test (Chromogranin A).
• consult your doctor if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Sandoz GmbH that reduces gastric acidity. If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazole Sandoz GmbH. Remember to also report any other adverse effects such as joint pain.

Inform your doctor immediately, before and after taking this medicine, if you notice
the onset of any of the following symptoms, which could indicate a more
serious underlying condition:

• unintentional weight loss
• vomiting, particularly if repeated
• presence of blood in vomit; this may appear as dark, coffee-ground-like material in the vomit
• presence of blood in stools; stools may appear black or tarry
• difficulty swallowing or pain when swallowing
• paleness and weakness (anaemia)
• 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 prescribe certain tests to rule out a malignant condition, because
pantoprazole may also relieve symptoms of tumours and could therefore delay diagnosis. If your symptoms
persist despite treatment, further investigations will be necessary.
Children and adolescents
Pantoprazole Sandoz GmbH is not recommended for use in children, as efficacy has not been demonstrated in individuals under 18 years of age.
Other medicines and Pantoprazole Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those not requiring a prescription.
This is because Pantoprazole Sandoz GmbH may reduce 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 Sandoz GmbH may prevent these and other medicines from working properly
• warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required
• medicines used to treat HIV infections, 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 Sandoz GmbH, 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
Adequate data on the use of pantoprazole in pregnant women are not available. Excretion into human milk has also been reported.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or nurse before taking any medicine. You should use this medicine only if your doctor considers that the benefits to you outweigh the potential risks to the foetus or newborn.
Driving and using machines
Pantoprazole Sandoz GmbH has no or negligible influence on the ability to drive and use machines.
However, if you experience adverse effects such as dizziness or visual disturbances, you must not drive or operate machinery.

3. How to use Pantoprazolo Sandoz GmbH

The nurse or doctor will administer your daily dose as an intravenous injection
over a period of 2–15 minutes.
The recommended dose is described below.
Adults

• For gastric and duodenal ulcers and for reflux esophagitis One vial (40 mg of pantoprazole) per day.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions causing excessive gastric acid production

Two vials (80 mg of pantoprazole) per day.
Subsequently, your doctor may adjust the dose depending on the amount of gastric acid you produce.
If you have been prescribed more than two vials (80 mg) per day, the injections will be given in
two equal divided doses. Your doctor may prescribe a temporary dose of more than four
vials (160 mg) per day. If gastric acidity needs to be controlled rapidly, an initial dose of 160 mg (four vials) should be sufficient to adequately reduce gastric acid production.
Hepatic impairment
If you have severe liver problems, the daily injection should 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 Sandoz GmbH than you should
These doses are carefully controlled by the nurse or doctor, therefore overdose is extremely unlikely.
Symptoms of overdose are not known.
If you have any doubts about how to use Pantoprazolo Sandoz GmbH, 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 experience any of the following side effects, tell your doctor immediately
or go to the nearest hospital emergency department:

• Severe allergic reactions (uncommon: 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 (angioedema/Quincke's edema), severe dizziness with very rapid heartbeat and excessive sweating
• Severe skin disorders (frequency not known: frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), and sensitivity to light
• Other serious disorders (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 rashes and kidney enlargement, sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects
Common (may affect up to 1 in 10 people)

• inflammation of the vein wall and blood clot formation (thrombophlebitis) at the injection site
• benign gastric polyps

Uncommon (may affect up to 1 in 100 people)

• headache, dizziness, diarrhoea, nausea, vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, skin rashes, exanthema, rash, itching, feeling of weakness, fatigue or general malaise, sleep disorders, fractures of the hip, wrist or spine

Rare (may affect up to 1 in 1,000 people)

• complete loss or distortion of taste sensation, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, weight changes, increased body temperature, swelling of the extremities (peripheral oedema), allergic reactions, 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)

• hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling sensation, itching, pins and needles, burning or numbness, erythema, possible joint pain.

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 lipid levels, marked decrease in circulating granulocytes, associated with high fever.

Very rare (may affect up to 1 in 10,000 people)

• reduced platelet count, which may make you more prone to bleeding and bruising than usual; reduced white blood cell count, which may increase the frequency of infections; concomitant abnormal reduction in the number of red blood cells and white blood cells, as well as platelets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Sandoz GmbH

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 label and on the
packaging after the word EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the container in the 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 medicine should be used immediately. Otherwise,
the storage times in use and the conditions prior to use are the responsibility of the user and
normally do not exceed 12 hours at a temperature not exceeding 25°C.
Do not use Pantoprazolo Sandoz GmbH if you notice any change in appearance (for example, if
turbidity or precipitation is observed).
The contents of the vial are intended for single use only: any remaining solution left in the container
must be discarded.
Do not dispose of any medicine 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 Sandoz GmbH contains
Active substance: one vial of Pantoprazolo Sandoz GmbH contains 45.11 mg of sodium pantoprazole sesquihydrate, equivalent to 40 mg of pantoprazole.
Other components: this medicinal product contains no other ingredients besides the active substance.

Description of the appearance of Pantoprazolo Sandoz GmbH and package contents
Pantoprazolo Sandoz GmbH is supplied as a glass vial, closed with a red rubber stopper and sealed with an aluminium cap with a "flip-off" seal, containing a white to slightly yellowish powder for injectable solution.
The vials are packaged in cardboard boxes, each containing 1, 5, 10 or 20 glass vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH – Biochemiestrasse, 10 – 6250 Kundl (Austria)
Local representative in Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturer responsible for batch release
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana - Slovenia

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria: Pantoprazol Sandoz 40 mg – Pulver zur Herstellung einer Injektionslösung
Belgium: Pantoprazol Sandoz 40 mg poeder voor oplossing voor injectie
Denmark: Pantoprazol Sandoz
Finland: PANTOPRAZOL SANDOZ 40 MG Injektiokuiva-aine, liuosta varten
Italy: PANTOPRAZOLO SANDOZ GmbH 40 mg powder for solution for injection
Netherlands: Pantoprazol Sandoz injectie 40 mg, poeder voor oplossing voor injectie
Norway: Pantoprazol Sandoz
Poland: Pantoprazol Sandoz
Portugal: Pantoprazol Sandoz
Slovak Republic: Pantoprazol Sandoz 40 mg prášok na injekčný roztok
Slovenia: ACIPAN 40 mg prašek za raztopino za injiciranje
Spain: Pantoprazol Sandoz 40 mg polvo para solución inyectable EFG
United Kingdom: Pantoprazole 40 mg powder for solution for injection

The following information is intended for healthcare professionals only
An ready-to-use solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) solution into a vial containing the powder. The reconstituted solution should range from colourless to pale yellow. This solution may be administered directly or after further dilution with 100 ml of sodium chloride 9 mg/ml (0.9%) solution or glucose monohydrate 55 mg/ml (5%) solution. Glass or plastic containers should be used for dilution.
Pantoprazole powder for solution for injection must not be prepared or mixed with solvents other than those specified.

After preparation, the solution must be used within 12 hours. From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the in-use storage conditions and duration are the responsibility of the user and normally do not exceed 12 hours at a temperature not exceeding 25°C.

The medicinal product must be administered intravenously over 2 to 15 minutes.

The contents of the vial are intended for single use only. Any unused solution remaining in the container, or any solution showing visible changes in appearance (e.g. cloudiness or precipitation), must be discarded in accordance with local regulations.