Pantoprazole sun

Package leaflet: Information for the patient

Pantoprazol SUN 40 mg, powder for solution for injection
pantoprazole sodium sesquihydrate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Pantoprazol SUN is and what it is used for
2. Important information before using Pantoprazol SUN
3. How to use Pantoprazol SUN
4. Possible side effects
5. How to store Pantoprazol SUN
6. Contents of the pack and other information

1. What Pantoprazol SUN is and what it is used for

Pantoprazol SUN contains the active substance pantoprazole. Pantoprazol SUN is a selective
proton pump inhibitor, a medicine that reduces the secretion of hydrochloric acid in the stomach.
It is used in the treatment of stomach and intestinal disorders associated with excessive hydrochloric acid secretion in the stomach.
This medicine is administered intravenously and only when the doctor considers that pantoprazole injections are more beneficial at that time than taking pantoprazole tablets. Injections will be replaced by tablets as soon as the doctor considers it appropriate.
Pantoprazol SUN is indicated for the following conditions:

• Gastroesophageal reflux disease (GERD) – inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with backflow of stomach acid into the oesophagus;
• Gastric and duodenal ulcers;
• Zollinger-Ellison syndrome and other conditions causing excessive acid production in the stomach.

2. Important information before using Pantoprazol SUN

When not to use Pantoprazol SUN

• if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazol SUN, discuss this with your doctor, pharmacist, or
nurse

• if the patient has severe liver disease. Inform the doctor about any previous liver-related conditions. The doctor may recommend more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, treatment should be discontinued;
• if the patient is taking a protease inhibitor of HIV virus such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, please consult your doctor for detailed advice.
• the use of a proton pump inhibitor such as pantoprazole, especially for periods longer than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has osteoporosis or if corticosteroids are being used (which may increase the risk of osteoporosis);
• if the patient takes Pantoprazol SUN for more than three months, it may lead to reduced magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• if the patient has ever had a skin reaction due to treatment with a medicine similar to Pantoprazol SUN that reduces gastric acid secretion.
• if the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as treatment with Pantoprazol SUN may need to be discontinued. Also report any other adverse reactions, such as joint pain.
• if the patient is scheduled for a specific blood test (chromogranin A levels).

In case of the following symptoms, inform the doctor immediately:

• unintentional weight loss;
• vomiting, especially recurrent;
• difficulty swallowing or pain when swallowing;
• vomiting blood, which may look like dark coffee grounds;
• paleness and weakness (anaemia);
• blood in stool, black or tarry stools;
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhoea, as use of this medicine is associated with a small increased risk of infectious diarrhoea.

The doctor may decide that tests are necessary to rule out an underlying tumour disease, as treatment with pantoprazole may relieve symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Children and adolescents
Pantoprazol SUN is not recommended for use in children, as its effects have not been studied in individuals under 18 years of age.
Pantoprazol SUN and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Pantoprazol SUN may affect the effectiveness of other medicinal products; therefore, inform your doctor if the patient is taking:

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazol SUN may inhibit the proper action of these and other drugs;
• warfarin and phenprocoumon, which affect blood clotting – further testing may be required;
• medicines used in the treatment of HIV infection such as atazanavir;
• methotrexate (used in the treatment of rheumatoid arthritis, a type of rheumatism, psoriasis – a skin condition where the skin is red with dry scales, and cancerous diseases); when methotrexate is used, the doctor may temporarily discontinue Pantoprazol SUN, as pantoprazole may increase methotrexate levels in the blood;
• fluvoxamine (used in the treatment of depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend reducing the dose;
• rifampicin (used to treat infections);
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion of pantoprazole in human milk has been reported.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
If the patient is pregnant or suspects she may be pregnant, or is breastfeeding, she should use this medicine only if the doctor considers the benefit of treatment to outweigh the risk to the unborn child or infant.
Driving and operating machinery
Pantoprazol SUN has no effect or negligible effect on the ability to drive motor vehicles and operate mechanical equipment.
Do not drive or operate machinery if the patient experiences adverse reactions such as dizziness or visual disturbances.
Pantoprazol SUN contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Pantoprazol SUN

The daily dose will be administered by a nurse or doctor as an intravenous injection lasting from 2 to 15
minutes.
The recommended dose is
For the treatment of gastric and duodenal ulcers, and reflux esophagitis
One vial (40 mg of pantoprazole) per day.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with
excessive production of hydrochloric acid in the stomach
Two vials (80 mg of pantoprazole) per day.
The doctor may later adjust the dose depending on the amount of hydrochloric acid produced in the
stomach. If more than two vials (80 mg) per day have been prescribed, the injections will be given in two
equal doses. The doctor may temporarily prescribe more than four vials (160 mg) per day. If gastric acid
secretion requires immediate control, an initial dose of 160 mg (four vials) should be sufficient to reduce
the amount of hydrochloric acid in the stomach.
Patients with impaired liver function
If the patient has severe liver disease, the daily intravenous dose 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.
Use of a higher than recommended dose of Pantoprazol SUN
Doses are carefully checked by the nurse or doctor, so overdose is unlikely. Symptoms of overdose are
unknown.
If you have any further doubts regarding the use of this medicine, please consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, contact your doctor immediately or go to the emergency department of your nearest hospital.

• Severe allergic reactions (rare, occurring in less than 1 in 1,000 treated patients): swelling of the tongue and/or throat, difficulty swallowing, urticaria (a rash resembling nettle rash), breathing difficulties, angioedema (Quincke's oedema, angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown, cannot be estimated from available data): one or more of the following symptoms may occur: blistering of the skin and sudden worsening of general condition; erosions (with slight bleeding) affecting the eyes, nose, mouth, or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to light/sunlight. Joint pain or flu-like symptoms, fever, and swollen glands (e.g. under the arms) may also occur. Blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS], photosensitivity).
• Other severe reactions (frequency unknown, cannot be estimated from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever; rash; and kidney problems manifesting as kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

• Common (affecting less than 1 in 10 people): inflammation of the vein wall and blood clot formation (thrombophlebitis) at the injection site, benign gastric polyps.
• Uncommon (affecting less than 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with gas release; constipation; dry mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion, or general malaise; sleep disturbances; fractures of the hip, wrist, or spine.
• Rare (affecting less than 1 in 1,000 people): disturbances or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; increased body temperature; high fever; limb swelling (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (affecting less than 1 in 10,000 people): disorientation.
• Frequency not known (cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms), sensations of tingling, pricking, numbness, burning, or stinging; rash possibly accompanied by joint pain, colitis causing persistent watery diarrhoea.

Adverse reactions identified by blood tests

• Uncommon (affecting less than 1 in 100 people): increased liver enzyme activity.
• Rare (affecting less than 1 in 1,000 people): increased bilirubin levels, increased blood lipid levels, sudden decrease in circulating granulocytes – white blood cells associated with high fever.
• Very rare (affecting less than 1 in 10,000 people): decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may increase susceptibility to infections; concurrent abnormal reduction in red blood cells, white blood cells, and platelets.
• Frequency not known (cannot be estimated from available data): decreased levels of sodium, magnesium, or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Faks: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pantoprazol SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and vial after:
EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
After reconstitution or after reconstitution and dilution, the solution is chemically and physically stable for 12 hours at 25°C.
From a microbiological point of view, unless the method of opening and dilution excludes the risk of microbiological contamination, the product should be used immediately.
Do not use this medicine if you notice any changes in its appearance (e.g. if cloudiness or a precipitate occurs).
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Pantoprazol SUN contains

• The active substance is pantoprazole sodium sesquihydrate. Each vial contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

What Pantoprazol SUN looks like and contents of the pack
Pantoprazol SUN is a white to almost white powder for solution for injection. It is supplied in a clear, glass vial with a capacity of 10 ml, closed with a red aluminium cap and a grey rubber stopper, containing 40 mg of powder for solution for injection.
Pantoprazol SUN is available in the following pack sizes:
1, 5, 10 or 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
This medicinal product is authorised for marketing in the European Economic Area and in the United Kingdom of Great Britain and Northern Ireland under the following names:
Austria Pantoprazol SUN 40 mg Powder for solution for injection
Belgium Pantoprazol SUN 40 mg powder for solution for injection
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
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 and Northern Ireland Pantoprazole 40 mg powder for solution for injection

Information intended exclusively for medical professionals:

A ready-to-inject solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) for injection into a vial containing the dry powder. After reconstitution, the product is a clear, colourless solution free from particulate matter. This solution may be administered directly or after mixing with 100 ml of sodium chloride 9 mg/ml (0.9%) for injection or glucose 55 mg/ml (5%) for injection. Glass or plastic containers may be used for dilution.
Pantoprazol SUN medicinal product must not be mixed or prepared using solvents other than those specified.
The prepared solution must be used within 12 hours. From a microbiological point of view, 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. Generally, the medicinal product should not be stored for longer than 12 hours at a temperature not exceeding 25°C.
The medicinal product should be administered intravenously over 2 to 15 minutes.
The contents of the vial are intended for single intravenous use only. Any unused medicinal product or product showing changes in appearance (e.g. cloudiness or precipitation) must be discarded.