Pantoprazol Accord

Leaflet accompanying the packaging: information for the user

Pantoprazol Accord, 40 mg, powder for solution for injection

Pantoprazolum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Pantoprazol Accord and what is it used for
• 2. Important information before taking Pantoprazol Accord
• 3. How to take Pantoprazol Accord
• 4. Possible side effects
• 5. How to store Pantoprazol Accord
• 6. Contents of the packaging and other information

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

Pantoprazol Accord is a selective "proton pump inhibitor", a medicine that reduces the secretion of acid in the stomach. It is used to treat stomach and intestinal diseases related to the secretion of hydrochloric acid.
This medicine is administered intravenously and is used only when, in the doctor's opinion, this route of administration is more beneficial for the patient than taking pantoprazole in tablet form. The intravenous medicine will be replaced with a tablet form as soon as the doctor considers it appropriate.

Pantoprazol Accord is used in adults for the treatment of:

• Reflux esophagitis. This is an inflammatory condition of the esophagus (the tube connecting the throat to the stomach) in which acid flows back from the stomach.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid.

2. Important information before taking Pantoprazol Accord

When not to take Pantoprazol Accord:

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

Warnings and precautions

Before starting treatment with Pantoprazol Accord, the patient should discuss it with their doctor, pharmacist, or nurse:

• If the patient has severe liver function disorders. The patient should inform their doctor if they have ever had liver function disorders. The doctor may order more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, the use of the medicine should be discontinued.
• If the patient is taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), they should ask their doctor for detailed advice.
• Taking a proton pump inhibitor, such as pantoprazole, especially for a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures.
• The patient should tell their doctor if they have osteoporosis (decreased bone density) or if their doctor has informed them that they are at risk of osteoporosis (e.g., if they are taking steroid medications). If the patient takes Pantoprazol Accord for more than three months, they may experience a decrease in magnesium levels in the blood, which can cause fatigue, muscle cramps, convulsions, dizziness, and heart rhythm disorders. If the patient experiences any of these symptoms, they should inform their doctor. Low magnesium levels in the blood can also cause a decrease in potassium and calcium levels in the blood. The doctor may decide to periodically check the patient's magnesium levels in the blood.
• If the patient has ever experienced a skin reaction after taking a medicine similar to Pantoprazol Accord, which reduces the secretion of hydrochloric acid in the stomach.
• If the patient is planning to undergo a specific blood test (chromogranin A).
• If the patient experiences a rash, especially on sun-exposed skin, they should inform their doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol Accord. The patient should also inform their doctor about other accompanying side effects, such as joint pain.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. The patient should stop taking pantoprazole and seek medical attention immediately if they notice any symptoms related to these severe skin reactions described in section 4.
• The medicine may affect the way the body absorbs vitamin B, especially if the patient is treated for a long time. The patient should contact their doctor if they notice any of the following symptoms, which may indicate a low level of vitamin B:
• extreme fatigue or lack of energy,
• tingling,
• painful or red tongue, mouth ulcers,
• weak muscles,
• vision problems,
• memory problems, confusion, depression.

The patient should immediately inform their doctorif they experience any of the following symptoms before or after taking the medicine, which may be a sign of a more serious disease:

• unintentional weight loss,
• vomiting, especially if it is recurrent,
• difficulty or pain when swallowing,
• bloody vomiting (presence of dark flecks in vomit),
• pallor and weakness (anemia),
• blood in the stool (stool may be black or tarry),
• chest pain,
• abdominal pain,
• severe and/or persistent diarrhea, as the use of the medicine is associated with a slight increase in the risk of infectious diarrhea.

The doctor may decide to perform tests to rule out a malignant disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.

Children and adolescents

The use of pantoprazole has not been proven in children and adolescents under the age of 18, so it is not recommended for this age group.

Pantoprazol Accord and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription. Pantoprazol Accord may affect the efficacy of other medicines or other medicines may affect the way pantoprazole works.
The patient should inform their doctor if they are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Accord may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood density. Further tests may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer)
• If the patient is taking methotrexate, the doctor may temporarily discontinue treatment with Pantoprazol Accord, as pantoprazole increases the level of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if the patient is taking fluvoxamine, the doctor may order a dose reduction.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before starting treatment with pantoprazole, the patient should discuss it with their doctor if they are to undergo a specific urine test (for the presence of tetrahydrocannabinol (THC)).

Pregnancy and breastfeeding

There is no data on the use of pantoprazole in pregnant women. It has been found that pantoprazole passes into breast milk. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine may be used in pregnant women or women who may become pregnant or are breastfeeding only if the doctor considers that the benefit of its use outweighs the potential risk to the unborn child or infant.

Driving and using machines

Pantoprazol Accord has no or negligible influence on the ability to drive and use machines.
The patient should not drive or use machines if they experience side effects such as dizziness or vision disturbances.

Pantoprazol Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means it is considered "sodium-free".

3. How to take Pantoprazol Accord

The medicine is administered intravenously in a single daily dose over a period of 2-15 minutes by a nurse or doctor.
Recommended dose:

Adults:

In the treatment of stomach and duodenal ulcers and reflux esophagitis.

One vial (40 mg of pantoprazole) per day.

In the long-term treatment of Zollinger-Ellison syndrome and other diseases associated with excessive secretion of hydrochloric acid.

Two vials (80 mg of pantoprazole) per day.
The doctor may adjust the dosage according to the amount of acid secreted. Daily doses greater than 2 vials (80 mg) should be administered in two equal doses. It is possible to increase the dose of pantoprazole to more than four vials (160 mg) per day. For rapid control of acid secretion, an initial dose of 160 mg (4 vials) should be sufficient to reduce acid secretion.

• Patient with liver function disorders:In severe liver disease, the daily dose should be 20 mg (½ vial).
• Use in children and adolescents:It is not recommended to use this medicine in children and adolescents under the age of 18.

Overdose of Pantoprazol Accord

The doctor or nurse will carefully check the dosage, so overdose of the medicine is unlikely. The symptoms of overdose are not known.
If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop taking pantoprazole and seek medical attention immediately:

• red, non-raised spots or round patches on the torso, often with blisters in the center, peeling skin, mouth ulcers, throat, nose, genital, or eye inflammation. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome).

In case of the following side effects, the patient should immediately inform their doctor or contact the nearest hospital with an emergency department:

• Severe allergic reactions (rare: may occur in 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known, cannot be estimated from available data):
• the patient may notice one or more of the following symptoms - blistering of the skin and sudden worsening of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ throat, or genital areas, or skin sensitivity/rash, especially in areas of skin exposed to the sun. Joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in white blood cell counts or liver enzymes may also occur.
• Other severe reactions (frequency not known): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems, including kidney enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• Common(may occur in 1-10 in 100 people) Inflammation of the blood vessel walls and blood clots (thrombophlebitis) at the injection site. Mild stomach polyps
• Uncommon(may occur in 1-10 in 1000 people) Headache, dizziness, diarrhea, nausea, vomiting, feeling of fullness in the abdominal cavity and bloating with gas (gas), constipation, dry mouth, abdominal pain and discomfort, skin rash, redness, skin eruptions, itching, weakness, fatigue, or general malaise, sleep disturbances, fractures of the hip, wrist, or spine.
• Rare(may occur in 1-10 in 10,000 people) Disturbances or complete loss of taste, vision disturbances, such as blurred vision, hives, joint pain, muscle pain, changes in body weight, elevated body temperature, high fever, swelling of the limbs (peripheral edema), allergic reactions, depression, breast enlargement in men.
• Very rare(may occur in 1 in 10,000 people) Disorientation.
• Frequency not known(cannot be estimated from available data) Hallucinations, confusion (especially in patients who have experienced such symptoms before), feeling of tingling, pricking, numbness, or burning, rash that may be accompanied by joint pain, colitis that causes persistent watery diarrhea.

Side effects detected by blood tests:

• Uncommon(may occur in 1-10 in 1000 people) Increased liver enzyme activity.
• Rare(may occur in 1-10 in 10,000 people) Increased bilirubin levels, increased fat levels in the blood. Very significant decrease in white blood cell count, associated with high fever.
• Very rare(may occur in 1 in 10,000 people) Decreased platelet count, which can cause more frequent bleeding and bruising, decreased white blood cell count, which can lead to more frequent infections, concurrent decrease in white and red blood cell counts and platelets.
• Frequency not known(frequency cannot be estimated from available data) Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Pantoprazol Accord

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after the abbreviation "EXP".
The expiry date refers to the last day of the specified month.
Do not store above 25°C. Store the vial in its original packaging to protect it from light.
Chemical and physical stability of the solution after reconstitution and after reconstitution and dilution for 12 hours at 25°C has been demonstrated. Due to the maintenance of microbiological purity, the solution should be used immediately after preparation.
Do not use this medicine if the appearance has changed (e.g., if the solution has become cloudy or precipitated).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazol Accord contains

The active substance of the medicine is pantoprazole (in the form of pantoprazole sodium sesquihydrate).
Each vial contains 42.29 mg of pantoprazole sodium, which corresponds to 40 mg of pantoprazole.
The other ingredient is sodium hydroxide (to adjust the pH).

What Pantoprazol Accord looks like and what the pack contains

Pantoprazol Accord is a white or almost white lyophilized powder for solution for injection.
Pack sizes:
1 vial
10 vials
20 vials
50 vials
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw

Manufacturer/Importer

Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
Wessling Hangary Kft
Fòti ùt 56
1047 Budapest
Hungary
Accord Healthcare Polska Sp.z o.o.
Lutomierska Street 50
95-200 Pabianice
Poland

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

Date of last revision of the leaflet: January 2025

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Information intended for healthcare professionals only:

The ready-to-use solution is obtained by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride injection into the vial containing the powder. The prepared solution can be administered directly or after mixing with 100 ml of 9 mg/ml (0.9%) sodium chloride injection or 100 ml of 55 mg/ml (5%) glucose injection. Only glass or plastic containers should be used for dilution.
Pantoprazole in the form of powder for solution for injection should not be reconstituted or mixed with solvents other than those specified above.
After preparation, the solution must be used within 12 hours. Due to the maintenance of microbiological purity, the solution should be used immediately after preparation. If the solution is not used immediately after preparation, the user is responsible for the storage time and conditions before use. It is not recommended to store the solution for more than 12 hours at a temperature not exceeding 25°C.
The medicine should be administered intravenously over a period of 2 to 15 minutes.
The contents of the vial are intended for single use. Any unused medicine or medicine that has changed appearance (e.g., if the solution has become cloudy or precipitated) should be discarded.