Pantoprazole Aptapharma

Leaflet attached to the packaging: information for the user

Pantoprazole AptaPharma, 40 mg, powder for solution for injection

pantoprazole

Read the leaflet carefully before using 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What is Pantoprazole AptaPharma and what is it used for
Important information before using Pantoprazole AptaPharma
How to use Pantoprazole AptaPharma
Possible side effects
How to store Pantoprazole AptaPharma
Contents of the packaging and other information

What is Pantoprazole AptaPharma and what is it used for

Pantoprazole AptaPharma contains the active substance pantoprazole. Pantoprazole AptaPharma is a
selective "proton pump inhibitor", a medicine that reduces the secretion of hydrochloric acid in the
stomach. It is used to treat stomach and intestinal diseases associated with hydrochloric acid secretion.
This medicine is given intravenously and is only used 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.

Pantoprazole AptaPharma is used in adults for the treatment of:

Reflux esophagitis. Esophagitis (the section connecting the throat to the stomach) is accompanied by
the reflux of hydrochloric acid from the stomach.
Stomach and duodenal ulcer disease.
Zollinger-Ellison syndrome and other disease states associated with excessive hydrochloric acid secretion in the stomach.

Important information before using Pantoprazole AptaPharma

When not to use Pantoprazole AptaPharma

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 Pantoprazole AptaPharma, the patient should inform 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 in the past.
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.
the use of a proton pump inhibitor such as pantoprazole, especially for a period of more than 1 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 Pantoprazole AptaPharma for more than three months, they may experience a decrease in blood magnesium levels, which can cause fatigue, tremors, disorientation, seizures, dizziness, and cardiac arrhythmias. If the patient experiences any of these symptoms, they should inform their doctor. Low blood magnesium levels can also cause a decrease in blood potassium and calcium levels. The doctor may decide to periodically check the patient's blood magnesium levels.
if the patient has ever experienced a skin reaction after taking a medicine similar to Pantoprazole AptaPharma, which reduces hydrochloric acid secretion in the stomach.
if the patient has ever experienced a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazole AptaPharma. The patient should also report any other side effects, such as joint pain.
severe skin reactions have been reported in association with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. The patient should discontinue pantoprazole and seek medical attention immediately if they notice any symptoms related to these severe skin reactions described in section 4.
about a planned specific blood test (chromogranin A levels).
The patient should immediately inform their doctorbefore starting or during treatment with the medicine if they experience any of the following symptoms, which may be a sign of a more serious disease:
unintentional weight loss;
vomiting, especially if it is recurrent;
bloody vomiting, which may look like dark coffee grounds;
blood in the stool, black or tarry stools;
difficulty swallowing or pain when swallowing;
pale skin and weakness (anemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhea, as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea.
The doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with Pantoprazole AptaPharma may alleviate the symptoms of the malignant disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.

Children and adolescents

Pantoprazole AptaPharma is not recommended for use in children, as its efficacy has not been established in children under 18 years of age.

Pantoprazole AptaPharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Since Pantoprazole AptaPharma may affect the efficacy of other medicines, 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 Pantoprazole AptaPharma may inhibit the proper functioning of these and other medicines.
warfarin and phenprocoumon, which affect blood density and prevent blood clots. 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 the use of Pantoprazole AptaPharma, as pantoprazole may increase methotrexate levels 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 this with their doctor if they are to undergo a specific urine test [for the presence of tetrahydrocannabinol (THC)].

Pregnancy, breastfeeding, and fertility

Experience with the use of Pantoprazole AptaPharma in pregnant women is limited. It has been found that the active substance of the medicine passes into human 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 using this medicine.
The medicine may be used if the doctor considers that the benefit of its use is greater than the potential risk to the unborn child or infant.

Driving and using machines

Pantoprazole AptaPharma has no influence 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.

Pantoprazole AptaPharma contains sodium

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

How to use Pantoprazole AptaPharma

The medicine is given 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 ulcer disease and reflux esophagitis
One vial (40 mg of pantoprazole) per day.
In long-term treatment of Zollinger-Ellison syndrome and other diseases associated with excessive hydrochloric acid secretion in the stomach
Two vials (80 mg of pantoprazole) per day.
The dose may be adjusted by the doctor according to the amount of acid secreted. Daily doses greater than 2 vials (80 mg) should be given in two equal doses. The doctor may order an increase in 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.

Patients with liver function disorders

In severe liver disease, the daily dose should be only 20 mg (half a vial).

Use in children and adolescents

Pantoprazole AptaPharma is not recommended for use in children and adolescents under 18 years of age.

Missing a dose of Pantoprazole AptaPharma

Since the medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, if it is suspected that a dose has been missed, the patient should inform their doctor or pharmacist.

Overdose of Pantoprazole AptaPharma

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

Possible side effects

Like all medicines, Pantoprazole AptaPharma can cause side effects, although not everybody gets them.

In case of any of the following side effects, the patient should immediately inform their doctor or contact the nearest hospital where emergency services are available:

Severe allergic reactions (rare:may affect up to 1 in 1000 people ):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic edema of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
Severe skin reactions (frequency not known:frequency cannot be estimated from the available data ):the patient may notice one or more of the following symptoms - blistering of the skin and rapid deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals, or rash, especially in areas of the skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in blood test results may also occur.
red, target-like, or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers of the mouth, throat, nose, genitals, and eyes. The appearance of such a severe 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).
Other severe reactions (frequency not known):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and 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:
Common(may affect up to 1 in 10 people)
inflammation of the blood vessel walls and blood clots (thrombophlebitis) at the injection site;
mild stomach polyps.
Uncommon(may affect up to 1 in 100 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 of the skin;
weakness, fatigue, or general malaise;
sleep disturbances;
fractures of the hip, wrist, or spine.
Rare(may affect up to 1 in 1000 people)
disturbances or complete loss of taste;
vision disturbances, such as blurred vision;
hives;
joint pain;
muscle pain;
weight changes;
high fever;
swelling of the limbs (peripheral edema);
allergic reactions;
depression;
breast enlargement in men.
Very rare(may affect up to 1 in 10,000 people)
disorientation.
Frequency not known(frequency cannot be estimated from the available data)
hallucinations,
confusion (especially in patients who have experienced such symptoms before);
tingling, prickling, burning, or numbness, rash that may be accompanied by joint pain, inflammation of the colon causing persistent watery diarrhea.
Side effects detected by blood tests
Uncommon(may affect up to 1 in 100 people) - increased liver enzyme activity.
Rare(may affect up to 1 in 1000 people) - increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in the number of granulocytes in the blood (white blood cells). Very rare(may affect up to 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, abnormal decrease in the number of red and white blood cells, as well as platelets. Frequency not known(frequency cannot be estimated from the available data) decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

• white blood cells. Very rare(may affect up to 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, abnormal decrease in the number of red and white blood cells, as well as platelets. Frequency not known(frequency cannot be estimated from the 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 tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 to gather more information on the safety of the medicine.

How to store Pantoprazole AptaPharma

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after the expiry date.
Store in a temperature below 30°C.
Store the vial in the outer packaging to protect it from light.
The reconstituted solution should be used within 24 hours, the reconstituted and diluted solution should be used within 12 hours.
From a microbiological point of view, the solution should be used immediately after preparation. If the solution is not used immediately after preparation, the user is responsible for the storage conditions and time before use, and this usually should not exceed 24 hours at a temperature of 2-8 °C, unless the dissolution and dilution took place in controlled and validated aseptic conditions.
Do not use Pantoprazole AptaPharma if the appearance of the medicine has changed (e.g., the solution has become cloudy or a precipitate has formed).
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.

Contents of the packaging and other information

What does Pantoprazole AptaPharma contain

The active substance of the medicine is pantoprazole (in the form of pantoprazole sodium sesquihydrate). Each vial contains 40 mg of pantoprazole.
The other ingredients are: disodium edetate and sodium hydroxide (to adjust the pH).

What Pantoprazole AptaPharma looks like and contents of the pack

Powder for solution for injection.
Pantoprazole AptaPharma is a white or almost white porous "disk" or powder. The medicine is packed in a 10 mL vial made of colorless glass (type I) with a 20mm neck, closed with a gray rubber stopper with a diameter of 20mm and protected with an aluminum seal with a polypropylene disk.
Pack sizes: 1, 5, 10, and 20 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Phone: 00386 51 615 015
e-mail: [email protected]

Manufacturer/Importer

APL Swift Services (Malta) Limited
Hf26, Hal Far Industrial Estate
Qasam Industrijali Hal Far
BBG 3000 Birzebbuga
Malta

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

Date of last revision of the leaflet:
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Information intended for healthcare professionals only

Reconstituted solution

The ready-to-use solution is prepared by injecting 10 mL of 0.9% sodium chloride solution for injection (at a concentration of 9 mg/mL) into the vial containing the dry powder. The prepared solution can be administered directly. After preparation, the solution is chemically and physically stable for 24 hours at a temperature not exceeding 25°C.

Reconstituted and diluted solution

The ready-to-use solution is prepared by injecting 10 mL of 0.9% sodium chloride solution for injection (at a concentration of 9 mg/mL) into the vial containing the dry powder, then diluted by mixing with 100 mL of 0.9% sodium chloride solution for injection (at a concentration of 9 mg/mL) or 50 mg/mL (5%) glucose solution for injection (at a concentration of approximately 0.4 mg/mL). After reconstitution and dilution, the solution is chemically and physically stable for 12 hours in 0.9% sodium chloride solution for injection (at a concentration of 9 mg/mL) and 50 mg/mL (5%) glucose solution for injection at a temperature not exceeding 25°C. Plastic containers should be used for dilution.
Pantoprazole AptaPharma should not be prepared or mixed with solvents other than those specified above.
The reconstituted and diluted solution must be used within 12 hours or within 24 hours if it has not been further diluted.
From a microbiological point of view, the solution should be used immediately after preparation. If the solution is not used immediately after preparation, the user is responsible for the storage conditions and time before use, and this usually should not exceed 24 hours at a temperature of 2-8 °C, unless the dissolution and dilution took place in controlled and validated aseptic conditions.
The medicine is administered intravenously over a period of 2-15 minutes.
The contents of the vial are intended for single use. The medicine that remains in the vial or whose appearance has changed (e.g., the solution has become cloudy or a precipitate has formed) should be discarded.
The reconstituted solution is a clear, colorless to yellowish solution.