Pantoprazole Kalceks

Leaflet attached to the packaging: information for the user

Pantoprazole Kalceks, 40 mg, powder for solution for injection

Pantoprazolum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 Pantoprazole Kalceks and what is it used for
• 2. Important information before using Pantoprazole Kalceks
• 3. How to use Pantoprazole Kalceks
• 4. Possible side effects
• 5. How to store Pantoprazole Kalceks
• 6. Contents of the packaging and other information

1. What is Pantoprazole Kalceks and what is it used for

This medicine contains the active substance pantoprazole. It is a selective "proton pump inhibitor", a medicine that reduces the production of stomach acid. It is used to treat stomach and intestinal diseases related to the production of hydrochloric acid.
This medicine is administered 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 tablets as soon as the doctor considers it appropriate.

Pantoprazole is used in adults to treat:

• Reflux esophagitis. This is an inflammatory condition of the esophagus (the section connecting the throat to the stomach), accompanied by the reflux of stomach acid.
• Gastric and duodenal ulcer disease.
• Zollinger-Ellison syndrome and other disease states associated with excessive production of stomach acid.

2. Important information before using Pantoprazole Kalceks

When not to use Pantoprazole Kalceks

• 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 Kalceks, the patient should discuss it with their doctor 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 will order more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, treatment should be discontinued.
• If the patient is taking HIV protease inhibitors such as atazanavir (used to treat HIV infection).
• If the patient has osteoporosis (reduced bone density) or is taking corticosteroids (which may increase the risk of osteoporosis). Taking a proton pump inhibitor, such as Pantoprazole Kalceks, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures.
• If the patient has ever had a skin reaction after taking a medicine similar to Pantoprazole Kalceks, which reduces stomach acid production.
• About a planned specific blood test (chromogranin A levels).

The patient should immediately inform their doctorbefore starting or during treatment with this medicine if they experience any of the following symptoms, which may be a sign of a more serious disease:

• unintentional weight loss;
• vomiting, especially recurring;
• bloody vomiting, which may look like dark coffee grounds;
• blood in the stool, black or tarry stool;
• difficulty swallowing or pain when swallowing;
• pale appearance and feeling of 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 may alleviate the symptoms of the malignant disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.
The patient should immediately inform their doctorif a rash appears on the skin, especially in areas exposed to sunlight, as it may be necessary to discontinue treatment with pantoprazole. The patient should also report any other symptoms, such as joint pain.
If the patient takes pantoprazole for more than three months, it is possible that the magnesium level in their blood may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat.
If the patient experiences any of these symptoms, they should immediately inform their doctor. Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. The doctor may order regular blood tests to monitor magnesium levels.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age, as its safety and efficacy have not been established in this age group.

Pantoprazole Kalceks 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.
In particular, the patient should inform their doctor if they are taking:

• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, and posaconazole);
• Erlotinib (used to treat certain types of cancer);
• Warfarin and phenprocoumon (used to thin the blood);
• Medicines used to treat HIV infection (such as atazanavir);
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer);
• Fluvoxamine (used to treat depression and other mental disorders);
• Rifampicin (used to treat infections);
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

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.
There are no adequate data on the use of pantoprazole in pregnant women. It has been found that pantoprazole passes into human milk.
The patient should only receive this medicine if their doctor considers that the benefits to the patient outweigh the potential risk to the unborn child or infant.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.
If the patient experiences side effects such as dizziness or visual disturbances, they should not drive or operate machines.

Pantoprazole Kalceks contains sodium

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

3. How to use Pantoprazole Kalceks

The medicine is administered intravenously over 2-15 minutes by a nurse or doctor.

Adults

In the treatment of gastric or duodenal ulcer disease or reflux esophagitis
40 mg of pantoprazole per day.
In long-term treatment of Zollinger-Ellison syndrome and other diseases associated with excessive production of stomach acid
80 mg of pantoprazole per day.
The dosage may be adjusted by the doctor, depending on the amount of stomach acid produced. Daily doses greater than 80 mg should be administered in two equal doses. The attending doctor may periodically increase the doses of pantoprazole to more than 160 mg per day. To quickly control stomach acid production, an initial dose of 160 mg should be sufficient to reduce acid production.

Patients with liver function disorders

In severe liver disease, the daily dose should be only 20 mg.

Use in children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age.

Using a higher than recommended dose of Pantoprazole Kalceks

Overdose of this medicine is unlikely, as it is administered by a doctor or nurse. The symptoms of overdose are not known.
In case of any further doubts about the use of this medicine, the patient 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.
The patient should immediately inform their doctorif they experience any of the following side effects:

• Severe allergic reactions(may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions(frequency not known): the patient may notice one or more of the following symptoms - blistering of the skin and rapid worsening of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals, or hypersensitivity of the skin/skin rash, especially in areas exposed to sunlight. Joint pain and flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in blood test results may also occur (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS), hypersensitivity to light).
• Other severe reactions(frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and swelling of the kidneys, 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)

• mild gastric polyps;
• inflammation of the walls of blood vessels and blood clots (thrombophlebitis) at the injection site.

Uncommon(may affect up to 1 in 100 people)

• sleep disorders;
• pain, dizziness;
• diarrhea, nausea, vomiting, feeling of fullness in the abdominal cavity and bloating with gas (gas), constipation, dryness in the mouth, abdominal pain and discomfort;
• skin rash, redness, skin eruptions, itching of the skin;
• fractures of the hip, wrist, or spine;
• weakness, fatigue, or general malaise.

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

• allergic reactions;
• weight changes;
• depression;
• disturbances or complete loss of taste;
• visual disturbances, such as blurred vision;
• joint pain, muscle pain;
• breast enlargement in men;
• increased body temperature, swelling of the limbs (peripheral edema).

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, or numbness, rash that may be accompanied by joint pain;
• inflammation of the colon, causing persistent watery diarrhea.

Side effects identified through blood tests:

Uncommon(may affect up to 1 in 100 people)

• increased liver enzyme activity.

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

• increased bilirubin levels;
• increased fat levels in the blood;
• sudden decrease in the number of white blood cells, associated with high fever.

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

• decrease in the number of platelets, which can cause more frequent bleeding and bruising;
• decrease in the number of white blood cells, which can lead to more frequent infections;
• concomitant, 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)

• decrease in 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 this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 to gather more information on the safety of this medicine.

5. How to store Pantoprazole Kalceks

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the carton and on the vial after "EXP". The expiry date refers to the last day of the month.
EXP - expiry date
There are no special precautions for storage temperature.
The vials should be stored in the outer packaging to protect them from light.
Shelf life after reconstitution or reconstitution and dilution
Chemical and physical stability during use after reconstitution or reconstitution and dilution with 9 mg/mL sodium chloride solution for injection (0.9%) has been demonstrated for 24 hours at a temperature of 2 to 8 °C and 25 °C.
Chemical and physical stability during use after reconstitution with 9 mg/mL sodium chloride solution for injection (0.9%) and dilution with 50 mg/mL glucose solution for injection (5%) has been demonstrated for 24 hours at a temperature of 2 to 8 °C and for 12 hours at a temperature of 25 °C.
From a microbiological point of view, the prepared solution should be used immediately. If it is not used immediately, the user is responsible for the storage time and conditions before use, and it should not be longer than 24 hours at a temperature of 2 to 8 °C, unless the reconstitution/dilution was performed in controlled and validated aseptic conditions.
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 Pantoprazole Kalceks contains

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: sodium citrate, mannitol (E 421), sodium hydroxide (to adjust pH).

What Pantoprazole Kalceks looks like and contents of the pack

White or almost white uniform porous mass.
The powder is placed in type I colorless glass vials with a capacity of 10 mL. The vials are closed with bromobutyl rubber stoppers and sealed with aluminum/polypropylene flip-off caps.
The vials are placed in cardboard boxes.
Pack sizes: 1, 5, 10, or 50 vials
Not all pack sizes may be marketed.

Marketing authorization holder and importer

AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Phone: +371 67083320
Email: kalceks@kalceks.lv

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

Denmark
Pantoprazol Kalceks
Austria, Germany
Pantoprazol Kalceks 40 mg Pulver zur Herstellung einer Injektionslösung
Czech Republic, Norway
Pantoprazol Kalceks
Belgium
Pantoprazole Kalceks 40 mg poudre pour solution injectable
Pantoprazole Kalceks 40 mg poeder voor oplossing voor injectie
Pantoprazole Kalceks 40 mg Pulver zur Herstellung einer Injektionslösung
Bulgaria
Пантопразол Калцекс 40 mg прах за инжекционен разтвор
Croatia
Pantoprazol Kalceks 40 mg prašak za otopinu za injekciju
Finland
Pantoprazole Kalceks 40 mg injektiokuiva-aine, liuosta varten
France
PANTOPRAZOLE KALCEKS 40 mg, poudre pour solution injectable
Hungary
Pantoprazole Kalceks 40 mg por oldatos injekcióhoz
Ireland
Pantoprazole 40 mg powder for solution for injection
Italy
Pantoprazolo Kalceks
Latvia
Pantoprazole Kalceks 40 mg pulveris injekciju šķīduma pagatavošanai
Lithuania
Pantoprazole Kalceks 40 mg milteliai injekciniam tirpalui
Poland, Portugal, Sweden
Pantoprazole Kalceks
Romania
Pantoprazol Kalceks 40 mg pulbere pentru soluție injectabilă
Slovakia
Pantoprazol Kalceks 40 mg prášok na injekčný roztok
Slovenia
Pantoprazol Kalceks 40 mg prašek za raztopino za injiciranje
Spain
Pantoprazol Kalceks 40 mg polvo para solución inyectable EFG
Netherlands
Pantoprazol Kalceks 40 mg poeder voor oplossing voor injectie

Date of last revision of the leaflet:

---------------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:

Incompatibilities

This medicinal product must not be mixed with other medicinal products, except for those mentioned below.

Instructions for use and disposal

For single use only.
The ready-to-use solution is prepared by injecting 10 mL of 9 mg/mL sodium chloride solution for injection (0.9%) into the vial containing the powder. The prepared solution may be administered directly or after mixing with 100 mL of 9 mg/mL sodium chloride solution for injection (0.9%) or 50 mg/mL glucose solution for injection (5%).
The prepared solution should be inspected before use to assess its appearance. The appearance of the product after reconstitution is a clear, yellowish solution. Only clear solutions free from particles should be used.
Any unused product or waste material should be disposed of in accordance with local requirements.