Pantoprazole kalceks

Package leaflet: Information for the user

Pantoprazole Kalceks, 40 mg, powder for solution for injection
Pantoprazolum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Pantoprazole Kalceks is and what it is used for
2. What you need to know before you use Pantoprazole Kalceks
3. How to use Pantoprazole Kalceks
4. Possible side effects
5. How to store Pantoprazole Kalceks
6. Contents of the pack and other information

1. What Pantoprazole Kalceks is and what it is 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 in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
This medicine is administered intravenously and is used only when, in the opinion of the doctor, this route of administration is more beneficial for the patient than taking pantoprazole in tablet form. Intravenous administration will be switched to tablets as soon as the doctor considers it appropriate.
Pantoprazole is used in adults to treat:

• Gastroesophageal reflux disease. This is inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with the backflow of hydrochloric acid from the stomach.
• Gastric and duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

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 previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazole Kalceks, discuss the following with your doctor or nurse:

• If the patient has severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor may 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 in the treatment of 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 more than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine.
• If the patient has ever had a skin reaction while taking a medicine similar to Pantoprazole Kalceks that reduces gastric acid secretion.
• Regarding a planned specific blood test (chromogranin A levels).

Contact your doctor immediately before starting or during treatment if any of the following symptoms occur, as they may indicate a more serious underlying condition:

• Unintentional weight loss;
• Vomiting, especially recurrent;
• Vomiting blood, which may look like dark coffee grounds;
• Blood in the stool, black or tarry stools;
• Difficulty swallowing or pain when swallowing;
• Pale appearance and feeling of weakness (anaemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhoea, as use of this medicine is associated with a slightly increased risk of infectious diarrhoea.

Your doctor may decide that further tests are needed to rule out a tumour-related cause of the disease, as treatment with pantoprazole may relieve symptoms of cancer and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Contact your doctor immediately if a skin rash appears, especially in areas exposed to sunlight, as treatment with pantoprazole may need to be discontinued. Also report any other symptoms such as joint pain.
If the patient takes pantoprazole for longer than three months, blood magnesium levels may decrease. Symptoms of low magnesium levels include fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. Your 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 the safety and efficacy of the medicine have not been established in this age group.

Pantoprazole Kalceks and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform your doctor if the patient is taking:

• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, and posaconazole);
• Erlotinib (used in certain types of cancer);
• Warfarin and phenprocoumon (used to thin the blood);
• Medicines used to treat HIV infection (such as atazanavir);
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer);
• Fluvoxamine (used to treat depression and other psychiatric 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There are insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been shown to pass into human milk.
The patient should only be given this medicine if the doctor considers that the benefits to the patient outweigh the potential risks to the unborn child or infant.

Driving and operating machinery
This medicine has no or negligible effect on the ability to drive or operate machinery.
However, if the patient experiences adverse effects such as dizziness or visual disturbances, driving and operating machinery should be avoided.

Pantoprazole Kalceks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. this medicine 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
For the treatment of gastric or duodenal ulcer and reflux esophagitis
40 mg of pantoprazole per day.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive
hydrochloric acid secretion in the stomach
80 mg of pantoprazole per day.
The dosage may be appropriately adjusted by the physician, depending on the amount of hydrochloric acid secreted in the stomach. Daily doses exceeding 80 mg should be administered in two equal doses. The treating physician may periodically increase the pantoprazole dose to more than 160 mg per day. To achieve rapid control of gastric acid secretion, an initial dose of 160 mg should be sufficient to reduce acid secretion.
Patients with impaired liver function
In severe liver disease, the daily dose should be only 20 mg.
Use in children and adolescents
Pantoprazole Kalceks is not recommended for use in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Pantoprazole Kalceks
Overdosing is unlikely because this medicine is administered by a doctor or nurse. Symptoms of overdose are not known.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicinal product can cause adverse effects, although not everybody will experience them.
You should contact your doctor immediately if any of the following adverse effects occur:

• Severe allergic reactions (may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic facial swelling (angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown): the patient may notice one or more of the following symptoms – formation of skin blisters and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to light/sunlight. Joint pain and flu-like symptoms, fever, and swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity).
• Other severe reactions (frequency unknown): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation, which may lead to kidney failure).

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

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

Uncommon (may affect up to 1 in 100 people)

• sleep disturbances;
• pain, dizziness;
• diarrhoea, nausea, vomiting, feeling of fullness in the abdomen and bloating with flatulence (passing wind), constipation, dry 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;
• changes in body weight;
• depression;
• disturbances or complete loss of taste sensation;
• visual disturbances, such as blurred vision;
• joint pain, muscle pain;
• breast enlargement in men;
• increased body temperature, swelling of limbs (peripheral oedema).

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

• disturbances in orientation.

Frequency unknown (frequency cannot be estimated from available data)

• hallucinations, confusional state (particularly in patients who have previously experienced such symptoms);
• sensations of tingling, pricking or numbness, skin rash possibly accompanied by joint pain;
• inflammation of the large intestine causing persistent watery diarrhoea.

Adverse 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 1,000 people)

• increased bilirubin levels;
• increased blood lipid levels;
• sudden decrease in white blood cell granulocytes, associated with high fever.

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

• decreased platelet count, which may cause more frequent bleeding and bruising;
• decreased white blood cell count, which may increase susceptibility to infections;
• concurrent abnormal decrease in red blood cells, white blood cells, and platelets.

Frequency unknown (frequency cannot be estimated from available data)

• decreased blood levels of sodium, magnesium, calcium, or potassium (see section 2).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Pantoprazole Kalceks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the vial after "EXP". The expiry date refers to the last day of the stated month.
EXP – expiry date
No special requirements for storage temperature.
Store vials in the outer packaging to protect from light.

Storage period after reconstitution or reconstitution and dilution
Chemical and physical in-use stability after reconstitution or reconstitution and dilution with sodium chloride 9 mg/mL (0.9%) solution for injection has been demonstrated for 24 hours at temperatures from 2 to 8 °C and at 25 °C.
Chemical and physical in-use stability after reconstitution with sodium chloride 9 mg/mL (0.9%) solution for injection and subsequent dilution with glucose 50 mg/mL (5%) solution for injection has been demonstrated for 24 hours at temperatures from 2 to 8 °C and for 12 hours at 25 °C.
From a microbiological point of view, the prepared solution should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should generally not exceed 24 hours at 2 to 8 °C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Pantoprazole Kalceks contains

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

What Pantoprazole Kalceks looks like and contents of the pack
A white or almost white, homogeneous, porous mass.
The powder is placed in 10 mL clear type I glass vials, closed with bromobutyl rubber stoppers and sealed with aluminium/ polypropylene flip-off caps.
The vials are packed in cardboard boxes.
Pack sizes: 1, 5, 10 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicinal product is authorised 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

Information intended exclusively for medical professionals:

Pharmaceutical incompatibilities
Do not mix this medicinal product with other medicinal products, except those mentioned
below.
Instructions for use and disposal
For single use only.
The ready-to-administer solution is prepared by injecting 10 mL of 9 mg/mL sodium chloride injection (0.9%) into a vial containing the powder. The resulting solution may be administered directly or after mixing with 100 mL of 9 mg/mL sodium chloride injection (0.9%) or 50 mg/mL glucose injection (5%).
The prepared solution should be visually inspected prior to use. Following reconstitution, the product is a clear, yellowish solution. Only clear solutions free from particulate matter should be used.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.