PANTOPRAZOL KALCEKS 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet:Information for the User

Pantoprazole Kalceks 40mg powder for solution for injection EFG

Read all of this leaflet carefully before you start 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Pantoprazole Kalceks and what is it used for
2. What you need to know before you are given Pantoprazole Kalceks
3. How Pantoprazole Kalceks will be given to you
4. Possible side effects
5. Storage of Pantoprazole Kalceks
6. Contents of the pack 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 inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

This medicine is injected into a vein and will only be given to you if your doctor considers that injection of pantoprazole is more convenient for you at this time than pantoprazole tablets. The tablets will replace the injections as soon as your doctor considers it appropriate.

Pantoprazole is used in adults for the treatment of:

• reflux esophagitis. It is an inflammation of the esophagus (the tube that connects the throat to the stomach) accompanied by regurgitation of stomach acid.
• stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which there is an excess of acid in the stomach.

2. What you need to know before you are given Pantoprazole Kalceks

You should not be givenPantoprazoleKalceks

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines that contain other proton pump inhibitors.

Warnings and precautions

Talk to your doctor or nurse before you are given Pantoprazole Kalceks:

• if you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor you more frequently for liver enzymes and if they increase, you should stop treatment.
• if you are taking HIV protease inhibitors, such as atazanavir (for the treatment of HIV infection).
• if you have osteoporosis (reduced bone density) or are taking corticosteroids (which can increase the risk of osteoporosis). Taking a proton pump inhibitor, such as this medicine, especially for more than a year, may slightly increase the risk of hip, wrist, or spine fractures.
• if you have ever had a skin reaction after treatment with a medicine similar to pantoprazole, to reduce stomach acidity.
• if you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediately, before or after you are given this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• unintentional weight loss
• vomiting, especially if it is repeated
• blood in the vomit: it may appear as dark coffee grounds in your vomit
• if you notice blood in your stools, which may be black or tar-like
• difficulty swallowing or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a small increase in infectious diarrhea

Your doctor will decide if you need any additional tests to rule out cancer, as pantoprazole may alleviate the symptoms of this and delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you experience a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to stop treatment with pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in your blood. The symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in your blood. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Children and adolescents

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

Other medicines andPantoprazole Kalceks

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Especially, tell your doctor if you are taking:

• medicines used to treat fungal infections (such as ketoconazole, itraconazole, and posaconazole)
• erlotinib (used for 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 psychiatric disorders)
• rifampicin (used to treat infections)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before you are given this medicine.

There are limited data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

You should only be given this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or nonexistent.

You should not drive or use machines if you experience side effects such as dizziness or altered vision.

Pantoprazole Kalceks contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., it is essentially "sodium-free".

3. How Pantoprazole Kalceks will be given to you

Your nurse or doctor will give you this medicine as an injection into a vein over a period of 2-15 minutes.

Adults

Forstomach ulcers, duodenal ulcers, andreflux esophagitis

40 mg of pantoprazole per day.

For long-term treatment of Zollinger-Ellison syndrome and otherconditionsin which there is an excess of acid in the stomach

80 mg of pantoprazole per day.

Your doctor may adjust the dose later, depending on the amount of acid secretion you produce. If you are prescribed more than 80 mg per day, the injections will be given in two equal doses. Your doctor may prescribe a dose of more than 160 mg per day for a short period. If you need to quickly control the amount of acid in your stomach, an initial dose of 160 mg should be sufficient to reduce the amount of stomach acid.

Patients with liver problems

If you have severe liver problems, the daily dose should not exceed 20 mg.

Children and adolescents

This medicine is not recommended for children under 18 years of age.

If you are given too much Pantoprazole Kalceks

Since a doctor or nurse will give you this medicine, it is unlikely that you will receive an incorrect dose. No symptoms of overdose are known.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately,if you 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, swelling of the face of allergic origin (angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin reactions(frequency not known): you may notice one or more of the following: blisters on the skin and a rapid deterioration of your condition, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, and excessive sensitivity of the skin/urticaria in areas exposed to light/sun. You may also experience joint pain and symptoms similar to those of the flu, fever, inflammation of the lymph nodes (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), and photosensitivity).

• Other serious conditions(frequency not known): yellowing of the skin or the whites of the eyes (severe liver cell damage, jaundice) or fever, rash, increase in kidney size, 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)

• benign polyps in the stomach
• inflammation of the vein wall and blood clots (thrombophlebitis) at the injection site

Uncommon(may affect up to 1 in 100 people)

• sleep disorders
• headache, dizziness
• diarrhea, nausea, vomiting, bloating, and gas, constipation, dry mouth, abdominal pain and discomfort
• skin rash, exanthema, itching
• hip, wrist, or spine fractures
• feeling of weakness, extreme fatigue, or general malaise

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

• allergic reactions
• weight changes
• depression
• alteration or loss of taste
• vision disorders, such as blurred vision
• joint pain, muscle pain
• breast enlargement in men
• increased body temperature, swelling in 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 with a history of these symptoms)
• tingling, pinching, or numbness, skin rash, possibly with joint pain
• inflammation of the large intestine that causes persistent watery diarrhea

Side effects identified through blood tests

Uncommon(may affect up to 1 in 100 people)

• increase in liver enzymes

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

• increase in bilirubin
• increase in blood fat levels
• sharp decrease in white blood cell count, associated with high fever

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

• reduction in platelet count, which can increase the risk of bleeding or bruising
• reduction in white blood cell count, which can lead to more frequent infections
• coexistence of an abnormal decrease in red blood cell count, white blood cell count, and platelet count

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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Kalceks

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature.

Keep the vials in the outer packaging to protect them from light.

Shelf life after reconstitution or reconstitution and dilution

The chemical and physical stability after reconstitution, or reconstitution and dilution with sodium chloride 9 mg/ml (0.9%) injection solution has been demonstrated for 24 hours at 2-8°C and 25°C.

The chemical and physical stability after reconstitution with sodium chloride 9 mg/ml (0.9%) injection solution and dilution with glucose 5 mg/ml (5%) injection solution has been demonstrated for 24 hours at 2-8°C and 12 hours at 25°C.

From a microbiological point of view, the prepared solution should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2-8°C, unless the reconstitution/dilution has been performed in controlled and validated aseptic conditions.

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

6. Container Contents and Additional Information

Composition of Pantoprazol Kalceks

• The active ingredient is pantoprazole.

Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).

• The other components are sodium citrate, mannitol (E 421), and sodium hydroxide (for pH adjustment).

Appearance of Pantoprazol Kalceks and Container Contents

Compact, porous, and uniform powder, white or almost white in color.

The powder is packaged in 10 ml type I transparent glass vials. The vials are closed with bromobutyl stoppers and sealed with aluminum/polypropylene flip-off caps.

The vials are packaged in cardboard boxes.

Presentation: 1, 5, 10, or 50 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057, Latvia

Tel.: +371 67083320

E-mail: kalceks@kalceks.lv

For further information about this medicinal product, please contact the local representative of the marketing authorization holder

EVER Pharma Therapeutics Spain SL

c/ Toledo 170

28005 Madrid

Spain

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

Denmark Pantoprazol Kalceks

Germany, Austria 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 мг 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 šķiduma 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 the last revision of this leaflet April 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

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This information is intended only for healthcare professionals:

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.

A solution is prepared for immediate use by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride solution 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 solution for injection or with a 50 mg/ml (5%) glucose solution for injection.

Inspect the solution visually before use. The appearance of the product after reconstitution is a clear, slightly yellowish solution. It should only be used if the solution is clear and particle-free.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.