Pantoprazol Krka

Leaflet accompanying the packaging: information for the user

Pantoprazole Krka, 20 mg, gastro-resistant tablets

Pantoprazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Pantoprazole Krka is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. Pantoprazole Krka is used to treat stomach and gut diseases.

Pantoprazole Krka is used:

Adults and adolescents aged 12 years and older:

• to treat symptoms (such as heartburn, acid regurgitation, pain when swallowing) associated with acid reflux disease, where acid from the stomach flows back into the esophagus;
• for long-term treatment of reflux esophagitis (esophagitis with acid reflux) and to prevent its recurrence.

Adults:

• to prevent stomach and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who need to take NSAIDs continuously.

2. Important information before taking Pantoprazole Krka

When not to take Pantoprazole Krka:

• if you are allergic to pantoprazole, sorbitol or any of the other ingredients of this medicine (listed in section 6);
• if you have previously been diagnosed with an allergy to other proton pump inhibitors.

Warnings and precautions

Before taking Pantoprazole Krka, discuss it with your doctor, pharmacist, or nurse.

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially if you are taking Pantoprazole Krka for a long time. If your liver enzymes increase, your doctor will stop the treatment.

and control liver enzymes, especially when Pantoprazole Krka is used for a long time. If liver enzymes increase, the doctor will stop the treatment.

• If you need to take NSAIDs continuously and are taking Pantoprazole Krka, due to the increased risk of stomach or gut problems. The increased risk will be assessed according to the risk factors in the individual patient, such as age (65 years or older), stomach or duodenal ulcers in the medical history, or stomach or gut bleeding.
• If you have a vitamin B12 deficiency or risk factors for low vitamin B12 levels and are taking pantoprazole long-term. Like all medicines that reduce stomach acid, pantoprazole may lead to reduced vitamin B12 absorption. You should contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy;
• numbness or tingling;
• pain or redness of the tongue;
• mouth ulcers;
• muscle weakness;
• vision problems;
• memory problems, disorientation, depression.
• If you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), you should ask your doctor for specific advice.
• Taking a proton pump inhibitor like pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g. if you are taking corticosteroids).
• If you take Pantoprazole Krka for more than 3 months, it may lead to a decrease in blood magnesium levels, which can cause fatigue, muscle cramps, seizures, dizziness, and cardiac arrhythmias. If you experience any of these symptoms, you should inform your doctor. Low blood magnesium levels can also lead to low blood potassium and calcium levels. Your doctor may decide to periodically check your blood magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid, such as pantoprazole.
• If you get a skin rash, especially in areas exposed to sunlight, you should contact your doctor as soon as possible, as you may need to stop taking Pantoprazole Krka. You should also tell your doctor about any other side effects, such as joint pain.
• Severe skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. You should stop taking pantoprazole and seek medical advice immediately if you notice any of the symptoms associated with these severe skin reactions described in section 4.
• A specific blood test (chromogranin A level)

Tell your doctor immediatelyif you experience any of the following symptoms:

• unintentional weight loss;
• vomiting, especially if it is repeated;
• bloody vomiting, which may look like 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 diarrhea and/or persistent diarrhea, as taking Pantoprazole Krka is associated with a slight increase in the risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out an underlying 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.
In case of long-term use of Pantoprazole Krka (more than 1 year), your doctor will probably recommend regular monitoring. During each visit to the doctor, you should report any new or unexpected symptoms and the circumstances of their occurrence.

Children and adolescents

Pantoprazole Krka is not recommended for use in children under 12 years of age.

Pantoprazole Krka and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Since Pantoprazole Krka may affect the effectiveness of other medicines, you should tell your doctor if you 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 Krka may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. Further tests may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate, your doctor may temporarily stop taking Pantoprazole Krka, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before taking pantoprazole, discuss it with your doctor if you are going to have a specific urine test (for tetrahydrocannabinol (THC)).

Pantoprazole Krka with food and drink

Take the tablets 1 hour before a meal. Swallow the tablet whole, without chewing or crushing, with water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is not enough data on the use of pantoprazole in pregnant women. It has been shown that the medicine passes into breast milk in nursing women. The medicine should only be used if the doctor considers that the benefit of taking it is greater than the potential risk to the unborn baby or infant.

Driving and using machines

Pantoprazole Krka has no or negligible influence on the ability to drive and use machines.
Patients who experience side effects such as dizziness and vision disturbances should not drive or operate machines.

Pantoprazole Krka contains sorbitol and sodium

This medicinal product contains 18 mg of sorbitol in each tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Pantoprazole Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

When and how to take Pantoprazole Krka

Take the tablets 1 hour before a meal. Swallow the tablet whole, without chewing or crushing, with water.
If your doctor has not prescribed a different dosage, the recommended dosage is:

Treatment of symptoms (such as heartburn, acid regurgitation, pain when swallowing) associated with acid reflux disease

The recommended dose is 1 tablet per day.
This dose usually provides relief within 2 to 4 weeks - no later than after another 4 weeks.
Your doctor will decide how long you should take the medicine. Then, recurring symptoms can be controlled by taking one tablet per day, if necessary.

Long-term treatment and prevention of recurrence of reflux esophagitis

The recommended dose is 1 tablet per day.
If symptoms of the disease return, your doctor may double the dose. In this case, Pantoprazole Krka 40 mg, one tablet per day, can be used. After healing, the dose can be reduced again to one tablet (20 mg) per day.
Adults:

Prevention of stomach and duodenal ulcers in patients who need to take NSAIDs continuously

The recommended dose is 1 tablet per day.

Special patient groups:

• In case of severe liver problems, do not take more than one 20 mg tablet per day.

Use in children and adolescents

Children under 12 years of age
Pantoprazole Krka is not recommended for use in children under 12 years of age.

Taking a higher dose of Pantoprazole Krka than recommended

Contact your doctor or pharmacist. Symptoms of overdose are not known.

Missing a dose of Pantoprazole Krka

Do not take a double dose to make up for a forgotten tablet. Take the next planned dose at the usual time.

Stopping treatment with Pantoprazole Krka

Do not stop taking the tablets without consulting your doctor or pharmacist first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking pantoprazole and contact your doctor immediately.

• red spots or patches on the body, often with blisters in the center, peeling skin, mouth ulcers, throat, nose, genitals, or eyes. 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).

If you experience any of the following side effects, stop taking the medicine and contact your doctor or the emergency department of your nearest hospital immediately:

• Severe allergic reactions, rare(less than 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema/anaphylactic shock), severe dizziness with very 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 - blisters and severe worsening of general health, erosion (including mild bleeding) of the eyes, nose, mouth/lips, or genitals, or rash, especially on 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 some white blood cells or liver enzymes in blood tests may also occur.
• Other severe conditions, frequency not known(frequency cannot be estimated from the available data): yellowing of the skin or whites of the 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 include:

• Common(may affect up to 1 in 10 people) Mild stomach polyps.
• Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea; vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash; itching; fractures of the hip, wrist, or spine; weakness; fatigue or general feeling of being unwell; sleep disturbances.
• Rare(may affect up to 1 in 1000 people) Visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever, swelling of the limbs (peripheral edema);

allergic reactions; depression; breast enlargement in men; disturbances or complete loss of taste.

• Very rare(may affect up to 1 in 10,000 people) Disorientation.
• Not known(frequency cannot be estimated from the available data) Hallucinations, confusion (especially in patients who have had these symptoms before); feeling of tingling, prickling, burning, or numbness; inflammation of the colon, which can cause persistent watery diarrhea, rash that may be accompanied by joint pain.

Side effects detected in blood tests:

• Uncommon(may affect up to 1 in 100 people) Increased liver enzymes
• Rare(may affect up to 1 in 1000 people) Increased bilirubin; increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very rare(may affect up to 1 in 10,000 people) Decreased platelet count, which can cause more frequent than usual bleeding or 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.
• 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 you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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:
Aleje 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
Blister: store in the original packaging to protect from moisture.
Bottle: keep the bottle tightly closed to protect from moisture.
After opening the bottle, the medicine is valid for 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pantoprazole Krka contains

• Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are mannitol, crospovidone (type A, type B), sodium carbonate, sorbitol (E 420), calcium stearate in the tablet core, and hypromellose, povidone (K 25), titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, methacrylic acid, and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000, and talc in the tablet coating.

What Pantoprazole Krka looks like and contents of the pack

The 20 mg gastro-resistant tablets are light brown-yellow, oval, slightly biconvex.
Packaging: 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112, or 140 gastro-resistant tablets in blisters or a bottle containing 250 gastro-resistant tablets, in a cardboard box

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer/Importer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of this medicine in other EU member states, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:17.10.2024