Pantoprazol Krka

Leaflet attached to the packaging: information for the user

Pantoprazole Krka, 40 mg, gastro-resistant tablets

pantoprazole

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 hydrochloric acid produced in the stomach. Pantoprazole Krka is used to treat stomach and intestinal diseases.

Pantoprazole Krka is used to treat:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. Inflammation of the esophagus (the section connecting the throat to the stomach), which is accompanied by reflux of stomach acid into the esophagus.

Adults:

• Infections with the bacterium Helicobacter pyloriin patients with gastric and duodenal ulcers, in combination with 2 antibiotics (eradication therapy), in order to eliminate the bacteria and prevent recurrence of ulcers.
• Gastric and duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach.

2. Important information before taking Pantoprazole Krka

When not to take Pantoprazole Krka:

• if the patient is allergic to pantoprazole, sorbitol, 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 to take Pantoprazole Krka, the patient should discuss it with their doctor, pharmacist, or nurse.

• If the patient has severe liver problems. The patient should tell their doctor if they have ever had liver function disorders. The doctor will order more frequent liver enzyme tests, especially if Pantoprazole Krka is taken for a long time. If liver enzyme levels increase, the doctor will stop the treatment.

and control of liver enzymes, especially if Pantoprazole Krka is taken for a long time. If liver enzyme levels increase, the doctor will stop the treatment.

• If the patient has a vitamin B12 deficiency or risk factors for low vitamin B12 levels and is being treated with pantoprazole for a long time. Like all medicines that reduce stomach acid, pantoprazole may lead to reduced absorption of vitamin B12. The patient should contact their doctor if they 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 the patient is taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), they should ask their doctor for detailed 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. The patient should tell their doctor if they have osteoporosis (reduced bone density) or if their doctor has informed them that they are at risk of osteoporosis (e.g., if they are taking steroid medicines).
• If the patient takes Pantoprazole Krka for more than three months, they may experience a decrease in blood magnesium levels, which can cause fatigue, tetany, 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 low blood potassium and calcium levels. The doctor may decide to periodically check the patient's blood magnesium levels.
• If the patient has ever had a skin reaction after taking a medicine similar to Pantoprazole Krka, which reduces stomach acid.
• If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Pantoprazole Krka. The patient should also tell their 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. The patient should stop taking pantoprazole and seek medical advice immediately if they notice any symptoms of these serious skin reactions described in section 4.
• About a planned specific blood test (chromogranin A levels).

The patient should tell their doctor immediatelybefore or during treatment with Pantoprazole Krka if they experience any of the following symptoms, which may be a sign of a more serious illness:

• unintentional weight loss;
• vomiting, especially if it is recurrent;
• bloody vomiting, which may look like coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• chest pain;
• abdominal pain;
• pallor and weakness (anemia);
• 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 a malignant underlying 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 the case of long-term use of Pantoprazole Krka (more than 1 year), the doctor will likely recommend regular monitoring. During each visit to the doctor, the patient should report any new and 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

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.
Pantoprazole Krka may affect the efficacy of other medicines, so 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 Krka 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 stop the use of Pantoprazole Krka, 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 to take pantoprazole, the patient should discuss it with their doctor if they are to undergo a specific urine test (for the presence of tetrahydrocannabinol (THC)).

Pantoprazole Krka with food and drink

The tablets should be taken 1 hour before a meal. The tablet should be swallowed whole, without chewing or crushing, with a glass of water.

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 taking this medicine.
There is not enough data on the use of pantoprazole in pregnant women. It has been found that the medicine passes into human milk. The medicine can only 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 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 36 mg of sorbitol in each tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "essentially sodium-free".

3. How to take Pantoprazole Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.

When and how to take Pantoprazole Krka

The tablets should be taken 1 hour before a meal. The tablet should be swallowed whole, without chewing or crushing, with a glass of water.
If the doctor has not prescribed a different dosage, the recommended dosage is:

Treatment of reflux esophagitis

The recommended dose is 1 tablet per day. The doctor may double the dose. The treatment period for reflux esophagitis is usually 4 to 8 weeks. The doctor will decide how long the patient should take the medicine.
Adults:

Treatment of Helicobacter pylori infections in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy)

One tablet twice a day plus two tablets of antibiotics: amoxicillin, clarithromycin, or metronidazole (or tinidazole); each antibiotic should be taken twice a day with a pantoprazole tablet. The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet 1 hour before dinner. The patient should follow the instructions given by the doctor and read the leaflets in the antibiotic packaging. The treatment period usually lasts from 1 to 2 weeks.

Treatment of gastric and duodenal ulcer disease

The recommended dose of the medicine is 1 tablet per day. The doctor may recommend increasing the dose to 2 tablets per day. The doctor will decide how long the patient should take the medicine. The treatment period for gastric ulcers is usually 4 to 8 weeks. The treatment period for duodenal ulcers is usually 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid production in the stomach

The usual initial dose is 2 tablets per day.
Both tablets should be taken 1 hour before a meal. Later, the doctor may change the dose of the medicine, depending on the amount of stomach acid produced. If the doctor prescribes more than two tablets per day, the medicine should be taken in two divided doses.
If the doctor prescribes a daily dose greater than four tablets per day, they will inform the patient exactly when to stop taking the medicine.

Special patient groups:

• patients with kidney problems, moderate to severe liver problems should not take Pantoprazole Krka for the eradication of Helicobacter pylori;
• patients with severe liver problems should not take more than 1 tablet of 20 mg pantoprazole per day (for this purpose, the doctor may prescribe tablets containing 20 mg pantoprazole).

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

The patient should contact their doctor or pharmacist. Symptoms of overdose are not known.

Missing a dose of Pantoprazole Krka

The patient should not take a double dose to make up for a missed tablet. They should take the next planned dose at the usual time.

Stopping treatment with Pantoprazole Krka

The patient should not stop taking the tablets without consulting their doctor or pharmacist first.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pantoprazole Krka can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop taking pantoprazole and contact their doctor immediately.

• red, non-raised spots or round patches on the torso, often with blisters in the center, peeling skin, mouth ulcers, throat, nose, genitalia, 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 drug hypersensitivity syndrome).

If the patient experiences any of the following side effects, they should stop taking the medicine and inform their doctor or contact the emergency department of the nearest hospital:

• Rare severe allergic reactions(occurring in less than 1 in 1000 patients): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/anaphylaxis), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin reactions, frequency unknown(frequency cannot be estimated from the available data): the patient may notice one or more of the following symptoms - blisters and sudden worsening of general health, ulcers (including slight bleeding) of the eyes, nose, mouth/lips, or genitalia, or rash, especially in areas of 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.
• Other severe conditions, frequency unknown(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 enlarged kidneys, sometimes painful urination, and lower back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• Common(may occur in up to 1 in 10 patients) Mild gastric polyps.
• Uncommon(may occur in up to 1 in 100 patients) Headache; dizziness; diarrhea; nausea; vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash; pruritus; fractures of the hip, wrist, or spine; weakness; fatigue or general malaise; sleep disturbances.
• Rare(may occur in up to 1 in 1000 patients) Visual disturbances, such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; increased temperature; high fever, peripheral edema; allergic reactions; depression; gynaecomastia in men; taste disturbances or complete loss of taste.
• Very rare(may occur in up to 1 in 10,000 patients) Disorientation.
• Unknown(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; colitis, causing persistent watery diarrhea; rash that may be accompanied by joint pain.

Side effects detected in blood tests:

• Uncommon(may occur in up to 1 in 100 patients) Increased liver enzyme activity
• Rare(may occur in up to 1 in 1000 patients) Increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in circulating granulocytes - white blood cells.
• Very rare(may occur in up to 1 in 10,000 patients) Decreased platelet count, which may cause more frequent than usual bleeding or bruising; decreased white blood cell count, which may lead to more frequent infections; concurrent, abnormal decrease in red and white blood cell count, as well as platelet count.
• Unknown(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 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Pantoprazole Krka

The medicine should be stored out of 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 stated.
The batch number is stated on the packaging after "Lot".
Blister: store in the original packaging to protect from moisture.
Container: store the container tightly closed to protect from moisture.
After opening the container, the medicine is valid for 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazole Krka contains

• Each gastro-resistant tablet contains 40 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 packaging

The 40 mg gastro-resistant tablets are light brown-yellow, oval, and slightly convex on both sides.
Packaging: 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112, or 140 gastro-resistant tablets in blisters or a container 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
To obtain more detailed information about the names of this medicine in other European Economic Area countries, the patient should 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