Patient Information Leaflet

Pantoprazol Krka 20 mg, enteric-coated tablets
pantoprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

What Pantoprazol Krka is and what it is used for
What you need to know before taking Pantoprazol Krka
How to take Pantoprazol Krka
Possible side effects
How to store Pantoprazol Krka
Contents of the pack and other information

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

Pantoprazol Krka is a selective "proton pump inhibitor", a medicine that reduces the amount of
hydrochloric acid produced in the stomach. Pantoprazol Krka is used in the treatment of stomach and intestinal disorders.
Pantoprazol Krka is used:
Adults and adolescents aged 12 years and older:

for the treatment of symptoms (e.g. heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease (GERD), caused by the backflow of stomach acid into the oesophagus;
for the long-term treatment of reflux oesophagitis (inflammation of the oesophagus associated with the backflow of gastric acid) and prevention of its recurrence.

Adults:

for the prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

2. Important information before using Pantoprazol Krka

When not to use Pantoprazol 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 previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazol Krka, discuss this with your doctor,
pharmacist, or nurse.

If the patient has severe liver problems. Inform the doctor if the patient has ever had liver function disorders. The doctor may order more frequent
monitoring of liver enzymes, especially if Pantoprazol Krka is used
long-term. If liver enzyme activity increases, the doctor will discontinue
treatment.
If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) chronically and is also receiving Pantoprazol Krka due to increased risk of gastrointestinal complications. The level of risk will be assessed according to individual patient risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
If the patient has vitamin B deficiency or risk factors for low vitamin B levels and is receiving long-term pantoprazole treatment. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B. Contact the doctor if any of the following symptoms occur, which may indicate low vitamin B levels:
extremely severe fatigue or lack of energy,
numbness or tingling sensations,
pain or redness of the tongue,
mouth ulcers,
muscle weakness,
visual disturbances,
memory problems, disorientation, depression.
If the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should seek detailed advice from the doctor.
Use of a proton pump inhibitor such as pantoprazole, especially for periods longer than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient of being at risk of osteoporosis (e.g. if the patient is taking steroid medicines).
If the patient takes Pantoprazol Krka for longer than three months, blood magnesium levels may decrease, which could subsequently lead to fatigue, tetany, disorientation, seizures, dizziness, and ventricular cardiac arrhythmias. If any of these symptoms occur, inform the doctor immediately. Low blood magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic blood magnesium monitoring is necessary.
If the patient has previously experienced a skin reaction to a medicine similar to Pantoprazol Krka that reduces gastric acid secretion.
If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Pantoprazol Krka may be necessary. Also report any other adverse reactions such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. Discontinue pantoprazole and seek immediate medical advice if any symptoms of these serious skin reactions described in section 4 occur.
Planned specific blood test (chromogranin A levels)

Contact your doctor immediately if any of the following symptoms occur:

unintentional weight loss;
vomiting, particularly if recurrent;
vomiting blood, which may look like dark coffee grounds;
blood in the stool, black or tarry stools;
difficulty swallowing or pain during swallowing;
pallor and weakness (anaemia);
chest pain;
abdominal pain;
severe diarrhoea and/or persistent diarrhoea, as use of Pantoprazol Krka is associated with a small increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Pantoprazol Krka is taken for a long time (more than 1 year), the doctor will likely recommend regular monitoring. During every visit to the doctor, report any new or unexpected symptoms and the circumstances of their occurrence.
Children and adolescents
Pantoprazol Krka is not recommended for use in children under 12 years of age.
Pantoprazol Krka and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Since Pantoprazol Krka may affect the effectiveness of other medicines, inform the doctor if the patient is taking:

Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazol Krka may inhibit the proper action of these and other medicines.
Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional testing may be required.
Medicines used to treat HIV infection, such as atazanavir.
Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancerous diseases). In case of methotrexate use, the doctor may temporarily discontinue Pantoprazol Krka, as pantoprazole may increase methotrexate blood levels.
Fluvoxamine (used to treat depression and other psychiatric disorders). If the patient is taking fluvoxamine, the doctor may prescribe a lower dose.
Rifampicin (used to treat infections).
St. John's wort (Hypericum perforatum) (used to treat mild depression).

Before starting pantoprazole, discuss this with your doctor if a specific urine test [for tetrahydrocannabinol (THC)] is planned.
Pantoprazol Krka with food and drink
Take tablets 1 hour before a meal. Swallow the tablet whole, without chewing or crushing, with water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of pantoprazole in pregnant women. It has been shown that the drug passes into breast milk. The medicine may be used only if the doctor considers that the benefit outweighs the potential risk to the unborn child or infant.
Driving and operating machinery
Pantoprazol Krka has no effect or negligible effect on the ability to drive
motor vehicles and operate machinery.
Patients who experience adverse reactions such as dizziness or visual disturbances should not drive or operate machinery.
Pantoprazol 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, therefore it can be considered essentially "sodium-free".

3. How to use Pantoprazol Krka

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
When and how to take Pantoprazol Krka
Tablets should be taken 1 hour before a meal. Swallow the tablet whole, without
chewing or crushing, with water.
If the doctor has not advised otherwise, the recommended dosage is:
Adults and adolescents aged 12 years and older:
Treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with
gastroesophageal reflux disease
The recommended dose is 1 tablet per day.
This dose usually provides relief within 2 to 4 weeks – at the latest after the following 4 weeks.
The doctor will decide how long the treatment should continue. After that, recurring symptoms can be controlled
by taking one tablet per day , as needed.
Long-term treatment and prevention of relapse of reflux esophagitis
The recommended dose is 1 tablet per day.
If symptoms recur, the doctor may double the dose. In this case, Pantoprazol Krka 40 mg, one tablet per day, may be used. After healing, the dose can be reduced again
to one tablet (20 mg) per day.
Adults:
Prevention of gastric and duodenal ulcers in patients who must continuously
take NSAIDs
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
Pantoprazol Krka is not recommended for use in children under 12 years of age.
Taking more Pantoprazol Krka than recommended
Contact a doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Pantoprazol Krka
Do not take a double dose to make up for a missed tablet. Take the next scheduled dose at the usual time.
Stopping Pantoprazol Krka
Do not stop taking the tablets without first consulting a doctor or pharmacist.
If you have any further doubts about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, pantoprazole should be discontinued and medical advice should be sought immediately.

Red, non-blanching spots or circular lesions on the trunk, often with blisters in the centre, skin peeling, ulceration of the mouth, throat, nose, genital organs and 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 body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

If any of the following adverse reactions occur, the medicine should be discontinued immediately
and the doctor should be informed or the emergency department of the nearest hospital contacted without delay:

Severe allergic reactions (rare: not more than 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash similar to nettle rash), difficulty breathing, angioedema of the face (Quincke's oedema/angio-oedema), severe central dizziness with very rapid heartbeat and profuse 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 – skin blisters and sudden worsening of general health, erosions (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, glandular swelling (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
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 pain during urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

Common (may affect up to 1 in 10 patients): Benign gastric polyps.
Uncommon (may affect up to 1 in 100 patients): Headache; central dizziness; diarrhoea; nausea; vomiting; flatulence and wind; constipation; dryness of the mouth; abdominal pain and discomfort; skin rash; urticaria, skin eruptions; itching; fractures of the hip, wrist or spine; weakness; exhaustion or general malaise; sleep disturbances.
Rare (may affect up to 1 in 1000 patients): Visual disturbances, such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated temperature; high fever, swelling of limbs (peripheral oedema);

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

Very rare (may affect up to 1 in 10,000 patients): Disorientation.
Unknown (frequency cannot be estimated from the available data): Hallucinations, confusion (particularly in patients who have previously experienced such symptoms); sensations of tingling, pricking, burning or numbness; inflammation of the large intestine causing persistent watery diarrhoea, rash possibly associated with joint pain.

Adverse reactions identified in blood tests:

Uncommon (may affect up to 1 in 100 patients): Increased liver enzyme activity.
Rare (may affect up to 1 in 1000 patients): Increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating granulocytes – white blood cells – associated with high fever.
Very rare (may affect up to 1 in 10,000 patients): Decreased platelet count, which may lead to bleeding or bruising more frequently than usual; decreased white blood cell count, which may lead to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets.
Unknown (frequency cannot be estimated from the available data): Decreased concentration of sodium, magnesium, calcium or potassium in blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pantoprazol Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
Blister pack: store in the original packaging to protect from moisture.
Container: keep the container tightly closed to protect from moisture.
After first opening the container, the medicine is valid for 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Pantoprazol Krka contains

Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole hemiheptahydrate).
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-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the tablet coating.

What Pantoprazol Krka looks like and contents of the pack
The 20 mg enteric-coated tablets are light brownish-yellow, oval, slightly biconvex on both sides.
Pack sizes: 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112 or 140 enteric-coated tablets in blisters
or 250 enteric-coated tablets in a container, packed in a cardboard box.

Marketing Authorisation 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

For further information about the names of this medicinal product in the other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500