Pantoprazole krka

Patient Information Leaflet

Pantoprazol Krka, 40 mg, enteric-coated tablets
pantoprazolum
Please read all of this leaflet carefully before taking 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Pantoprazol Krka is and what it is used for
2. What you need to know before taking Pantoprazol Krka
3. How to take Pantoprazol Krka
4. Possible side effects
5. How to store Pantoprazol Krka
6. 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 to treat:
Adults and adolescents 12 years of age and older:

• Gastroesophageal reflux disease (GERD) – inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with the backflow of stomach acid into the oesophagus.

Adults:

• Helicobacter pylori infection in patients with peptic ulcer disease, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent ulcer recurrence.
• Peptic ulcer disease of the stomach and duodenum.
• Zollinger-Ellison syndrome and other conditions associated with excessive secretion of hydrochloric acid in the stomach.

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 increased liver enzyme activity occurs, the doctor will discontinue
  treatment.

• If the patient has vitamin B deficiency or risk factors for low vitamin B levels and is being treated long-term with pantoprazole. As with all drugs 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:

• extreme fatigue or lack of energy,

• numbness or tingling sensations,

• pain or redness of the tongue,

• oral ulcers,

• muscle weakness,

• vision 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 that they are at risk of developing osteoporosis (e.g. if the patient is taking steroid medications).

• If the patient takes Pantoprazol Krka for longer than three months, they may develop low blood magnesium levels, which can subsequently cause fatigue, tetany, confusion, 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 ever had a skin reaction due to taking a medicine similar to Pantoprazol Krka that reduces gastric acid secretion.

• If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Pantoprazol Krka may be necessary. Also report any other adverse reactions occurring, 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 immediately and seek urgent medical advice if any symptoms related to these serious skin reactions described in section 4 occur.

• Regarding a planned specific blood test (chromogranin A levels).

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

• unintentional weight loss;
• vomiting, especially if recurrent;
• vomiting blood, which may look like dark coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• chest pain;
• abdominal pain;
• pallor and weakness (anaemia);
• severe and/or persistent diarrhoea, as use of this medicine 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 relieve symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Pantoprazol Krka is taken for a prolonged period (over 1 year), the doctor will likely recommend regular monitoring. During each visit to the doctor, report any new or unexpected symptoms and the circumstances under which they occurred.

Children and adolescents
Pantoprazol Krka is not recommended for use in children under 12 years of age.

Pantoprazol Krka and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pantoprazol Krka may affect the effectiveness of other medicines, so 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 monitoring 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 recommend reducing the dose).
• Rifampicin (used to treat infections).
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Discuss with the doctor before starting pantoprazole if a specific urine test [for tetrahydrocannabinol (THC)] is planned.

Pantoprazol Krka with food and drink
Tablets should be taken 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 a doctor or pharmacist before using this medicine.
There are insufficient data on the use of pantoprazole in pregnant women. It has been shown that the drug passes into human milk. The medicine may be used only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.

Driving and using machines
Pantoprazol Krka has no effect or negligible effect on the ability to drive
motor vehicles and operate machinery.
Patients who experience adverse effects such as dizziness or visual disturbances
should not drive or operate machinery.

Pantoprazol Krka contains sorbitol and sodium
This medicinal product contains 36 mg of sorbitol per tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, thus essentially "sodium-free".

3. How to take 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
The tablets should be taken 1 hour before a meal. Swallow the tablet whole, without
chewing or crushing, with water.
If your doctor has not advised otherwise, the recommended dosage is:
Adults and adolescents aged 12 years and older:
Treatment of reflux oesophagitis
The recommended dose is 1 tablet per day. Your doctor may double the dose. The treatment period for reflux oesophagitis is usually 4 to 8 weeks. Your doctor will decide how long you should take the medicine.
Adults:
Treatment of Helicobacter pylori infection in patients with duodenal and gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin, or metronidazole (or tinidazole); each antibiotic should be taken twice daily together with a pantoprazole tablet. The first pantoprazole tablet should be taken 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and read the leaflets included in the antibiotic packaging. The treatment period usually lasts 1 to 2 weeks.
Treatment of gastric and duodenal ulcer disease
The recommended dose is 1 tablet per day. Your doctor may recommend increasing the dose to 2 tablets per day. Your doctor will decide how long you 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 hydrochloric acid production in the stomach
The usual initial recommended dose is 2 tablets per day.
Both tablets should be taken 1 hour before a meal. Later, your doctor may adjust the dose depending on the amount of gastric acid secreted. If your doctor prescribes more than 2 tablets per day, the medicine should be taken in two divided doses.
If your doctor prescribes a daily dose exceeding four tablets per day, you will be specifically informed when to stop taking the medicine.
Special patient groups:

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

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.
If you take more Pantoprazol Krka than you should
Contact your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take 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 your doctor or pharmacist.
If you have any further questions 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 immediately and
medical advice should be sought without delay.

• Red, non-itchy spots or round patches 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 promptly or contact should be made with the emergency department
of the nearest hospital:

• Severe allergic reactions ( rare : not more than 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle rash), difficulty breathing, angioedema of the face (Quincke's oedema/angio-oedema), severe central vertigo 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 deterioration in general health, erosions (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or a 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 kidney enlargement, sometimes pain during

urination and pain in the lower back (severe kidney inflammation), which may lead
to kidney failure.
Other adverse reactions include:

• Common (may affect up to 1 in 10 people): Benign gastric polyps.
• Uncommon (may affect up to 1 in 100 people): Headache; central vertigo; diarrhoea; nausea; vomiting; bloating and flatulence; constipation; dryness of the mouth; pain and discomfort in the abdomen; 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 people): Visual disturbances, such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated temperature; high fever, swelling of the 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 people): Disorientation.
• Not known (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 which may be associated with joint pain.

Adverse reactions identified in blood tests:

• Uncommon (may affect up to 1 in 100 people): Increased activity of liver enzymes.
• Rare (may affect up to 1 in 1000 people): Increased bilirubin concentration; 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 people): Decreased platelet count, which may lead to more frequent bleeding or bruising 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.
• Not known (frequency cannot be estimated from the available data): Decreased concentration of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring of Adverse Drug Reactions of 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 can also be reported to the marketing authorisation holder.
Reporting of adverse reactions enables further collection of 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 given 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 packaging and other information

What Pantoprazol Krka contains

• Each enteric-coated tablet contains 40 mg of pantoprazole (as sodium pantoprazole hemihydrate).
• 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, polyethylene glycol 6000 and talc in the tablet coating.

What Pantoprazol Krka looks like and contents of the pack
The 40 mg enteric-coated tablets are light brownish-yellow, oval-shaped, slightly convex 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 a container containing 250 enteric-coated tablets, 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
For further information on the names of this medicinal product in the countries of the European Economic Area, 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