Leaflet: information for the patient

Pantoprazol Krka40mggastro-resistant tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist,evenifthey do not appear in this leaflet. See section 4.

Pantoprazol Krka contains the active ingredient pantoprazol. Pantoprazol is a selective proton pump inhibitor. Proton pump inhibitors like pantoprazol reduce the amount of acid in your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

Pantoprazol is used for:

Adults and adolescents 12 years of age or older:

• Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults

• Infection of a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing.
• Treatment of duodenal and stomach ulcers.
• Treatment of Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Pantoprazol Krka:

-if you are allergic to pantoprazole, sorbitol, or any of the other ingredients of this medication (listed in section 6);

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Pantoprazol Krka

Inform your doctor immediately if you notice any of the following symptoms:

Your doctor will decide if you need additional testing to rule out malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you takePantoprazol Krkafor a prolonged period (more than one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Children and adolescents

The use of pantoprazole is not recommended in children as it has not been tested in children under 12 years.

Other medications and Pantoprazol Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Pantoprazol Krka may interfere with the effectiveness of other medications, so inform your doctor if you are taking:

Consult your doctor before taking pantoprazole if you need to undergo a specific urine test (for THC; Tetrahidrocanabinol).

Use of Pantoprazol Krka with food and drinks

Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with a little water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is insufficient data on the use of pantoprazole in pregnant women.Pantoprazole is excreted in human breast milk. You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Consult your doctor before taking any medication.

Driving and operating machinery

Pantoprazol Krka has no influence or insignificant influence on the ability to drive or operate machinery.

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazol Krka contains sorbitol and sodium

This medication contains 36 mg of sorbitol in each tablet.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration Form

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

Unless your doctor has indicated another schedule, the recommended dose is:

Adults and adolescents 12 years and older:

For esophagitis due to reflux

The recommended dose is one tablet per day. The dose may be doubled by your doctor. The treatment time for esophagitis due to reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long to take this medication.

Adults:

For the treatment of an infection with a bacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcer in combination with two antibiotics (eradication treatment).One tablet twice a day plus two antibiotic tablets: amoxicillin, clarithromycin, and metronidazole (or tinidazole), each must be taken twice a day with your pantoprazole tablet.

Take the first pantoprazole tablet 1 hour before breakfast and the second before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses. The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The recommended dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you for how long to take this medication. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison Syndrome and other conditions in which there is an increase in stomach acid production:

The recommended starting dose is two tablets per day.

Take the two tablets 1 hour before breakfast. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than two tablets per day, take the tablets twice a day.

If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems

If you have kidney problems, do not take pantoprazole for eradication ofHelicobacter pylori.

Patients with liver problems

If you have severe liver problems, do not take more than one 20 mg tablet per day (for this, tablets with 20 mg of pantoprazole are available).

If you have moderate or severe liver problems, do not take pantoprazole for eradication ofHelicobacter pylori.

Use in children and adolescents

Children under 12 years.

These tablets are not recommended for use in children under 12 years.

If you take morePantoprazol Krkathan you should

Inform your doctor or pharmacist. There are no known symptoms of overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takePantoprazol Krka

Do not take a double dose to compensate for a missed dose.Take your next dose as usual.

If you interrupt treatment withPantoprazol Krka

Do not stop taking these tablets without first consulting your doctor or pharmacist.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop using pantoprazole and seek medical attention immediately if you notice any of the following symptoms:

• flat red spots, not raised, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

If you notice any of the following side effects, stop taking the tablets and inform your doctor immediately or contact the nearest hospital emergency service:

Severe allergic reactions (rare (may affect up to 1 in 1,000 people):

• swelling of the tongue and/or throat,
• difficulty swallowing,
• hives,
• difficulty breathing,
• allergic swelling of the face (Quincke's edema/angioedema),
• intense dizziness with very rapid heartbeats and excessive sweating.

Severe skin disorders (frequency unknown (cannot be estimated from available data):you may notice one or more of the following:

• blistering of the skin and rapid deterioration of general condition,
• erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun.

you may also have joint pain or flu-like symptoms, fever, swollen glands (e.g., in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes.

Other severe disorders (frequency unknown (cannot be estimated from available data):

• yellow discoloration of the skin or white of the eyes (severe liver cell damage, jaundice) or fever,
• skin redness, and
• enlarged kidneys sometimes with painful urination and lower back pain (severe kidney inflammation, which may progress to kidney failure).

Other side effects are:

Frequent (may affect up to 1 in 10 patients):

• benign stomach polyps.

Infrequent (may affect up to 1 in 100 patients):

• headache,
• dizziness,
• diarrhea,
• nausea;
• vomiting,
• gas and bloating,
• constipation,
• dry mouth,
• abdominal pain and discomfort,
• erythema; exanthema, rash,
• itching,
• fracture of the hip, wrist, or spine,
• sensation of weakness, fatigue, or general malaise,
• sleep disturbances.

Rare (may affect up to 1 in 1,000 patients):

• vision changes such as blurred vision,
• hives,
• joint pain,
• muscle pain,
• weight changes,
• high body temperature,
• high fever,
• swelling of the extremities (peripheral edema),
• allergic reactions,
• depression,
• enlargement of the breasts in men,
• alteration or complete loss of taste.

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

• disorientation.

Frequency unknown (cannot be estimated from available data):

• hallucinations, confusion (especially in patients with a previous history of these symptoms),
• sensation of tingling, pinching, numbness, burning, or numbness,
• inflammation in the large intestine, causing persistent watery diarrhea,
• skin eruption, possibly with joint pain.

Side effects identified through blood tests:

Infrequent (may affect up to 1 in 100 patients):

• increase in liver enzyme values.

Rare (may affect up to 1 in 1,000 patients):

• increase in bilirubin values,
• increase in blood fat levels,
• sudden drop in granular white blood cells in circulation, associated with high fever.

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

• reduction in platelet count in blood, which may cause excessive bleeding or more frequent bruising,
• reduction in white blood cell count, which may lead to more frequent infections,
• abnormal reduction in the balance between red and white blood cells, as well as platelets.

Frequency unknown (cannot be estimated from available data):

• decrease in sodium, magnesium, calcium, or potassium levels in blood (see section 2).

Reporting side effects:

If you experience any type of side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Blister: store in the original packaging to protect it from moisture.

Bottle: keep perfectly closed to protect it from moisture.

After opening the bottle for the first time, the product must be used within 3 months.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Pantoprazol Krka Composition

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of pantoprazol sodium sesquihydrate).
• The other components are:

Tablet core: mannitol, crospovidone (type A, type B), sodium carbonate, sorbitol (E420), calcium stearate.

Coating: hypromellose, povidone (K25), titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, ethyl acrylate-methacrylic acid copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000, and talc.

Appearance ofPantoprazol Krkaand packaging contents

Light yellow-brown, oval, and slightly biconvex tablets.

Packaging sizes

Blister pack of7, 10, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112, or 140 gastro-resistant tablets per box.

Plastic bottles of 250 gastro-resistant tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

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

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

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product has been authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet:October 2024

More detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/