PANTOPRAZOL KRKA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Pantoprazol Krka20mggastro-resistant EFG tablets

Read all of this leaflet carefully before you start 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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Pantoprazol Krka and what is it used for
2. What you need to know before you take Pantoprazol Krka
3. How to take Pantoprazol Krka
4. Possible side effects
5. Storage of Pantoprazol Krka
6. Contents of the pack and other information

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

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

Pantoprazoleis used for:

Adultsand adolescents aged 12 years and older:

• Treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease, caused by reflux of acid from the stomach.
• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

• Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continued treatment with these anti-inflammatory drugs.

2. What you need to know before you take Pantoprazol Krka

Do not take Pantoprazol Krka:

• if you are allergic to pantoprazole, sorbitol or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start taking Pantoprazol Krka

• If you have severe liver disease. Tell your doctor if you have ever had problems with your liver. Your doctor will monitor you more closely, especially when you take Pantoprazol Krka for long-term treatment. If the levels increase, treatment should be stopped.
• If you need to take medicines called NSAIDs continuously and take Pantoprazol Krka, as there is a greater risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to your personal risk factors, such as age (65 years or older), history of stomach or duodenal ulcers or bleeding from the stomach or intestine.
• If you have low body stores of vitamin B12 or risk factors for this and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12. Talk to your doctor if you notice any of the following symptoms, as they may indicate a vitamin B12 deficiency:
• • Extreme tiredness or lack of energy
  • Numbness
  • Pain in the tongue or red tongue, ulcers in the mouth
  • Muscle weakness
  • Vision problems
  • Memory problems, confusion, depression

• Tell your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hip, wrist or spine.
• Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (e.g. if you are taking corticosteroids).
• If you take Pantoprazol Krka for more than three months, it is possible that the levels of magnesium in your blood may decrease. Low levels of magnesium can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to your doctor immediately. Low levels of magnesium can also lead to a decrease in the levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• • If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Krka to reduce stomach acid.

• If you get a skin rash, especially in areas of the skin exposed to the sun, tell your doctor as soon as possible, as it may be necessary to interrupt treatment with Pantoprazol Krka. Remember to mention any other symptoms you may notice, such as joint pain.
• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and erythema multiforme, have been reported with pantoprazole treatment. Stop using pantoprazole and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.
• • A specific blood test (Chromogranin A) is scheduled.

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

• unintentional weight loss

• vomiting, particularly if it is repeated
• blood in the vomit: it may appear as a dark brown powder in your vomit
• if you notice blood in your stools, which may appear black or tarry
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
  • severe and/or persistent diarrhea, as Pantoprazol Krka has been associated with a small increase in infectious diarrhea

Your doctor will decide if you need any additional tests to rule out a malignant disease, as pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, additional tests will be performed.

If you take Pantoprazol Krka for a prolonged period (more than one year), your doctor may monitor you regularly. You should tell your doctor about any symptoms and/or new or unexpected events each time you visit your doctor.

Children and adolescents

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

Other medicines and Pantoprazol Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pantoprazol Krkamay interfere with the effectiveness of other medicines, so tell your doctor if you are taking:

• Any medicine such as ketoconazole, itraconazole or posaconazole (medicines used in fungal infections) or erlotinib (used to treat some types of cancer), as Pantoprazol Krka may cause other medicines to not work properly.
• Warfarin or phenprocoumon, which affect blood clotting. You may need additional checks.

• 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 treatment with Pantoprazol Krka, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric 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).

Talk to your doctor before taking pantoprazole if you need to have a specific urine test (for THC; Tetrahydrocannabinol).

Using 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, 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 reported that pantoprazole is excreted in human breast milk. You should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol Krka has no or negligible influence on the ability to drive or use machines.

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Pantoprazol Krkacontains sorbitol and sodium

This medicine contains 18 mg of sorbitol in each tablet

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Pantoprazol Krka

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

Method of administration

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

Unless your doctor has told you otherwise, the recommended doseis:

Adults and adolescents aged 12 years and older:

For the treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease

The recommended dose is one tablet per day. This dose usually provides relief within 2-4 weeks, or at most after another 4 weeks. Your doctor will tell you how long you need to take this medicine. Once this period is over, and if the symptoms come back, they can be controlled by taking one tablet per day.

For long-term treatment and prevention of relapses of reflux esophagitis

The recommended dose is one tablet per day. If the disease comes back, your doctor may double the dose, in which case you can take one 40 mg pantoprazole tablet per day instead. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

For the prevention ofgastroduodenalulcersin patients who need continuous treatment with NSAIDs

The recommended dose is one tablet per day.

Patient with liver problems

If you have severe liver problems, you should not take more than one 20 mg tablet per day.

Use in children and adolescents

Children under 12 years.

The use of these tablets is not recommended in children under 12 years of age.

If you take morePantoprazol Krkathan you should

Tell 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takePantoprazol Krka

Do not take a double dose to make up for a forgotten dose. Take your next dose as usual.

If you stop takingPantoprazol Krka

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• red spots, not raised, in a target or circular shape on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

Severe allergic reactions (rare frequency(may affect up to 1 in 1000 people)):

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

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

• blisters on the skin and rapid deterioration of general conditions,
• erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun.
• you may also experience joint pain or flu-like symptoms, 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 not known (frequency cannot be estimated from available data)):

• yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or
• fever,
• redness of the skin, and
• enlargement of the kidneys, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation, possibly progressing to kidney failure).

Other adverse effects are:

Frequent(may affect up to 1 in 10 patients)

• Benign polyps in the stomach.

Infrequent(may affect up to 1 in 100 patients)

• Headache,
• dizziness,
• diarrhea,
• nausea, vomiting,
• meteorism and flatulence,
• constipation,
• dry mouth,
• abdominal pain and discomfort,
• erythema; exanthema, rash,
• itching,
• hip, wrist, or spine fracture,
• feeling of weakness, fatigue, or general malaise,
• sleep disturbances.

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

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

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

• Disorientation.

Frequency not known(frequency cannot be estimated from available data)

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

Adverse effects identified through blood tests:

Infrequent(may affect up to 1 in 100 patients)

• Increased liver enzyme values.

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

• Increased bilirubin values,
• increased 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)

• Reduced platelet count in blood, which can cause more bleeding or bruising than usual,
• reduced white blood cell count, which could lead to more frequent infections,
• abnormal reduction in the balance between the number of red and white blood cells, as well as platelets.

Frequency not known(cannot be estimated from available data

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

Reporting of adverse effects

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

5. Storage of Pantoprazol Krka

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

Do not use this medicine after the expiration date stated 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 it 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 via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Pantoprazol Krka Composition

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• The other ingredients 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 Package Contents

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

Package sizes

Blister pack of 7, 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 package sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany

You can request more information about this medicine by contacting 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 medicine has been authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last revision of this leaflet:October 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/