Pantoprazole Krka 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pantoprazole Krka 40 mg gastro-resistant tablets EFG

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

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

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Pantoprazol Krka contains the active substance pantoprazol. Pantoprazol is a selective proton pump inhibitor. Proton pump inhibitors such as pantoprazol reduce the amount of acid in your stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.

Pantoprazol is used for:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of acid from the stomach.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thus reduce the likelihood of ulcer recurrence.
• Treatment of duodenal and gastric ulcers.
• Treatment of Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach.

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

• If you have severe liver disease. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially if you are taking Pantoprazol Krka for long-term treatment. If enzyme levels increase, treatment should be discontinued.
• If you have low body stores of vitamin B12 or risk factors for this, and are receiving long-term treatment with pantoprazole. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, which could indicate vitamin B12 deficiency:
  • Extreme tiredness or lack of energy
  • Tingling
  • Tongue pain or red tongue, mouth ulcers
  • Muscle weakness
  • Vision disturbances
  • Memory problems, confusion, depression
• Talk to your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or have been told you are at risk of osteoporosis (e.g., if you are taking corticosteroids).
• If you are taking Pantoprazol Krka for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels may also lead to decreased 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 used to reduce stomach acidity.
• If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Pantoprazol Krka. Remember to mention any other symptoms you may notice, such as joint pain.
• Serious 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 symptoms related to these serious skin reactions described in section 4.
• You are scheduled to have a specific blood test (chromogranin A).

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

• unintentional weight loss
• vomiting, particularly if repeated
• blood in vomit: this may appear as dark coffee-ground-like material in your vomit
• blood in your stools, which may appear black or tarry (melena)
• difficulty swallowing, or pain when swallowing
• chest pain
• stomach pain
• pale appearance and feeling weak (anaemia)
• severe and/or persistent diarrhoea, as Pantoprazol Krka has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve cancer symptoms and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take Pantoprazol Krka for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

The use of pantoprazole is not recommended in children, as it has not been studied 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 need to take any other medicines, including those obtained without a prescription.

Pantoprazol Krka may interfere with the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, or posaconazole (used for fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Krka may cause these medicines to be less effective.
• Warfarin or phenprocoumon, which affect blood clotting. You may need additional monitoring.
• 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 discontinue treatment with Pantoprazol Krka, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric conditions). If you are taking fluvoxamine, your doctor may reduce your 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 undergo a specific urine test (for THC; tetrahydrocannabinol).

Use of Pantoprazol Krka with food and drinks

Take the tablets 1 hour before a meal. Do not chew or split the tablets; 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 become pregnant, consult your doctor or pharmacist before using this medicine.

There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Consult your doctor before taking any medicine.

Driving and using machines

Pantoprazol Krka has no effect or has a negligible effect on the ability to drive or operate machinery.

However, 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 medicine contains 36 mg of sorbitol in each tablet.

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

3. How to take Pantoprazol Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration

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

Unless your doctor has instructed you otherwise, the recommended dose is:

Adults and adolescents aged 12 years and older:

For reflux esophagitis

The recommended dose is one tablet per day. Your doctor may double the dose. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long to take this medicine.

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). One tablet twice daily, plus two antibiotic tablets: amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice daily along with your pantoprazole tablet.

Take the first pantoprazole tablet one hour before breakfast and the second before dinner. Follow your doctor's instructions and make sure to read the package leaflets of the antibiotics. The duration of treatment is normally one to two weeks.

For the treatment of gastric and duodenal ulcers:

The recommended dose is one tablet per day. Your doctor may double the dose.

Your doctor will advise you on how long you should take this medicine. The treatment duration for gastric ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is normally between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion:

The initial recommended dose is two tablets per day.

Take both tablets one hour before breakfast. Afterwards, your doctor may adjust your dose depending on the amount of gastric acid secreted. If you are prescribed more than two tablets per day, take the tablets divided into two daily doses.

If you are prescribed more than four tablets per day, you will be informed exactly when treatment should be discontinued.

Patients with kidney problems

If you have kidney problems, you must not take pantoprazole for Helicobacter pylori eradication.

Patients with liver problems

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

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

Use in children and adolescents

Children under 12 years of age.

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

If you take more Pantoprazol Krka than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Pantoprazol Krka

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

If you stop taking Pantoprazol Krka

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

If you have any further questions about 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 everyone will experience them.

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

• Red, non-elevated, target-like or circular rashes on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may 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 nearest hospital emergency service:

Severe allergic reactions (rare frequency (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),
• Severe dizziness with very rapid heartbeat and excessive 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 a rapid deterioration in general condition,
• Erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun.

You may also experience 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 serious 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,
• Skin redness,
• Kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation, possibly progressing to kidney failure).

Other adverse effects are:

Common (may affect up to 1 in 10 people)

• Benign stomach polyps.

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

• Disorientation.

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

• Hallucinations, confusion (especially in patients with a prior history of these symptoms),
• Tingling, pricking, numbness, burning sensation, or loss of sensation,
• Inflammation of the large intestine causing persistent watery diarrhea,
• Skin rash, possibly with joint pain.

Adverse effects identified through blood tests:

Uncommon (may affect up to 1 in 100 people)

• Increased liver enzyme values.

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

• Increased bilirubin levels,
• increased blood fat levels,
• sudden drop in circulating granular white blood cells, associated with high fever.

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

• Reduction in the number of platelets in the blood, which may lead to increased bleeding or bruising,
• Reduction in the number of white blood cells, which could lead to more frequent infections,
• Abnormal decrease in the balance between red blood cells, white blood cells, and platelets.

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Krka

Keep this medicine out of the 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 indicated.

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

Bottle: keep tightly closed to protect from moisture.

After first opening the bottle, the product should be used within 3 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Krka

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• The other components are:

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

Film 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 of Pantoprazole Krka and contents of the pack

Yellowish-brown, oval, slightly biconvex tablets.

Pack sizes

Blister packs containing 7, 10, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112 or 140 gastro-resistant tablets per box.

Plastic bottles containing 250 gastro-resistant tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For further 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 authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.es/