Package Leaflet: Information for the Patient

Pantoprazol Krka20mggastro-resistant tablets EFG

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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, even if they are not listed in this leaflet. See section 4.

Pantoprazol Krka contains the active ingredient pantoprazole.Pantoprazole is a selective proton pump inhibitor. 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.

Pantoprazolis used for:

Adultsand adolescents aged 12 years or older:

Adults:

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);

Warnings and precautions

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

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) 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.
• Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of developing osteoporosis (e.g., if you are taking corticosteroids).
• If you are taking Pantoprazol Krka for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause decreased potassium and calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• • If you have ever had a skin reaction after treatment with a similar medicine to Pantoprazol Krka to reduce stomach acid.

• If you suffer from a skin rash, especially in sun-exposed areas, consult 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 associated with pantoprazole treatment. Stop using pantoprazole and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.
• • You will be scheduled to undergo a specific blood test (Cromogranin A).

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

• Unintentional weight loss

-vomiting, particularly if repeated

-blood in vomit: may appear as a dark brown powder in your vomit

-blood in stools, which may appear black or melena

-difficulty swallowing, or pain when swallowing

-pale appearance and feeling of weakness (anemia)

-chest pain

-stomach pain

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

If you takePantoprazol Krkafor a prolonged period (more than a 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 appointment.

Children and adolescents

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

Other medicines and Pantoprazol Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including over-the-counter medicines.

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

• Medicines used to treat HIV infection, such as atazanavir.

-Metotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), if you are taking metotrexate your doctor may temporarily interrupt treatment with Pantoprazol Krka as pantoprazole may increase metotrexate levels in the blood.

-Fluvoxamine (used to treat depression and other psychiatric disorders) if you are taking fluvoxamine your doctor may reduce your dose.

-Rifampicin (used to treat infections).

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, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machines

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

You should not drive or operate 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; 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, therecommended doseis:

Adults and adolescents 12 years and older:

For the treatment of symptoms (e.g., stomach burning, acid regurgitation, swallowing pain) 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 should continue taking this medication. Once this period is over, and if symptoms recur, they may be controlledby taking one tablet per day.

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

The recommended dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take instead 1 tablet of40 mgpantoprazol per day. After recovery, you can reduce the dose again to one tablet of 20 mg per day.

Adults:

For the prevention of gastric and duodenal ulcersin patients requiring long-term treatment with NSAIDs

The recommended dose is one tablet per day.

Patients with liver problems

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

Use in children and adolescents

Children under 12 years.

This medication is 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 medicines, this medicine can 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 department:

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

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

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

Other side effects are:

Frequent(may affect up to 1 in 10 patients)

Infrequent(may affect up to 1 in 100 patients)

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

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

Frequency unknown(cannot be estimated from the available data)

Side effects identified through blood tests:

Infrequent(may affect up to 1 in 100 patients)

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

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

Frequency unknown(cannot be estimated from the available data)

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are not listed 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 medicine.

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 medicines at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Pantoprazol Krka

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

Core of the tablet: 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 contents of the package

Yellowish-brown, oval, and slightly biconvex tablets.

Package sizes

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

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:

Last review date of this leaflet:October 2024

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