Nolpaza 40 mg tabletki doielitove

Leaflet attached to the packaging: information for the user

Nolpaza 40 mg gastro-resistant tablets

Pantoprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Nolpaza and what is it used for
• 2. Important information before taking Nolpaza
• 3. How to take Nolpaza
• 4. Possible side effects
• 5. How to store Nolpaza
• 6. Contents of the pack and other information

1. What is Nolpaza and what is it used for

Nolpaza is a selective "proton pump inhibitor", a medicine that reduces the amount of hydrochloric acid produced in the stomach. Nolpaza is used to treat stomach and intestinal diseases associated with excessive hydrochloric acid production.

Nolpaza is used:

Adults and adolescents aged 12 and over:

• For reflux oesophagitis; inflammation of the oesophagus (the section connecting the throat to the stomach), accompanied by acid reflux from the stomach into the oesophagus.

Adults:

• For infections with the bacterium Helicobacter pyloriin patients with gastric and duodenal ulcers in combination with 2 antibiotics (eradication therapy), to eliminate the bacteria and prevent ulcer recurrence.
• For gastric and duodenal ulcers.
• For Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid production in the stomach.

2. Important information before taking Nolpaza

When not to take Nolpaza

• 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 been diagnosed with an allergy to proton pump inhibitors.

Warnings and precautions

Before starting to take Nolpaza, the patient should discuss it with their doctor or pharmacist or nurse.

• If the patient has severe liver problems. The patient should inform their doctor if they have ever had liver problems. The doctor will order more frequent liver enzyme tests, especially if the patient is taking Nolpaza for a long time. If liver enzyme levels increase, the doctor will stop the treatment.
• If the patient has a vitamin B12 deficiency or risk factors for reduced vitamin B12 levels and is being treated with pantoprazole for a long time. Like all medicines that reduce stomach acid, pantoprazole may lead to reduced vitamin B12 absorption. The patient should contact their doctor if they notice any of the following symptoms, which may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy,
• numbness or tingling,
• pain or redness of the tongue,
• mouth ulcers,
• muscle weakness,
• vision problems,
• memory problems, disorientation, depression.
• If the patient is taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), they should ask their doctor for detailed advice.
• Taking a proton pump inhibitor, such as pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist or spine fractures.
• The patient should tell their doctor if they have osteoporosis (reduced bone density) or if their doctor has told them that they are at risk of osteoporosis (e.g. if they are taking steroid medicines).
• If the patient takes Nolpaza for more than three months, they may experience a decrease in magnesium levels in the blood, which can cause fatigue, muscle cramps, convulsions, dizziness and cardiac arrhythmias. If the patient experiences any of these symptoms, they should inform their doctor. Low magnesium levels in the blood can also cause low potassium and calcium levels in the blood. The doctor may decide to periodically check the patient's magnesium levels.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid, similar to Nolpaza.
• If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Nolpaza. The patient should also tell their doctor about any other side effects, such as joint pain.
• Severe 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 pantoprazole. The patient should stop taking pantoprazole and seek medical attention immediately if they notice any symptoms related to these serious skin reactions described in section 4.
• A specific blood test (chromogranin A levels).

The patient should tell their doctor immediatelyif they experience any of the following symptoms:

• unintentional weight loss;
• vomiting, especially if it is recurrent;
• bloody vomiting, which may look like coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• chest pain;
• abdominal pain;
• pallor and weakness (anaemia);
• severe diarrhoea and (or) persistent diarrhoea, as Nolpaza may be associated with a small increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out a malignant underlying disease, as pantoprazole treatment may alleviate the symptoms of the disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.
In the case of long-term use of Nolpaza (more than 1 year), the doctor will probably recommend regular monitoring. The patient should report any new and unexpected symptoms and their circumstances to their doctor at each visit.

Children and adolescents

Nolpaza is not recommended for use in children under 12 years of age.

Nolpaza and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken or might take.
As Nolpaza may affect the efficacy of other medicines, the patient should inform their doctor if they are taking:

• medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Nolpaza may inhibit the proper functioning of these and other medicines.
• warfarin and phenprocoumon, which affect blood density and prevent blood clots. Further tests may be necessary.
• medicines used to treat HIV infection, such as atazanavir.
• methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if the patient is taking methotrexate, their doctor may temporarily stop Nolpaza, as pantoprazole may increase methotrexate levels in the blood.
• fluvoxamine (used to treat depression and other mental disorders) - if the patient is taking fluvoxamine, their doctor may reduce the dose.
• rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before starting to take pantoprazole, the patient should discuss it with their doctor if they are to undergo a specific urine test (for the presence of tetrahydrocannabinol (THC)).

Nolpaza with food and drink

The tablets should be taken 1 hour before a meal. The tablet should be swallowed whole, without chewing or crushing, with water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
There are not enough data on the use of pantoprazole in pregnant women. It has been found that the medicine passes into breast milk in nursing mothers. The medicine may be used in pregnant women or women who are breastfeeding, or women who may become pregnant, only if the doctor considers that the benefit of its use is greater than the potential risk to the unborn child or infant.

Driving and using machines

Nolpaza has no or negligible influence on the ability to drive and use machines.
Patients who experience side effects such as dizziness and vision problems should not drive or operate machinery.

Nolpaza 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, so it can be considered "essentially sodium-free".

3. How to take Nolpaza

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

When and how to take Nolpaza

The tablets should be taken 1 hour before a meal. The tablet should be swallowed whole, without chewing or crushing, with water.
If the doctor has not prescribed a different dosage, the recommended dosage is:
Adults and adolescents aged 12 and over:

Treatment of reflux oesophagitis

The recommended dose is 1 tablet per day. The doctor may recommend increasing the dose to 2 tablets per day.
The treatment period for reflux oesophagitis is usually 4 to 8 weeks.
The doctor will decide how long to take the medicine.
Adults:
Treatment of Helicobacter pylori infections in patients with duodenal and gastric ulcers in combination with 2 antibiotics (eradication therapy).

One tablet twice a day plus two antibiotic tablets: amoxicillin, clarithromycin or metronidazole (or tinidazole); each antibiotic should be taken twice a day with a pantoprazole tablet. The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet 1 hour before dinner. The patient should follow the doctor's instructions and read the leaflets in the antibiotic packaging. The treatment period usually lasts from 1 to 2 weeks.

Treatment of gastric and duodenal ulcers

The recommended dose of the medicine is 1 tablet per day. The doctor may double the dose.
The doctor will decide how long to take the medicine. The treatment period for gastric ulcers usually lasts from 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts from 2 to 4 weeks.

In the case of long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much hydrochloric acid is produced in the stomach

The usual initial dose of the medicine is 2 tablets per day.
Both tablets should be taken 1 hour before a meal. Later, the doctor may change the dose of the medicine, depending on the amount of hydrochloric acid produced in the stomach. If the doctor prescribes more than two tablets per day, the medicine should be taken in two divided doses.
If the doctor prescribes a daily dose greater than four tablets per day, they will inform the patient exactly when to stop taking the medicine.

Special patient groups:

• patients with kidney problems, moderate to severe liver problems should not take Nolpaza 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, the doctor may prescribe tablets containing 20 mg pantoprazole).

Use in children and adolescents

Children under 12 years of age
Nolpaza is not recommended for use in children under 12 years of age.

Taking a higher dose of Nolpaza than recommended

The patient should contact their doctor or pharmacist. The symptoms of overdose are not known.

Missing a dose of Nolpaza

The patient should not take a double dose to make up for a missed tablet. They should take the next scheduled dose at the usual time.

Stopping Nolpaza treatment

The patient should not stop taking the medicine without consulting their doctor or pharmacist first.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nolpaza can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should contact their doctor or go to the nearest hospital immediately:

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

• swelling of the tongue and (or) throat,
• difficulty swallowing,
• hives (nettle rash),
• difficulty breathing,
• allergic swelling of the face (Quincke's oedema/anaphylactic shock),
• severe dizziness with very rapid heartbeat and profuse sweating.

Severe skin reactions [frequency not known (cannot be estimated from the available data)]:

The patient may notice one or more of the following symptoms:

• blisters and severe deterioration of general health,
• ulcers (including slight bleeding) of the eyes, nose, mouth/lips or genitals or rash, especially on areas of skin exposed to sunlight.
• the patient may also experience joint pain or flu-like symptoms, fever, swelling of the glands (e.g. under the arms), and blood test results may show changes in some white blood cells or liver enzymes.
• red, non-raised dots or circular patches on the torso, often with blisters in the centre, peeling skin, mouth ulcers, throat, nose, genitals 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 fever and swollen lymph nodes (DRESS or hypersensitivity syndrome).

Other serious conditions [frequency not known (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
• enlarged kidneys, sometimes pain when urinating and pain in the lower back (severe kidney inflammation, sometimes leading to kidney failure).

Other side effects include:
Common(may affect up to 1 in 10 people)

• mild polyps in the stomach.

Uncommon(may affect up to 1 in 100 people):

• headache,
• dizziness,
• diarrhoea,
• nausea, vomiting,
• bloating and gas,
• constipation,
• dry mouth,
• abdominal pain and discomfort,
• skin rash; urticaria, skin eruptions,
• itching,
• fractures of the hip, wrist or spine,
• weakness; fatigue or general feeling of being unwell,
• sleep disorders.

Rare(may affect up to 1 in 1000 people):

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

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

• disorientation.

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

• hallucinations, confusion (especially in patients who have had such symptoms before),
• tingling, prickling, burning, numbness or tingling,
• inflammatory bowel disease, causing persistent watery diarrhoea,
• rash that may be accompanied by joint pain.

Side effects detected in blood tests:
Uncommon(may affect up to 1 in 100 people):

• increased liver enzyme activity.

Rare(may affect up to 1 in 1000 people):

• increased bilirubin levels,
• increased fat levels in the blood,
• sudden decrease in the number of 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 cause more frequent bleeding and bruising;
• decreased white blood cell count, which may cause more frequent infections,
• concomitant, abnormal decrease in red and white blood cell count, as well as platelet count.

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Nolpaza

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storage temperature.
The medicine should be stored in its original packaging to protect it from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nolpaza contains

• The active substance of the medicine is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• 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 (1:1), sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the tablet coating. See section 2 "Nolpaza contains sorbitol and sodium".

What Nolpaza looks like and contents of the pack

The 40 mg gastro-resistant tablets are light brown-yellow, oval, slightly convex on both sides.
Packaging: 14, 20, 28, 30, 50, 56, 60, 90, 98 or 112 gastro-resistant tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

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
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of this medicine in other EU Member States and the UK (Northern Ireland), the patient should contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:29.12.2024