Nolpaza 20 mg tabletki doielitove

Leaflet accompanying the packaging: information for the user

Nolpaza 20 mg gastro-resistant tablets

Pantoprazole

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 those 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 packaging 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 gut diseases associated with excessive production of hydrochloric acid.

Nolpaza is used:

Adults and adolescents aged 12 years and older:

• to treat symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by the backflow of acidic stomach contents into the esophagus,
• for long-term treatment and prevention of relapses of reflux esophagitis (a condition in which the backflow of stomach contents into the esophagus causes inflammation and pain).

Adults:

• to prevent stomach and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at high risk who require continuous NSAID treatment.

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 medicines containing other 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 must constantly take NSAIDs and take Nolpaza at the same time, due to the increased risk of complications from the stomach and intestines. The increased risk will be assessed according to the patient's risk factors, such as age (65 years or older), stomach or duodenal ulcers in their medical history, or stomach or intestinal bleeding.
• 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 gastric acid secretion, 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 informed 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 blood magnesium levels, which can cause fatigue, muscle cramps, seizures, dizziness, and cardiac arrhythmias. If the patient experiences any of these symptoms, they should inform their doctor. Low blood magnesium levels can also cause low blood potassium and calcium levels. The doctor may decide to periodically check the patient's blood magnesium levels.
• If the patient has ever had a skin reaction after taking a medicine similar to Nolpaza that reduces stomach acid production.
• 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 have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. The patient should stop taking pantoprazole and seek medical advice immediately if they notice any symptoms related to these serious skin reactions described in section 4.
• A planned 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 recurs;
• bloody vomiting, which may look like coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pallor and weakness (anemia);
• chest pain;
• abdominal pain;
• severe diarrhea and (or) persistent diarrhea, as taking Nolpaza is associated with a slight increase in the risk of infectious diarrhea.

The doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If the symptoms persist despite treatment, the doctor may consider further tests.
In the case of taking Nolpaza for a long time (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.
Since Nolpaza may affect the action 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 action 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 prescribe a lower 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 a glass of water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
There is not enough data on the use of pantoprazole in pregnant women. It has been found that the medicine passes into the breast milk of 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 18 mg of sorbitol in each tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, and can therefore be considered "sodium-free".

3. How to take Nolpaza

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient 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 a glass of water.
If the doctor has not prescribed a different dosage, the recommended dosage is:
Adults and adolescents aged 12 years and older:

Treatment of symptoms (such as heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease

The recommended dose of Nolpaza is 1 tablet per day.
This dose usually provides relief within 2 to 4 weeks, and at most after an additional 4 weeks. The doctor will decide how long the patient should take the medicine. Recurring symptoms can be controlled by taking one tablet per dayas needed.

Long-term treatment and prevention of relapses of reflux esophagitis

The recommended dose of Nolpaza is 1 tablet per day.
If the symptoms of the disease return, the doctor may double the dose. In this case, Nolpaza 40 mg, one tablet per day, can be used. After the disease has been cured, the doctor may reduce the dose to one tablet (20 mg) per day.
Adults:

Prevention of stomach and duodenal ulcers in patients requiring continuous NSAID treatment

The recommended dose of Nolpaza is 1 tablet per day.

Special patient groups:

In the case of severe liver problems, the patient should not take more than one 20 mg tablet per day.

Use in children and adolescents

Children under 12 years of age
This medicine 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. The patient should take the next scheduled dose at the usual time.

Stopping treatment with Nolpaza

The patient should not stop taking Nolpaza without consulting their doctor or pharmacist first.
In case of any further doubts about taking this medicine, the patient 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 (urticaria),
• difficulty breathing,
• allergic swelling of the face (Quincke's edema/anaphylaxis),
• severe dizziness with a very fast 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 a sudden worsening of the general condition,
• ulcers (including slight bleeding) of the eyes, nose, mouth/throat or genitals or a rash, especially on areas of the skin exposed to sunlight.
• the patient may also experience joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g. in the armpits), and changes in the blood test results for certain white blood cells or liver enzymes.
• red, non-raised spots or circular patches on the torso, often with blisters in the center, peeling of the 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 syndrome or hypersensitivity syndrome).

Other serious conditions [frequency not known (cannot be estimated from the available data)]:

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

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

• mild stomach polyps.

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

• headache,
• dizziness,
• diarrhea,
• 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 edema),
• 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),
• a feeling of tingling, pricking, burning, or numbness,
• inflammatory bowel disease, causing persistent watery diarrhea,
• a rash that may be associated with 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 can cause more frequent bleeding and bruising;
• decreased white blood cell count, which can cause more frequent infections,
• concomitant, abnormal decrease in the number of red and white blood cells, as well as platelets.

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 those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Nolpaza

The medicine should be stored out of 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 stated.
There are no special storage temperature requirements.
Store in the original packaging to protect 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 packaging and other information

What Nolpaza contains

• The active substance of Nolpaza is pantoprazole. Each gastro-resistant tablet contains 20 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 20 mg gastro-resistant tablets are light brown-yellow, oval, slightly convex on both sides.
Packaging: 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, or 112 gastro-resistant tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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 about 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 authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:29.12.2024