Nolpaza control

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nolpaza control (Nolpaza 20 mg)

20 mg, gastro-resistant tablets

Pantoprazole
Nolpaza control and Nolpaza 20 mg are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.
• The medicine Nolpaza control should not be taken for longer than 4 weeks without consulting a doctor.

Table of contents of the leaflet:

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

1. What is Nolpaza control and what is it used for

The active substance of Nolpaza control is pantoprazole, which blocks the enzyme that produces stomach acid. This reduces the amount of acid in the stomach.
Nolpaza control is used for the short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid regurgitation) in adults.
Reflux occurs when acid from the stomach flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Symptoms such as burning pain in the chest that can reach the throat (heartburn), sour taste in the mouth (acid regurgitation) may also appear.
Nolpaza control can eliminate symptoms of reflux disease (such as heartburn, acid regurgitation) as early as the first day of use, but it is not a medicine intended for immediate relief of symptoms.
To achieve complete relief of symptoms, it may be necessary to take tablets for 2-3 consecutive days.
If there is no improvement after 14 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Nolpaza control

When not to take Nolpaza control

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• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). See "Nolpaza control and other medicines".

Warnings and precautions

Before starting to take Nolpaza control, the patient should consult a doctor if they:

• have been treated for heartburn or indigestion continuously for 4 or more weeks;
• are over 55 years old and take over-the-counter indigestion medicines every day;
• are over 55 years old and have noticed new worrying symptoms or a change in the nature of existing reflux disease symptoms;
• have had stomach ulcers or stomach surgery;
• have liver problems or jaundice (yellowing of the skin and eyes);
• are under regular medical supervision for other serious conditions or diseases;
• are going to have an endoscopy or urea breath test;
• have ever had a skin reaction after taking a medicine similar to Nolpaza control that reduces stomach acid production;
• are going to have a specific blood test (chromogranin A levels);
• are taking HIV protease inhibitors, such as atazanavir or nelfinavir (used to treat HIV infection) at the same time as pantoprazole, they should ask their doctor for specific advice.

The patient should not take this medicine without consulting a doctor for a period longer than 4 weeks. If the symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, the patient should consult a doctor, who will decide whether long-term use of the medicine is necessary.
Long-term use of Nolpaza control may be associated with additional risks, such as:

• reduced absorption of vitamin B and vitamin B deficiency in case of low vitamin B levels in the body;
• hip, wrist, or spine fractures, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of osteoporosis (e.g., if the patient is taking steroid medicines);
• decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. If the medicine is used for more than 4 weeks, the patient should consult a doctor. The doctor may order regular blood tests to monitor magnesium levels.

The patient should immediately inform their doctorbefore or after taking this medicine if they notice the occurrence of any of the following symptoms, which may be a sign of other, more serious diseases:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially recurring;
• bloody vomiting, which may look like coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pale skin and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea, (as the use of Nolpaza control is associated with a slight increase in the risk of infectious diarrhea);

The doctor may decide to perform additional tests.
If the patient is going to have a blood test, they should inform their doctor that they are taking this medicine.
It is possible that the patient may experience relief from reflux and heartburn symptoms as early as the first day of taking Nolpaza control. However, this is not a medicine intended for immediate relief of symptoms.
Nolpaza control should not be used as a preventive measure.
If the patient has been experiencing recurring heartburn or indigestion for some time, they should remain under regular medical supervision.

Children and adolescents

Nolpaza control should not be used in children and adolescents under 18 years of age due to the lack of data on the safety of use of this medicine in this age group.

Nolpaza control and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Nolpaza control may affect the efficacy of other medicines. The patient should tell their doctor or pharmacist about all medicines they are taking, especially those containing:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). Nolpaza control should not be taken at the same time as HIV protease inhibitors. See "When not to take Nolpaza control";
• ketokonazole (used to treat fungal infections);
• warfarin and phenprocoumon (affecting blood density and preventing blood clots). Additional blood tests may be necessary;
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) in case of methotrexate use, the doctor may temporarily stop the use of Nolpaza control, as pantoprazole may increase methotrexate levels in the blood.

Nolpaza control should not be taken with medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).
Nolpaza control can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.

Pregnancy and breastfeeding

Nolpaza control should not be taken if the patient is pregnant or 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.

Driving and using machines

If the patient experiences side effects such as dizziness or vision disturbances, they should not drive vehicles or operate machinery.

Nolpaza control contains sorbitol

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Nolpaza control contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
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3. How to take Nolpaza control

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
The recommended dose is 1 tablet per day. The daily dose should not exceed 20 mg.
The medicine should be taken for at least 2-3 consecutive days. The use of Nolpaza control should be stopped after complete relief of symptoms. It is possible to experience relief from reflux and heartburn symptoms as early as the first day of taking Nolpaza control, but the patient should remember that this medicine is not intended for immediate relief of symptoms.
The patient should consult their doctor if the symptoms do not improve after taking the medicine for 2 full weeks.
Nolpaza control should not be taken for longer than 4 weeks without consulting a doctor.
Tablets should be taken before a meal, at the same time every day. Tablets should be swallowed whole, not chewed or divided, with plenty of water.

Taking a higher dose of Nolpaza control than recommended

The patient should immediately inform their doctor or pharmacist if they have taken a higher dose of Nolpaza control than recommended. If possible, they should bring the medicine and the leaflet with them.

Missing a dose of Nolpaza control

The patient should not take a double dose to make up for a missed dose. They should take the next planned dose the next day at the usual time.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nolpaza control can cause side effects, although not everybody gets them.
The patient should immediately inform their doctoror contact the nearest hospital emergency department if they experience any of the following serious side effects.
At the same time, the patient should stop taking the medicine and bring the leaflet and/or tablets with them.

• Severe allergic reactions (rare (may occur in 1 in 1,000 patients)):hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known (frequency cannot be estimated from the available data)):the patient may notice one or more of the following symptoms - rash with swelling, blisters, or peeling of the skin, patchy skin peeling, bleeding from the eyes, nose, mouth, or genitals, and rapid deterioration of general condition. Sun-induced rash. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., in the armpits), and changes in blood test results may also occur.
• Other severe reactions (frequency not known):yellowing of the skin and whites of the eyes (due to severe liver damage), or fever, rash, and swelling of the kidneys, sometimes with kidney problems, manifested by painful urination and back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:
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• Common (may occur in 1 in 10 patients):mild stomach polyps.
• Uncommon (may occur in 1 in 100 patients):headache, dizziness, diarrhea, nausea, vomiting, bloating and gas, constipation, dry mouth; abdominal pain and discomfort, skin rash or hives, itching, weakness, fatigue, or malaise, sleep disturbances; increased liver enzyme activity in blood tests, hip, wrist, or spine fractures.
• Rare (may occur in 1 in 1,000 patients):taste disturbances or complete loss of taste; vision disturbances, such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; limb swelling; depression; increased bilirubin and lipid levels in the blood (detected in blood tests); breast enlargement in men; high fever and sudden decrease in the number of circulating granulocytes - white blood cells (detected in blood tests).
• Very rare (may occur in less than 1 in 10,000 patients):disorientation, decreased platelet count, which can cause increased bleeding tendency and bruising, decreased white blood cell count, which can lead to more frequent infections, concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets (detected in blood tests).
• Frequency not known (frequency cannot be estimated from the available data):hallucinations; confusion (especially in patients who have experienced such symptoms), decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2), sensation of tingling, prickling, burning, or numbness, infectious colitis causing persistent watery diarrhea, rash that may be accompanied by joint pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Nolpaza control

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiration date stated on the packaging after EXP.
The expiration date refers to the last day of the specified month.
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.
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6. Contents of the packaging and other information

What Nolpaza control contains

• The active substance of Nolpaza control is pantoprazole. One gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• The other ingredients of the medicine are: in the tablet core: mannitol, crospovidone (type A), crospovidone (type B), sodium carbonate, sorbitol (E 420), calcium stearate, and in the tablet coating: hypromellose, povidone K 25, titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, macrogol 6000, talc, and methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion containing: sodium lauryl sulfate, polysorbate 80. See section 2 "Nolpaza control contains sorbitol".

What Nolpaza control looks like and what the packaging contains

Light brown-yellow, oval, slightly convex gastro-resistant tablets.
Packaging: 15 gastro-resistant tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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 Str. 5 Cuxhaven, D-27472, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export: 10738/2018/05

Parallel import authorization number: 378/21

Date of leaflet approval: 30.11.2023

[Information about the trademark]
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The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms in the stomach.

• Avoiding large meals.
• Eating slowly.
• Quitting smoking.
• Limiting alcohol and caffeine consumption.
• Losing weight (in case of excess weight).
• Avoiding tight clothing or belts.
• Avoiding eating meals later than three hours before bedtime.
• Sleeping with the head elevated (in case of nighttime symptoms).
• Limiting consumption of foods that usually cause heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits and juices, tomatoes.

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