Nolpaza control

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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.

You should 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or further information, you should speak to your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, you should contact your doctor.
• You should not take Nolpaza control for more than 4 weeks without consulting your 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 pack 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. In this way, the medicine 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 painful burning in the chest extending up to the throat (heartburn), sour taste in the mouth (acid regurgitation) may also appear.
Nolpaza control may relieve symptoms associated with reflux disease (such as heartburn, acid regurgitation) as early as the first day of treatment, but it is not a medicine intended for immediate relief of symptoms.
In order to achieve complete relief of symptoms, it may be necessary to take tablets for

• 2 - 3 consecutive days.

If after 14 days there is no improvement or you feel worse, you should consult your doctor.

2. Important information before taking Nolpaza control

When not to take Nolpaza control

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

Warnings and precautions

Before taking Nolpaza control, you should consult your doctor if you:

• 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 that reduces stomach acid production, similar to Nolpaza control;
• 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, you should ask your doctor for specific advice.

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

• reduced absorption of vitamin B12 and vitamin B12 deficiency in case of low vitamin B12 levels in the body;
• hip, wrist, or spine fractures, especially if you already have osteoporosis (reduced bone density) or if your doctor has informed you that you are at risk of osteoporosis (e.g., if you are 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 you take the medicine for more than 4 weeks, you should consult your doctor. Your doctor may order regular blood tests to monitor magnesium levels.

You should immediately inform your doctorbefore or after taking this medicine if you notice the appearance of any of the following symptoms, which may be signs of other, more serious diseases:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially recurring;
• bloody vomiting, which may look like dark 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 and/or persistent diarrhea, (as the use of Nolpaza control is associated with a slight increase in the risk of infectious diarrhea);

Your doctor may decide to perform additional tests.
If you are going to have a blood test, you should inform your doctor that you are taking this medicine.
It is possible that you may notice 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 you have been suffering from recurring heartburn or indigestion symptoms for some time, you 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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Nolpaza control may affect the efficacy of other medicines. You should tell your doctor or pharmacist about all medicines you are taking, especially those containing one of the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). You should not take Nolpaza control 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, your doctor may temporarily stop the use of Nolpaza control, as pantoprazole may increase methotrexate levels in the blood.

You should not take Nolpaza control 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 used if necessary with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations).

Pregnancy and breastfeeding

You should not take Nolpaza control if you are pregnant or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, you should not drive or operate machinery.

Nolpaza control contains sorbitol

If you have been diagnosed with intolerance to some sugars, you should contact your 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".

3. How to take Nolpaza control

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The recommended dose is 1 tablet per day. You should not take a daily dose greater than 20 mg.
The medicine should be taken for at least 2-3 consecutive days. You should stop taking Nolpaza control after complete relief of symptoms. It is possible that you may notice relief from reflux and heartburn symptoms as early as the first day of taking Nolpaza control, but you should remember that this medicine is not intended for immediate relief of symptoms.
You should consult your doctor if symptoms do not improve after taking the medicine for 2 full weeks.
You should not take Nolpaza control for more than 4 weeks without consulting your doctor.
Tablets should be taken before meals, once a day, at the same time. Tablets should be swallowed whole, not chewed or divided, with plenty of water.

Taking a higher dose of Nolpaza control than recommended

You should immediately inform your doctor or pharmacist if you have taken a higher dose of Nolpaza control than recommended. If possible, you should bring the medicine and the leaflet with you.

Missing a dose of Nolpaza control

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

4. Possible side effects

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

• 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)):you 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 blood test results may show changes in some white blood cells or liver enzymes.

Other side effects include:

• 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):disturbances or complete loss of taste, vision disturbances, such as blurred vision, joint pain, muscle pain, weight changes, elevated body temperature, swelling of the limbs, depression, elevated 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 may cause increased bleeding tendency and bruising, decreased white blood cell count, which may predispose 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 had such symptoms before), 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 associated with joint pain.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. 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, you can help provide more information on the safety of the medicine.

5. How to store Nolpaza control

The medicine should be stored out of sight and reach of children.
You should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 control contains

• The active substance of the medicine 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 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-ethyl acrylate copolymer (1:1), 30% dispersion containing sodium lauryl sulfate, polysorbate 80. See section 2 "Nolpaza control contains sorbitol and sodium".

What Nolpaza control looks like and contents of the pack

Light brown-yellow, oval, slightly convex gastro-resistant tablets.
Packaging: 10 or 15 gastro-resistant tablets in OPA/Al/PVC/Al blisters, in a cardboard box.
For more detailed information, you 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 10738/2018/03
10738/2018/05
10738/2018/07
10738/2018/09
Parallel import authorization number: 156/23

Date of leaflet approval: 04.08.2023

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

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