Nolpaza control

Leaflet attached to the packaging: patient information

Nolpaza control, 20 mg, gastro-resistant tablets

Pantoprazole

Read the leaflet carefully 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 the doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or the patient feels worse, they should contact their doctor.
• The patient should not take Nolpaza control for more 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 short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid regurgitation) in adults.

Reflux occurs when stomach acid flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Symptoms may also include painful burning in the chest that can spread to the throat (heartburn), sour taste in the mouth (acid regurgitation).

Nolpaza control can relieve symptoms of reflux disease (such as heartburn, acid regurgitation) after the first day of use, but it is not intended for immediate relief of symptoms.

In order to achieve complete relief of symptoms, it may be necessary to take the tablets for 2-3 consecutive days.

• 2-3 consecutive days.

If after 14 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Nolpaza control

When not to take Nolpaza control

• 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 have been taking over-the-counter indigestion remedies every day for more than 3 years;
• are over 55 years old and have noticed any unusual symptoms or a change in their reflux disease symptoms;
• have had stomach ulcers or stomach surgery;
• have liver or jaundice (yellowing of the skin and eyes) problems;
• 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;
• 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 for more than 4 weeks without consulting a doctor. If 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 B12 and vitamin B12 deficiency in case of low vitamin B12 levels in the body. The patient should contact their doctor if they notice any of the following symptoms that may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy,
• tingling or numbness,
• pain or redness of the tongue,
• mouth ulcers,
• muscle weakness,
• vision problems,
• memory problems, disorientation, depression.
• 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 (for example, if the patient is taking steroid medicines);
• reduced magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to reduced potassium and calcium levels in the blood. If the patient is taking the medicine for more than 4 weeks, they should consult their 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 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 if it is recurring;
• bloody vomiting, which may look like dark 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);
• 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 attention immediately if they notice any symptoms of these serious skin reactions described in section 4. 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 after just one day of taking Nolpaza control. However, this medicine is not 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, 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 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 (which affect blood clotting and prevent thrombosis). Additional blood tests may be necessary.
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if the patient is taking methotrexate, 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, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.

Before starting to take pantoprazole, the patient should discuss this with their doctor if they are going to have a specific urine test (for tetrahydrocannabinol (THC)).

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 baby, 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 problems, they should not drive or operate machinery.

Nolpaza control contains sorbitol

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

3. How to take Nolpaza control

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

In case of doubt, the patient should consult their doctor or pharmacist.

The recommended dose is 1 tablet per day. The patient should not take more than 20 mg per day.

The medicine should be taken for at least 2-3 consecutive days. The patient should stop taking Nolpaza control after complete relief of symptoms. It is possible that the patient may experience relief from reflux and heartburn symptoms after just one day of taking Nolpaza control, but they should remember that this medicine is not intended for immediate relief of symptoms.

The patient should consult their doctor if symptoms do not improve after taking the medicine for 2 weeks.

The patient should not take Nolpaza control for more than 4 weeks without consulting a doctor.

The tablets should be taken before a meal, once a day, at the same time. The tablets should be swallowed whole, not chewed or broken, 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 more than the recommended dose of Nolpaza control. 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 scheduled dose the next day at the usual time.

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 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 affect up to 1 in 1,000 people)):hypersensitivity reactions, anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive 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
• rash with swelling, blisters, or peeling of the skin, exfoliative dermatitis, bleeding from the eyes, nose, mouth, or genitals, and rapid deterioration of the patient's 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.
• red, non-raised spots or circular patches on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genitals, and eyes. The onset 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Other severe reactions (frequency not known):yellowing of the skin and whites of the eyes (caused by severe liver damage), or fever, rash, and kidney enlargement, sometimes with kidney problems, which can lead to kidney failure.

Other side effects include:

• Common (may affect up to 1 in 10 people):mild gastric 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 or hives, itching, weakness, fatigue, or malaise, sleep disorders; increased liver enzyme activity in blood tests, hip, wrist, or spine fractures.
• Rare (may affect up to 1 in 1,000 people):disturbances or complete loss of taste; vision disturbances, such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of the limbs; depression; elevated bilirubin and lipid levels in the blood (detected in blood tests); gynecomastia in men; high fever and sudden decrease in the number of circulating granulocytes - white blood cells (detected in blood tests).
• Very rare (may affect less than 1 in 10,000 people):disorientation, decreased platelet count, which may cause increased bleeding and bruising; decreased white blood cell count, which may 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 (cannot be estimated from the available data):hallucinations; confusion (especially in patients who have experienced such symptoms before), decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2), feeling 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 those not listed in the leaflet, they should inform 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

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +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.

By reporting side effects, it is possible to gather 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.

The patient should not take this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month stated.

The medicine should be stored in the original packaging to protect it from moisture.

There are no special storage temperature requirements.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

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 (as pantoprazole sodium sesquihydrate).
• The other ingredients of the medicine are: in the tablet core: mannitol, crospovidone (type A), crospovidone (type B), sodium carbonate, sorbitol, calcium stearate, and in the tablet coating: hypromellose, povidone (K25), titanium dioxide (E 171), iron oxide yellow (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: 7 or 14 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

Manufacturer

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven,

Germany

To obtain more detailed information about the medicine, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

tel. 22 57 37 500

Date of the last revision of the leaflet:

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The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms:

• Avoid large meals.
• Eat slowly.
• Stop smoking.
• Limit alcohol and caffeine consumption.
• Lose weight (if overweight).
• Avoid tight clothing or belts.
• Avoid eating meals later than 3 hours before bedtime.
• Sleep with the head elevated (if symptoms occur at night).
• Limit or avoid foods that can trigger heartburn, such as: chocolate, peppermint, spearmint, fatty or fried foods, acidic, spicy, citrus fruits and juices, tomatoes.