Nolpaza control

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! 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.

Before taking the medicine, carefully read the contents of the leaflet, 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.

• This 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 or pharmacist. See section 4.
• If there is no improvement after 14 days or if the patient feels worse, they should contact their 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

If there is no improvement after 14 days or if the patient feels worse, they should consult their doctor.
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 reflux) 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 (heartburn), sour taste in the mouth (acid reflux), and others may also occur.
Nolpaza control can relieve symptoms of reflux disease (such as heartburn, acid reflux) as early as the first day of treatment, but it is not a medicine intended for immediate relief of symptoms.
To achieve complete relief of symptoms, it may be necessary to take the tablets for 2-3 consecutive days.

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 take antacids daily without a prescription;
• are over 55 years old and have noticed new worrying symptoms or a change in the character 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 illnesses or conditions;
• are scheduled for an endoscopy or urease test;
• have ever had a skin reaction after taking a medicine similar to Nolpaza control, which reduces stomach acid production;
• are scheduled for 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, and should ask their doctor for specific advice.

This medicine should not be taken without consulting a doctor for a period longer than 4 weeks. If symptoms of reflux disease (heartburn or acid reflux) persist for more than 2 weeks, the patient should consult a doctor, who will decide on the need for long-term treatment with the medicine.
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 the patient already has osteoporosis or is taking corticosteroids (which can increase the risk of osteoporosis);
• 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 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 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);

The doctor may decide on the need for additional tests.
If the patient is to have a blood test, they should inform their doctor about 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 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 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 inform 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 density and prevent 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 discontinue 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.

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 operating machinery

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

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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 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 discontinued after complete relief of symptoms. It is possible that the patient may experience relief from reflux and heartburn symptoms as early as the first day of taking Nolpaza control, but they should remember that this medicine is not intended for immediate relief of symptoms.
The patient should consult a doctor if symptoms do not improve after taking the medicine for 2 weeks.
Nolpaza control should not be taken for more 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, without chewing or breaking, with a sufficient amount 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, they 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, 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 (frequency cannot be estimated from the available data)):rash with swelling, blisters, or peeling of the skin, patchy skin peeling, bleeding from the eyes, nose, mouth, or genitals, and rapid deterioration of the general condition. Sun-induced rash.
• Other severe reactions (frequency not known):yellowing of the skin and whites of the eyes (due to severe liver damage), kidney problems with painful urination, back pain with fever.

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):taste 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; increased 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 occur in less than 1 in 10,000 patients):disorientation, decreased platelet count, which may cause increased bleeding and bruising, decreased white blood cell count, which may cause 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 before), decreased sodium levels in the blood, decreased magnesium levels in the blood, sensation of tingling, prickling, burning, or numbness, 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
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 used after the expiration date stated on the packaging. 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.

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, calcium stearate, and in the tablet coating: hypromellose, povidone K 25, titanium dioxide (E 171), iron oxide, yellow (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 a blister pack, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:10738/2018/05

Parallel import authorization number: 110/22 Date of leaflet approval: 24.02.2022

[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.
• Limited consumption of alcohol and caffeine.
• Weight loss (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).
• Limited consumption of foods that usually cause heartburn, such as: chocolate, peppermint, green mint, fatty and fried foods, acidic, spicy, citrus fruits and juices, tomatoes.