Nolpaza control

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nolpaza control (Nolpaza 20 mg)

20 mg, enteric-coated 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 additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. See section 4.
• If you do not feel better or feel worse after 14 days, 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 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 way, the medicine 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. Other symptoms may also appear, such as: painful burning in the chest extending up to the throat (heartburn), sour taste in the mouth (acid reflux).
Nolpaza control may 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.
In order to achieve complete relief of symptoms, it may be necessary to take the tablets for 2-3 consecutive days.
If you do not feel better or feel worse after 14 days, 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 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 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, 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 your reflux disease symptoms (heartburn or acid reflux) persist for more than 2 weeks, you should consult your doctor, who will decide whether you need to take the medicine for a longer period.
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 (for example, 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 are taking 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 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;
• 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);

Other side effects include:

Children and adolescents

Nolpaza control should not be taken by 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

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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, your doctor may temporarily stop taking 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 taken with antacids (e.g., magaldrate, aluminum hydroxide, sodium bicarbonate, magnesium carbonate, or their combinations) if necessary.

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 plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience side effects such as dizziness or visual disturbances, you should not drive vehicles or operate machinery.

Nolpaza control contains sorbitol and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol of sodium (23 mg) 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. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose is one tablet per day. You should not take a daily dose greater than 20 mg. You should take the medicine for at least 2-3 consecutive days. You should stop taking Nolpaza control after complete relief of symptoms. It is possible to relieve symptoms of reflux and heartburn as early as the first day of treatment with Nolpaza control, but you should remember that this medicine is not intended for immediate relief of symptoms.
You should consult your doctor if your symptoms do not improve after taking this 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 a meal, 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 take 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 scheduled dose the next day at the usual time.
If you have any further questions 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):

allergic reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms are: swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.

Severe skin reactions (frequency not known, cannot be estimated from 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.
Sunlight-induced rash. Joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and blood test results may show changes in some white blood cells or liver enzymes.

• Other severe reactions (frequency not known):yellowing of the skin and whites of the eyes (due to severe liver damage), kidney problems manifested by painful urination, pain in the lower back with accompanying fever.

Other side effects include:

Frequent (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; visual 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 lead to increased bleeding tendency and bruising; decreased white blood cell count, which can lead to more frequent infections, concurrent, abnormal decrease in red and white blood cell count, as well as platelet count (detected in blood tests).

Frequency not known (cannot be estimated from 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), feeling of tingling, pricking, burning, or numbness, infectious colitis causing persistent watery diarrhea, rash that may be accompanied by joint pain.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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 or parallel importer.
Reporting side effects will help gather more information on the safety of this 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 expiration date stated on the packaging. The expiration date refers to the last day of the specified 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 packaging and other information

What Nolpaza control contains

• The active substance of Nolpaza control is pantoprazole. One enteric-coated tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• 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, methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion containing sodium lauryl sulfate and polysorbate 80. See section 2 "Nolpaza control contains sorbitol and sodium".

What Nolpaza control looks like and what the packaging contains

Light brown-yellow, oval, slightly convex enteric-coated tablets.
Packaging: 15 enteric-coated tablets in a blister pack, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or 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:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35/37
87-100 Toruń

Marketing authorization number in Romania, the country of export:

10738/2018/03
10738/2018/05
10738/2018/07

Parallel import authorization number: 123/23

Date of leaflet approval: 28.06.2023

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

• Avoiding large meals.
• Eating slowly.
• Quitting smoking.
• Limits on alcohol and caffeine consumption.
• Weight loss (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).
• Limits on foods that usually cause heartburn, such as: chocolate, peppermint, green mint, fatty and fried foods, acidic, spicy, citrus fruits, and fruit juices, tomatoes.