Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is 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 medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.
Do not take Nolpaza control for longer than 4 weeks without consulting your doctor.

Contents of the leaflet:

What Nolpaza control is and what it is used for
Important information before taking Nolpaza control
How to take Nolpaza control
Possible side effects
How to store Nolpaza control
Contents of the pack and other information

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

The active substance in Nolpaza control is pantoprazole, which inhibits the enzyme responsible for producing gastric 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 regurgitation) in adults.
Reflux refers to the backward flow of stomach acid into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Nolpaza control may relieve symptoms associated with gastroesophageal reflux disease (such as heartburn, acid regurgitation) as early as on the first day of treatment, but it is not intended for immediate relief of symptoms.
For complete symptom relief, it may be necessary to take the tablets for 2–3 consecutive days.
If there is no improvement after 14 days, or if you feel worse, consult your doctor.

2. Important information before using Nolpaza control

When not to use 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 in the treatment of HIV infection). See "Nolpaza control and other medicines".

Warnings and precautions
Before starting to take Nolpaza control, consult a doctor if the patient:

is being treated for heartburn or indigestion continuously for 4 or more weeks;
is over 55 years old and regularly uses over-the-counter medicines for indigestion;
is over 55 years old and has noticed new or worsening symptoms, or a change in the pattern of existing reflux disease symptoms;
has a history of peptic ulcer disease or has undergone stomach surgery;
has liver problems or jaundice (yellowing of the skin and eyes);
is under ongoing medical care for other serious conditions or diseases;
is scheduled to undergo endoscopy or a urease test;
has previously experienced a skin reaction while taking a medicine similar to Nolpaza control that reduces gastric acid secretion;
is scheduled for a specific blood test (chromogranin A levels);
is taking HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection) together with pantoprazole; in such case, ask the doctor for detailed advice.

Do not take this medicine for longer than 4 weeks without consulting a doctor. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, consult a doctor who will decide whether long-term treatment 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 developing osteoporosis (e.g. if the patient is taking steroid medicines);
decreased magnesium levels in blood (possible symptoms: fatigue, involuntary muscle contractions, confusion, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to reduced potassium and calcium levels in blood. If the medicine is used for longer than 4 weeks, consult a doctor. The doctor may recommend regular blood tests to monitor magnesium levels.

Immediately inform the doctor before or after using this medicine if the patient experiences any of the following symptoms, which may indicate other, more serious conditions:

unintentional weight loss (not related to diet or exercise);
vomiting, particularly recurrent;
bloody vomit, which may look like dark coffee grounds;
blood in stool, black or tarry stools;
difficulty swallowing or pain during swallowing;
paleness and weakness (anaemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhoea (because use of Nolpaza control is associated with a slightly increased risk of infectious diarrhoea);
if the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Nolpaza control may be necessary. Also report any other adverse reactions such as joint pain. Page 2 of 6

The doctor may decide that additional tests are necessary.
If the patient is due to have a blood test, they should inform the doctor that they are taking this medicine.
The patient may notice improvement in reflux and heartburn symptoms as early as one day after starting Nolpaza control. However, this is not a medicine intended for immediate relief of symptoms.
Nolpaza control should not be used preventively.
If the patient has recurrent heartburn or indigestion symptoms over 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 lack of safety data in this age group.
Nolpaza control and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Nolpaza control may reduce the effectiveness of other medicines. Inform the doctor or pharmacist about all medicines being taken, especially those containing any of the following active substances:

HIV protease inhibitors, such as atazanavir, nelfinavir (used in the treatment of HIV infection). Concomitant use of Nolpaza control with HIV protease inhibitors is not allowed. See "When not to use Nolpaza control";
ketoconazole (used for fungal infections);
warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be required;
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancerous diseases). When methotrexate is used, the doctor may temporarily discontinue Nolpaza control, as pantoprazole may increase methotrexate blood levels.

Do not take Nolpaza control together with medicines that reduce stomach acid production, such as other proton pump inhibitors (omeprazole, lansoprazole or rabeprazole) or H2 antagonists (e.g. ranitidine, famotidine).
Nolpaza control may be used if necessary together with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or their combinations).
Pregnancy and breastfeeding
Do not use Nolpaza control if the patient is pregnant or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive or operate machinery.
Nolpaza control contains sorbitol
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Nolpaza control contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
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3. How to use Nolpaza control

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, 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. Treatment with Nolpaza control should be discontinued after complete resolution of symptoms. Relief of reflux and heartburn symptoms may occur as early as one day after starting Nolpaza control; however, it should be noted that this medicine is not intended for immediate relief of symptoms.
Consult a doctor if symptoms do not resolve after taking this medicine for a full 2 weeks.
Do not take Nolpaza control for longer than 4 weeks without consulting a doctor.
Tablets should be taken before a meal, at the same time each day. Swallow the tablets whole, without chewing or dividing, with plenty of water.

Overdose of Nolpaza control
Immediately inform a doctor or pharmacist if more than the recommended dose has been taken. If possible, bring the medicine and the package leaflet with you.

Missed dose of Nolpaza control
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time on the following day.

If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You must immediately inform your doctor or contact the nearest hospital emergency department if any of the following serious adverse reactions occur.
At the same time, you should stop taking this medicine and bring the package leaflet and (or) the tablets with you.

Serious allergic reactions (rare (may occur in 1 out of 1,000 treated patients)): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue and (or) throat, which may cause difficulty in swallowing or breathing, urticaria, severe dizziness with rapid heartbeat and excessive sweating.
Serious skin reactions (frequency unknown (frequency cannot be estimated from available data)): the patient may notice one or more of the following symptoms – rash with swelling, blisters or peeling skin, sheet-like peeling of the skin, bleeding from the eyes, nose, mouth or genital organs, and rapid deterioration in general condition. Skin rash after exposure to sunlight. Joint pain or flu-like symptoms, fever, gland swelling (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
Other serious reactions (frequency unknown): yellowing of the skin and whites of the eyes (due to severe liver damage), or fever, rash, and kidney enlargement sometimes with kidney problems manifesting as painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:
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Common (may occur in 1 out of 10 treated patients): benign gastric polyps.
Uncommon (may occur in 1 out of 100 treated patients): headache, dizziness, diarrhoea, nausea, vomiting, bloating and flatulence, constipation, dry mouth; abdominal pain and discomfort, skin rash or urticaria, skin itching, weakness, fatigue or malaise, sleep disturbances; increased liver enzyme activity in blood tests, fracture of the hip, wrist or spine.
Rare (may occur in 1 out of 1,000 treated patients): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; limb swelling; depression; increased blood levels of bilirubin and lipids (detected in blood tests); breast enlargement in males; high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
Very rare (may occur in less than 1 out of 10,000 treated patients): disorientation, decreased platelet count, which may cause increased tendency to bleed and development of skin petechiae (bruises); decreased white blood cell count, which may predispose to more frequent infections, concurrent abnormal decrease in red blood cells, white blood cells and platelets (detected in blood tests).
Frequency unknown (frequency cannot be estimated from available data): hallucinations; confusion (particularly in patients who have previously experienced such symptoms), decreased blood levels of sodium, magnesium, calcium or potassium (see section 2), sensations of tingling, pricking, numbness, burning or stinging, inflammation of the large intestine causing persistent watery diarrhoea, rash possibly accompanied by joint pain.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Nolpaza control

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
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6. Contents of the pack and other information

What Nolpaza control contains

The active substance is pantoprazole. One enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
Other components are: in the tablet core: mannitol, crospovidone (type A), crospovidone (type B), sodium carbonate, sorbitol (E 420), calcium stearate; 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-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 contents of the pack
Light brownish-yellow, oval, slightly convex on both sides, enteric-coated tablets.
Packaging: 15 enteric-coated tablets in blisters, in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Romania, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Romania, country of export: 10738/2018/05
Parallel import authorisation number: 378/21
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The following lifestyle recommendations and dietary changes may also help relieve heartburn
or other symptoms related to gastric acid.

Avoid large meals.
Eat slowly.
Stop smoking.
Limit alcohol and caffeine intake.
Reduce body weight (in case of overweight).
Avoid wearing tight clothes or belts.
Avoid eating meals less than three hours before lying down.
Sleep with the head elevated (in case of nocturnal symptoms).
Limit consumption of foods that usually trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic and spicy foods, citrus fruits and fruit juices, tomatoes.

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