Package leaflet: Information for the patient

Warning! Keep the leaflet! 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 brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if you feel worse, you should contact your doctor.

Table of 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

If there is no improvement after 14 days, or if you feel worse, you should consult your doctor.
The active substance in Nolpaza control is pantoprazole, which blocks the enzyme responsible for producing 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 gastro-oesophageal reflux disease (such as heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of acid from the stomach into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include a burning discomfort 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 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.
To achieve complete symptom relief, it may be necessary to take the tablets for 2–3 consecutive days.

2. Important information before using Nolpaza control

When not to use Nolpaza control

If the patient is allergic to the active substance or to 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 takes over-the-counter indigestion medicines daily;
is over 55 years old and has noticed new or worsening symptoms, or a change in the nature 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 continuous medical supervision due to other serious conditions or diseases;
is scheduled for an endoscopic examination or urease test;
has ever experienced a skin reaction when taking a medicine similar to Nolpaza control that reduces gastric acid secretion;
is scheduled for a specific blood test (chromogranin A level);
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 B12 and vitamin B12 deficiency in patients with low vitamin B12 levels;
hip, wrist, or spine fractures, especially if the patient already has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis);
decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to decreased potassium and calcium levels in the blood.

If using the medicine 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 taking 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, especially 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 (anemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhea (because use of Nolpaza control is associated with a slightly increased risk of infectious diarrhea);
if the patient develops a skin rash, especially in sun-exposed areas, inform the doctor immediately, as discontinuation of Nolpaza control may be necessary. Also report any other adverse effects such as joint pain.

The doctor may decide that additional tests are necessary.
If the patient is to undergo blood tests, he or she should inform the doctor about 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 symptom relief.
Nolpaza control should not be used preventively.
If the patient has been suffering from recurrent heartburn or indigestion symptoms for some time, regular medical monitoring should be maintained.

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 the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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). Nolpaza control must not be used concomitantly with HIV protease inhibitors. 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 cancer conditions). When methotrexate is used, the doctor may temporarily discontinue Nolpaza control, as pantoprazole may increase methotrexate blood levels. Do not use Nolpaza control together with other medicines that reduce stomach acid production, such as other proton pump inhibitors (e.g. 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 child, she should consult a doctor or pharmacist before taking this medicine.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

Nolpaza control contains sorbitol
If the patient has previously been diagnosed with intolerance to certain sugars, he or she 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; therefore, the medicine is considered "sodium-free".

3. How to use Nolpaza control

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day. The daily dose should not exceed 20 mg.
This 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 your doctor if symptoms do not improve after taking this medicine for a full 2 weeks.
Do not take Nolpaza control for longer than 4 weeks without consulting your doctor.
Tablets should be taken before a meal, at the same time each day. Swallow the tablets whole, do not chew or divide, with plenty of water.

Overdose of Nolpaza control
If you take more than the recommended dose, inform your doctor or pharmacist immediately. If possible, bring the medicine and this 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 the following day.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
You should immediately inform your doctor or contact the nearest hospital emergency department if any of the following serious adverse effects occur.
You should also stop taking this medicine and bring the leaflet and/or tablets with you.

Severe 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.
Severe skin reactions (frequency unknown (frequency cannot be determined from available data)): Rash with swelling, blistering or peeling of the skin, sheet-like peeling of the skin, bleeding from the eyes, nose, mouth or genital organs, and rapid deterioration in general condition. Rash after exposure to sunlight.
Other severe reactions (frequency unknown): 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 adverse effects include:

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, flatulence and bloating with gas release, constipation, dry mouth; abdominal pain and discomfort, skin rash or urticaria, itching of the skin, fatigue, exhaustion 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; swelling of limbs; depression; increased blood bilirubin and lipid levels (detected in blood tests); breast enlargement in men; 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): disturbances in orientation, decreased platelet count, which may lead to increased tendency to bleeding 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 determined from available data): hallucinations; confusion (particularly in patients who have previously experienced such symptoms), decreased sodium concentration in blood, decreased magnesium concentration in blood, sensation of tingling, pricking, numbness, burning or stinging, inflammation of the large intestine causing persistent watery diarrhoea, rash which may be associated with joint pain.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

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 ingredients are: in the tablet core: mannitol, crospovidone (type A), crospovidone (type B), sodium carbonate, sorbitol, magnesium 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 biconvex enteric-coated tablets.
Pack: 15 enteric-coated tablets in a blister pack, in a cardboard box.
For further 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Romania, country of export: 10738/2018/05
Parallel Import Authorisation Number: 110/22
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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.
Lose weight (if overweight).
Avoid tight clothing or belts.
Avoid eating meals less than three hours before going to bed.
Sleep with the head elevated (in case of nocturnal symptoms).
Limit consumption of foods that commonly trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, spicy foods, citrus fruits and fruit juices, tomatoes.