Nolpaza 20 mg tablets for oral use

Package leaflet: Information for the user

Nolpaza 20 mg enteric-coated tablets
Pantoprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Nolpaza is and what it is used for
2. What you need to know before taking Nolpaza
3. How to take Nolpaza
4. Possible side effects
5. How to store Nolpaza
6. Contents of the pack and other information

1. What Nolpaza is and what it is used for

Nolpaza is a selective "proton pump inhibitor," a medicine that reduces the amount of hydrochloric acid produced in the stomach. Nolpaza is used to treat stomach and intestinal disorders associated with excessive production of hydrochloric acid.
Nolpaza is used:
Adults and adolescents aged 12 years and older:

• For the treatment of symptoms (such as heartburn, acid regurgitation, pain on swallowing) associated with gastro-oesophageal reflux disease (GORD) caused by the backflow of acidic stomach contents into the oesophagus.
• For the long-term treatment and prevention of relapse of reflux oesophagitis (a condition in which backflow of stomach contents into the oesophagus causes inflammation and pain).

Adults:

• For the prevention of gastric and duodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in high-risk patients requiring continuous treatment with NSAIDs.

2. Important information before using Nolpaza

When not to use Nolpaza

• if the patient is allergic to pantoprazole, sorbitol, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Nolpaza, discuss this with your doctor, pharmacist, or nurse.

• If the patient has severe liver problems. Inform the doctor if there has ever been any liver dysfunction. The doctor may recommend more frequent monitoring of liver enzymes, especially during long-term treatment with Nolpaza. If liver enzyme activity increases, the doctor may discontinue treatment.
• If the patient is required to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and is also taking Nolpaza, due to an increased risk of gastrointestinal complications. This increased risk will be assessed based on individual risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If the patient has vitamin B deficiency or risk factors for reduced vitamin B levels and is receiving long-term treatment with pantoprazole. Like all drugs that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B. Contact the doctor if any of the following symptoms occur, which may indicate low vitamin B levels:
  • extreme fatigue or lack of energy,
  • numbness or tingling sensations,
  • pain or redness of the tongue,
  • mouth ulcers,
  • muscle weakness,
  • vision disturbances,
  • memory problems, disorientation, depression.
• If the patient is taking protease inhibitors for HIV, such as atazanavir (used in the treatment of HIV infection), together with pantoprazole, the patient should seek detailed advice from the doctor.
• The use of a proton pump inhibitor such as pantoprazole, especially for periods longer than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine.
• Inform the doctor if the patient has osteoporosis (reduced bone density) or if the doctor has previously informed the patient of being at risk of developing osteoporosis (e.g. if the patient is taking steroid medications).
• If the patient takes Nolpaza for longer than three months, magnesium levels in the blood may decrease, which may subsequently cause fatigue, tetany, disorientation, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, inform the doctor immediately. Low blood magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic monitoring of blood magnesium levels is necessary.
• If the patient has ever experienced a skin reaction due to taking a medicine similar to Nolpaza that reduces gastric acid secretion.
• If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Nolpaza may be necessary. Also report any other adverse effects such as joint pain.
• Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. Discontinue pantoprazole and seek immediate medical advice if any symptoms suggestive of these serious skin reactions (described in section 4) occur.
• Planned specific blood test (chromogranin A levels).

Contact your doctor immediately if any of the following symptoms occur:

• unintentional weight loss;
• vomiting, especially recurrent;
• vomiting blood, 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 is associated with a small increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Nolpaza is taken for a prolonged period (over 1 year), the doctor will likely recommend regular monitoring. In such cases, report any new or unexpected symptoms and their circumstances at every doctor's visit.

Children and adolescents
Nolpaza is not recommended for use in children under 12 years of age.

Nolpaza with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any other medicines.

Since Nolpaza may affect the effectiveness of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Nolpaza may inhibit the proper action of these and other drugs.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer conditions) – when methotrexate is used, the doctor may temporarily discontinue Nolpaza, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend reducing the dose.
• Rifampicin (used to treat infections).
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Before starting pantoprazole, discuss with the doctor if the patient is scheduled for a specific urine test [for tetrahydrocannabinol (THC)].

Nolpaza with food and drink
Tablets should be taken 1 hour before a meal. Swallow the tablet whole, without chewing or crushing, with water.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There are insufficient data on the use of pantoprazole in pregnant women. It has been shown that the drug passes into breast milk. The medicine may be used in pregnant women, women who may be pregnant, or breastfeeding women only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Nolpaza has no effect or negligible effect on the ability to drive motor vehicles or operate mechanical equipment.
Patients who experience adverse effects such as dizziness or visual disturbances should not drive or operate machinery.

Nolpaza contains sorbitol and sodium
This medicine contains 18 mg of sorbitol in each tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is essentially "sodium-free".

3. How to use Nolpaza

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
When and how to take Nolpaza
Tablets should be taken 1 hour before a meal. Swallow the tablet whole, without chewing or crushing,
with water.
Unless otherwise directed by a doctor, the recommended dosage is:
Adults and adolescents aged 12 years and older:
Treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with
gastro-oesophageal reflux disease
The recommended dose is 1 tablet per day.
This dose usually provides relief within 2 to 4 weeks, and at the latest after an additional
4 weeks. Your doctor will decide how long you should continue treatment. Recurring symptoms may be managed
by taking one tablet per day, as needed.
Long-term treatment and prevention of relapse in reflux oesophagitis
The recommended dose is 1 tablet per day.
If symptoms return, your doctor may double the dose. In this case, Nolpaza 40 mg, one tablet per day, may be used.
After healing, your doctor may reduce the dose again to one tablet (20 mg) per day.
Adults:
Prevention of gastric and duodenal ulcers in patients requiring continuous
non-steroidal anti-inflammatory drugs (NSAIDs)
The recommended dose is 1 tablet per day.
Special patient groups:
In case of severe liver problems, do not take more than one 20 mg tablet per day.
Use in children and adolescents
Children under 12 years of age
This medicine is not recommended for use in children under 12 years of age.
Taking more Nolpaza than recommended
Contact a doctor or pharmacist. Symptoms of overdose are unknown.
Missing a dose of Nolpaza
Do not take a double dose to make up for a missed tablet. Take the next scheduled dose at the usual time.
Stopping Nolpaza treatment
Do not stop taking this medicine without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur, you should
immediately contact a doctor or go to the nearest hospital:
Serious allergic reactions [rare (may occur in up to 1 in 1,000
patients)]:

• swelling of the tongue and/or throat,
• difficulty swallowing,
• hives (rash resembling nettle rash),
• difficulty breathing,
• allergic swelling of the face (angioedema/angioedema),
• severe dizziness with very rapid heartbeat and excessive sweating.

Serious skin reactions [frequency unknown (frequency cannot be estimated from the available data)]: the patient may notice one or more of the following symptoms:

• skin blisters and sudden worsening of general health,
• erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or rash, particularly in areas of skin exposed to sunlight.
• joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• red, non-elevated spots or round patches on the trunk, often with blisters in the center, skin peeling, and ulceration of the mouth, throat, nose, genitals and eyes. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other serious conditions [frequency unknown (frequency cannot be estimated from the available data)]:

• yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or
• fever,
• rash and
• enlarged kidneys, sometimes pain when passing urine and pain in the lower back (severe kidney inflammation, sometimes progressing to kidney failure).

Other adverse reactions include:
Common (may occur in up to 1 in 10 patients)

• benign gastric polyps.

Uncommon (may occur in up to 1 in 100 patients):

• headache,
• dizziness,
• diarrhoea,
• nausea, vomiting,
• bloating and flatulence,
• constipation,
• dryness of the mouth,
• pain and discomfort in the abdomen,
• skin rash; urticaria, skin eruptions,
• itching,
• fractures of the hip, wrist or spine,
• weakness; fatigue or general malaise,
• sleep disturbances.

Rare (may occur in up to 1 in 1,000 patients):

• visual disturbances, such as blurred vision,
• urticaria,
• joint pain,
• muscle pain,
• changes in body weight,
• elevated temperature,
• high fever,
• swelling of the limbs (peripheral oedema),
• allergic reactions,
• depression,
• breast enlargement in males,
• disturbances or complete loss of taste sensation.

Very rare (may occur in up to 1 in 10,000 patients):

• disorientation.

Unknown (frequency cannot be estimated from the available data):

• hallucinations, confusion (particularly in patients who have previously experienced such symptoms),
• sensations of tingling, pricking, numbness, burning or stinging,
• inflammation of the large intestine causing persistent watery diarrhoea,
• rash possibly accompanied by joint pain.

Adverse reactions identified in blood tests:
Uncommon (may occur in up to 1 in 100 patients):

• increased liver enzyme activity.

Rare (may occur in up to 1 in 1,000 patients):

• increased bilirubin levels,
• increased blood lipid levels,
• sudden decrease in circulating granulocytes - white blood cells, associated with high fever.

Very rare (may occur in up to 1 in 10,000 patients):

• decreased platelet count, which may cause more frequent bleeding and bruising;
• decreased white blood cell count in the blood, which may lead to more frequent infections,
• concurrent, abnormal decrease in red blood cells, white blood cells and platelets.

Frequency unknown (frequency cannot be estimated from the available data):

• decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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

5. How to store Nolpaza 20 mg enteric-coated tablets

Keep this medicine out of the 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.
There are no special requirements regarding storage temperature.
Store in the original container 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 in use. Proper disposal helps protect the environment.

6. Contents of the package and other information

What Nolpaza contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• Other ingredients are: mannitol, crospovidone (type A, type B), sodium carbonate, sorbitol (E 420), calcium stearate in the tablet core; and hypromellose, povidone (K 25), titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc in the tablet coating. See section 2 "Nolpaza contains sorbitol and sodium".

What Nolpaza looks like and contents of the pack
The 20 mg enteric-coated tablets are light brown-yellow, oval-shaped, slightly convex on both sides.
Pack sizes: 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 112 enteric-coated tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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
TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about the names of this medicinal product in the other European Economic Area countries and the United Kingdom (Northern Ireland), please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500