Nolpaza 40 mg tablets for oral use

Package leaflet: information for the user

Nolpaza 40 mg enteric-coated tablets
Pantoprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Leaflet contents

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 in the treatment of stomach and intestinal disorders associated with excessive hydrochloric acid secretion.
Nolpaza is used:
Adults and adolescents aged 12 years and older:

• For reflux oesophagitis; inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with the backflow of hydrochloric acid from the stomach into the oesophagus.

Adults:

• For Helicobacter pylori infections in patients with peptic ulcer disease, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent recurrence of ulcers.
• For peptic ulcer disease of the stomach and duodenum.
• For Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

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 it with your doctor, pharmacist, or nurse.

• If the patient has serious 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 has vitamin B__ deficiency or risk factors for reduced vitamin B__ levels and is undergoing long-term treatment with pantoprazole. As with all medicines 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 and tingling sensations,
• pain or redness of the tongue,
• mouth ulcers,
• muscle weakness,
• vision disturbances,
• memory problems, disorientation, depression.
• If the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should seek detailed advice from the doctor.
• 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 about being at risk of developing osteoporosis (e.g., if the patient is taking steroid medicines).
• If the patient takes Nolpaza for longer than three months, magnesium levels in the blood may decrease, potentially leading to fatigue, tetany, disorientation, seizures, dizziness, and ventricular cardiac 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 while taking a medicine similar to Nolpaza that reduces gastric acid secretion.
• If the patient develops a skin rash, especially in areas exposed to sunlight, the patient should inform the doctor immediately, as discontinuation of Nolpaza may be necessary. Also report any other adverse effects such as joint pain.
• Severe skin reactions have been reported with the use of pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. The patient should stop taking 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 the doctor immediately if any of the following symptoms occur:

• unintentional weight loss;
• vomiting, particularly recurrent;
• vomiting blood, which may look like dark coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain during swallowing;
• chest pain;
• abdominal pain;
• pallor and weakness (anaemia);
• severe diarrhoea and/or persistent diarrhoea, as use of Nolpaza is associated with a small increased risk of infectious diarrhoea.

The doctor may decide to perform diagnostic tests to rule out an underlying tumour, because treatment with pantoprazole may relieve symptoms of tumour-related disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Nolpaza is taken for a prolonged period (more than 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 and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, including over-the-counter medicines.

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

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), because Nolpaza may impair the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be required.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer conditions). In case of methotrexate use, the doctor may temporarily discontinue Nolpaza, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric disorders). If the patient is taking fluvoxamine, the doctor may recommend a dose reduction.
• 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 or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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 women who are breastfeeding only if the doctor considers the benefits of treatment to outweigh the potential risk to the unborn child or infant.

Driving and operating machinery
Nolpaza has no effect or a negligible effect on the ability to drive motor vehicles and 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 36 mg of sorbitol per tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is considered essentially "sodium-free".

3. How to take Nolpaza

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
When and how to take Nolpaza
The tablets should be taken 1 hour before a meal. Swallow the tablet whole, without chewing or crushing,
with water.
Unless otherwise directed by your doctor, the recommended dosage is:
Adults and adolescents aged 12 years and older:
Treatment of reflux oesophagitis
The recommended dose is 1 tablet per day. Your doctor may recommend increasing the dose to
2 tablets per day.
The treatment period for reflux oesophagitis is usually 4 to 8 weeks. Your doctor will decide how long
you should continue taking the medicine.
Adults:
Treatment of Helicobacter pylori infection in patients with duodenal ulcers and gastric ulcers,
in combination with two antibiotics (eradication therapy).
One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin or metronidazole (or
tinidazole); each antibiotic should be taken twice daily together with a pantoprazole tablet. The first
pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet
1 hour before dinner. Follow your doctor's instructions and read the package leaflets provided with
the antibiotics. The treatment usually lasts from 1 to 2 weeks.
Treatment of gastric and duodenal ulcers
The recommended dose is 1 tablet per day. Your doctor may double the dose.
Your doctor will decide how long you should continue taking the medicine. The treatment period
for gastric ulcers is usually 4 to 8 weeks. The treatment period for duodenal ulcers is usually
2 to 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with
excessive production of hydrochloric acid in the stomach
The usual initial recommended dose is 2 tablets per day.
Both tablets should be taken 1 hour before meals. Later, your doctor may adjust the dose depending
on the amount of hydrochloric acid produced in the stomach. If more than 2 tablets per day are
prescribed, the medicine should be taken in two divided doses.
If your doctor prescribes a daily dose greater than four tablets per day, they will provide specific
instructions on when to stop taking the medicine.
Special patient groups:

• Patients with kidney problems, or moderate to severe liver problems should not take Nolpaza for Helicobacter pylori eradication.
• Patients with severe liver problems should not take more than 1 tablet of 20 mg pantoprazole per day (for this purpose, your doctor may prescribe 20 mg pantoprazole tablets).

Use in children and adolescents
Children under 12 years of age
Nolpaza is not recommended for use in children under 12 years of age.
If you take more Nolpaza than you should
Contact your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take 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
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 listed adverse reactions occur, you should
immediately contact a doctor or go to the nearest hospital:
Serious allergic reactions [rare (may occur in no more than 1 in 1,000
patients)]:

• swelling of the tongue and (or) throat,
• difficulty swallowing,
• urticaria (rash resembling nettle rash),
• breathing difficulties,
• allergic facial swelling (Quincke's oedema/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,
• erosions (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), and blood tests may show changes in certain white blood cells or liver enzymes,
• red, non-elevated spots or circular lesions on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs 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
• kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation, sometimes progressing to kidney failure).

Other adverse reactions include:
Common (may occur in no more than 1 in 10 patients)

• benign gastric polyps.

Uncommon (may occur in no more than 1 in 100 patients):

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

Rare (may occur in no more than 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 limbs (peripheral oedema),
• allergic reactions,
• depression,
• breast enlargement in males,
• disturbances or complete loss of taste sensation.

Very rare (may occur in no more than 1 in 10,000 patients):

• disorientation.

Not known (frequency cannot be estimated from the available data):

• hallucinations, confusion (especially in patients who 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 no more than 1 in 100 patients):

• increased liver enzyme activity.

Rare (may occur in no more than 1 in 1,000 patients):

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

Very rare (may occur in no more than 1 in 10,000 patients):

• decreased platelet count, which may lead to more frequent bleeding and bruising;
• decreased white blood cell count, 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 concentration of sodium, magnesium, calcium or potassium in 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 for 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nolpaza 40 mg enteric-coated tablets

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 specified month.
There are no special requirements regarding storage temperature.
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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Nolpaza contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as sodium pantoprazole hemiheptahydrate).
• The other ingredients are: mannitol, crospovidone (type A, type B), sodium carbonate, sorbitol (E 420), calcium stearate in the tablet core; and in the tablet coating: hypromellose, povidone (K 25), titanium dioxide (E 171), yellow iron oxide (E 172), propylene glycol, methacrylic acid and ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, macrogol 6000 and talc. See section 2 "Nolpaza contains sorbitol and sodium".

What Nolpaza looks like and contents of the pack
The 40 mg enteric-coated tablets are light brownish-yellow, oval-shaped, slightly convex on both sides.
Pack sizes: 14, 20, 28, 30, 50, 56, 60, 90, 98 or 112 enteric-coated tablets in blister packs, 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 other European Economic Area and United Kingdom (Northern Ireland) countries, 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