NOLPAZA 40 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Nolpaza

Do not take Nolpaza

• if you are allergic to pantoprazole, sorbitol or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines that contain other proton pump inhibitors.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking this medicine:

• If you have severe liver disease. Tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you take pantoprazole for long-term treatment. If levels increase, treatment should be discontinued.
• If you have low body stores of vitamin B12 or risk factors for it and you receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, as they may indicate a vitamin B12 deficiency:

• Extreme fatigue or lack of energy
• Numbness
• Pain in the tongue or red tongue, ulcers in the mouth
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression

• If you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) while taking pantoprazole, consult your doctor.
• If you are taking proton pump inhibitors like pantoprazol, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spine fractures.

Tell your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (for example, if you are taking corticosteroids).

• If you are taking pantoprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If you have had allergic reactions after treatment with a medicine similar to pantoprazol that reduces stomach acid.
• If you experience a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with this medicine. Remember to mention any other symptoms you may notice, such as joint pain.
• There have been reports of serious skin reactions associated with pantoprazol treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazol and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• vomiting, particularly if it is repeated
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• if you notice blood in your stools, which may appear black or tarry
• difficulty swallowing, or pain when swallowing
• chest pain
• stomach pain
• pale appearance and feeling of weakness (anemia)
• severe and/or persistent diarrhea, as pantoprazol has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazol can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazol for a prolonged period (more than one year), your doctor may monitor you regularly. You should inform your doctor of any new symptoms and/or events each time you visit your doctor.

Children and adolescents

The use of these tablets is not recommended in children under 12 years of age.

Other medicines and Nolpaza

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This medicine may interfere with the effectiveness of other medicines, so tell your doctor if you are taking:

• Any medicine such as ketoconazole, itraconazole, or posaconazole (medicines used in fungal infections) or erlotinib (used to treat some types of cancer), as pantoprazol may cause other medicines to not work properly.
• Warfarin or phenprocoumon, which affect blood coagulation. You may need additional checks.

• Medicines used to treat HIV infection, such as atazanavir.

• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), if you are taking methotrexate, your doctor may temporarily stop treatment with pantoprazol because pantoprazol can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders), if you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking pantoprazol if you need to have a specific urine test (for THC, Tetrahydrocannabinol).

Using Nolpaza with food and drinks

Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with a little water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough data on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human breast milk. You should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

This medicine has no or negligible influence on the ability to drive or use machines.

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Nolpaza contains sorbitol and sodium

This medicine contains 36 mg of sorbitol in each tablet.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Nolpaza

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration

Take the tablets whole, without chewing or crushing, with the help of a little water, 1 hour before a meal.

Unless your doctor has told you otherwise, the recommended doseis:

Adults and adolescents from 12 years:

For reflux esophagitis

The recommended dose is one tablet per day. The dose may be doubled by your doctor. The treatment time for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you for how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment).

One tablet twice a day plus the two antibiotic tablets: amoxicillin, clarithromycin, and metronidazole (or tinidazole), each to be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics. The treatment duration is usually one to two weeks.

For the treatment of stomach and duodenal ulcers:

The recommended dose is one tablet per day. The dose may be doubled by your doctor. Your doctor will tell you for how long you should take this medicine. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion:

The recommended initial dose is two tablets per day.

Take the two tablets 1 hour before breakfast. Later, your doctor may adjust your dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, take the tablets divided into two doses per day.

If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have severe kidney problems, do not take pantoprazol for Helicobacter pylorieradication.
• If you have severe liver problems, do not take more than one tablet (20 mg) of pantoprazol per day.

Use in children and adolescents

Children under 12 years of age.

The use of these tablets is not recommended in children under 12 years of age.

If you take more Nolpaza than you should

Tell your doctor or pharmacist. There are no known symptoms of overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Nolpaza

Do not take a double dose to make up for a forgotten dose. Take your next dose as usual.

If you stop taking Nolpaza

Do not stop taking these tablets without first talking to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking pantoprazol and seek medical attention immediately if you experience any of the following symptoms:

• round or target-like red spots on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (drug hypersensitivity with eosinophilia and systemic symptoms, DRESS).

If you notice any of the following side effects, stop taking the tablets and tell your doctor immediately or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare; may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria, difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's edema), severe dizziness with very rapid heartbeat and profuse sweating.

• Severe skin disorders (frequency not known; cannot be estimated from the available data): you may notice one or more of the following - blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.

• Other severe disorders (frequency not known; cannot be estimated from the available data): yellowing of the skin or the whites of the eyes (severe liver cell damage, jaundice) or fever, redness of the skin, and kidney enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation) which may lead to kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 people)

Benign polyps in the stomach.

• Uncommon(may affect up to 1 in 100 people)

Headache; dizziness; diarrhea; nausea; vomiting, bloating, and gas; constipation; dry mouth; abdominal pain and discomfort; erythema; exanthema, rash; itching; hip, wrist, and spine fractures, feeling of weakness, fatigue, or general malaise; sleep disturbances.

• Rare(may affect up to 1 in 1,000 people)

Changes in vision such as blurred vision, urticaria; joint pain; muscle pain, weight changes; high body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men; alteration or complete loss of taste.

• Very rare(may affect up to 1 in 10,000 people)

Disorientation.

• Frequency not known(cannot be estimated from the available data)

Hallucinations, confusion (especially in patients with a history of these symptoms), feeling of numbness, pins and needles, burning, or tingling, inflammation of the large intestine that causes persistent watery diarrhea, skin rash, possibly with joint pain.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 people)

Increased liver enzyme values.

• Rare(may affect up to 1 in 1,000 people)

Increased bilirubin; increased blood fat levels; sudden drop in white blood cells, associated with high fever.

• Very rare(may affect up to 1 in 10,000 people)

Reduced platelet count in the blood, which can cause increased bleeding or bruising; reduced white blood cell count, which can lead to more frequent infections; abnormal reduction in the balance between red and white blood cell and platelet counts.

• Frequency not known(cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if you think they are not related to this medicine. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nolpaza

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after CAD.The expiry date is the last day of the month indicated.

Blister: Store in the original packaging to protect from moisture.

Bottle: Keep the bottle tightly closed to protect from moisture.

After opening the bottle for the first time, the product should be used within 3 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Nolpaza

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of pantoprazol sodium sesquihydrate).
• The other ingredients are:

Tablet core: mannitol, crospovidone (type A, type B), sodium carbonate, sorbitol (E420), and calcium stearate.

Tablet coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, ethyl acrylate-methacrylic acid copolymer, sodium lauryl sulfate, polysorbate 80, macrogol 6000, and talc.

Appearance of Nolpaza and Package Contents

Light brown-yellow, oval, and slightly biconvex tablets.

Package Sizes

Blister packs of 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 x 1, 112, or 140 gastro-resistant tablets per box.

HDPE plastic bottles of 250 gastro-resistant tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

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, 27472 Cuxhaven, Germany

For further information about this medicine, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine has been authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:October 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/