Package Insert: Information for the Patient

Nolpaza 40 mg Gastric-Resistant Tablets EFG

pantoprazol

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Nolpaza is a selective proton pump inhibitor. Proton pump inhibitors like pantoprazol reduce the amount of acid in your stomach. It is used for the treatment of diseases related to stomach acid and intestine.

Nolpaza is used for:

Adults and adolescents 12 years of age or older

• Gastroesophageal reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from your stomach.

Adults

• Infection of a bacteria called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcers reappearing.
• Treatment of stomach and duodenal ulcers.
• Treatment of Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

Do not take Nolpaza

• If you are allergic to pantoprazole, sorbitol, or any of the other components of this medication (listed in section 6).
• If you are allergic to medications that contain other proton pump inhibitors.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

• If you have a severe liver disease. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when taking pantoprazole for long-term treatment. If levels increase, treatment should be suspended.
• If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce stomach acid, pantoprazole may reduce vitamin B12 absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:

• Extreme fatigue or lack of energy
• Tingling
• Pain or redness in the tongue or mouth, mouth ulcers
• Muscle weakness
• Vision problems
• Memory or confusion problems, depression

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

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

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

Inform your doctor immediately if you experience any of the following symptoms:

-Unintentional weight loss

-Vomiting, particularly if repeated

-Blood in vomit: may appear as a dark brown powder in your vomit

-Blood in stool, which may appear black or melena

-Difficulty swallowing or pain when swallowing

-Chest pain

-Abdominal pain

-Pale appearance and feeling of weakness (anemia)

-Severe and/or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out cancer, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

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

Children and adolescents

This medication is not recommended for children under 12 years old.

Other medications and Nolpaza

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This medication may interfere with the effectiveness of other medications, so inform your doctor if you are taking:

• Any medication such as ketoconazole, itraconazole, or posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may make other medications less effective.
• Warfarin or phenprocoumon, which affect blood clotting. You may need additional monitoring.

• Medications used for HIV treatment, such as atazanavir.

-Metotrexate (used for rheumatoid arthritis, psoriasis, and cancer), if you are taking metotrexate, your doctor may temporarily interrupt pantoprazole treatment due to increased metotrexate levels in the blood.

-Fluvoxamine (used for depression and other psychiatric disorders) if you are taking fluvoxamine, your doctor may reduce the dose.

-Rifampicin (used for infections).

• St. John's Wort (Hypericum perforatum) (used for mild depression).

Consult your doctor before taking pantoprazole if you are scheduled to have a specific urine test (for THC, Tetrahidrocanabinol).

Use of 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. You should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

This medication has no influence or insignificant influence on the ability to drive or operate machinery.

Do not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Nolpaza contains sorbitol and sodium

This medication contains 36 mg of sorbitol in each tablet.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration Form

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

Unless your doctor has indicated another schedule, therecommended doseis:

Adults and adolescents 12 years and older:

For esophagitis due to reflux

The recommended dose is 1 tablet per day. The dose may be doubled by your doctor. The treatment time for esophagitis due to reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long you should take this medication.

Adults:

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

1 tablet twice a day plus the two antibiotic tablets: amoxicillin, clarithromycin, and metronidazole (or tinidazole), each must be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second before dinner. Follow your doctor's instructions and make sure to read the antibiotic leaflets. The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers:

The recommended dose is 1 tablet per day. The dose may be doubled by your doctor. Your doctor will tell you for how long you should take this medication. 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 production:

The recommended starting dose is 2 tablets per day.

Take the 2 tablets 1 hour before breakfast. Your doctor may then adjust your dose, depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, take the tablets twice a day.

If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have severe kidney problems, moderate or severe liver problems, you should not take pantoprazole forHelicobacter pylorieradication.
• If you have severe liver problems, you should not take more than 1 tablet (20 mg) of pantoprazole per day.

Use in children and adolescents

Children under 12 years.

These tablets are not recommended for use in children under 12 years.

If you take more Nolpaza than you should

Inform 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 medication and the amount ingested.

If you forgot to take Nolpaza

Do not take a double dose to compensate for a missed dose.Take your next dose as usual.

If you interrupt treatment with Nolpaza

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

• round or target-shaped, slightly reddish spots on the trunk, often with blisters in the center, peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe exanthems may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• generalized exanthem, elevated body temperature, and lymphadenopathy (DRESS syndrome or drug hypersensitivity syndrome).

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

• Severe allergic reactions (rare; may affect up to 1 in 1,000 patients):swelling of the tongue and/or throat, difficulty swallowing, urticaria, difficulty breathing, allergic facial swelling (Quincke's edema/angioedema), intense dizziness with rapid heart rate, and excessive sweating.

• Severe skin disorders (frequency unknown; cannot be estimated with available data):You may notice one or more of the following - skin blisters and rapid deterioration of general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips, or genitals, or skin sensitivity/eruption, particularly in exposed skin areas to light/sun. You may also experience joint pain or symptoms similar to the flu, 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 unknown; cannot be estimated with available data):yellow discoloration of the skin or white of the eyes (severe liver cell damage, jaundice) or fever, skin redness, and kidney enlargement, sometimes with painful urination and lower back pain (severe kidney inflammation) possibly leading to renal failure.

Other side effects are:

Benign stomach polyps.

• Infrequent(may affect up to 1 in 100 patients)

Headache; dizziness; diarrhea; nausea; vomiting, bloating, and flatulence; constipation; dry mouth; abdominal pain and discomfort; erythema; exanthem, rash; itching; hip, wrist, and spinal column fractures, feeling weak, tired, or generally unwell; sleep disturbances.

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

Visual disturbances such as blurred vision, urticaria; joint pain, muscle pain, weight changes; elevated body temperature; high fever; peripheral edema; allergic reactions; depression; gynecomastia in men; alteration or complete loss of taste.

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

Disorientation.

• Frequency unknown(cannot be estimated from available data)

Illusion, confusion (especially in patients with a history of these symptoms), feeling of tingling, pinching, numbness, burning, or numbness, inflammatory bowel disease causing persistent watery diarrhea, skin rash, possibly with joint pain.

Side effects identified through blood tests:

• Infrequent(may affect up to 1 in 100 patients)

Increased liver enzyme values.

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

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

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

Reduced platelet count in blood, which may cause excessive bleeding or more frequent bruising than usual; reduced white blood cell count, which could lead to more frequent infections; abnormal imbalance between red and white blood cells, as well as platelets.

• Frequency unknown(cannot be estimated from available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD..The expiration date is the last day of the month indicated.

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

Bottle:Keep perfectly closed to protect it from moisture.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Nolpaza Composition

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

Nolpaza Appearance and Packaging Contents

Clear yellowish-brown oval-shaped tablets that are slightly biconvex.

Packaging sizes

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

HDPE plastic bottles of 250 gastro-resistant tablets.

Only some packaging 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 medicinal product, 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 medicinal product has been authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:October 2024

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/