Package Insert: Information for the Patient

Nolpaza 20 mg Gastric-Resistant Tablets EFG

pantoprazol

Read this 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

• Treatment of symptoms (stomach burning, acid regurgitation, difficulty swallowing) associated with gastroesophageal reflux disease, caused by acid reflux from the stomach.
• Long-term treatment and prevention of recurrences of esophagitis caused by acid reflux (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults

• Prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastroduodenal ulcers in high-risk patients who require continued treatment with this type of anti-inflammatory.

Do not take Nolpaza

• if you are allergic to pantoprazole, sorbitol, or any of the other ingredients in 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 need to take nonsteroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing complications in the stomach and intestines. Any increased risk will be evaluated based on individual risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or gastrointestinal bleeding.
• If you have decreased vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. As all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption. Consult your doctor if you observe any of the following symptoms, as they may indicate vitamin B12 deficiency:

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

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of fractures of the hips, wrists, or spine.

Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of developing osteoporosis (e.g., 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 periodic 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, inform your doctor as soon as possible, as you may need to discontinue treatment with this medication. Remember to mention other negative effects 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.
• You will be scheduled to undergo 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

• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Abdominal pain
• 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 malignant disease, 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 to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may reduce the effectiveness of other medications.
• Warfarin or phenprocoumon, which affect blood clotting. You may need additional monitoring.

-Medications used to treat HIV infection, such as atazanavir.

-Metotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), as your doctor may temporarily discontinue pantoprazole treatment due to increased metotrexate levels in the blood.

-Fluvoxamine (used to treat depression and other psychiatric disorders), as your doctor may reduce the dose.

-Rifampicin (used to treat infections).

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

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

Use of Nolpaza with food and beverages

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. Pantoprazole has been 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 negligible influence on the ability to drive or operate machinery.

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

Nolpaza contains sorbitol and sodium

This medication contains 18 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 otherwise, the recommended dose is:

Adults and adolescents 12 years and older:

For the treatment of symptoms (heartburn, acid regurgitation, difficulty swallowing) associated with gastroesophageal reflux disease

The recommended dose is one tablet per day. This dose usually provides relief within 2-4 weeks, or at most after another 4 weeks. Your doctor will tell you how long you should continue taking this medication. Once this period is over, and if symptoms recur, they may be controlledby taking one tablet per day.

For long-term treatment and prevention of relapses of esophagitis due to reflux

The recommended dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take instead 1 tablet of pantoprazole 40 mg per day. After recovery, you can reduce the dose again to one tablet (20 mg) per day.

Adults:

For the prevention of gastric and duodenal ulcers in patients requiring continued treatment with NSAIDs

Continued treatment with NSAIDs

The recommended dose is one tablet per day.

Special patient groups:

If you have severe liver problems, do not take more than one tablet (20 mg) 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 forget to take Nolpaza

Do not take a double dose to make up 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, throat, nose, genital, and eye ulcers. These severe exanthems may be preceded by fever and flu-like symptoms (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. You may also experience 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 unknown; cannot be estimated with available data):yellowing 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, pruritus; fracture of the hip, wrist, and spine, feeling of weakness, fatigue, or general malaise; 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 not listed in this leaflet. You can also report them directly through the Spanish System for 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. This way, you will help protect the environment.

Composition of Nolpaza

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 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.

Appearance of Nolpaza and contents of the packaging

Yellowish-brown, oval, slightly biconvex tablets.

Pack 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 pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

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 revision 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/