NOLPAZA 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Nolpaza 20 mg Gastro-Resistant Tablets EFG

pantoprazole

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Nolpaza and what is it used for

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

Nolpaza is used for:

Adults and adolescents 12 years of age and older

• treatment of symptoms (heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease, caused by acid reflux from the stomach.
• long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults

• prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require continued treatment with these anti-inflammatory drugs.

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

Talk to 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 need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a greater risk of developing stomach and intestine complications. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers, or stomach or intestinal bleeding.
• If you have low body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all acid-reducing medicines, pantoprazole may reduce the absorption of vitamin B12. Talk to 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, mouth ulcers
• Muscle weakness
• Visual disturbances
• Memory problems, confusion, depression

• Tell your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection 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 hip, wrist, or spine fractures.

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

• If you take pantoprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, see your doctor immediately. Low magnesium levels can also lead to 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 medicine similar 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 stop treatment with this medicine. Also, 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 sensitivity with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking pantoprazole and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.
• It is planned that you will undergo 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
• • pale appearance and feeling of weakness (anemia)
  • chest pain
  • stomach 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 any additional tests to rule out a malignant disease because pantoprazole may alleviate symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a 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

Nolpaza is not recommended for use 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. Therefore, 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 pantoprazole may cause other medicines to not work properly.
• Warfarin or phenprocoumon, which affect blood coagulation. You may need additional monitoring.

• 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 pantoprazole because pantoprazole may 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 pantoprazole if you need to undergo 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 pantoprazole in pregnant women. Pantoprazole has been reported to be 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 and 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 18 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 dose is:

Adults and adolescents from 12 years:

For the treatment of symptoms (heartburn, acid regurgitation, pain when 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 medicine. Once this period is over, and if symptoms recur, they can be controlled by taking one tablet per dayif necessary.

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

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

Adults:

For the prevention of gastroduodenal ulcers in patients who require continued treatment with NSAIDs

The recommended dose is one tablet per day.

Special patient groups:

If you have severe liver problems, you should not take more than one tablet (20 mg) per day.

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

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 pantoprazole 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, mouth ulcers, ulcers on the genitals and eyes. These severe 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 (DRESS or drug hypersensitivity syndrome).

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, hives, difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known; cannot be estimated from 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 sun-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 not known; cannot be estimated from available data):yellowing of the skin or the whites of the eyes (severe liver cell damage, jaundice) or fever, skin redness, and kidney enlargement, sometimes with pain when urinating and lower back pain (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 flatulence (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)

Visual disturbances such as blurred vision; hives; 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 available data)

Hallucinations, confusion (especially in patients with a history of these symptoms), feeling of tingling, pinching, numbness, burning sensation, 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; sharp drop in white blood cells, associated with high fever.

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

Decreased platelet count in the blood, which can cause increased bleeding or bruising; decreased white blood cell count, which can lead to more frequent infections; abnormal decrease in the balance between red and white blood cells and platelets.

• Frequency not known(cannot be estimated from 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 packaging 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 medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Nolpaza

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole 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 tablets, slightly biconvex.

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 pack 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

You can request more information about this medicine by contacting 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/