Nolpaza 20 mg gastro-resistant tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Nolpaza 20 mg gastro-resistant tablets EFG

pantoprazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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. Proton pump inhibitors such as pantoprazole reduce the amount of acid in your stomach. It is used for the treatment of acid-related diseases of the stomach and intestine.

Nolpaza is used for:

Adults and adolescents 12 years of age or 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 at-risk patients who require ongoing treatment with these types of anti-inflammatory medicines.

2. What you need to know before taking 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 containing other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine:

• If you have severe liver disease. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially if you are taking pantoprazole for long-term treatment. If liver enzyme levels rise, treatment should be discontinued.

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as this may increase the risk of stomach and intestinal complications. Any increase in risk will be assessed according to individual risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.

• If you have reduced body stores of vitamin B12 or risk factors for this condition and are receiving long-term pantoprazole treatment. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you experience any of the following symptoms, which may indicate vitamin B12 deficiency:

• Extreme tiredness or lack of energy

• Tingling sensations

• Tongue pain or red tongue, mouth ulcers

• Muscle weakness

• Vision disturbances

• Memory problems, confusion, depression

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.

• Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may increase the risk of fractures of the hip, wrist, or spine.

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

• If you are taking pantoprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.
• If you have had allergic reactions after treatment with a medicine similar to pantoprazole that reduces stomach acidity.
• If you develop 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. Remember to also mention other adverse effects such as joint pain.
• Serious skin reactions have been reported with 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 serious skin reactions described in section 4.
• You are scheduled to have a specific blood test (Chromogranin A).

Contact your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in vomit: may appear as dark, coffee-ground-like material
• Blood in your stools, which may appear black or tarry (melena)
• Difficulty swallowing or pain when swallowing
• Pale appearance and feeling weak (anemia)
• Chest pain
• Stomach pain
• Severe and/or persistent diarrhea, as a small increased risk of infectious diarrhea has been associated with pantoprazole.

Your doctor will decide whether additional tests are needed to rule out malignancy, as pantoprazole may relieve cancer symptoms and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

If you take pantoprazole for a prolonged period (more than one year), your doctor will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at each visit.

Children and adolescents

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

Other medicines and Nolpaza

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

This medicine may interfere with the effectiveness of other medicines. Therefore, inform your doctor if you are taking:

• Medicines 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 these medicines.
• Warfarin or fenprocoumon, which affect blood clotting. You may require 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 discontinue pantoprazole treatment, as pantoprazole may increase methotrexate blood levels.
• 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).

Taking Nolpaza with food and drink

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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and using machines

This medicine has no effect or an insignificant effect on the ability to drive or operate machinery.

However, you should not drive or operate machinery if you experience adverse 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; i.e., it is essentially “sodium-free”.

3. How to take Nolpaza

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration

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

Unless your doctor has prescribed otherwise, the recommended dose is:

Adults and adolescents aged 12 years and older:

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

The recommended dose is one tablet per day. This dose generally provides relief within 2–4 weeks, or at most after another 4 weeks. Your doctor will advise you on how long you should continue taking this medicine. After this period, if symptoms recur, they may be controlled, if necessary, by taking one tablet per day.

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

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

Adults:

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

The recommended dose is one tablet per day.

Special patient groups:

If you have severe liver problems, you must not take more than one tablet (20 mg) 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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed dose. Take your next dose as usual.

If you stop taking Nolpaza

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, peeling, mouth, throat, nose, genital or eye ulcers. These serious rashes 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).

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

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

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

• Other serious disorders (frequency not known; frequency cannot be estimated from available data): yellowing of the skin or 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 possibly lead to kidney failure.

Other adverse effects are:

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

Benign polyps in the stomach.

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

Headache; dizziness; diarrhea; nausea; vomiting, bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; erythema; rash, eruption; itching; fracture of hip, wrist, and spine; feeling of weakness, exhaustion or general discomfort; sleep disturbances.

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

Vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men; altered or complete loss of taste sensation.

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

Disorientation.

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

Hallucination, confusion (especially in patients with a history of these symptoms), tingling sensation, pricking, numbness, burning or freezing sensation, inflammation of the large intestine causing persistent watery diarrhea, skin rash, possibly with joint pain.

Adverse effects identified through blood tests:

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

Increased liver enzyme values.

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

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

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

Reduction in the number of platelets in the blood, which may lead to increased bleeding or bruising; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal decrease in the balance between the number of red and white blood cells as well as platelets.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Bottle: Keep tightly closed to protect it from moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nolpaza

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium pantoprazole 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 pack

Yellowish-brown, oval-shaped, slightly biconvex tablets.

Pack sizes

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

HDPE plastic bottles containing 250 gastro-resistant tablets.

Only certain 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

For further information about this medicinal product, 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 under the following names:

Date of the most recent review of this leaflet: October 2024

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