Pantoprazole Normon 20 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Normon 20 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Pantoprazol Normon is and what it is used for

Pantoprazol Normon contains the active substance pantoprazol. Pantoprazol is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related disorders of the stomach and intestine.

Pantoprazol Normon is used in adults and adolescents aged 12 years and older to treat:

• Symptoms (e.g., heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of relapses.

Pantoprazol Normon is used in adults for:

• 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 medications.

2. What you need to know before starting to take Pantoprazol Normon

Do not take Pantoprazol Normon

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (for example, omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Pantoprazol:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. Your doctor will monitor your liver enzymes more frequently, especially if you are on long-term treatment with pantoprazole. If liver enzymes increase, treatment should be discontinued.

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal 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, and are receiving long-term treatment with pantoprazole. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12. Consult your doctor if you notice any of the following symptoms, which may indicate vitamin B12 deficiency:

  • Extreme tiredness or lack of energy
  • Tingling
  • Tongue pain or red tongue, mouth ulcers
  • Muscle weakness
  • Vision disturbances
  • Memory problems, confusion, depression

• Talk to 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 if you 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, seek medical attention 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 magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole used to reduce stomach acidity.

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with pantoprazole. Remember to mention any other symptoms you may notice, such as joint pain.

If you are scheduled to have a specific blood test (Chromogranin A).

Contact your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in vomit: this may appear as dark, coffee-ground-like material in your vomit
• 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 or persistent diarrhea, as this medicine has been associated with a small increased risk of infectious diarrhea.
• Serious skin reactions have been reported in association 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.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve symptoms of cancer 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 may monitor you regularly. You should inform your doctor of any new or unexpected symptoms and/or events during each visit.

Children and adolescents

The use of Pantoprazole is not recommended in children, as it has not been tested in children under 12 years of age.

Taking Pantoprazol Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.

Pantoprazol may affect the effectiveness of other medicines. Inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazol may cause these and other medicines to not work properly.
• Warfarin and 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 interrupt treatment with Pantoprazol Normon, as pantoprazol 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 Pantoprazol if you are due to undergo a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There are insufficient data available on the use of pantoprazol in pregnant women. It has been reported that pantoprazol is excreted in human milk.

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should only be used if your doctor considers the benefit to you to outweigh the potential risk to the fetus or infant.

Driving and using machines

Pantoprazol has no effect or an effect so slight that it is negligible 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.

Pantoprazol Normon contains sodium

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

3. How to take Pantoprazol Normon

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

Administration method:

Take the tablets 1 hour before meals, without chewing or breaking them, swallowing them whole with water.

The recommended dose is:

Adults and adolescents aged 12 years and older:

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

The usual dose is one tablet daily.

This dose generally provides relief within 2 to 4 weeks, and if not, at most within the following 4 weeks. Your doctor will advise you on how long you should continue taking the medicine.

Thereafter, any recurring symptoms can be managed as needed by taking one tablet daily.

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

The usual dose is one tablet daily. If the disease recurs, your doctor may double your dose, in which case you may take pantoprazole 40 mg once daily. After healing, the dose may be reduced again to one 20 mg tablet daily.

Adults:

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

The usual dose is one tablet daily.

Patients with liver problems

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

Use in children and adolescents:

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

If you take more Pantoprazol Normon than you should

Inform your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. Symptoms of overdose are not known.

If you forget to take Pantoprazol Normon

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

If you stop taking Pantoprazol Normon

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, pharmacist, or nurse.

4. Possible adverse effects

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

If you experience any of the following adverse effects, stop taking these tablets immediately and contact your doctor right away, or contact the nearest hospital emergency service:

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

• Severe skin disorders (frequency not known ; frequency cannot be estimated from available data): you may notice one or more of the following: blisters on the skin and rapid deterioration of 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/sunlight. You may also experience 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. (Stevens-Johnson syndrome, Lyell's syndrome, Erythema Multiforme, Subacute Cutaneous Lupus Erythematosus, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Photosensitivity). Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, skin peeling, ulcers in mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation), which may possibly lead to kidney failure.

Other adverse effects are:

• Frequent (may affect up to 1 in 10 patients): Benign gastric polyps.

• Uncommon (may affect up to 1 in 100 patients):
  Headache; dizziness; diarrhoea; dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances; hip, wrist and spinal fractures.

• Rare (may affect up to 1 in 1,000 patients):
  Disturbance or complete loss of taste sensation;
  visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the extremities (peripheral edema); allergic reactions; depression; enlargement of the breasts in men.

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

• Frequency not known (cannot be estimated from available data):
  Hallucination, confusion (especially in patients with a history of these symptoms), sensation of tingling, pricking, numbness, burning or tingling, skin rash, possibly accompanied by joint pain and inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 patients):
  Increased liver enzymes.

• Rare (may affect up to 1 in 1,000 patients):
  Increased bilirubin; increased blood fat 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):
  Reduction in the number of platelets, which could lead to bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; abnormal decrease in the balance between red blood cells, white blood cells, and platelets.

• Frequency not known (cannot be estimated from available data): decrease in blood levels of sodium, magnesium, calcium or potassium (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Normon

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, 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 Pantoprazole Normon

• The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components are:

Core: sodium carbonate, mannitol (E-421), sodium carmellose, sodium carboxymethyl starch (type A) (from potato), magnesium stearate, colloidal silica.

Coating: propylene glycol (E-1520), yellow iron oxide (E-172), titanium dioxide (E-171), hypromellose, triethyl citrate and methacrylic acid-ethyl acrylate copolymer (1:1).

Appearance of the product and contents of the pack

Pantoprazole Normon 20 mg is presented as orange-colored, oval, biconvex gastro-resistant tablets, available in packs of 28 and 56 tablets in Alu/Alu blisters or in HDPE bottles containing 28 or 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: September 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71299/P_71299.html