Package Leaflet: Information for the User

Pantoprazol Normon 20 mg gastro-resistant tablets EFG

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

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

2. What you need to know before taking Pantoprazol Normon

3. How to take Pantoprazol Normon

4. Possible side effects

5. Storage of Pantoprazol Normon

6. Contents of the pack and additional information

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

PantoprazolNormonis usedin adults and adolescents aged 12 years and older to treat::

• Symptoms (for example, stomach burning, acid regurgitation, difficulty swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of esophagitis caused by acid reflux (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 nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continued treatment with this type of medication.

Do not take Pantoprazol Normon

• If you are allergic to pantoprazole or any of the other ingredients of this medication (listed in section 6).
• If you are allergic to medications that contain other proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take 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 when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be discontinued.
• If you need to take NSAIDs continuously and take pantoprazole, as there is a higher risk of developing stomach and intestinal complications. 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 reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. Like all medications that reduce acid production, 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
  • Tickling
  • Pain or redness in the tongue, ulcers in the mouth
  • Muscle weakness
  • Vision problems
  • 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 Pantoprazol for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, 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 ever had a skin reaction after treatment with a similar medication to pantoprazole for reducing stomach acid.

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

If you are scheduled to undergo a specific blood test (Cromogranin A).

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

• 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
• Stomach pain
• Severe or persistent diarrhea, as this medication has been associated with a small increase in infectious diarrhea.
• Severe skin reactions have been reported in relation to Pantoprazol treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazol and contact your doctor immediately if you experience any symptoms related to severe skin reactions described in section 4.

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

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

Taking Pantoprazol Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pantoprazol may affect the efficacy of other medications, inform your doctor if you are taking:

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

Medications 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 Pantoprazol Normon treatment due to pantoprazole increasing 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).

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

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human breast milk.

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

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

Pantoprazol Normon contains sodium

This medication contains less than23 mg of sodium (1 mmol) per tablet; this 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 tablets 1 hour before meals without chewing or breaking them and swallow them whole with water.

The recommended dose is:

Adults and adolescents 12 years and older:

For treating symptoms associated with gastroesophageal reflux disease (stomach burning, acid regurgitation, difficulty swallowing)

The usual dose is 1 tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within a maximum of 4 weeks. Your doctor will tell you how long you should continue taking the medication.

Any repeated symptoms can be controlled as needed by taking 1 tablet per day.

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

The usual dose is 1 tablet per day. If the disease returns, your doctor may double the dose, in which case you can take pantoprazole 40 mg once a day. After healing, you can reduce the dose again to 1 tablet of 20 mg per day.

Adults:

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

The usual dose is 1 tablet per day.

Patients with liver problems

If you have severe liver problems, do not take more than 1 tablet of 20 mg per day.

Use in children and adolescents:

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

If you take more Pantoprazol Normon than you should

Inform your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. No symptoms of overdose are known.

If you forgot to take Pantoprazol Normon

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

If you interrupt treatment with Pantoprazol Normon

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

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

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

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

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

• Severe skin changes (unknown frequency; its frequency cannot be estimated with the available data): you may notice one or more of the following):blistering of the skin and a rapid deterioration of overall conditions, erosion (including mild bleeding) of eyes, nose, mouth/lips, or genitals, or skin sensitivity/eruption, particularly in areas of exposed skin to light/sun. You may also have 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. (Stevens-Johnson syndrome, Lyell syndrome, Multiform erythema, Acute cutaneous lupus erythematosus, Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), Photosensitivity). Circular or target-shaped red patches on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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 or drug hypersensitivity).

• Other serious conditions (unknown frequency):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased kidney size with occasional pain while urinating, and back pain in the lower part of the back (severe kidney inflammation), possibly leading to kidney failure.

Other side effects are:

• Frequent(may affect up to 1 in 10 patients): benign polyps in the stomach.

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

Headache; dizziness; diarrhea; sensation of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthem, rash; tingling; feeling of weakness, fatigue, or general discomfort; sleep disturbances; hip fracture, wrist fracture, and spinal column fracture.

Alteration or complete absence of the sense of taste;

vision changes 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; breast enlargement in men.

Disorientation

• Unknown frequency(cannot be estimated from the available data)

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

Side effects identified through blood tests:

• Infrequent(may affect up to1in100patients)
• increase in liver enzymes.

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

Increased bilirubin; increased levels of fats in the blood; 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 that could cause bleeding or more frequent bruising; reduction in the number of white blood cells that could lead to more frequent infections; abnormal reduction in the balance between the number of red and white blood cells, as well as platelets

.

• Unknown frequency(cannot be estimated from the available data)decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 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 medicine.

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

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pantoprazol Normon

-The active ingredient is pantoprazol. Each gastro-resistant tablet contains 20 mg of pantoprazol (in the form of sodium sesquihydrate).

- The other components are:

Core: sodium carbonate, mannitol (E-421), sodium caramelose, sodium carboxymethylcellulose (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 copolymer of methacrylic acid and ethyl acrylate (1:1).

Appearance of the product and contents of the packaging

PantoprazolNormon20 mgis presented in the form ofgastro-resistant tablets of orange color, oval and biconvex shape, which are presented in Alu/Alu blister packs of 28 and 56 tablets or in HDPE bottles of 28 and 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:September 2024

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/71299/P_71299.html