PANTOPRAZOL NORMON 40 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazol Normon 40 mg Gastro-Resistant Tablets EFG

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Pantoprazol Normon and what is it used for
2. What you need to know before you take Pantoprazol Normon
3. How to take Pantoprazol Normon
4. Possible side effects

5 Storage of Pantoprazol Normon

1. Contents of the pack and further information

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

Pantoprazol Normon contains the active substance pantoprazol

Pantoprazol Normon is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazol Normon is used in adults and adolescents from 12 yearstotreat:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of acid from the stomach.

Pantoprazol Normon is used in adults to treat:

• Infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcer recurrence.

• Stomach and duodenal ulcers.

• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

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

Do not take Pantoprazol Normon

• If you are allergic to pantoprazol 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 (e.g., omeprazol, lansoprazol, rabeprazol, esomeprazol)

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 perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazol.

In case of an increase in liver enzymes, treatment should be discontinued.

• - If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazol. Like all medicines that reduce the amount of acid, pantoprazol may reduce the absorption of vitamin B12. Consult 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
  • Vision problems
  • Memory problems, confusion, depression

• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazol.
  • Taking a proton pump inhibitor like pantoprazol, especially for more than a year, may increase the risk of hip, wrist, or spine fractures.
  • Inform 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 are taking Pantoprazol for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. 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 Pantoprazol to reduce stomach acid.

• If you suffer a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol.

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).

Tell 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 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 stool, which may appear black or tarry
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as pantoprazol has been associated with a small increase in infectious diarrhea.
• severe skin reactions have been reported in relation to treatment with Pantoprazol, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Pantoprazol and call your doctor immediately if you experience any of the symptoms related to severe skin reactions described in section 4.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazol may alleviate cancer symptoms and could delay its diagnosis.

If your symptoms persist despite treatment, additional tests will be performed.

If you take pantoprazol for a prolonged period (more than a year), your doctor may perform regular check-ups. You should inform your doctor of any new or unexpected symptoms or events each time you visit your doctor.

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 medicines

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

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

• Medicines such as ketoconazol, itraconazol, and posaconazol (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazol may make these and other medicines not work properly.
• Warfarin and fenprocumon, 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 discontinue treatment with Pantoprazol because 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 need to have a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazol in pregnant women. It has been reported that in humans, pantoprazol is excreted in breast milk.

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should only use this medicine if your doctor considers that the benefit for you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazol has no or negligible influence on the ability to drive or use machines.

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

Pantoprazol Normon contains sodium

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

3. How to take Pantoprazol Normon

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

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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 from 12 years:

For the treatment of reflux esophagitis

The usual dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will indicate how long you should take this medicine.

Adults:

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

One tablet twice a day plus the two antibiotic tablets, either amoxicillin, clarithromycin, and metronidazol (or tinidazol), each taken twice a day with your pantoprazol tablet. Take the first pantoprazol tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the leaflets of the antibiotics.

The treatment duration is usually one to two weeks.

For the treatment of stomach and duodenal ulcers

The usual dose is one tablet per day. The dose may be doubled by your doctor.

Your doctor will indicate how long you should take this medicine. The treatment duration for stomach ulcers is usually between 4 and 8 weeks. The treatment duration for duodenal ulcers is usually between 2 and 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion

The initial recommended dose is two tablets per day.

Take the two tablets one hour before a meal. Afterwards, your doctor may adjust your dose, depending on the amount of acid secretion you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

If you are prescribed more than four tablets per day, you will be told exactly when to stop treatment.

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• If you have kidney problems, you should not take this medicine for the elimination of Helicobacter pylori.

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• If you have severe liver problems, you should not take more than one 20 mg pantoprazol tablet per day (20 mg pantoprazol tablets are available for this case).

If you have moderate or severe liver problems, you should not take pantoprazol for the elimination of Helicobacter pylori.

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

If you take more Pantoprazol Normon than you should

Tell your doctor or pharmacist or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount taken. There are no known symptoms of overdose.

If you forget to take Pantoprazol Normon

Do not take a double dose to make up for forgotten 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 on the use of this product, ask your doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, pantoprazol can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking these tablets and

Inform your doctor immediately, or contact the emergency service of the nearest hospital.

• 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, swelling of the face of allergic origin (Quincke's edema/angioedema), intense dizziness with very rapid heartbeats and profuse sweating.

• - Severe skin disorders (frequency not known, its frequency cannot be estimated with the available data): you may notice one or more of the following - blisters on the skin and a rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or symptoms similar to those of the flu, 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 syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-like spots of slightly reddish color 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 severe conditions (frequency not known; its frequency cannot be estimated with the available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size sometimes with pain when urinating and pain in the lower back (severe kidney inflammation) which may cause kidney failure.

Other adverse 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; feeling of dizziness, vomiting; swelling and flatulence (gases); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, exanthem, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.

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

Alteration or complete loss of taste;

vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral edema); allergic reactions; depression; increased breast size in men.

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

Disorientation

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

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

Adverse effects identified through blood tests:

• Infrequent (may affect up to 1 in 100 patients) Increase) of liver enzymes.

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

Increased bilirubin; increased levels of fat 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 of platelet count, which could produce bleeding or more hematomas than usual; reduction of white blood cell count, which could lead to more frequent infections; abnormal reduction of the balance between the number of red and white blood cells, as well as platelets.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pantoprazol Normon

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Pantoprazol Normon

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of 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

Copolymer of methacrylic acid and ethyl acrylate (1:1).

Appearance of the product and package contents

Pantoprazol Normon 40 mg is presented in the form of gastro-resistant tablets, orange, oval, biconvex. Each package contains 14, 28, and 56 gastro-resistant tablets in Alu/Alu blisters or in HDPE bottles of 28 and 56 gastro-resistant tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON S.A.

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

Date of the last revision of this prospectus:September 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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/69548/P_69548.html

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