Leaflet: information for the user

Pantoprazol Normon 40 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking the 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 give it to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take 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 Normon is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach acid and intestine.

Pantoprazol Normon is used in adults and adolescents aged 12 and abovetotreat:

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

Pantoprazol Normon is used in adults to treat:

- Infection caused by a bacteria 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 bacteria and thus reduce the likelihood of ulcers reappearing.

- Stomach and duodenal ulcers.

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

Do not take Pantoprazol Normon

- If you are allergic to pantoprazole or any of the other components 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.

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

• - If you have reduced vitamin B12 reserves or risk factors for it and receive long-term treatment with pantoprazole. As all medications that reduce the amount of acid, pantoprazole may reduce vitamin B12 absorption. Consult your doctor if you notice any of the following symptoms, as they may indicate vitamin B12 deficiency:
• • Congestive fatigue or lack of energy
  • Tickling
  • Pain or redness in the tongue or mouth ulcers
  • Muscle weakness
  • Vision problems
  • Mental confusion, depression

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

• Long-term use of a proton pump inhibitor like pantoprazole 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 developing osteoporosis (for example, 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, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.

• If you have ever had a skin reaction after treatment with a similar medication to Pantoprazol for reducing stomach acid.

• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt 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 (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 your stool, which may appear black or melena
• Difficulty swallowing or pain when swallowing
• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Abdominal pain
• Severe or persistent diarrhea, as pantoprazole 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 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, as pantoprazole may alleviate cancer symptoms and delay diagnosis.

If your symptoms persist despite treatment, further investigations will be performed.

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

Pantoprazol use 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 interrupt treatment with Pantoprazol as 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)

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

Pregnancy, breastfeeding, and fertility

No sufficient data is available on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human breast milk.

If you are pregnant, or in the breastfeeding period, believe you may be pregnant, or intend to become 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 adverse effects such as dizziness or blurred vision.

Pantoprazol Normon contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Form of administration:

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 the treatment of esophagitis caused by reflux

The usual dose is 1 tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time for esophagitis caused by reflux usually lasts between 4 and 8 weeks. Your doctor will tell you for how long to take this medication.

Adults:

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

1 tablet twice a day plus the 2 antibiotic tablets, either amoxicillin, clarithromycin, and metronidazole (or tinidazole), each must be taken twice a day with your pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second 1 hour before dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually 1 to 2 weeks.

For the treatment of stomach and duodenal ulcers

The usual dose is 1 tablet per day. The dose may be doubled by your doctor.

Your doctor will tell you for how long to take this medication. 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 production

The initial recommended dose is 2 tablets per day.

Take the 2 tablets 1 hour before a meal. Your doctor may then adjust your dose depending on the amount of stomach acid you produce. If you are prescribed more than 2 tablets per day, you should take the tablets twice a day.

If you are prescribed more than 4 tablets per day, you will be told exactly when to stop treatment.

Patients with kidney problems:

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

Patients with liver problems

- If you have severe liver problems, you should not take more than 1 tablet of 20 mg of pantoprazole per day (for this case, tablets of 20 mg of pantoprazole are available).

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

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

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

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 the treatment with Pantoprazol Normon

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

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

Like all medications, pantoprazole may have 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 emergency service at the nearest hospital.

-Severe allergic reactions (frequency: 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.

-Other serious conditions(frequency: unknown; cannot be estimated with available data):yellowing of the skin and eyes (severe liver cell damage, jaundice), or fever, hives, enlarged kidneys sometimes with painful urination and lower back pain (severe kidney inflammation) possibly leading to renal failure.

Other side effects are:

• Frequent(may affect up to 1 in 10 patients):

Benign stomach polyps.

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

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

Loss or complete absence of taste;

vision disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; elevated body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; gynecomastia in men.

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

Disorientation

-Frequency unknown(cannot be estimated from available data)

Altered perception, confusion (especially in patients with a history of these symptoms),sensation of tingling, pinching, numbness, burning, or numbness,, skin rash, possibly with joint pain andinflammatory bowel disease causing persistent watery diarrhea.

Side 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)

Reduced platelet count, which could cause bleeding or more frequent bruising; reduced white blood cell count, which could lead to more frequent infections; abnormal reduction in the balance between red and white blood cells, as well as platelets.

-Frequency unknown(cannot be estimated from available data)

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

Reporting 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 the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or 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 40 mg of pantoprazol (in the form of sodium sesquihydrate).

• The other components are:

Core:

Sodium carbonate

Manitol (E-421)

Sodium carmelose

Carboxymethylcellulose sodium (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 contents of the packaging

PantoprazolNormon40 mg is presented in the form of gastro-resistant, orange, oval, biconvex tablets. Each package contains 14, 28 and 56 gastro-resistant tablets in Alu/Alu blister or in HDPE bottles of 28 and 56 gastro-resistant 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 mobile phone (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/69548/P_69548.html

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