PANTOPRAZOL NORMON 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazol Normon 20 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
6. Contents of the pack and further information

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

Pantoprazol Normon contains the active substance pantoprazole. Pantoprazole 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 usedin adults and adolescents from 12 years to treat:

• Symptoms (such as heartburn, acid reflux, pain when 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 reflux 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, such as ibuprofen) in patients at risk who require continued treatment with these types of drugs.

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

Do not take Pantoprazol Normon

• If you are allergic to pantoprazole 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 (such as omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Pantoprazol:

• If you have severe liver problems. Tell 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 pantoprazol. If there is an increase in liver enzymes, treatment should be discontinued.
• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazol, as there is a higher risk of developing complications in the stomach and intestine. Any increased risk will be assessed according to your personal risk factors, such as age (65 years or older), history of stomach or duodenal ulcers, or stomach or intestinal bleeding.
• If you have low body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazol. Like all medicines that reduce acid, pantoprazol may reduce the absorption of vitamin B12. Talk to 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
  • Visual disturbances
  • Memory problems, confusion, depression

• Talk to your doctor if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) 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.

Tell 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 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 have any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazol to reduce stomach acid.

If you get a skin rash, especially in areas of the skin exposed to the sun, talk to your doctor as soon as possible, as it may be necessary to stop 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 immediatelybefore 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, especially 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 stools, 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 this medicine has been associated with a small increase in infectious diarrhea.
• There have been reports of serious skin reactions in relation to treatment with Pantoprazol, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug hypersensitivity 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 serious skin reactions described in section 4.

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

If, despite treatment, your symptoms persist, further investigations will be carried out. If you take pantoprazol for a prolonged period (more than a year), your doctor may monitor you regularly. You should inform your doctor of any new symptoms and/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 of age.

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 effectiveness of other medicines. Tell your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (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 phenprocoumon, 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 stop 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 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 pantoprazol is excreted in human breast milk.

If you are pregnant or 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 and 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 the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

F:

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:

To treat symptoms associated with gastroesophageal reflux disease(heartburn, acid reflux, pain when swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within the following 4 weeks. Your doctor will tell you how long you should keep taking the medicine.

Afterwards, any recurring symptoms can be controlled by taking one tablet per day as needed.

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

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take pantoprazol 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

P

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

U

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

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. No symptoms of overdose are known.

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 consulting your doctor or pharmacist first.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

• Severe allergic reactions (rare; 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 (angioedema), severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known; frequency cannot be estimated from the available data): you may notice one or more of the following): blisters on the skin and 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 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. (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug hypersensitivity with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-like red patches on the trunk, often with blisters in the center, peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. These severe rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known; frequency cannot be estimated from the available data): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side 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; feeling of dizziness, vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; numbness; 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;

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

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

Disorientation

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

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

Side effects identified through blood tests:

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

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

increase in bilirubin; increase in blood fat levels; sudden drop in white blood cells with high fever.

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

reduction in the number of platelets that could lead to bleeding or more bruising than usual; 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

.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Pantoprazol Normon Composition

• 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 carmellose, sodium carboxymethyl starch (type A) (from potato), magnesium stearate, colloidal silicon dioxide.

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).

Product Appearance and Packaging Contents

Pantoprazol Normon 20 mg is presented in the form of orange, oval, and biconvex gastro-resistant tablets, which are available in packs of 28 and 56 tablets in Alu/Alu blisters or in HDPE bottles of 28 and 56 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 Leaflet:September 2024

Detailed information on this medicinal product 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 medicinal product by scanning the QR code included in the leaflet 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/71299/P_71299.html