Pantoprazole Normon 40 mg gastro-resistant tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the user

Pantoprazole Normon 40 mg gastro-resistant tablets EFG

Read the entire 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 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, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

• Reflux esophagitis. This is inflammation of your esophagus (the tube connecting 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 gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacterium and thereby reduce the likelihood of ulcer recurrence.

• Gastric and duodenal ulcers.

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

2. What you need to know before taking Pantoprazole Normon

Do not take Pantoprazole 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 Pantoprazole:

• 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 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 experience any of the following symptoms, as they may indicate vitamin B12 deficiency:

  • Extreme tiredness or lack of energy
  • Tingling sensations
  • 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, contact your doctor 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 conditions:

• 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 (anaemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.
• Serious skin reactions have been reported during treatment with Pantoprazole, 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 malignant disease, 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 will likely monitor you regularly. You should inform your doctor of any new or unexpected symptoms or events at 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 pantoprazole may cause these and other medicines to not work properly.
• Warfarin and phenprocoumon, 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, 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).

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 on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk.

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

You should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and using machines

Pantoprazole has no effect or a negligible effect 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; therefore, it is essentially "sodium-free".

3. How to take Pantoprazol Normon

Follow exactly the instructions for use of this medicine given 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, and swallow them whole with water.

The recommended dose is:

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis

The usual dose is one tablet daily. Your doctor may instruct you to increase the dose to two tablets daily. The treatment duration for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will advise you on how long you should take this medicine.

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy)

One tablet twice daily, together with two antibiotic tablets—either amoxicillin, clarithromycin, and metronidazole (or tinidazole)—each to be taken twice daily along with your pantoprazole tablet. Take the first pantoprazole tablet one hour before breakfast and the second one hour before dinner. Follow your doctor's instructions and make sure to read the package leaflets of the antibiotics.

The treatment duration is normally one to two weeks.

For the treatment of gastric and duodenal ulcers

The usual dose is one tablet daily. Your doctor may double the dose.

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

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with increased gastric acid secretion

The recommended initial dose is two tablets daily.

Take both tablets one hour before a meal. Subsequently, your doctor may adjust your dose depending on the amount of gastric acid secreted. If you are prescribed more than two tablets daily, you should take them in two divided doses per day.

If you are prescribed more than four tablets daily, you will be specifically informed about when to discontinue treatment.

Patients with kidney problems:

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

Patients with liver problems

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

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

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 Normondel than you should

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

If you forget to take Pantoprazol Normon

Do not take a double dose to make up for 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, pantoprazole may have adverse effects, although not everyone will experience them.

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

Contact your doctor immediately, or contact the emergency service at 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, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.

• • Severe skin disorders (frequency unknown; frequency cannot be estimated from available data): you may notice one or more of the following – blisters on the skin and a rapid worsening 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/sun. 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, mouth, throat, nose, genital or eye ulcers. These severe rashes may 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 unknown; frequency cannot be estimated from available data): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys sometimes with pain during urination 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; diarrhea; feeling of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances; fractures of the hip, wrist, and spine.

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

Disturbance or complete loss of taste;

vision disorders such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; 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 available data):

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

Adverse 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):

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):

Decreased levels of sodium, magnesium, calcium, or potassium 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 they are possible adverse effects not listed in this leaflet. You can 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 sight and reach of children.

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If 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 Pantoprazol Normon

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).

• The other components are:

Core:

Sodium carbonate
Mannitol (E-421)
Sodium carboxymethylcellulose
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 contents of the pack

Pantoprazol Normon 40 mg is presented as orange, oval, biconvex gastro-resistant tablets. Each pack contains 14, 28, or 56 gastro-resistant tablets in Alu/Alu blisters or in HDPE bottles containing 28 or 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 most recent 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 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 can also access this information at the following internet address:

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