PANTOPRAZOL DAVUR 40 mg GASTRO-RESISTANT TABLETS

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

Do not take Pantoprazol Davur

• If you are allergic to pantoprazole or to any of the other ingredients of this medicine (included in section 6).
• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Consult your doctor or pharmacist before starting to take pantoprazole

• • If you have serious liver problems. Tell your doctor if you have ever had liver problems. Your doctor will perform more frequent monitoring of liver enzymes, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.
• If you need to take medicines called NSAIDs continuously and take pantoprazole, as there is a greater risk of developing complications in the stomach and intestine. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestinal bleeding.
• If you have decreased body reserves of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce the amount of acid, pantoprazole could reduce the absorption of vitamin B12.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection 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 hip, wrist, or spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told that you are at risk of osteoporosis (for example, if you are taking corticosteroids).

• If you have ever had a skin reaction after treatment with a medicine similar to pantoprazole 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.
• A specific blood test (Chromogranin A) is planned.
• If you take pantoprazole for more than three months, you may suffer a decrease in magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you have any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may produce a decrease in potassium and calcium levels in the blood. Your doctor will decide to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing, or pain when swallowing
• blood in the vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools
• severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole may alleviate the symptoms of cancer and could delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than a year), your doctor will possibly monitor you regularly. You should inform your doctor of any new or unexpected symptoms and/or events each time you visit your doctor.

Taking Pantoprazol Davur 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 Davur may affect the efficacy of other medicines, so inform 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 Davur may cause these and other medicines to not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional controls.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking a high dose of methotrexate, your doctor will temporarily stop treatment with pantoprazole.
  • Fluvoxamine (used to treat depression and other psychiatric disorders) if you are taking fluvoxamine, your doctor may reduce the dose.
  • Rifampicin (used to treat infections).

St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or 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 for you is greater than the potential risk to the fetus or baby.

Driving and using machines

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

Pantoprazol Davur contains sodium

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

3. How to take Pantoprazol Davur

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Method of administration

Take the tablets whole, without chewing or crushing, with the help of a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the recommended dose is:

Adults and adolescents from 12 years:

For the treatment of reflux esophagitis:

The recommended dose is one tablet per day. Your doctor may indicate an increase to 2 tablets per day. The treatment time 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 calledHelicobacter pyloriin 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 metronidazole (or tinidazole), each to 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 package inserts of the antibiotics.

The duration of treatment is usually one to two weeks.

For the treatment of stomach and duodenal ulcers

The recommended 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 time for stomach ulcers is usually between 4 and 8 weeks. The treatment time 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 1 hour before a meal. Later, your doctor may adjust the 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 you should finish the treatment.

Patients with kidney problems

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

Patients with liver problems

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

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

Use in children and adolescents

Children (under 12 years): The use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazol Davur than you should

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

If you forget to take Pantoprazol Davur

Do not take a double dose to make up for forgotten doses. Take your next dose as usual.

If you stop taking Pantoprazol Davur

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 or pharmacist.

4. Possible side effects

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

The frequency of the possible side effects described below is classified as follows:

very common (may affect more than 1 in 10 people)

common (may affect up to 1 in 10 people)

uncommon (may affect up to 1 in 100 people)

rare (may affect up to 1 in 1,000 people)

very rare (may affect up to 1 in 10,000 people)

frequency not known (cannot be estimated from the available data).

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

• Severe allergic reactions (rare frequency):swelling of the tongue and/or throat, difficulty swallowing, hives (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 changes (frequency not known):blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

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).

• Other serious conditions (frequency not known):yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating, and lower back pain (severe kidney inflammation), which may possibly cause kidney failure.

Other side effects are:

• Common

benign polyps in the stomach.

• Uncommon

headache; dizziness; diarrhea; feeling of dizziness, nausea, 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; hip, wrist, and spine fractures.

• Rare

alteration or complete loss of taste, vision changes such as blurred vision; hives; 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

disorientation

• Frequency not known

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

Side effects identified through blood tests:

• Uncommon:

increased liver enzymes

• Rare:

increased bilirubin; increased blood fat levels, sudden drop in circulating granulocytes.

• Very rare:

reduction of platelet count that could cause bleeding or more bruising than usual; reduction of white blood cell count that could lead to more frequent infections; coexistence of an abnormal reduction of red blood cell, white blood cell, and platelet counts.

• Frequency not known: decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazol Davur

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.

HDPE bottle:

This medicine does not require special storage conditions.

Aluminum/Aluminum blister:

Store below 30 °C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Pantoprazol Davur Composition

• The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).
• The other components (excipients) are: Core: anhydrous disodium phosphate (E-339), mannitol (E-421), microcrystalline cellulose (E-460), sodium croscarmellose, magnesium stearate (E-470b), hypromellose, triethyl citrate, sodium carboxymethyl starch (type A) (potato), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, and yellow iron oxide (E172).

Product Appearance and Packaging Contents

Gastro-resistant tablet, yellow, oval, concave, smooth.

Each package contains 14 or 28 gastro-resistant tablets.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

Anabel Segura 11 Edificio B

28108 Alcobendas (Madrid)

Spain

Manufacturer

Teva Pharma S.L.U.

Polígono Malpica c/ C, 4.

50016 Zaragoza

Spain

Date of the Last Revision of this Leaflet: May 2023

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/