Pantoprazole Davur 40 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pantoprazole Davur 40 mg gastro-resistant tablets EFG

Read this entire leaflet carefully before you start taking this 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 or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not effects listed in this leaflet. See section 4.

Leaflet contents

1. What Pantoprazole Davur is and what it is used for
2. What you need to know before taking Pantoprazole Davur
3. How to take Pantoprazole Davur
4. Possible side effects
5. How to store Pantoprazole Davur
6. Contents of the pack and other information

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

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

Pantoprazole 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.

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

2. What you need to know before taking Pantoprazole Davur

Do not take Pantoprazole Davur

• 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 (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole).

Warnings and precautions

Talk to your doctor or pharmacist before starting pantoprazole

• • If you have severe liver problems. Inform your doctor if you have ever had liver problems. 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 need to take NSAIDs (non-steroidal anti-inflammatory drugs) continuously while taking pantoprazole, as there is an increased risk of developing stomach and intestinal complications. Any increase in risk will be assessed according to personal risk factors such as age (65 years or older), history of stomach or duodenal ulcer, or gastrointestinal bleeding.

• If you have reduced body stores of vitamin B12 or risk factors for this and are receiving pantoprazole treatment for a long period. Like all medicines that reduce acid levels, pantoprazole may reduce the absorption of vitamin B12.

• Consult 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 have been told you are at risk of osteoporosis (e.g., if you are taking corticosteroids).

• 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 stop 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).

• If you take pantoprazole for more than three months, you may experience 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 experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing or pain when swallowing
• Blood in vomit
• Pale appearance and feeling weak (anemia)
• Blood in your stools
• Severe or persistent diarrhoea, as pantoprazole has been associated with a small increased risk of infectious diarrhoea.

Your doctor will decide whether additional tests are needed to rule out malignancy, 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 during each visit.

Taking Pantoprazole Davur with other medicines

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

Pantoprazole Davur may affect the effectiveness of other medicines; therefore, 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 Davur may cause these and other medicines to be less effective.
• Warfarin and phenprocoumon, which affect blood clotting. 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 a high dose of methotrexate, your doctor may need to temporarily stop treatment with pantoprazole.
  • Fluvoxamine (used to treat depression and other psychiatric conditions). 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).

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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or baby.

Driving and use of machines

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Pantoprazole 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 exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Method of administration

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

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

Adults and adolescents aged 12 years and older:

For the treatment of reflux esophagitis:

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

Adults:

For the treatment of infection with a bacterium called Helicobacter pylori in patients with stomach 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 1 hour before breakfast and the second 1 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 recommended dose is one tablet per day. Your doctor may double the dose. Your doctor will inform you 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 per day.

Take both tablets 1 hour before a meal. Afterwards, your doctor may adjust your dose depending on the amount of gastric acid you produce. If you are prescribed more than two tablets per day, you should take the tablets divided into two daily doses.

If you are prescribed more than four tablets per day, you will be informed exactly when to stop 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 severe liver problems, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this case).

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 of age.

If you take more Pantoprazol Davur than you should

Inform your doctor or pharmacist, or call the Toxicology Information Service at 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 missed doses. Take your next dose as usual.

If you stop taking Pantoprazol Davur

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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 immediately and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, facial swelling of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known):

You may notice one or more of the following reactions:

• Skin rash with swelling, blistering, or peeling of the skin and a rapid deterioration in general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips, or genitals, and sensitivity to light.

• 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.

• Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. 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 syndrome).

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

Other side effects include:

• Common: benign gastric polyps.

• Uncommon: headache; dizziness; diarrhoea; 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; fractures of the hip, wrist, and spine.

• Rare: altered or complete loss of taste, visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.

• Very rare: disorientation.

• Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms), skin rash, possibly accompanied by joint pain, tingling, pricking, numbness, burning, or stiffness, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

• Uncommon: increased liver enzymes

• Rare: increased bilirubin; increased blood fat levels; sudden drop in circulating granulocytes (a type of white blood cell).

• Very rare: reduced platelet count, which could lead to bleeding or more bruising than usual; reduced white blood cell count, which could lead to more frequent infections; concurrent abnormal reduction in red blood cells, white blood cells, and platelets.

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

Reporting of side effects:

If you experience any side effect, 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Davur

Keep this medicine out of the 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.

HDPE bottle:

This medicine does not require any special storage conditions.

Aluminum/Aluminum blister:

Store below 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Davur

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as 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) (from potato), methacrylic acid-ethyl acrylate copolymer (1:1), 30% dispersion, and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Yellow, oval, concave, smooth gastro-resistant tablet.

Each pack contains 14 or 28 gastro-resistant tablets.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Building B

28108 Alcobendas (Madrid)

Spain

Manufacturer

Teva Pharma S.L.U.

Malpica Industrial Estate, Street C, 4

50016 Zaragoza

Spain

Date of the most recent revision of this leaflet: February 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/